A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03845517

Enrollment

350

Registered

2019-02-19

Start date

2019-04-18

Completion date

2023-10-05

Last updated

2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Brief summary

Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

Interventions

DRUGPlacebo

Placebo

DRUGPF-06700841 15 mg

PF-06700841 15 mg

DRUGPF-06700841 30 mg

PF-06700841 30 mg

DRUGPF-06700841 45 mg

PF-06700841 45 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male and/or female subjects between ≥18 and ≤75 years of age inclusive. * Diagnosis of moderate to severe active Lupus. * Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.

Exclusion criteria

* Active renal lupus * Severe active central nervous system (CNS) lupus * Have cancer or a history of cancer within 5 years of screening. * Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus. * Active bacterial, viral, fungal, mycobacterial or other infections * Psychiatric condition including recent or active suicidal ideation or behavior * Have active fibromyalgia/myofascial/chronic pain. * Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52	Week 52	SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (\>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than \[\<\] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52	Week 52	LLDAS was defined as SLE disease activity index (SLEDAI-2k \<=4, with no activity in major organ systems \[renal, central nervous system, cardiopulmonary, vasculitis, fever\]) and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with the previous assessment; a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI PhGA (scale 0-3; higher scores = higher severity) \<=1; a current prednisolone (or equivalent) dose \<=7.5 milligram per day (mg/daily); and well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.
Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/Day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline	Week 52 for achieving reduction in dose along with Week 40 to Week 52 for sustained dosing	In this outcome measure data is reported for participants who achieved a reduction in prednisone (or equivalent) dose to \<=7.5 mg/day and sustained for 12 Weeks prior at Week 52 and they also sustained this dose reduction for 12 weeks prior to Week 52 (Week 40 to Week 52).
Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/Day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline	12 Weeks prior at Week 52 (Week 40 to Week 52)	In this outcome measure data is reported for participants who achieved a reduction in SRI-4 response with prednisone dose reduced to \<=7.5 mg/day and sustained for 12 weeks at Week 52.
Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10	Week 52	CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).
Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52	Baseline, Week 52	The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52	Baseline, Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others; measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Physical health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52	Baseline, Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Emotional health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52	Baseline, Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Body image domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Change From Baseline in Pain Domain Scores of LupusQoL at Week 52	Baseline, Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Pain domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Change From Baseline in Planning Domain Scores of LupusQoL at Week 52	Baseline, Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Planning domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52	Week 52	BICLA included: BILAG-2004, SLEDAI-2K and PhGA. Participants were classified as responders, if they met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =\<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (\<10 percent \[%\] worsening) in analogue PhGA. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).
Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52	Baseline, Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Intimate relationship domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52	Baseline, Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Burden to others domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Incidence Rate of Severe Flare Event	Week 52	Incidence rate was defined as the number of new events per 100 person-years.
Number of Participants With Treatment-Emergent Adverse Events (AE)	Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)	An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are events from first dose of study intervention to 4 weeks after last dose of study intervention that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs.
Number of Participants With Serious Adverse Events (SAEs)	Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)	An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Adverse Events Leading to Discontinuation From Study	Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)	An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. In this outcome measure, participants with adverse events leading to discontinuation from study were reported.
Number of Participants With Clinically Significant Vital Signs Abnormalities	Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)	Vital signs included blood pressure, pulse rate, respiratory rate, and temperature. Clinical significance in vital signs abnormalities was judged by investigator.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)	Clinical significance in ECG abnormalities was judged by investigator.
Number of Participants With Laboratory Test Abnormalities	Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)	Hematology (Hemoglobin\[hgb\], hematocrit, erythrocytes\[ery\]:\<0.8\lower limit of normal\[LLN\];reticulocytes, reticulocytes/ery:\<0.5\LLN,\>1.5\upper LN\[ULN\];ery mean corpuscular volume\[EMC\], EMC hgb:\<0.9\LLN,\>1.5\ULN;EMC hgb concentration:\<0.9\ LLN;platelet:\<0.5\LLN;leukocytes\[leu\]:\<0.6\LLN,\>1.5\ULN;lymphocytes, lymphocytes/leu, neutrophils, neutrophils/leu:\<0.8\ LLN,\>1.2\ULN;basophils, basophils/leu, eosinophils, eosinophils/leu, monocytes, monocytes/leu:\>1.2\ULN;activated partial thromboplastin time\[PTT\], PTT, prothrombin time:\>1.1\ULN);Clinical chemistry (Total/direct/indirect bilirubin, glucose-fasting:\>1.5\ULN; aspartate aminotransferase\[AT\], alanine AT:\>3.0\ULN; protein, albumin, HDL cholesterol:\<0.8\LLN;urea nitrogen, creatinine, triglyceride, cholesterol:\>1.3\ULN;urate, LDL cholesterol:\>1.2\ULN;potassium:\<0.9\LLN,\>1.1\ULN;calcium, bicarbonate:\<0.9\LLN;creatine kinase:\>2.0\ULN);Urinalysis (pH\<4.5;glucose, protein, hgb, ketones, nitrite, leu esterase, granular/hyaline/WBCs casts:\>1).
Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52	Baseline, Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Fatigue domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.

Countries

Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Poland, Portugal, Romania, Serbia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States

Participant flow

Recruitment details

A total of 350 participants with active systemic lupus erythematosus (SLE) were enrolled and randomized in the study.

Participants by arm

Arm	Count
Placebo Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.	100
PF-06700841 15 mg Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.	50
PF-06700841 30 mg Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.	101
PF-06700841 45 mg Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.	99
Total	350

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Follow-up Period (4 Weeks)	Adverse Event	4	2	0	2
Follow-up Period (4 Weeks)	Death	0	0	1	1
Follow-up Period (4 Weeks)	Lost to Follow-up	2	1	2	0
Follow-up Period (4 Weeks)	Other	1	0	1	0
Follow-up Period (4 Weeks)	Physician's decision	0	0	1	1
Follow-up Period (4 Weeks)	Pregnancy	1	0	0	0
Follow-up Period (4 Weeks)	Protocol Violation	0	0	0	1
Follow-up Period (4 Weeks)	Study terminated by sponsor	0	0	0	1
Follow-up Period (4 Weeks)	Withdrawal by Subject	3	5	7	1
Treatment Period (52 Weeks)	Adverse Event	12	7	10	17
Treatment Period (52 Weeks)	Death	0	0	1	0
Treatment Period (52 Weeks)	Lack of Efficacy	8	1	3	4
Treatment Period (52 Weeks)	Lost to Follow-up	2	0	1	0
Treatment Period (52 Weeks)	Non-compliance with study drug	1	0	0	0
Treatment Period (52 Weeks)	Other	2	0	0	0
Treatment Period (52 Weeks)	Physician's decision	0	0	1	0
Treatment Period (52 Weeks)	Pregnancy	1	0	0	1
Treatment Period (52 Weeks)	Protocol Violation	0	0	1	1
Treatment Period (52 Weeks)	Site Terminated by Sponsor	2	0	0	0
Treatment Period (52 Weeks)	Withdrawal by Subject	4	6	6	5

Baseline characteristics

Characteristic	Total	Placebo	PF-06700841 15 mg	PF-06700841 30 mg	PF-06700841 45 mg
Age, Continuous	42.0 Years STANDARD_DEVIATION 11.37	42.5 Years STANDARD_DEVIATION 9.6	41.5 Years STANDARD_DEVIATION 11.79	42.8 Years STANDARD_DEVIATION 12.71	41.0 Years STANDARD_DEVIATION 11.47
Ethnicity (NIH/OMB) Hispanic or Latino	115 Participants	29 Participants	17 Participants	34 Participants	35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	232 Participants	71 Participants	32 Participants	67 Participants	62 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	11 Participants	2 Participants	0 Participants	7 Participants	2 Participants
Race (NIH/OMB) Asian	47 Participants	14 Participants	9 Participants	11 Participants	13 Participants
Race (NIH/OMB) Black or African American	23 Participants	6 Participants	4 Participants	6 Participants	7 Participants
Race (NIH/OMB) More than one race	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	28 Participants	5 Participants	6 Participants	8 Participants	9 Participants
Race (NIH/OMB) White	239 Participants	71 Participants	31 Participants	69 Participants	68 Participants
Sex: Female, Male Female	327 Participants	94 Participants	45 Participants	97 Participants	91 Participants
Sex: Female, Male Male	23 Participants	6 Participants	5 Participants	4 Participants	8 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 / 100	0 / 50	1 / 101	1 / 99
other Total, other adverse events	47 / 100	19 / 50	53 / 101	47 / 99
serious Total, serious adverse events	8 / 100	4 / 50	8 / 101	9 / 99

Outcome results

Primary

Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52

SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (\>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than \[\<\] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).

Time frame: Week 52

Population: Full analysis set (FAS) included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here Number of Participants Analyzed signifies participants at Week 52 with Non-Responder Imputation (NRI) and Last Observation Carried Forward from Week 48 (LOCF48) applied.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52	64.6 Percentage of participants
PF-06700841 15 mg	Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52	57.4 Percentage of participants
PF-06700841 30 mg	Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52	69.7 Percentage of participants
PF-06700841 45 mg	Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52	66.3 Percentage of participants

p-value: 0.807695% CI: [-24.5, 9.5]Cochran-Mantel-Haenszel

p-value: 0.218995% CI: [-7.9, 18.3]Cochran-Mantel-Haenszel

p-value: 0.40195% CI: [-11.8, 15.3]Cochran-Mantel-Haenszel

Secondary

Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Body image domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.

Time frame: Baseline, Week 52

Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure with observed data at the specified visit.

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Placebo	Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52	9.207 Units on a scale
PF-06700841 15 mg	Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52	10.935 Units on a scale
PF-06700841 30 mg	Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52	8.169 Units on a scale
PF-06700841 45 mg	Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52	15.599 Units on a scale

Secondary

Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Burden to others domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.

Time frame: Baseline, Week 52

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Placebo	Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52	12.535 Units on a scale
PF-06700841 15 mg	Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52	17.739 Units on a scale
PF-06700841 30 mg	Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52	11.560 Units on a scale
PF-06700841 45 mg	Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52	18.878 Units on a scale

Secondary

Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Emotional health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.

Time frame: Baseline, Week 52

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Placebo	Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52	8.113 Units on a scale
PF-06700841 15 mg	Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52	10.469 Units on a scale
PF-06700841 30 mg	Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52	7.547 Units on a scale
PF-06700841 45 mg	Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52	11.823 Units on a scale

Secondary

Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Fatigue domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.

Time frame: Baseline, Week 52

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Placebo	Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52	10.317 Units on a scale
PF-06700841 15 mg	Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52	11.893 Units on a scale
PF-06700841 30 mg	Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52	11.701 Units on a scale
PF-06700841 45 mg	Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52	16.443 Units on a scale

Secondary

Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Intimate relationship domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.

Time frame: Baseline, Week 52

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Placebo	Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52	12.430 Units on a scale
PF-06700841 15 mg	Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52	12.625 Units on a scale
PF-06700841 30 mg	Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52	6.494 Units on a scale
PF-06700841 45 mg	Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52	15.363 Units on a scale

Secondary

Change From Baseline in Pain Domain Scores of LupusQoL at Week 52

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Pain domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.

Time frame: Baseline, Week 52

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Placebo	Change From Baseline in Pain Domain Scores of LupusQoL at Week 52	15.065 Units on a scale
PF-06700841 15 mg	Change From Baseline in Pain Domain Scores of LupusQoL at Week 52	15.480 Units on a scale
PF-06700841 30 mg	Change From Baseline in Pain Domain Scores of LupusQoL at Week 52	16.855 Units on a scale
PF-06700841 45 mg	Change From Baseline in Pain Domain Scores of LupusQoL at Week 52	24.418 Units on a scale

Secondary

Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others; measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Physical health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.

Time frame: Baseline, Week 52

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Placebo	Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52	11.585 Units on a scale
PF-06700841 15 mg	Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52	10.892 Units on a scale
PF-06700841 30 mg	Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52	12.371 Units on a scale
PF-06700841 45 mg	Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52	14.875 Units on a scale

Secondary

Change From Baseline in Planning Domain Scores of LupusQoL at Week 52

The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Planning domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.

Time frame: Baseline, Week 52

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Placebo	Change From Baseline in Planning Domain Scores of LupusQoL at Week 52	14.168 Units on a scale
PF-06700841 15 mg	Change From Baseline in Planning Domain Scores of LupusQoL at Week 52	12.013 Units on a scale
PF-06700841 30 mg	Change From Baseline in Planning Domain Scores of LupusQoL at Week 52	10.335 Units on a scale
PF-06700841 45 mg	Change From Baseline in Planning Domain Scores of LupusQoL at Week 52	20.310 Units on a scale

Secondary

Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52

The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).

Time frame: Baseline, Week 52

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Placebo	Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52	4.6 Units on a scale
PF-06700841 15 mg	Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52	7.4 Units on a scale
PF-06700841 30 mg	Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52	5.8 Units on a scale
PF-06700841 45 mg	Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52	7.6 Units on a scale

Secondary

Incidence Rate of Severe Flare Event

Incidence rate was defined as the number of new events per 100 person-years.

Time frame: Week 52

Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention.

Arm	Measure	Value (NUMBER)
Placebo	Incidence Rate of Severe Flare Event	8.32 Events per 100 person-years
PF-06700841 15 mg	Incidence Rate of Severe Flare Event	6.92 Events per 100 person-years
PF-06700841 30 mg	Incidence Rate of Severe Flare Event	3.24 Events per 100 person-years
PF-06700841 45 mg	Incidence Rate of Severe Flare Event	6.95 Events per 100 person-years

Secondary

Number of Participants With Adverse Events Leading to Discontinuation From Study

An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. In this outcome measure, participants with adverse events leading to discontinuation from study were reported.