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Tofacitinib, adalimumab similar in treatment of rheumatoid arthritis patients on MTX
Tofacitinib was similar to adalimumab and superior to placebo in treatment of patients with rheumatoid arthritis who were receiving methotrexate, according to a study.
During a 12-month, phase 3 trial of tofacitinib, researchers studied 717 patients (81.7% women) receiving stable methotrexate doses. Patients were assigned 5 mg (n=204) or 10 mg (n=201) tofacitinib twice daily or 40 mg adalimumab once every 2 weeks (n=204) or placebo (n=108). Placebo patients without a 20% reduction of swollen or tender joints at 3 months were switched to 5 mg or 10 mg of tofacitinib twice daily, with remaining patients receiving tofacitinib treatment at 6 months. Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) scores was measured at 3 months. At 6 months, percentages of patients with at least a 20% improvement in the American College of Rheumatology scale (ACR 20) and a Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]) of less than 2.6 were measured.
Tofacitinib 5-mg and 10-mg groups met ACR 20 criteria at a higher percentage (51.5% and 52.6%, respectively) than patients assigned adalimumab (47.2%) or placebo (28.3%) (P<.001, all comparisons). HAQ-DI score reductions were greater in tofacitinib and adalimumab groups compared with placebo. Patients with DAS28-4(ESR) below 2.6 were higher in percentage in active-treatment groups. Rates of serious adverse and infectious events through month 3 were higher in tofacitinib groups compared with placebo or adalimumab.
Rates of serious adverse events in months 6 to 12 were:
■ 4.9%, 5-mg tofacitinib
■ 3%, 10-mg tofacitinib
■ 3.4%, adalimumab.
Rates of serious infectious events in months 6 to 12 were:
■ 1%, 5-mg tofacitinib
■ 1.5%, 10-mg tofacitinib
■ .5%, adalimumab.
Two cases of pulmonary tuberculosis developed in the 10-mg tofacitinib group. Low- and high-density lipoprotein cholesterol levels increased and neutrophil counts decreased with tofacitinib.
“Patients from our study could continue taking tofacitinib as part of a long-term extension trial,” the researchers said. “The safety of tofacitinib should be evaluated in a larger number of patients who have received treatment for longer durations.”
Disclosure: See the study for a full list of relevant disclosures.