Tofacitinib, an oral Janus kinase inhibitor, is approved for the treatment of rheumatoid arthritis (RA). An analysis compared patient-reported outcomes (PROs) from the ORAL Strategy trial, a phase 3b/4, triple-dummy, controlled trial that randomized patients with RA 1:1:1 to receive tofacitinib monotherapy 5 mg twice daily, tofacitinib 5 mg twice daily plus methotrexate (MTX), or subcutaneous adalimumab (40 mg every other week) plus MTX, with MTX dosed at 15 mg to 25 mg per week.
PROs were secondary end points of the trial, and included mean changes from baseline in patient global assessment (PtGA) of disease activity (visual analog scale [VAS]); arthritis pain (VAS); Health Assessment Questionnaire Disability Index (HAQ-DI); 36-Item Short Form Survey (SF-36); EuroQol 5-Dimensions Questionnaire; Work Productivity and Activity Impairment Questionnaire; Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and the proportion of patients reporting improvements in HAQ-DI ≥minimum clinically important difference (MCID; –0.22).
At months 6 and 12, all treatment groups showed similar mean changes from baseline in HAQ-DI scores as well as improvements in MCID. Between the tofacitinib plus MTX and adalimumab plus MTX arms, improvements in all PROs except FACIT-F were similar at months 6 and 12. For FACIT-F, there were significant improvements with tofacitinib combination therapy versus the adalimumab arm at month 6 but not month 12. The PROs relating to PtGA, patient pain, were improved with both combination arms (tofacitinib or adalimumab plus MTX) compared with tofacitinib monotherapy at months 6 and 12. Tofacitinib combination therapy showed improvements in SF-36 at months 6 and 12 versus tofacitinib monotherapy.
These results showed that patients with RA who had an inadequate response to MTX achieved clinically meaningful improvements in PROs with all 3 treatment regimens.
Source: Strand V, Mysler E, Moots RJ, et al. Tofacitinib with and without methotrexate versus adalimumab with methotrexate for the treatment of rheumatoid arthritis: patient-reported outcomes from a phase 3b/4 randomized trial. Arthritis Rheumatol. 2017;69(suppl 10). Abstract 1906.