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Evaluation of disease activity in patients with rheumatoid arthritis treated with tofacitinib by RAPID3: Post hoc analyses from two phase 3 trials

Clinical Rheumatology Apr 19, 2018

Strand V, et al. - Authors analyzed the association between disease activity in patients with rheumatoid arthritis and long-term outcomes at 24 months according to Routine Assessment of Patient Index Data 3 (RAPID3) after 6-month treatment with tofacitinib (an oral Janus kinase inhibitor). The use of RAPID3 to monitor longer-term disease activity in conjunction with physician-assessed measures was supported by the results.

Methods

  • Researchers conducted a post hoc analysis of two 24-month, phase 3, randomized controlled trials in methotrexate (MTX)-naïve (ORAL Start [NCT01039688]) or MTX-inadequate responder patients (ORAL Scan [NCT00847613]) receiving tofacitinib 5 or 10mg twice daily (BID) as monotherapy or with background MTX.
  • They calculated the RAPID3 scores at baseline, month (M)6, and M24, and defined as remission (≤3), low (LDA; >3-≤6), moderate (MDA; >6-≤12), or high disease activity (HDA; >12).
  • Experts assessed the clinical Disease Activity Index (CDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI) scores, and radiographic non-progression (modified Total Sharp Scores ≤0) at M24 by M6 RAPID3 response.

Results

  • As per data, amomg patients receiving tofacitinib 5 or 10 mg BID, respectively, 42.2 and 51.5% (ORAL Start) and 29.8 and 39.0% (ORAL Scan) achieved RAPID3 remission/LDA at M6.
  • Findings suggested that RAPID3 responses at M24 were maintained/improved by most patients.
  • Results demonstrated a higher proportion of patients in RAPID3 remission/LDA vs MDA/HDA at M6 to achieve CDAI remission, report normative HAQ-DI scores (<0.5), and achieve both normative HAQ-DI scores and radiographic non-progression at M24.
  • Compared to patients with MDA/HDA, patients achieving RAPID3 remission/LDA after 6-month treatment with tofacitinib 5 or 10 mg BID had improved long-term outcomes.

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