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Tofacitinib monotherapy lessened rheumatoid arthritis symptoms
Tofacitinib monotherapy reduced rheumatoid arthritis symptoms and improved physical function in patients with the disease, according to a study.
Researchers studied 610 patients (428 women) in the phase 3 trial of the novel oral Janus kinase inhibitor who were assigned 5 mg (n=243) or 10 mg (n=245) of tofacitinib twice daily or placebo for 3 months followed by 5 mg or 10 mg of tofacitinib twice daily (combined n=122). At 3 months, researchers measured the percentage of patients with at least 20% improvement in the American College of Rheumatology scale (ACR 20) and a Disease Activity Score for 28-joint counts based on the erythroycte sedimentation rate (DAS28-4[ESR]) of less than 2.6, as well as the change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) scores.
The tofacitinib groups met ACR 20 criteria at a higher percentage than the placebo groups (59.8% and 65.7% in 5 mg and 10 mg dosage, respectively, vs. 26.7% in combined placebo; P<.001 for both comparisons). HAQ-DI score reductions were greater in the 5-mg (−0.50 points) and 10-mg (−0.57 points) cohorts compared with the placebo groups (−.19 points; P<.001). Patients with a DAS28-4(ESR) of less than 2.6 were not significantly higher in percentage in the tofacitinib cohorts (5.6%, 5 mg; 8.7% 10 mg) compared with placebo groups (4.4%). Six patients receiving tofacitinib developed serious infections during 3 months. Three hundred thirty patients reported 701 adverse events, including upper respiratory tract infection, headache and diarrhea. Low-density lipoprotein cholesterol level elevations and neutrophil count reductions were associated with treatment. Patients were tested again at 6 months for safety measures and serious adverse effects.
“Continued use of background treatment with disease-modifying drugs was not necessary to achieve improvements in ACR responses and physical function over the course of 3 months,” the researchers said. “These clinical benefits will need to be weighed against the risk of serious infections and adverse effects … associated with tofacitinib therapy. The safety … must be evaluated in a larger number of patients who have received treatment for longer periods.”
Disclosure: See the study for a full list of relevant disclosures