Article Figures & Data
Figures
- Figure 1.
Percentage of patients achieving minimal disease activity (MDA): A. Five out of 7 criteria fulfilled. B. Five out of 6 criteria fulfilled. Data are observed values. For A, MDA is calculated using all 7 conditions with an enthesitis criterion of ≤ 1. Comparisons between adalimumab and placebo were significantly different from Week 4 (p < 0.05 at Week 4; p < 0.001 at Weeks 8 through 24). Note that a modified definition of MDA using enthesitis = 0 did not differ from this result (significant differences showed the same pattern). For B, MDA is calculated using 6 conditions (enthesitis is excluded). Comparisons between adalimumab and placebo were significantly different from Week 4 (p < 0.05 at Weeks 4 and 8; p < 0.001 at Weeks 12 through 24).
- Figure 2.
Percentage of patients achieving minimal disease activity (MDA), MDAPGA1, and MDAPGA2 at Week 24. MDA is calculated using all 7 conditions, with an enthesitis criterion of ≤ 1. For MDAPGA1, PASI is replaced by PGA of “Clear.” For MDAPGA2, PASI is replaced by PGA of “Clear” or “Almost clear.” PASI: Psoriasis Activity and Severity Index; PGA: physician global assessment. P < 0.001 for all treatment comparisons.
Tables
Characteristic Placebo, n = 69 Adalimumab, n = 67 Age, yrs 48 ± 12 50 ± 14 Male, n (%) 39 (57) 38 (57) Minimal disease activity criteria, mean ± SD TJC (0–78) 28 ± 18 26 ± 19 SJC (0–76) 16 ± 12 17 ± 13 PASI (0–72) 8 ± 7 7 ± 6 HAQ (0–3) 1.10 ± 0.68 1.10 ± 0.64 Pain (0–100 mm) 49 ± 23 52 ± 21 PaGA (0–100 mm) 48 ± 23 48 ± 23 Enthesitis* (0–4) 1.0 ± 1.4 0.8 ± 1.3 Physician global assessment category, n (%) Clear 0 0 Almost clear 1 (1.5) 1 (1.5) Mild 9 (13.2) 12 (17.9) Mild to moderate 19 (27.9) 15 (22.4) Moderate 25 (36.8) 17 (25.4) Moderate to severe 11 (16.2) 19 (28.4) Severe 3 (4.4) 3 (4.5) -
↵* Plantar fascia and Achilles tendon insertion. HAQ: Health Assessment Questionnaire; PASI: Psoriasis Activity and Severity Index; PaGA: patient global assessment of disease activity; SJC: swollen joint count; TJC: tender joint count.
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- Table 2.
Percentage of responders for individual criteria for minimal disease activity (MDA) at baseline* and Week 24**.
MDA Criteria Placebo,% Adalimumab, % Tender joint count ≤ 1 Baseline 0 0 Week 24 10.0 38.7 Swollen joint count ≤ 1 Baseline 0 0 Week 24 13.3 32.3 Patient global assessment of disease activity ≤ 20 Baseline 14.7 17.9 Week 24 18.3 50.0 Pain ≤ 15 Baseline 8.8 6.0 Week 24 11.7 48.4 Health Assessment Questionnaire ≤ 0.5 Baseline 27.5 23.9 Week 24 35.0 51.6 Enthesitis ≤ 1*** Baseline 68.1 75.4 Week 24 66.7 82.0 Psoriasis Activity and Severity Index ≤ 1 Baseline 4.4 1.5 Week 24 3.4 59.7 Physician global assessment “Clear” Baseline 0 0 Week 24 0 33.9 Physician global assessment “Clear” or “Almost clear” Baseline 1.5 1.5 Week 24 12.1 72.6 - Table 3.
Agreement between Psoriasis Activity and Severity Index (PASI) and physician global assessment (PGA) outcome measures at Week 24.
PASI ≤ 1 PGA “Clear” Observed Agreement, % Kappa PGA “Clear” or “Almost Clear” Observed Agreement, % Kappa Yes No Yes No Yes 20 15 87 0.65 34 1 86 0.69 No 0 83 16 67
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