TUESDAY, Aug. 9 (HealthDay News) -- Tofacitinib with methotrexate (MTX) is effective, tolerable, and safe for patients with active rheumatoid arthritis (RA) and inadequate response to MTX alone, according to a study published in the August issue of Arthritis Care & Research.
Yoshiya Tanaka, M.D., Ph.D., from the University of Occupational and Environmental Health in Kitakyushu, Japan, and colleagues compared the efficacy, safety, and tolerability of oral tofacitinib (randomized to groups of 1, 3, 5 or 10 mg twice daily) with placebo in 140 Japanese patients with active RA currently taking MTX, who were having an inadequate response to MTX alone. Data for safety and efficacy were collected for weeks one, two, four, eight, and 12. The American College of Rheumatology 20 percent improvement criteria (ACR20) response rate at week 12 was the primary efficacy end point. The Health Assessment Questionnaire (HAQ), Disability Index (DI), and C-reactive protein (CRP) level were measured at week 12. The Disease Activity Score (DAS), ACR50, and ACR70 were also assessed.
The investigators found that, compared with placebo (14.3 percent), significant ACR20 response rates were seen at week 12 for twice-daily tofacitinib treatment groups of 1 mg (64.3 percent), 3 mg (77.8 percent), 5 mg (96.3 percent), and 10 mg (80.8 percent). Of the patients with high baseline disease activity, 72.7 percent of those treated with tofacitinib 10 mg twice daily achieved low disease activity at week 12. The ACR50, ACR70, HAQ, DI, DAS, and CRP showed significant improvement. Nasopharyngitis and raised alanine and aspartate aminotransferase were the most commonly reported adverse events (AEs), and were of mild to moderate severity. There were no deaths, but five patients had severe AEs.
"Tofacitinib in combination with MTX over 12 weeks was efficacious and had a manageable safety profile," the authors write.
Two authors disclosed financial relationships with the pharmaceutical industry including Pfizer, which funded the study.