Background/Purpose: Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). RA affects all domains of health-related quality of life (HR-QoL), which patients report being more important to them than the joint counts and laboratory tests favored by many physicians.¹

Objectives: To compare improvements in HR‑QoL using the Medical Outcomes Survey Short Form-36 (SF-36) by Health Assessment Questionnaire-Disability Index (HAQ-DI) responders (based on improvement ≥0.3) and non-responders in the tofacitinib database at Month 3, by treatment.

Methods: Data are reported from 3 double-blind randomized controlled Phase 3 trials of tofacitinib: a) 6-month tofacitinib monotherapy in patients with an inadequate response (IR) to nonbiologic or biologic disease-modifying antirheumatic drugs (DMARDs) (ORAL Solo, NCT00814307); b) 12-month tofacitinib with methotrexate (MTX) combination in MTX-IR patients (ORAL Standard, NCT00853385); and c) 6-month tofacitinib with MTX combination in tumor necrosis factor inhibitors (TNFi)-IR patients (ORAL Step, NCT00960440). Patients were randomized to tofacitinib 5 mg or 10 mg BID, placebo or adalimumab (ADA; in ORAL Standard only).

Results: For each treatment group in ORAL Solo, regardless of HAQ-DI responder status, there were significant correlations between changes from baseline in HAQ-DI and SF-36 Physical Component Scores [PCS] at Month 3: tofacitinib 5 mg, r = ‑0.55 (N= 230; P<0.0001); 10 mg, r = -0.56 (N= 222; P<0.0001) placebo, r = -0.51 (N= 107; P<0.0001). HAQ-DI responders reported consistently greater improvements in all 8 domains of SF-36 compared with non-responders, all of which exceeded MCID (Table). This was similarly true when analyzed by treatment group, where HAQ-DI responders reported large improvements in BP and VT as well as PF, RP and GH domains (Table). Results from ORAL Standard and ORAL Step were similar.

Conclusion: In 3 Phase 3 trials of tofacitinib as monotherapy or in combination with MTX, there were positive correlations between improvements in physical function by HAQ-DI and all domains of HR-QoL by SF-36 – particularly physical, pain and vitality domains.

References:    1.         Kirwan JR et al. J Rheumatol 2005; 32: 2250-2256.