Plaque Psoriasis
Conditions
Keywords
Adalimumab, Biosimilars, Tumor necrosis factor, Psoriasis Area and Severity Index
Brief summary
Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.
Interventions
DRUGAdalimumab
Participants will receive subcutaneous (SC) injection of adalimumab
DRUGABP 501
Participants will receive SC injection of ABP 501
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Study is double-blind.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months * Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline * Participant has no known history of latent or active tuberculosis
Exclusion criteria
* Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis * Participant has an active infection or history of infections * Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment * Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment * Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment * Participant has received topical psoriasis treatment within 2 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose | Participants analyzed according to actual treatment received. |
| Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose | Participants analyzed according to treatment received. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI Percent Improvement From Baseline (Day 1) to Week 30 | Baseline (Day 1) and Week 30 | The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline). |
| Number of Participants Achieving PASI 75 Response at Week 30 | Baseline (Day 1) and Week 30 | A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. |
| Number of Participants Achieving PASI 90 Response at Week 30 | Baseline (Day 1) and Week 30 | A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. |
| Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Pre-dose at Week 12, Week 16, Week 20, and Week 28 | — |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Baseline up to Week 32 | TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event. |
| Number of Participants Experiencing Events of Interest (EOI) | Baseline up to Week 32 | An EOI is defined as a noteworthy event for a particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals. |
| Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Week 16, Week 20, Week 28, Week 30, and Week 32 | Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits. |
| Number of Participants Achieving PASI 100 Response at Week 30 | Baseline (Day 1) and Week 30 | A PASI 100 response is a 100% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. |
| Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose | Time to reach maximum serum concentration. |
Countries
Canada, Estonia, Germany, Latvia, Poland, United States
Participant flow
Recruitment details
A total of 425 participants were enrolled in the study at 83 centers across 6 countries (Canada, Estonia, Germany, Latvia, Poland, and the US) between October 2021 and December 2022.
Pre-assignment details
Participants were enrolled in Period 1 of the study (Lead-in Period) and received adalimumab (Humira®) subcutaneously (SC) during a 12-week period. Participants who responded to treatment during Period 1 (achieving PASI ≥ 50) were randomized in Period 2 to either the Continued-use Group or the Switching Group. Period 2 lasted 20 weeks from Week 12 to Week 32.
Participants by arm
| Arm | Count |
|---|---|
| Period 2 (Switching Group) Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]). | 186 |
| Period 2 (Continued-use Group) Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W. | 194 |
| Total | 380 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 1 (Lead-in Period) | Adverse Event | 6 | 0 | 0 |
| Period 1 (Lead-in Period) | Death | 1 | 0 | 0 |
| Period 1 (Lead-in Period) | Did not Meet PASI 50 at Week 12 | 23 | 0 | 0 |
| Period 1 (Lead-in Period) | Lack of Efficacy | 1 | 0 | 0 |
| Period 1 (Lead-in Period) | Lost to Follow-up | 3 | 0 | 0 |
| Period 1 (Lead-in Period) | Protocol Violation | 5 | 0 | 0 |
| Period 1 (Lead-in Period) | Withdrawal by Subject | 6 | 0 | 0 |
| Period 2 | Adverse Event | 0 | 3 | 6 |
| Period 2 | Lost to Follow-up | 0 | 5 | 5 |
| Period 2 | Protocol Violation | 0 | 0 | 1 |
| Period 2 | Withdrawal by Subject | 0 | 4 | 9 |
Baseline characteristics
| Characteristic | Period 2 (Continued-use Group) | Total | Period 2 (Switching Group) |
|---|---|---|---|
| Age, Continuous | 44.3 Years STANDARD_DEVIATION 13.91 | 44.6 Years STANDARD_DEVIATION 13.59 | 44.9 Years STANDARD_DEVIATION 13.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants | 63 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 158 Participants | 316 Participants | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 24 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) White | 172 Participants | 334 Participants | 162 Participants |
| Sex: Female, Male Female | 63 Participants | 119 Participants | 56 Participants |
| Sex: Female, Male Male | 131 Participants | 261 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 425 | 0 / 194 | 0 / 186 |
| other Total, other adverse events | 38 / 425 | 28 / 194 | 26 / 186 |
| serious Total, serious adverse events | 5 / 425 | 4 / 194 | 3 / 186 |
Outcome results
Primary
Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
Participants analyzed according to actual treatment received.
Time frame: Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
Population: The Pharmacokinetic (PK) Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between Weeks 28 and 30.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Period 2 (Switching Group) | Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | 1458.03 hr*μg/mL | Geometric Coefficient of Variation 156.6 |
| Period 2 (Continued-use Group) | Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | 1472.68 hr*μg/mL | Geometric Coefficient of Variation 174.9 |
90% CI: [0.901, 1.2273]
Primary
Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
Participants analyzed according to treatment received.
Time frame: Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
Population: The PK Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between weeks 28 and 30.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Period 2 (Switching Group) | Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | 4.91 μg/mL | Geometric Coefficient of Variation 153.6 |
| Period 2 (Continued-use Group) | Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | 5.01 μg/mL | Geometric Coefficient of Variation 160.4 |
90% CI: [0.8717, 1.1574]
Secondary
Number of Participants Achieving PASI 100 Response at Week 30
A PASI 100 response is a 100% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline (Day 1) and Week 30
Population: Based on the PP efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Period 2 (Switching Group) | Number of Participants Achieving PASI 100 Response at Week 30 | 52 Participants |
| Period 2 (Continued-use Group) | Number of Participants Achieving PASI 100 Response at Week 30 | 61 Participants |
Secondary
Number of Participants Achieving PASI 75 Response at Week 30
A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline (Day 1) and Week 30
Population: Based on the PP efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Period 2 (Switching Group) | Number of Participants Achieving PASI 75 Response at Week 30 | 131 Participants |
| Period 2 (Continued-use Group) | Number of Participants Achieving PASI 75 Response at Week 30 | 134 Participants |
Secondary
Number of Participants Achieving PASI 90 Response at Week 30
A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time frame: Baseline (Day 1) and Week 30
Population: Based on the PP efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Period 2 (Switching Group) | Number of Participants Achieving PASI 90 Response at Week 30 | 92 Participants |
| Period 2 (Continued-use Group) | Number of Participants Achieving PASI 90 Response at Week 30 | 108 Participants |
Secondary
Number of Participants Experiencing Events of Interest (EOI)
An EOI is defined as a noteworthy event for a particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals.
Time frame: Baseline up to Week 32
Population: Population from the SAS. Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Period 2 (Switching Group) | Number of Participants Experiencing Events of Interest (EOI) | 13 Participants |
| Period 2 (Continued-use Group) | Number of Participants Experiencing Events of Interest (EOI) | 17 Participants |
Secondary
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Time frame: Baseline up to Week 32
Population: Population from the Safety Analysis Set (SAS). Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Period 2 (Switching Group) | Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | TEAE | 97 Participants |
| Period 2 (Switching Group) | Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Serious TEAE | 3 Participants |
| Period 2 (Continued-use Group) | Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | TEAE | 106 Participants |
| Period 2 (Continued-use Group) | Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Serious TEAE | 4 Participants |
Secondary
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization
Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits.
Time frame: Week 16, Week 20, Week 28, Week 30, and Week 32
Population: Population from the SAS. Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Period 2 (Switching Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Neutralizing antibody negative or no result prior to the first dose of post-randomization IP | 174 Participants |
| Period 2 (Switching Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Neutralizing antibody positive with negative/no result prior to first dose post-randomization | 21 Participants |
| Period 2 (Switching Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Transient neutralizing antibody positive with negative/no result prior first dose post-randomization | 2 Participants |
| Period 2 (Switching Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Binding antibody negative or no result prior to the first dose of post-randomization IP | 25 Participants |
| Period 2 (Switching Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Binding antibody positive with negative/no result prior to first dose post-randomization | 16 Participants |
| Period 2 (Switching Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Transient binding antibody positive with negative/no result prior to first dose post-randomization | 3 Participants |
| Period 2 (Switching Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Participants with a post-randomization result | 186 Participants |
| Period 2 (Continued-use Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Binding antibody positive with negative/no result prior to first dose post-randomization | 10 Participants |
| Period 2 (Continued-use Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Neutralizing antibody negative or no result prior to the first dose of post-randomization IP | 182 Participants |
| Period 2 (Continued-use Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Binding antibody negative or no result prior to the first dose of post-randomization IP | 18 Participants |
| Period 2 (Continued-use Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Neutralizing antibody positive with negative/no result prior to first dose post-randomization | 27 Participants |
| Period 2 (Continued-use Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Transient binding antibody positive with negative/no result prior to first dose post-randomization | 2 Participants |
| Period 2 (Continued-use Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Transient neutralizing antibody positive with negative/no result prior first dose post-randomization | 3 Participants |
| Period 2 (Continued-use Group) | Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization | Participants with a post-randomization result | 194 Participants |
Secondary
PASI Percent Improvement From Baseline (Day 1) to Week 30
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Time frame: Baseline (Day 1) and Week 30
Population: Based on the per-protocol (PP) efficacy analysis set as observed, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Period 2 (Switching Group) | PASI Percent Improvement From Baseline (Day 1) to Week 30 | 88.56 Percentage Change |
| Period 2 (Continued-use Group) | PASI Percent Improvement From Baseline (Day 1) to Week 30 | 91.01 Percentage Change |
90% CI: [-5.23, 0.29]
Secondary
Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
Time to reach maximum serum concentration.
Time frame: Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
Population: The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of investigational product (IP) post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Period 2 (Switching Group) | Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | 72.30 Hours |
| Period 2 (Continued-use Group) | Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | 72.35 Hours |
Secondary
Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
Time frame: Pre-dose at Week 12, Week 16, Week 20, and Week 28
Population: The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of IP post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization. All participants reported in the overall number of participants analyzed contributed data to this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Period 2 (Switching Group) | Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 12 | 4528.7316 ng/mL | Geometric Coefficient of Variation 88.9 |
| Period 2 (Switching Group) | Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 20 | 4113.0839 ng/mL | Geometric Coefficient of Variation 160.8 |
| Period 2 (Switching Group) | Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 16 | 4046.3069 ng/mL | Geometric Coefficient of Variation 144.1 |
| Period 2 (Switching Group) | Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 28 | 3736.9917 ng/mL | Geometric Coefficient of Variation 182.1 |
| Period 2 (Continued-use Group) | Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 16 | 3682.0016 ng/mL | Geometric Coefficient of Variation 188.1 |
| Period 2 (Continued-use Group) | Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 12 | 4072.5556 ng/mL | Geometric Coefficient of Variation 119 |
| Period 2 (Continued-use Group) | Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 28 | 4014.4980 ng/mL | Geometric Coefficient of Variation 193.5 |
| Period 2 (Continued-use Group) | Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) | Week 20 | 4332.1272 ng/mL | Geometric Coefficient of Variation 148.9 |