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Patient-Reported Outcomes Improve With RA Treatment

March 11, 2016

Clinically meaningful improvements across a broad range of outcomes were noted in patients with rheumatoid arthritis (RA) after adding either Xeljanz (tofacitinib) or Humira (adalimumab) to methotrexate, a new analysis shows.
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Results from the phase III ORAL Standard trial, published in Rheumatology, found that 67.03% of patients given 5 mg tofacitinib twice daily and 70.49% of those given 10 mg tofacitinib twice per day, as well as 4.89% of those given 40 mg of adalimumab once every 2 weeks, reported changes greater than the minimum clinically important difference (MCID) of -0.22 on the Health Assessment Questionnaire (HAQ) disability index, compared with 48.96% of those receiving placebo.

Researchers also noted improvements in quality of life for patients on the treatment. Health-related quality of life Short-Form-36 Physical and Mental Component Summaries (PCS and MCS) scores were highest for those taking tofacitinib 10 mg, with the greatest improvement of all 8 domains seen at 3 months when compared to patients on placebo (P <.05). Patients receiving the lower dose of tofacitinib or adalimumab reported statistically significant changes in PCS but not MCS scores.

Compare to placebo, tofacitinib was found to significantaly improve sleep and fatigue levels based on the Functional Assessment of Chronic Illness Therapy-Fatigue and the Medical Outcomes Study Sleep scales

"These results indicate that tofacitinib not only improves physical function, global assessments of disease activity, pain, and fatigue, but also other aspects of health-related quality of life, particularly well-being and emotional health of patients with RA," wrote the authors.



Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis. Rheumatology. doi:10.1093/rheumatology/kev442

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