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Tofacitinib combined with conventional disease-modifying antirheumatic drug therapy led to improvements in patient-reported outcomes, according to a recently published phase 3 trial.
Vibeke Strand, MD, at the Stanford University School of Medicine, and colleagues performed a 12-month phase 3 trial — called ORAL SYNC — of 795 patients with active rheumatoid arthritis who had a previous inadequate response to therapy with at least one disease-modifying antirheumatic drug (DMARD). Patients were randomized 4:4:1:1 to receive — for two times per day — either 5 mg of tofacitinib, 10 mg tofacitinib, placebo advanced to 5 mg tofacitinib or placebo advanced to 10 mg tofacitinib all in combination with background DMARD therapy. Patient-reported outcomes included patient global assessment of arthritis (PtGA), patient assessment of arthritis pain, Health assessment questionnaire disability index (HAQ-DI), SF-36, functional assessment of chronic illness therapy-fatigue (FACIT-F) and medical outcomes study sleep (MOS Sleep).
Vibeke Strand
At 3 months, there were significant improvements vs. placebo in PtGA, pain, HAQ-DI, eight SF-36 domains, FACIT-F and MOS Sleep in the 10-mg group and improvements in PtGA, pain, HAQ-DI, seven SF-36 domains, FACIT-F and MOS Sleep in the 5-mg group, which were sustained through 12 months. At 3 months, significantly more patients treated with tofacitinib reported improvements of greater than or equal to the minimum clinically important differences vs. placebo for all patient-reported outcomes, except for the SF-36 emotional domain, which remained significant for the 10-mg group only. – by Will Offit
Disclosure:Strand reports she received consulting fees and is an advisory board member for AbbVie, Amgen, Biogen Idec, BMS, Crescendo, Genentech/Roche, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer Inc., Regeneron, Sanofi, Takeda, UCB and Vertex; received consulting fees from Alder, AstraZeneca, Biotest, Celgene, Celltrion, Corrona LLC, Horizon, Hospira, Incyte, Merck, Serono and Protalex.
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