Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. The treatment target for RA is remission or low disease activity (LDA). Routine assessment of patient index data 3 (RAPID3) consists of 3 patient-reported ACR RA core data set measures: function, pain, and patient global estimate of status. Here, we use RAPID3 to evaluate disease activity in RA patients treated with tofacitinib in 6 Phase 3 (P3) studies.

Methods: Data were analyzed from 6 P3 studies in which MTX-naïve patients or patients with inadequate response (IR) to MTX, biologic/conventional synthetic DMARDs, or TNF inhibitors (TNFi) received tofacitinib as monotherapy, or with MTX or other csDMARDs. ORAL Standard also included an adalimumab arm. All patients were required to meet the ACR classification criteria for the diagnosis of RA. To calculate RAPID3 scores, each of the 3 individual measures (HAQ-DI, pain visual analog scale [VAS], and patient global assessment VAS) was scored from 0–10 (HAQ-DI was scored from 0–3 × 3.33) for a total of 30, and divided by 3 to give an adjusted 0–10 score. Remission was defined as RAPID3 ≤1 and LDA was defined as RAPID3 ≤2. RAPID3 scores were calculated at the time of the primary endpoint of the index study (either 3 or 6 months) and at the end of each study (either 6, 12, or 24 months). Non-responder imputation was used for all comparisons between treatment and control groups. This analysis was post-hoc. No multiple comparison adjustment was done. 

Results: Of the 4,218 patients included in the P3 studies, 3,162 (75.0%) patients were treated with tofacitinib. Across studies, baseline demographics and disease characteristics were similar with the exception of shorter and longer disease duration in ORAL Start and ORAL Step, respectively. Mean RAPID3 score (0–10) at baseline ranged from 5.1 to 6.1 and the proportion of patients with RAPID3 LDA at baseline ranged from 2.8% to 6.3%. At the time of the primary endpoint, significantly (p<0.05) higher rates of RAPID3 remission and LDA were observed with tofacitinib 5 mg or 10 mg twice daily (BID) vs the control groups (placebo/MTX) in ORAL Standard, Start and Solo. Adalimumab was not significant vs placebo in ORAL Standard. In ORAL Scan (MTX-IR), ORAL Step (TNFi-IR) and ORAL Sync (DMARD-IR), higher rates of RAPID3 remission and LDA were observed vs placebo, respectively, however these were not consistently significant. At the end of each P3 study, the rates of RAPID3 remission and LDA were sustained or slightly increased vs at the time of the primary endpoint. Higher rates were seen in patients receiving tofacitinib 10 mg BID vs 5 mg BID (Table).

Conclusion: This analysis of the tofacitinib P3 studies demonstrated that patients receiving tofacitinib had improvements in the 3 patient-reported ACR RA core data set measures, and can achieve RAPID3-defined remission and LDA.