Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
Standard of Care therapies, Oral Corticosteroids, Inmunosuppressants, Immunomodulators, Systemic Lupus Erythematosus, B cell Activating Factor (BAFF), Inducible T cell costimulator ligand (ICOSL)
Brief summary
The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.
Detailed description
This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including oral corticosteroids (OCS), immunosuppressants and immunomodulators. Previous biologic use is allowed with an adequate washout period.
Interventions
DRUGRozibafusp Alfa
Rozibafusp Alfa will be presented in 5 mL glass vial
DRUGPlacebo for Rozibafusp Alfa
Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including OCS, immunosuppressants, and immunomodulators. Subjects will be randomized to receive placebo or 1 of 3 doses of Rozibafusp Alfa with the last dose at week 50. Treatment will be administered every 2 weeks (Q2W). All subjects will be required to complete a 16-week follow-up period after the 52-week treatment period. The first interim analysis (IA) will be executed after the first 40 enrolled subjects have had the opportunity to complete the week 24 assessment. Additional IAs may be executed after approximately every 32 newly enrolled subjects have had the opportunity to complete the week 24 assessment. The last IA will occur when all subjects have had the opportunity to complete the week 24 assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Screening Visit: * Subject has provided informed consent prior to initiation of any study-specific activities/procedures. * Age ≥ 18 years to ≤ 75 years at screening visit. * Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody ≥ 1:80 by immunofluorescence on Hep-2 cells being present at screening. * Hybrid SLEDAI score ≥ 6 points with a Clinical hSLEDAI score ≥ 4 points. The Clinical hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters. * Additional protocol-specific rules are applied at screening and throughout the study, as follows: * Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring. * Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia ≥ 2. * Oral ulcers: Ulcers location and appearance must be documented by the investigator. * Scleritis and Episcleritis: the presence of stable SLE-related scleritis and episcleritis must be documented by an ophthalmologist and other causes excluded. * Renal: subjects with urine protein/creatinine ratio \< 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI ≥ 4 and did not receive induction treatment for nephritis within the last year. * Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI. * Unless there is a documented intolerance, subjects must be taking: * Only 1 of the following SLE treatments: anti-malarial (hydroxychloroquine, chloroquine, or quinacrine), azathioprine, methotrexate, leflunomide, mycophenolate mofetil/acid mycophenolic, or dapsone. OR • 2 of the above-mentioned SLE treatments in which 1 must be anti-malarial (hydroxychloroquine, chloroquine, or quinacrine). * Treatment should be taken for ≥ 12 weeks prior to screening and must be a stable dose for ≥ 8 weeks prior to screening. * For subjects taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit for ≥ 2 weeks prior to screening visit.
Exclusion criteria
Screening Visit Subjects are excluded from the study if any of the following criteria apply: Disease Related * Urine protein creatinine ratio ≥ 3000 mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit. * Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52 | Week 52 | SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24 | Week 24 | The BICLA response is defined as: 1. An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A) 2. No new BILAG 2004 A domain score and no \> 1 new BILAG 2004 B domain scores compared with baseline 3. No worsening of the hSLEDAI score from baseline 4. No ≥ 0.3-point deterioration from baseline in PGA 5. No use of more than protocol-allowed therapies 6. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants. |
| Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | Week 52 | LLDAS was defined as meeting all the following conditions: 1. hSLEDAI ≤ 4, with no activity in major organ system (renal, central nervous system \[CNS\], cardiopulmonary, vasculitis, fever) and hemolytic anemia or gastrointestinal activity 2. No new lupus disease activity as compared with the previous assessment 3. PGA ≤ 1 (on a scale of 0 to 3) 4. Current prednisone or equivalent dose of ≤ 7.5 mg/day 5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved treatments, as allowed and specified in the protocol. |
| Number of Participants Who Achieved a BICLA Response at Week 52 | Week 52 | The BICLA response is defined as: 1. An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A) 2. No new BILAG 2004 A domain score and no \> 1 new BILAG 2004 B domain scores compared with baseline 3. No worsening of the hSLEDAI score from baseline 4. No ≥ 0.3-point deterioration from baseline in PGA 5. No use of more than protocol-allowed therapies 6. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants. |
| Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose ≥ 10 mg/Day | Up to Week 52 | SRI-4 response is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. Participants also had to meet a reduction if OCS to ≤ 7.5 mg/day by Week 44 sustained through Week 52. |
| Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI) | Up to Week 52 | The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Moderate and severe flare: • Moderate: meeting criteria like SELENA-SLEDAI score change of 3 to 12 points, SLE symptom development, prednisone dose increase, non-steroidal anti-inflammatory drugs (NSAIDs)/hydrochloroquine addition, or PGA score increase by 1 to 2.5. • Severe: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. Annualized flare rate was calculated as the number of flares divided by flare exposure time in days, multiplied by 365.25 for each Group. |
| Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI | Up to Week 52 | The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Severe flare: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group. |
| Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of Worse or New Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ | Up to Week 52 | The BILAG flare index was derived from BILAG 2004, as measured by BILAG score designation of 'worse' or 'new' resulting in a B score in \>= 2 organs or an A score in \>= 1 organ. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group. |
| Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12, 24, 36, and 52 | The tender and swollen joint count is a physical assessment where for each swollen and tender joint a score of 1 is assigned. Scores are then summed up to provide a total score for both swollen and tender joints. Higher total score indicate a severe disease activity and a lower score indicates a lees severe disease activity. |
| Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12, 24, 36, and 52 | The CLASI is an assessment tool consisting of two scores: one for disease activity and one for damage. Activity Score: Ranges from 0 to 70, and is assessed based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia. Higher scores indicate more severe disease activity. Damage Score: Ranges from 0 to 56, and is evaluated through dyspigmentation and scarring, including scarring alopecia. Dyspigmentation that remains visible for more than 12 months is considered permanent, and its score is doubled. Higher scores indicate greater damage. |
| Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 12, 24, 36, 44, and 52 | The PROMIS-Fatigue SF7a is a 7-item instrument that assesses the experience of fatigue as well as its impact on physical, mental and social activities. Each item is scored on a 5-point Likert scale, ranging from 1 (Never) to 5 (Always). The scores of all 7 items are summed up with a total raw score range of 7(low level of fatigue)-35(high level of fatigue). Raw scores are converted to a T-score ranging from 29.4(low level of fatigue)-83.2(high level of fatigue). |
| Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
| Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
| Number of Participants With a SRI-4 Response at Week 24 | Week 24 | SRI-4 response at Week 24 is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. |
| Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
| Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
| Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
| Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 12, 24, 36, 44, and 52 | The PtGA assesses disease activity on a 10 cm numeric rating scale (NRS; 0 to 10 cm). The scale for the assessment ranges from very well (0) to very poor (10). |
| Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
| Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
| Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
| Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
| Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Week 12, 24, 36, 44, and 52 | The LupusQoL questionnaire consists of 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Each item in the questionnaire is scored on a 5 point scale and items within a given domain are summed and converted to a 0-100 scale. Each domain is scored 0-100 with higher scores representing better quality of life in the specific domain. Lower scores signify poorer quality of life within the domain. |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Up to approximately 68 weeks | An adverse event (AE) was any negative medical occurrence linked to an intervention in humans, regardless of its relation to the intervention. Treatment-emergent AEs (TEAEs) were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered. |
| Serum Concentration of Rozibafusp Alfa | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 44, Week 52, Week 56, Week 60, Week 64, and Week 68 | — |
| Terminal Half-life of Rozibafusp Alfa | Up to Week 68 | — |
| Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12, 24, 36, 44, and 52 | The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
Countries
Argentina, Australia, Bulgaria, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Poland, Portugal, Russia, South Korea, Spain, United States
Participant flow
Recruitment details
Participants with active systemic lupus erythematosus (SLE) were recruited across 81 centers in Argentina, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Poland, Portugal, Russia, South Korea, Spain, and the United States from February 2020 to July 2023.
Pre-assignment details
Response adaptive randomization was used to assign eligible participants to receive rozibafusp alfa at 70, 280, and 420 mg administered subcutaneously (SC) every 2 weeks (Q2W), or matching placebo. Randomization started with a 1:1:1:1 ratio and was subsequently adapted according to clinical efficacy.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo for a maximum duration of 52 weeks. | 62 |
| Rozibafusp Alfa 70mg Participants received Rozibafusp Alfa 70mg SC Q2W for a maximum duration of 52 weeks. | 58 |
| Rozibafusp Alfa 280mg Participants received Rozibafusp Alfa 280mg SC Q2W for a maximum duration of 52 weeks. | 36 |
| Rozibafusp Alfa 420mg Participants received Rozibafusp Alfa 420mg SC Q2W for a maximum duration of 52 weeks. | 88 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Decision by Sponsor | 13 | 4 | 1 | 35 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 |
| Overall Study | Withdrawal of Consent from Study | 12 | 8 | 6 | 7 |
Baseline characteristics
| Characteristic | Placebo | Total | Rozibafusp Alfa 420mg | Rozibafusp Alfa 280mg | Rozibafusp Alfa 70mg |
|---|---|---|---|---|---|
| Age, Continuous | 42.6 Years STANDARD_DEVIATION 10.3 | 43.5 Years STANDARD_DEVIATION 10.9 | 44.0 Years STANDARD_DEVIATION 10.5 | 42.2 Years STANDARD_DEVIATION 10.5 | 44.6 Years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 68 Participants | 25 Participants | 5 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 175 Participants | 63 Participants | 31 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 19 Participants | 8 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Black (or African American) | 4 Participants | 17 Participants | 5 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 53 Participants | 201 Participants | 71 Participants | 30 Participants | 47 Participants |
| Sex: Female, Male Female | 57 Participants | 228 Participants | 82 Participants | 33 Participants | 56 Participants |
| Sex: Female, Male Male | 5 Participants | 16 Participants | 6 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 1 / 58 | 0 / 36 | 0 / 88 |
| other Total, other adverse events | 29 / 62 | 34 / 58 | 20 / 36 | 51 / 87 |
| serious Total, serious adverse events | 6 / 62 | 7 / 58 | 5 / 36 | 3 / 87 |
Outcome results
Primary
Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52
SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies.
Time frame: Week 52
Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52 | 26 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52 | 29 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52 | 21 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52 | 35 Participants |
Secondary
Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of Worse or New Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ
The BILAG flare index was derived from BILAG 2004, as measured by BILAG score designation of 'worse' or 'new' resulting in a B score in \>= 2 organs or an A score in \>= 1 organ. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group.
Time frame: Up to Week 52
Population: The FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of Worse or New Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ | 0.13 Flares/year |
| Rozibafusp Alfa 70mg | Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of Worse or New Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ | 0.22 Flares/year |
| Rozibafusp Alfa 280mg | Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of Worse or New Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ | 0.30 Flares/year |
| Rozibafusp Alfa 420mg | Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of Worse or New Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ | 0.31 Flares/year |
Secondary
Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI)
The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Moderate and severe flare: • Moderate: meeting criteria like SELENA-SLEDAI score change of 3 to 12 points, SLE symptom development, prednisone dose increase, non-steroidal anti-inflammatory drugs (NSAIDs)/hydrochloroquine addition, or PGA score increase by 1 to 2.5. • Severe: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. Annualized flare rate was calculated as the number of flares divided by flare exposure time in days, multiplied by 365.25 for each Group.
Time frame: Up to Week 52
Population: The FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI) | 0.34 Flares/year |
| Rozibafusp Alfa 70mg | Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI) | 0.52 Flares/year |
| Rozibafusp Alfa 280mg | Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI) | 0.46 Flares/year |
| Rozibafusp Alfa 420mg | Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI) | 0.34 Flares/year |
Secondary
Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI
The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Severe flare: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group.
Time frame: Up to Week 52
Population: The FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI | 0.21 Flares/year |
| Rozibafusp Alfa 70mg | Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI | 0.24 Flares/year |
| Rozibafusp Alfa 280mg | Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI | 0.30 Flares/year |
| Rozibafusp Alfa 420mg | Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI | 0.16 Flares/year |
Secondary
Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52
The LupusQoL questionnaire consists of 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Each item in the questionnaire is scored on a 5 point scale and items within a given domain are summed and converted to a 0-100 scale. Each domain is scored 0-100 with higher scores representing better quality of life in the specific domain. Lower scores signify poorer quality of life within the domain.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 24 | 10.185 Score on a scale | Standard Deviation 23.763 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 12 | 7.435 Score on a scale | Standard Deviation 23.94 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 36 | 12.729 Score on a scale | Standard Deviation 21.678 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 52 | 13.710 Score on a scale | Standard Deviation 27.348 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 44 | 14.120 Score on a scale | Standard Deviation 28.159 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 24 | 2.59 Score on a scale | Standard Deviation 24.86 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 12 | 9.498 Score on a scale | Standard Deviation 22.989 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week36 | 16.260 Score on a scale | Standard Deviation 27.32 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 24 | 10.556 Score on a scale | Standard Deviation 30.896 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 36 | 4.63 Score on a scale | Standard Deviation 26.66 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 12 | 10.294 Score on a scale | Standard Deviation 23.368 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 12 | 12.092 Score on a scale | Standard Deviation 22.068 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 52 | 11.90 Score on a scale | Standard Deviation 27.8 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 44 | 5.00 Score on a scale | Standard Deviation 31.46 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 52 | 12.500 Score on a scale | Standard Deviation 22.765 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 44 | 11.892 Score on a scale | Standard Deviation 25.253 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 44 | 11.3 Score on a scale | Standard Deviation 27.3 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 44 | 10.764 Score on a scale | Standard Deviation 17.205 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 36 | 9.909 Score on a scale | Standard Deviation 19.664 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 52 | 18.448 Score on a scale | Standard Deviation 22.827 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 52 | 16.129 Score on a scale | Standard Deviation 19.357 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 24 | 9.861 Score on a scale | Standard Deviation 23.175 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 12 | 10.049 Score on a scale | Standard Deviation 21.253 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 12 | 14.869 Score on a scale | Standard Deviation 27.199 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 44 | 9.491 Score on a scale | Standard Deviation 26.959 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 52 | 8.9 Score on a scale | Standard Deviation 20.2 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 36 | 4.4 Score on a scale | Standard Deviation 25 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 24 | 16.296 Score on a scale | Standard Deviation 29.46 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 24 | 12.986 Score on a scale | Standard Deviation 24.461 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 24 | 5.9 Score on a scale | Standard Deviation 26.2 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 12 | 9.2 Score on a scale | Standard Deviation 24.4 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 36 | 14.837 Score on a scale | Standard Deviation 26.972 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 12 | 6.76 Score on a scale | Standard Deviation 26.94 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 52 | 7.258 Score on a scale | Standard Deviation 23.545 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 44 | 6.134 Score on a scale | Standard Deviation 23.369 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 44 | 14.815 Score on a scale | Standard Deviation 31.755 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 36 | 11.179 Score on a scale | Standard Deviation 21.214 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 36 | 5.589 Score on a scale | Standard Deviation 19.557 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 24 | 8.056 Score on a scale | Standard Deviation 22.322 |
| Placebo | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 52 | 25.538 Score on a scale | Standard Deviation 23.367 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 52 | 14.352 Score on a scale | Standard Deviation 24.929 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 12 | 12.160 Score on a scale | Standard Deviation 15.607 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 24 | 14.097 Score on a scale | Standard Deviation 21.972 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 36 | 14.375 Score on a scale | Standard Deviation 22.61 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 44 | 16.753 Score on a scale | Standard Deviation 22.124 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 52 | 13.976 Score on a scale | Standard Deviation 19.799 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 12 | 14.493 Score on a scale | Standard Deviation 22.8 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 24 | 13.148 Score on a scale | Standard Deviation 22.647 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 36 | 13.125 Score on a scale | Standard Deviation 19.327 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 44 | 16.667 Score on a scale | Standard Deviation 23.905 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 52 | 8.565 Score on a scale | Standard Deviation 23.527 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 12 | 3.52 Score on a scale | Standard Deviation 24.64 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 24 | 5.47 Score on a scale | Standard Deviation 28.74 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 36 | 9.26 Score on a scale | Standard Deviation 27.21 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 44 | 8.00 Score on a scale | Standard Deviation 23.9 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 52 | 3.26 Score on a scale | Standard Deviation 23.3 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 12 | 5.072 Score on a scale | Standard Deviation 20.373 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 24 | 9.444 Score on a scale | Standard Deviation 27.328 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week36 | 11.042 Score on a scale | Standard Deviation 22.754 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 44 | 14.352 Score on a scale | Standard Deviation 23.955 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 52 | 8.333 Score on a scale | Standard Deviation 25.973 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 12 | 4.529 Score on a scale | Standard Deviation 15.611 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 24 | 7.963 Score on a scale | Standard Deviation 19.337 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 36 | 3.958 Score on a scale | Standard Deviation 16.15 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 44 | 9.722 Score on a scale | Standard Deviation 15.685 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 52 | 6.134 Score on a scale | Standard Deviation 19.606 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 12 | 3.7 Score on a scale | Standard Deviation 23.9 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 24 | -0.1 Score on a scale | Standard Deviation 24.9 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 36 | 3.8 Score on a scale | Standard Deviation 24.3 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 52 | -5.0 Score on a scale | Standard Deviation 26.7 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 12 | 8.424 Score on a scale | Standard Deviation 19.509 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 24 | 10.972 Score on a scale | Standard Deviation 20.127 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 36 | 9.219 Score on a scale | Standard Deviation 20.363 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 44 | 12.153 Score on a scale | Standard Deviation 18.717 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 52 | 9.722 Score on a scale | Standard Deviation 20.291 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 12 | 11.594 Score on a scale | Standard Deviation 21.551 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 24 | 6.667 Score on a scale | Standard Deviation 29.226 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 36 | 9.583 Score on a scale | Standard Deviation 23.232 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 44 | 13.426 Score on a scale | Standard Deviation 20.919 |
| Rozibafusp Alfa 70mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 44 | 4.6 Score on a scale | Standard Deviation 26.4 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 36 | 6.173 Score on a scale | Standard Deviation 20.359 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 12 | 6.250 Score on a scale | Standard Deviation 20.88 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 12 | 6.250 Score on a scale | Standard Deviation 21.997 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 52 | 8.449 Score on a scale | Standard Deviation 20.156 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 12 | 13.1 Score on a scale | Standard Deviation 31.7 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 24 | 6.458 Score on a scale | Standard Deviation 17.79 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 24 | 7.778 Score on a scale | Standard Deviation 16.109 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 24 | 15.556 Score on a scale | Standard Deviation 23.947 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 52 | 9.568 Score on a scale | Standard Deviation 24.428 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 36 | 7.407 Score on a scale | Standard Deviation 17.076 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 24 | 11.667 Score on a scale | Standard Deviation 18.856 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 44 | 11.049 Score on a scale | Standard Deviation 15.625 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 44 | 9.821 Score on a scale | Standard Deviation 19.779 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 44 | 9.821 Score on a scale | Standard Deviation 16.876 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 24 | 0.2 Score on a scale | Standard Deviation 29.7 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 44 | -3.95 Score on a scale | Standard Deviation 21.67 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 52 | 14.815 Score on a scale | Standard Deviation 28.898 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 44 | 7.292 Score on a scale | Standard Deviation 15.533 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 44 | 11.905 Score on a scale | Standard Deviation 21.328 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 52 | -1.47 Score on a scale | Standard Deviation 18.69 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 36 | 4.8 Score on a scale | Standard Deviation 27.7 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 36 | -2.63 Score on a scale | Standard Deviation 20.66 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 36 | 15.123 Score on a scale | Standard Deviation 23.912 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 12 | 13.281 Score on a scale | Standard Deviation 30.59 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 44 | 12.7 Score on a scale | Standard Deviation 32 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 24 | 9.722 Score on a scale | Standard Deviation 24.279 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 52 | 9.954 Score on a scale | Standard Deviation 18.036 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 24 | 15.000 Score on a scale | Standard Deviation 25.931 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 12 | 12.240 Score on a scale | Standard Deviation 26.939 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 24 | 0.69 Score on a scale | Standard Deviation 20.77 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 36 | 13.272 Score on a scale | Standard Deviation 21.836 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week36 | 18.827 Score on a scale | Standard Deviation 28.457 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 52 | 7.0 Score on a scale | Standard Deviation 31.3 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 52 | 8.951 Score on a scale | Standard Deviation 20.888 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 36 | 13.542 Score on a scale | Standard Deviation 17.313 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 44 | 15.476 Score on a scale | Standard Deviation 26.324 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 12 | 5.469 Score on a scale | Standard Deviation 23.817 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 12 | 0.60 Score on a scale | Standard Deviation 30.99 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 12 | 8.398 Score on a scale | Standard Deviation 20.992 |
| Rozibafusp Alfa 280mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 52 | 15.741 Score on a scale | Standard Deviation 30.865 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 36 | 15.057 Score on a scale | Standard Deviation 28.22 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 12 | 9.142 Score on a scale | Standard Deviation 19.493 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 44 | 17.824 Score on a scale | Standard Deviation 24.893 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 12 | 12.438 Score on a scale | Standard Deviation 22.631 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 24 | 13.083 Score on a scale | Standard Deviation 22.096 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 24 | 11.063 Score on a scale | Standard Deviation 16.551 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 36 | 13.920 Score on a scale | Standard Deviation 25.903 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 36 | 18.939 Score on a scale | Standard Deviation 27.159 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 52 | 19.524 Score on a scale | Standard Deviation 23.565 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 44 | 13.194 Score on a scale | Standard Deviation 23.853 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Emotional Health: Week 52 | 14.167 Score on a scale | Standard Deviation 21.561 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 24 | 17.667 Score on a scale | Standard Deviation 20.8 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 24 | 9.500 Score on a scale | Standard Deviation 23.988 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 12 | 10.1 Score on a scale | Standard Deviation 23.9 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 24 | 14.9 Score on a scale | Standard Deviation 26.4 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Pain: Week 12 | 14.552 Score on a scale | Standard Deviation 22.349 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 52 | 12.381 Score on a scale | Standard Deviation 22.81 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 36 | 11.1 Score on a scale | Standard Deviation 29.2 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 44 | 10.4 Score on a scale | Standard Deviation 20.2 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Body Image: Week 52 | 9.6 Score on a scale | Standard Deviation 24 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 52 | 14.107 Score on a scale | Standard Deviation 18.847 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 36 | 14.773 Score on a scale | Standard Deviation 29.414 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 12 | 10.541 Score on a scale | Standard Deviation 22.488 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 12 | 9.748 Score on a scale | Standard Deviation 16.541 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 24 | 10.625 Score on a scale | Standard Deviation 23.257 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 44 | 12.760 Score on a scale | Standard Deviation 17.008 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 52 | 17.143 Score on a scale | Standard Deviation 29.632 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 44 | 12.500 Score on a scale | Standard Deviation 22.952 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 44 | 9.13 Score on a scale | Standard Deviation 31.54 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 36 | 5.17 Score on a scale | Standard Deviation 23.27 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Physical Health: Week 36 | 13.991 Score on a scale | Standard Deviation 21.264 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 52 | 4.17 Score on a scale | Standard Deviation 19.61 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Planning: Week 44 | 12.037 Score on a scale | Standard Deviation 27.418 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 12 | 9.577 Score on a scale | Standard Deviation 27.762 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 24 | 6.25 Score on a scale | Standard Deviation 23.08 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 24 | 11.500 Score on a scale | Standard Deviation 27.914 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Fatigue: Week 52 | 9.464 Score on a scale | Standard Deviation 21.404 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week36 | 13.447 Score on a scale | Standard Deviation 29.268 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Intimate Relationship: Week 12 | 4.75 Score on a scale | Standard Deviation 20.81 |
| Rozibafusp Alfa 420mg | Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52 | Burden to Others: Week 44 | 13.194 Score on a scale | Standard Deviation 26.902 |
Secondary
Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52
The PtGA assesses disease activity on a 10 cm numeric rating scale (NRS; 0 to 10 cm). The scale for the assessment ranges from very well (0) to very poor (10).
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 44 | -2.1 Score on a scale | Standard Deviation 3 |
| Placebo | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 24 | -1.9 Score on a scale | Standard Deviation 2.6 |
| Placebo | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 52 | -2.3 Score on a scale | Standard Deviation 2.7 |
| Placebo | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 36 | -2.0 Score on a scale | Standard Deviation 2.6 |
| Placebo | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 12 | -0.9 Score on a scale | Standard Deviation 2.8 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 36 | -1.7 Score on a scale | Standard Deviation 2.5 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 44 | -2.1 Score on a scale | Standard Deviation 2.8 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 52 | -1.8 Score on a scale | Standard Deviation 2.5 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 24 | -1.2 Score on a scale | Standard Deviation 2.7 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 12 | -1.1 Score on a scale | Standard Deviation 1.9 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 36 | -1.6 Score on a scale | Standard Deviation 2.3 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 12 | -1.8 Score on a scale | Standard Deviation 3 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 24 | -1.7 Score on a scale | Standard Deviation 2.7 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 44 | -2.0 Score on a scale | Standard Deviation 2.8 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 52 | -2.6 Score on a scale | Standard Deviation 2.5 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 44 | -2.6 Score on a scale | Standard Deviation 2.3 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 24 | -2.2 Score on a scale | Standard Deviation 2.1 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 12 | -1.7 Score on a scale | Standard Deviation 2.2 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 36 | -2.6 Score on a scale | Standard Deviation 2.6 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52 | Week 52 | -2.1 Score on a scale | Standard Deviation 2.8 |
Secondary
Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52
The PROMIS-Fatigue SF7a is a 7-item instrument that assesses the experience of fatigue as well as its impact on physical, mental and social activities. Each item is scored on a 5-point Likert scale, ranging from 1 (Never) to 5 (Always). The scores of all 7 items are summed up with a total raw score range of 7(low level of fatigue)-35(high level of fatigue). Raw scores are converted to a T-score ranging from 29.4(low level of fatigue)-83.2(high level of fatigue).
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 44 | -4.44 T-score | Standard Deviation 7.94 |
| Placebo | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 24 | -6.48 T-score | Standard Deviation 11.97 |
| Placebo | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 52 | -8.57 T-score | Standard Deviation 8.36 |
| Placebo | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 36 | -7.26 T-score | Standard Deviation 8.26 |
| Placebo | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 12 | -8.40 T-score | Standard Deviation 9.61 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 36 | -7.12 T-score | Standard Deviation 8 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 44 | -8.65 T-score | Standard Deviation 9.75 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 52 | -10.22 T-score | Standard Deviation 8.89 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 24 | -5.61 T-score | Standard Deviation 8.54 |
| Rozibafusp Alfa 70mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 12 | -6.89 T-score | Standard Deviation 5.71 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 36 | -3.26 T-score | Standard Deviation 7.64 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 12 | -4.22 T-score | Standard Deviation 8.45 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 24 | -5.86 T-score | Standard Deviation 7.76 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 44 | -4.47 T-score | Standard Deviation 7.23 |
| Rozibafusp Alfa 280mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 52 | -6.57 T-score | Standard Deviation 7.25 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 44 | -8.25 T-score | Standard Deviation 10.38 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 24 | -8.82 T-score | Standard Deviation 6.02 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 12 | -8.01 T-score | Standard Deviation 7.6 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 36 | -8.73 T-score | Standard Deviation 8.98 |
| Rozibafusp Alfa 420mg | Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52 | Week 52 | -7.88 T-score | Standard Deviation 11.88 |
Secondary
Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 18.9 Score on a scale | Standard Deviation 23.9 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 17.5 Score on a scale | Standard Deviation 26.7 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 19.8 Score on a scale | Standard Deviation 22.5 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 18.7 Score on a scale | Standard Deviation 23.2 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 15.5 Score on a scale | Standard Deviation 25.7 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 15.9 Score on a scale | Standard Deviation 27.9 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 19.2 Score on a scale | Standard Deviation 31.9 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 16.7 Score on a scale | Standard Deviation 28.4 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 14.4 Score on a scale | Standard Deviation 27.6 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 12.0 Score on a scale | Standard Deviation 23.1 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 14.1 Score on a scale | Standard Deviation 24 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 10.9 Score on a scale | Standard Deviation 21.5 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 13.5 Score on a scale | Standard Deviation 24.6 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 10.7 Score on a scale | Standard Deviation 20.5 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 16.6 Score on a scale | Standard Deviation 23 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 26.0 Score on a scale | Standard Deviation 29.4 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 18.3 Score on a scale | Standard Deviation 19.4 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 18.4 Score on a scale | Standard Deviation 19.5 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 22.1 Score on a scale | Standard Deviation 26.3 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 21.8 Score on a scale | Standard Deviation 25.2 |
Secondary
Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 20.139 Score on a scale | Standard Deviation 32.512 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 13.888 Score on a scale | Standard Deviation 27.352 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 18.011 Score on a scale | Standard Deviation 30.814 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 15.208 Score on a scale | Standard Deviation 24.306 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 13.888 Score on a scale | Standard Deviation 26.961 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 4.058 Score on a scale | Standard Deviation 21.364 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 8.564 Score on a scale | Standard Deviation 21.314 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 10.647 Score on a scale | Standard Deviation 25.008 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 5.072 Score on a scale | Standard Deviation 23.339 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 5.141 Score on a scale | Standard Deviation 26.384 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 6.250 Score on a scale | Standard Deviation 29.886 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 2.083 Score on a scale | Standard Deviation 27.189 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 11.111 Score on a scale | Standard Deviation 20.8 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 7.441 Score on a scale | Standard Deviation 25.493 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 6.481 Score on a scale | Standard Deviation 28.62 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 16.899 Score on a scale | Standard Deviation 30.045 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 15.334 Score on a scale | Standard Deviation 28.54 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 12.935 Score on a scale | Standard Deviation 27.382 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 14.773 Score on a scale | Standard Deviation 29.742 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 19.762 Score on a scale | Standard Deviation 23.491 |
Secondary
Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 7.61 Score on a scale | Standard Deviation 19.32 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 7.44 Score on a scale | Standard Deviation 15.97 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 9.55 Score on a scale | Standard Deviation 21.62 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 10.35 Score on a scale | Standard Deviation 16.43 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 5.90 Score on a scale | Standard Deviation 14.71 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 10.15 Score on a scale | Standard Deviation 16.97 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 11.81 Score on a scale | Standard Deviation 18.99 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 12.54 Score on a scale | Standard Deviation 18.23 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 6.98 Score on a scale | Standard Deviation 16.11 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 5.85 Score on a scale | Standard Deviation 16.06 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 5.96 Score on a scale | Standard Deviation 16.28 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 4.69 Score on a scale | Standard Deviation 14.87 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 9.13 Score on a scale | Standard Deviation 14.83 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 3.11 Score on a scale | Standard Deviation 16.92 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 5.81 Score on a scale | Standard Deviation 19.6 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 11.76 Score on a scale | Standard Deviation 16.74 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 11.75 Score on a scale | Standard Deviation 14.11 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 9.97 Score on a scale | Standard Deviation 14.15 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 11.40 Score on a scale | Standard Deviation 17.81 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 9.58 Score on a scale | Standard Deviation 18.22 |
Secondary
Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 6.556 Score on a scale | Standard Deviation 12.984 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 4.889 Score on a scale | Standard Deviation 10.772 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 6.675 Score on a scale | Standard Deviation 12.074 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 5.002 Score on a scale | Standard Deviation 9.405 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 5.433 Score on a scale | Standard Deviation 10.477 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 1.407 Score on a scale | Standard Deviation 10.943 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 3.208 Score on a scale | Standard Deviation 9.125 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 3.778 Score on a scale | Standard Deviation 9.91 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 1.123 Score on a scale | Standard Deviation 7.767 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 1.941 Score on a scale | Standard Deviation 8.689 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 2.111 Score on a scale | Standard Deviation 11.263 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 2.235 Score on a scale | Standard Deviation 11.754 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 5.008 Score on a scale | Standard Deviation 8.063 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 1.914 Score on a scale | Standard Deviation 9.247 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 2.613 Score on a scale | Standard Deviation 10.841 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 5.903 Score on a scale | Standard Deviation 10.847 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 5.786 Score on a scale | Standard Deviation 9.278 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 4.965 Score on a scale | Standard Deviation 9.413 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 6.531 Score on a scale | Standard Deviation 10.543 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 7.186 Score on a scale | Standard Deviation 9.185 |
Secondary
Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 11.8 Score on a scale | Standard Deviation 24.3 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 10.1 Score on a scale | Standard Deviation 22.7 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 12.3 Score on a scale | Standard Deviation 21.4 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 10.0 Score on a scale | Standard Deviation 18.7 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 10.7 Score on a scale | Standard Deviation 21.5 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 5.5 Score on a scale | Standard Deviation 21.8 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 10.3 Score on a scale | Standard Deviation 16 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 9.0 Score on a scale | Standard Deviation 19 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 2.7 Score on a scale | Standard Deviation 15.3 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 4.3 Score on a scale | Standard Deviation 16.2 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 3.0 Score on a scale | Standard Deviation 20.2 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 6.4 Score on a scale | Standard Deviation 21 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 9.2 Score on a scale | Standard Deviation 15.1 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 3.0 Score on a scale | Standard Deviation 16.1 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 4.6 Score on a scale | Standard Deviation 17.4 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 12.5 Score on a scale | Standard Deviation 20.1 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 10.6 Score on a scale | Standard Deviation 18 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 8.9 Score on a scale | Standard Deviation 17.1 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 13.1 Score on a scale | Standard Deviation 19.3 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 13.9 Score on a scale | Standard Deviation 18.3 |
Secondary
Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 15.001 Score on a scale | Standard Deviation 24.582 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 15.777 Score on a scale | Standard Deviation 23.93 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 20.807 Score on a scale | Standard Deviation 21.138 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 17.752 Score on a scale | Standard Deviation 22.417 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 14.019 Score on a scale | Standard Deviation 25.397 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 15.640 Score on a scale | Standard Deviation 21.031 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 17.222 Score on a scale | Standard Deviation 24.007 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 15.416 Score on a scale | Standard Deviation 23.002 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 13.043 Score on a scale | Standard Deviation 22.961 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 11.383 Score on a scale | Standard Deviation 21.076 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 11.608 Score on a scale | Standard Deviation 23.533 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 10.000 Score on a scale | Standard Deviation 22.966 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 13.000 Score on a scale | Standard Deviation 24.657 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 8.036 Score on a scale | Standard Deviation 19.924 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 12.778 Score on a scale | Standard Deviation 22.632 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 17.200 Score on a scale | Standard Deviation 20.702 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 14.048 Score on a scale | Standard Deviation 21.031 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 12.595 Score on a scale | Standard Deviation 18.765 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 16.142 Score on a scale | Standard Deviation 21.924 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 16.568 Score on a scale | Standard Deviation 18.357 |
Secondary
Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 16.319 Score on a scale | Standard Deviation 28.554 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 20.278 Score on a scale | Standard Deviation 28.24 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 23.387 Score on a scale | Standard Deviation 22.475 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 19.219 Score on a scale | Standard Deviation 24.16 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 15.074 Score on a scale | Standard Deviation 25.378 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 12.660 Score on a scale | Standard Deviation 29.991 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 18.924 Score on a scale | Standard Deviation 28.169 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 17.708 Score on a scale | Standard Deviation 27.73 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 10.190 Score on a scale | Standard Deviation 28.788 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 7.979 Score on a scale | Standard Deviation 24.09 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 13.839 Score on a scale | Standard Deviation 23.653 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 9.961 Score on a scale | Standard Deviation 21.701 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 11.667 Score on a scale | Standard Deviation 19.609 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 10.714 Score on a scale | Standard Deviation 22.876 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 9.028 Score on a scale | Standard Deviation 23.852 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 20.313 Score on a scale | Standard Deviation 32.915 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 16.625 Score on a scale | Standard Deviation 27.217 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 13.713 Score on a scale | Standard Deviation 22.957 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 19.886 Score on a scale | Standard Deviation 30.863 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 14.464 Score on a scale | Standard Deviation 31.933 |
Secondary
Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 17.71 Score on a scale | Standard Deviation 27.61 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 15.28 Score on a scale | Standard Deviation 26.23 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 23.79 Score on a scale | Standard Deviation 25.07 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 15.63 Score on a scale | Standard Deviation 25.28 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 14.46 Score on a scale | Standard Deviation 22.83 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 7.05 Score on a scale | Standard Deviation 25.78 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 8.68 Score on a scale | Standard Deviation 27.52 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 10.42 Score on a scale | Standard Deviation 26.98 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 7.88 Score on a scale | Standard Deviation 25.05 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 8.24 Score on a scale | Standard Deviation 20.4 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 14.29 Score on a scale | Standard Deviation 23 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 9.77 Score on a scale | Standard Deviation 24.54 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 14.58 Score on a scale | Standard Deviation 19.72 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 7.14 Score on a scale | Standard Deviation 22.16 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 13.89 Score on a scale | Standard Deviation 23.34 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 14.24 Score on a scale | Standard Deviation 23.75 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 15.25 Score on a scale | Standard Deviation 21.32 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 15.11 Score on a scale | Standard Deviation 23.89 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 19.60 Score on a scale | Standard Deviation 23.72 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 17.50 Score on a scale | Standard Deviation 21.9 |
Secondary
Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 7.465 Score on a scale | Standard Deviation 24.313 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 10.556 Score on a scale | Standard Deviation 24.419 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 12.903 Score on a scale | Standard Deviation 23.659 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 11.094 Score on a scale | Standard Deviation 20.09 |
| Placebo | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 10.662 Score on a scale | Standard Deviation 22.441 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 10.256 Score on a scale | Standard Deviation 19.102 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 11.632 Score on a scale | Standard Deviation 19.489 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 11.806 Score on a scale | Standard Deviation 20.199 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 7.880 Score on a scale | Standard Deviation 15.78 |
| Rozibafusp Alfa 70mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 8.112 Score on a scale | Standard Deviation 18.054 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 8.036 Score on a scale | Standard Deviation 18.854 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 8.594 Score on a scale | Standard Deviation 21.402 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 12.083 Score on a scale | Standard Deviation 18.346 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 5.804 Score on a scale | Standard Deviation 19.089 |
| Rozibafusp Alfa 280mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 8.796 Score on a scale | Standard Deviation 21.249 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 15.104 Score on a scale | Standard Deviation 21.67 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 13.125 Score on a scale | Standard Deviation 18.482 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 11.287 Score on a scale | Standard Deviation 20.361 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 15.199 Score on a scale | Standard Deviation 22.083 |
| Rozibafusp Alfa 420mg | Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 11.250 Score on a scale | Standard Deviation 21.693 |
Secondary
Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52
The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Week 12, 24, 36, 44, and 52
Population: The FAS included all randomized participants. Only participants with observed data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 4.881 Score on a scale | Standard Deviation 9.2 |
| Placebo | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 6.055 Score on a scale | Standard Deviation 8.043 |
| Placebo | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 7.235 Score on a scale | Standard Deviation 7.097 |
| Placebo | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 6.652 Score on a scale | Standard Deviation 7.957 |
| Placebo | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 4.612 Score on a scale | Standard Deviation 8.241 |
| Rozibafusp Alfa 70mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 6.536 Score on a scale | Standard Deviation 9.646 |
| Rozibafusp Alfa 70mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 7.298 Score on a scale | Standard Deviation 9.903 |
| Rozibafusp Alfa 70mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 6.598 Score on a scale | Standard Deviation 9.452 |
| Rozibafusp Alfa 70mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 5.440 Score on a scale | Standard Deviation 8.807 |
| Rozibafusp Alfa 70mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 4.261 Score on a scale | Standard Deviation 7.609 |
| Rozibafusp Alfa 280mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 5.360 Score on a scale | Standard Deviation 8.736 |
| Rozibafusp Alfa 280mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 4.013 Score on a scale | Standard Deviation 8.456 |
| Rozibafusp Alfa 280mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 4.570 Score on a scale | Standard Deviation 8.994 |
| Rozibafusp Alfa 280mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 3.508 Score on a scale | Standard Deviation 7.538 |
| Rozibafusp Alfa 280mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 5.056 Score on a scale | Standard Deviation 9.429 |
| Rozibafusp Alfa 420mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 44 | 7.522 Score on a scale | Standard Deviation 9.735 |
| Rozibafusp Alfa 420mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 24 | 5.847 Score on a scale | Standard Deviation 6.971 |
| Rozibafusp Alfa 420mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 12 | 5.409 Score on a scale | Standard Deviation 6.207 |
| Rozibafusp Alfa 420mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 36 | 6.833 Score on a scale | Standard Deviation 9.467 |
| Rozibafusp Alfa 420mg | Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52 | Week 52 | 5.456 Score on a scale | Standard Deviation 9.151 |
Secondary
Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose ≥ 10 mg/Day
SRI-4 response is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. Participants also had to meet a reduction if OCS to ≤ 7.5 mg/day by Week 44 sustained through Week 52.
Time frame: Up to Week 52
Population: The FAS included all randomized participants. Only participants who had a baseline OCS dose ≥ 10 mg/day and had the opportunity to complete Week 52 visit by the date of the study termination were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose ≥ 10 mg/Day | 5 Participants |
| Rozibafusp Alfa 70mg | Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose ≥ 10 mg/Day | 1 Participants |
| Rozibafusp Alfa 280mg | Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose ≥ 10 mg/Day | 2 Participants |
| Rozibafusp Alfa 420mg | Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose ≥ 10 mg/Day | 8 Participants |
Secondary
Number of Participants Who Achieved a BICLA Response at Week 52
The BICLA response is defined as: 1. An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A) 2. No new BILAG 2004 A domain score and no \> 1 new BILAG 2004 B domain scores compared with baseline 3. No worsening of the hSLEDAI score from baseline 4. No ≥ 0.3-point deterioration from baseline in PGA 5. No use of more than protocol-allowed therapies 6. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants.
Time frame: Week 52
Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Achieved a BICLA Response at Week 52 | 21 Participants |
| Rozibafusp Alfa 70mg | Number of Participants Who Achieved a BICLA Response at Week 52 | 20 Participants |
| Rozibafusp Alfa 280mg | Number of Participants Who Achieved a BICLA Response at Week 52 | 15 Participants |
| Rozibafusp Alfa 420mg | Number of Participants Who Achieved a BICLA Response at Week 52 | 29 Participants |
Secondary
Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24
The BICLA response is defined as: 1. An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A) 2. No new BILAG 2004 A domain score and no \> 1 new BILAG 2004 B domain scores compared with baseline 3. No worsening of the hSLEDAI score from baseline 4. No ≥ 0.3-point deterioration from baseline in PGA 5. No use of more than protocol-allowed therapies 6. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants.
Time frame: Week 24
Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24 | 24 Participants |
| Rozibafusp Alfa 70mg | Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24 | 19 Participants |
| Rozibafusp Alfa 280mg | Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24 | 18 Participants |
| Rozibafusp Alfa 420mg | Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24 | 35 Participants |
Secondary
Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52
LLDAS was defined as meeting all the following conditions: 1. hSLEDAI ≤ 4, with no activity in major organ system (renal, central nervous system \[CNS\], cardiopulmonary, vasculitis, fever) and hemolytic anemia or gastrointestinal activity 2. No new lupus disease activity as compared with the previous assessment 3. PGA ≤ 1 (on a scale of 0 to 3) 4. Current prednisone or equivalent dose of ≤ 7.5 mg/day 5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved treatments, as allowed and specified in the protocol.
Time frame: Week 52
Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | 12 Participants |
| Rozibafusp Alfa 70mg | Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | 18 Participants |
| Rozibafusp Alfa 280mg | Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | 6 Participants |
| Rozibafusp Alfa 420mg | Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52 | 21 Participants |
Secondary
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any negative medical occurrence linked to an intervention in humans, regardless of its relation to the intervention. Treatment-emergent AEs (TEAEs) were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered.
Time frame: Up to approximately 68 weeks
Population: The Safety Analysis Set (SAS) included all randomized participants who received at least 1 dose of investigational product (IP).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 42 Participants |
| Placebo | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs | 6 Participants |
| Placebo | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Fatal AEs | 0 Participants |
| Rozibafusp Alfa 70mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 47 Participants |
| Rozibafusp Alfa 70mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs | 7 Participants |
| Rozibafusp Alfa 70mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Fatal AEs | 0 Participants |
| Rozibafusp Alfa 280mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Fatal AEs | 0 Participants |
| Rozibafusp Alfa 280mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 23 Participants |
| Rozibafusp Alfa 280mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs | 5 Participants |
| Rozibafusp Alfa 420mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | All TEAEs | 71 Participants |
| Rozibafusp Alfa 420mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs | 3 Participants |
| Rozibafusp Alfa 420mg | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Fatal AEs | 0 Participants |
Secondary
Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52
The tender and swollen joint count is a physical assessment where for each swollen and tender joint a score of 1 is assigned. Scores are then summed up to provide a total score for both swollen and tender joints. Higher total score indicate a severe disease activity and a lower score indicates a lees severe disease activity.
Time frame: Week 12, 24, 36, and 52
Population: The FAS included all randomized participants. Only participants who had ≥ 6 tender and swollen joints involving hands and wrists at baseline and had opportunity to complete the visit by the date of the study termination were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12 | 20 Participants |
| Placebo | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 24 | 23 Participants |
| Placebo | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 36 | 26 Participants |
| Placebo | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 52 | 19 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 24 | 23 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 36 | 22 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 52 | 20 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12 | 16 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 36 | 10 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 24 | 7 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 52 | 9 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12 | 8 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 52 | 27 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 24 | 34 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12 | 31 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 36 | 29 Participants |
Secondary
Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52
The CLASI is an assessment tool consisting of two scores: one for disease activity and one for damage. Activity Score: Ranges from 0 to 70, and is assessed based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia. Higher scores indicate more severe disease activity. Damage Score: Ranges from 0 to 56, and is evaluated through dyspigmentation and scarring, including scarring alopecia. Dyspigmentation that remains visible for more than 12 months is considered permanent, and its score is doubled. Higher scores indicate greater damage.
Time frame: Week 12, 24, 36, and 52
Population: The FAS included all randomized participants. Only participants who had CLASI activity score ≥ 8 at baseline and had the opportunity to complete the visit by the date of the study termination were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12 | 3 Participants |
| Placebo | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 24 | 3 Participants |
| Placebo | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 36 | 1 Participants |
| Placebo | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 52 | 0 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 24 | 3 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 36 | 5 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 52 | 4 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12 | 2 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 36 | 7 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 24 | 6 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 52 | 7 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12 | 5 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 52 | 3 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 24 | 3 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 12 | 4 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52 | Week 36 | 2 Participants |
Secondary
Number of Participants With a SRI-4 Response at Week 24
SRI-4 response at Week 24 is defined as a ≥ 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies.
Time frame: Week 24
Population: The FAS included all randomized participants. Only participants who had the opportunity to complete the visit by the date of the study termination decision being communicated to sites were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With a SRI-4 Response at Week 24 | 33 Participants |
| Rozibafusp Alfa 70mg | Number of Participants With a SRI-4 Response at Week 24 | 30 Participants |
| Rozibafusp Alfa 280mg | Number of Participants With a SRI-4 Response at Week 24 | 20 Participants |
| Rozibafusp Alfa 420mg | Number of Participants With a SRI-4 Response at Week 24 | 46 Participants |
Secondary
Serum Concentration of Rozibafusp Alfa
Time frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 44, Week 52, Week 56, Week 60, Week 64, and Week 68
Population: The pharmacokinetic (PK) concentration analysis set contained all participants who received at least one dose of IP and had at least one quantifiable PK sample collected. PK concentration data was analyzed according to the actual treatment received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 1 | 0.0 μg/mL | Standard Deviation 0 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 24 | 3.69 μg/mL | Standard Deviation 3.37 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 4 | 1.29 μg/mL | Standard Deviation 1.34 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 8 | 1.70 μg/mL | Standard Deviation 1.93 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 12 | 2.05 μg/mL | Standard Deviation 2.03 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 16 | 2.58 μg/mL | Standard Deviation 2.67 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 20 | 3.42 μg/mL | Standard Deviation 3.15 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 36 | 3.62 μg/mL | Standard Deviation 3.73 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 44 | 2.98 μg/mL | Standard Deviation 3.78 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 52 | 4.15 μg/mL | Standard Deviation 4.5 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 56 | 0.230 μg/mL | Standard Deviation 0.495 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 64 | 0.0 μg/mL | Standard Deviation 0 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 68 | 0.0 μg/mL | Standard Deviation 0 |
| Rozibafusp Alfa 70mg | Serum Concentration of Rozibafusp Alfa | Week 60 | 0.00346 μg/mL | Standard Deviation 0.012 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 60 | 3.45 μg/mL | Standard Deviation 4.31 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 20 | 35.4 μg/mL | Standard Deviation 19.8 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 24 | 35.8 μg/mL | Standard Deviation 19.1 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 68 | 0.0484 μg/mL | Standard Deviation 0.125 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 36 | 40.5 μg/mL | Standard Deviation 20.7 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 64 | 0.609 μg/mL | Standard Deviation 1.07 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 44 | 39.0 μg/mL | Standard Deviation 18.6 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 52 | 43.8 μg/mL | Standard Deviation 25.3 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 1 | 0.0 μg/mL | Standard Deviation 0 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 4 | 20.7 μg/mL | Standard Deviation 10.8 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 56 | 11.3 μg/mL | Standard Deviation 8.03 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 8 | 26.6 μg/mL | Standard Deviation 15.7 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 12 | 31.3 μg/mL | Standard Deviation 16.5 |
| Rozibafusp Alfa 280mg | Serum Concentration of Rozibafusp Alfa | Week 16 | 29.8 μg/mL | Standard Deviation 18.9 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 56 | 13.3 μg/mL | Standard Deviation 12.4 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 16 | 47.0 μg/mL | Standard Deviation 28.4 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 60 | 3.08 μg/mL | Standard Deviation 4.45 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 12 | 46.8 μg/mL | Standard Deviation 24.6 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 20 | 48.9 μg/mL | Standard Deviation 30 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 52 | 51.6 μg/mL | Standard Deviation 30.8 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 24 | 55.5 μg/mL | Standard Deviation 30.6 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 1 | 0.0 μg/mL | Standard Deviation 0 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 68 | 0.102 μg/mL | Standard Deviation 0.271 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 36 | 54.7 μg/mL | Standard Deviation 35.9 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 8 | 40.7 μg/mL | Standard Deviation 21.8 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 4 | 26.2 μg/mL | Standard Deviation 17.1 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 44 | 54.1 μg/mL | Standard Deviation 38.3 |
| Rozibafusp Alfa 420mg | Serum Concentration of Rozibafusp Alfa | Week 64 | 0.718 μg/mL | Standard Deviation 1.41 |
Secondary
Terminal Half-life of Rozibafusp Alfa
Time frame: Up to Week 68
Population: Per the SAP, data for this outcome measure was not to be analyzed unless it could be adequately estimated.