Tofacitinib With Methotrexate in Third‐Line Treatment of Patients With Active Rheumatoid Arthritis: Patient‐Reported Outcomes From a Phase III Trial

• Published in: Arthritis care & research (2010) 2015-04, Vol.67 (4), p.475-483
• Main Authors: Strand, Vibeke, Burmester, Gerd R., Zerbini, Cristiano A. F., Mebus, Charles A., Zwillich, Samuel H., Gruben, David, Wallenstein, Gene V.
• Format: Article
• Language: English
• Subjects: Antirheumatic Agents - administration & dosage; Arthritis, Rheumatoid - diagnosis; Arthritis, Rheumatoid - drug therapy; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Methotrexate - administration & dosage; Middle Aged; Piperidines - administration & dosage; Pyrimidines - administration & dosage; Pyrroles - administration & dosage; Self Report; Treatment Outcome
• ISSN: 2151-464X; 2151-4658
• DOI: 10.1002/acr.22453

Objective To assess patient‐reported outcomes (PROs) for tofacitinib, an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA), in a 6‐month, phase III, randomized controlled trial. Methods Patients ages ≥18 years with active RA with an inadequate response to ≥1 tumor necrosis factor inhibitor (TNFi) and receiving stable background methotrexate were randomized 2:2:1:1 to tofacitinib 5 mg or 10 mg twice daily, or placebo advanced to tofacitinib 5 mg or 10 mg twice daily at month 3. PROs measured at month 3 included patient global assessment of disease activity (PtGA), pain, Health Assessment Questionnaire (HAQ) disability index (DI), Medical Outcomes Study (MOS) Short Form 36 Health Survey version 2 (SF‐36v2; acute), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT‐F), and MOS Sleep Scale. Results Patients received tofacitinib 5 mg (n = 133) or 10 mg (n = 134) or placebo advanced to tofacitinib 5 mg (n = 66) or 10 mg (n = 66). HAQ DI (reported previously), PtGA (P < 0.0001), and SF‐36v2 physical and mental component summary (P < 0.05) scores were improved for both tofacitinib doses versus placebo. Furthermore, improvements greater than or equal to the minimum clinically important difference were more frequently reported by tofacitinib‐treated patients versus placebo for PtGA (P < 0.05), pain (P < 0.0001), HAQ DI (P < 0.05), SF‐36v2 physical and mental component summary scores (P < 0.05), and FACIT‐F (P < 0.001 for 5 mg twice daily). No statistical differences were observed in the MOS Sleep Scale. Conclusion Tofacitinib treatment resulted in significant, clinically meaningful improvements in multiple PROs versus placebo over 3 months of treatment in patients with active RA and a previous inadequate response to TNFi.