(HealthDay News) – The addition of tofacitinib to rheumatoid arthritis (RA) treatment regimens improves patient response to non-biologic disease-modifying antirheumatic drugs (DMARDs), according to a study published in the Aug. 20 issue of the Annals of Internal Medicine.
Joel Kremer, MD, from Albany Medical College in New York, and colleagues conducted a one-year trial of tofacitinib in 792 patients with active RA despite non-biologic DMARD therapy seen at 114 centers in 19 countries. Patients were randomly assigned in a 4:4:1:1 ratio to oral tofacitinib (5 or 10mg twice daily) or placebo advanced to tofacitinib (5 or 10mg twice daily). Improvement was determined using American College of Rheumatology (ACR20) criteria; Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4 [ESR]) of less than 2.6; DAS28-4(ESR)-defined remission; and change in Health Assessment Questionnaire Disability Index (HAQ-DI) score.
The researchers found that, for the 5-mg and 10-mg tofacitinib groups, the mean treatment differences by ACR20 criteria compared with the combined placebo groups were 21.2 and 25.8 percent, respectively. The tofacitinib groups also had superior HAQ-DI scores (month three) and DAS28-4(ESR) less than 2.6 response rates (month six) compared to placebo. For patients receiving 5-mg tofacitinib, 10-mg tofacitinib, and placebo, the incidence rates of serious adverse events were 6.9, 7.3, and 10.9 events per 100 patient-years of exposure, respectively. Additionally, in the tofacitinib groups, neutrophil counts decreased, hemoglobin and low- and high-density lipoprotein cholesterol levels increased, and serum creatinine levels had small increases.
“Tofacitinib improved disease control in patients with active RA despite treatment with non-biologic DMARDs, primarily methotrexate,” the authors write.
This study was funded by Pfizer, the manufacturer of tofacitinib.