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Tofacitinib combination therapy led to improvements in patient-reported outcomes
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).
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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The efficacy of tofacitinib has been demonstrated in previous trials. I believe Strand and colleagues have provided important and useful information on how patients experience their disease while receiving tofacitinib in a randomized clinical trial.
The authors performed a well-designed phase 3 clinical trial in people we see in our practices every day – those with active rheumatoid arthritis (RA) despite taking at least one disease-modifying antirheumatic drugs (DMARDs). They demonstrated positive, statistically significant impacts on outcomes that are important to my patients. The patients entering this trial had substantial burden of disease as measured by SF-36.
These outcomes included patients’ global perception of their arthritis, pain experienced from their arthritis, associated fatigue they endured and the quality of sleep, as well as their perception of disability as measured by multiple accepted measures.
In the active arms of this study, patients showed improvements, greater than what is thought to be clinically meaningful – at 3 months – and this improvement was sustained at 12 months.
To the patients with RA who I treat, the impact on life (i.e., the experience of disease) is of utmost importance in the assessment of interventions. It is also important to me as a clinician. This study shows that interventions with tofacitinib, like the parenteral biologicals, make positive differences in lives when methotrexate alone or in combination with other conventional DMARDs has not.
The authors discuss potential limitations of the study. I think most of us would have liked to see data about the adverse reactions that may have occurred during the clinical trial to balance the demonstrated positive outcomes.