Placebo-controlled cohorta: relative contribution of the secondary ACR components (PGA, PtGA, Pain, HAQ-DI, and CRP) to the overall ACR70 response rates in patients treated with TOF 5 mg BID + csDMARDs, TOF 10 mg BID + csDMARDs, ADA + csDMARDsb, or placebo + csDMARDs at month 3 (FAS).
| TOF 5 mg BID + csDMARDs, N = 737 | TOF 10 mg BID + csDMARDs, N = 738 | ADA + csDMARDs, N = 185 | Placebo + csDMARDs, N = 378 | ||||
|---|---|---|---|---|---|---|---|
| ACR Component (By Rank) | n (%) | ACR Component (By Rank) | n (%) | ACR Component (By Rank) | n (%) | ACR Component (By Rank) | n (%) |
| 1. Pain | 59 (8.0) | 1. PGA | 91 (12.3) | 1. PGA | 10 (5.4) | 1. Pain | 1 (0.3) |
| 2. PtGA | 60 (8.1) | 2. Pain | 92 (12.5) | 1. PtGA | 10 (5.4) | 2. PtGA | 3 (0.8) |
| 3. PGA | 62 (8.4) | 3. PtGA | 97 (13.1) | 3. HAQ-DI | 12 (6.5) | 3. PGA | 4 (1.1) |
| 4. CRP | 70 (9.5) | 4. CRP | 107 (14.5) | 4. Pain | 13 (7.0) | 4. HAQ-DI | 5 (1.3) |
| 5. HAQ-DI | 71 (9.6) | 5. HAQ-DI | 109 (14.8) | 4. CRP | 13 (7.0) | 5. CRP | 6 (1.6) |
To assess the relative contribution of each secondary ACR component (PGA, PtGA, pain, HAQ-DI, and CRP) to the attainment of the overall ACR20 response rate, each component was sequentially set to “no improvement” (ie, value of 0 in change from baseline) and the ACR20 response rate was recalculated. The resulting response rates were then rank-ordered from 1–5, with 1 representing the largest contribution, corresponding to the largest decrease in ACR20 response rate and 5 representing the smallest contribution, corresponding to the smallest decrease in ACR20 response rate. The same approach was used to assess the relative contribution of each secondary ACR component to the attainment of the overall ACR50 and ACR70 response rates. Analyses are based on observed case data in patients with all 7 ACR components assessed at the analyzed time point.
↵aData were pooled from 3 phase III studies: ORAL Scan (NCT00847613), ORAL Sync (NCT00856544), and ORAL Standard (NCT00853385).
↵bORAL Standard only. ACR: American College of Rheumatology; ACR20/50/70: American College of Rheumatology ≥ 20/50/70% response rates; ADA: adalimumab; csDMARD: conventional synthetic disease-modifying antirheumatic drug; CRP: C-reactive protein; FAS: full analysis set; HAQ-DI: Health Assessment Questionnaire–Disability Index; n: no. of patients achieving ≥ 20/50/70% improvement when each secondary ACR component is set to “no improvement” (ie, value of 0 in change from baseline) and the ACR20/50/70 response rate was recalculated; N: no. of evaluable patients; Pain: patient-reported pain (visual analog scale); PGA: physician global assessment; PtGA: patient global assessment of disease activity; TOF: tofacitinib.