Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis
Detailed description
This was a continuation trial of adalimumab in participants with moderate to severe chronic plaque psoriasis who had completed Study M04-688 (NCT00338754), a 24-week, double-blind, placebo-controlled study. This study was an open-label extension study that continued until the approval of adalimumab for the treatment of psoriasis in Japan. During Study M04-688 (NCT00338754), participants received 24 weeks of treatment with adalimumab 40 mg every other week (eow) with or without a loading dose, adalimumab 80 mg eow, or placebo. At the start of this study, participants who had received adalimumab 40 mg eow or adalimumab 80 mg eow in Study M04-688 (NCT00338754) continued on the same treatment regimen. Participants who had received placebo during Study M04-688 (NCT00338754) were re-randomized at the start of this study to receive adalimumab 40 mg eow or adalimumab 80 mg eow. Participants in the adalimumab 40 mg eow treatment group who failed to achieve a PASI50 response (\>= 50% reduction in the Psoriasis Area and Severity Index score from Baseline of Study M04-688 \[NCT00338754\]) at or anytime after Week 12 of this study were given the option to increase their dose to adalimumab 80 mg eow. Once the dose was escalated, there was no option to de-escalate dosing back to 40 mg eow. Participants who failed to achieve PASI50 responses while receiving adalimumab 80 mg eow may have been discontinued from the study after evaluating the risk/benefit of further treatment with adalimumab. At Week 28 of this study, it was mandatory for all participants who started the study in the adalimumab 80 mg eow treatment group (i.e., not including the dose escalators described above) to reduce their dose to adalimumab 40 mg eow, regardless of their response status. Following this mandatory dose reduction, if these participants failed to achieve or maintain PASI50 response, they were permitted to escalate their dose to adalimumab 80 mg eow. There was no option to de-escalate dosing back to 40 mg eow following dose escalation. Data in this clinical trial results disclosure are analyzed as observed according to treatment received at the start of this study (i.e., adalimumab 40 mg eow or adalimumab 80 mg eow) regardless of subsequent dose escalation. Data are summarized according to participants' cumulative exposure to adalimumab in Study M04-688 (NCT00338754) and this study.
Interventions
BIOLOGICALadalimumab
Adalimumab 40 mg every other week, subcutaneous
Sponsors
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Participants who completed Study M04-688 (NCT00338754)
Exclusion criteria
\- Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab | PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab | PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754). |
| Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab | PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754). |
Countries
Japan
Participant flow
Recruitment details
Japanese participants with chronic plaque psoriasis who completed the blinded, placebo-controlled Study M04-688 (NCT00338754; 24-week duration) enrolled in the extension study, M04-702, an open-label study until adalimumab received approval for treatment of psoriasis in Japan.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab 40 mg Every Other Week Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study. | 89 |
| Adalimumab 80 mg Every Other Week Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure). | 58 |
| Total | 147 |
Baseline characteristics
| Characteristic | Adalimumab 80 mg Every Other Week | Adalimumab 40 mg Every Other Week | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 9 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 80 Participants | 136 Participants |
| Age Continuous | 42.9 years STANDARD_DEVIATION 11.88 | 45.1 years STANDARD_DEVIATION 13.39 | 44.2 years STANDARD_DEVIATION 12.82 |
| Region of Enrollment Japan | 58 participants | 89 participants | 147 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 48 Participants | 76 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 88 / 89 | 58 / 58 |
| serious Total, serious adverse events | 19 / 89 | 11 / 58 |
Outcome results
Primary
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Time frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
Population: All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow]) | 78 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow]) | 80 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow]) | 79 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow]) | 80 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow]) | 76 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow]) | 75 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow]) | 71 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow]) | 29 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow]) | 14 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow]) | 54 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow]) | 52 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow]) | 55 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow]) | 47 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow]) | 52 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow]) | 49 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) | 52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow]) | 51 Participants |
Secondary
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Time frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
Population: All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow]) | 54 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow]) | 70 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow]) | 65 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow]) | 66 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow]) | 69 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow]) | 69 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow]) | 27 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow]) | 67 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow]) | 13 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow]) | 41 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow]) | 45 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow]) | 50 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow]) | 51 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow]) | 48 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow]) | 47 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) | 100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow]) | 43 Participants |
Secondary
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Time frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
Population: All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow]) | 31 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow]) | 50 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow]) | 54 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow]) | 54 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow]) | 55 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow]) | 55 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow]) | 57 Participants |
| Adalimumab 40 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow]) | 23 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow]) | 12 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow]) | 29 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow]) | 38 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow]) | 39 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow]) | 33 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow]) | 44 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow]) | 35 Participants |
| Adalimumab 80 mg Every Other Week | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) | 52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow]) | 42 Participants |