The approval was based on data from a phase 3 study which evaluated tofacitinib in adults with active AS who had an inadequate response to at least 2 NSAIDs.
ACR/ARHP 2018 Annual Meeting
Although the incidence rate of venous thromboembolism was numerically higher in patients treated with tofacitinib vs TNF inhibitors, the risk was not statistically significant.
The addition of tofacitinib to rheumatoid arthritis (RA) treatment regimens improves patient response to non-biologic disease-modifying antirheumatic drugs (DMARDs).
For patients with rheumatoid arthritis, a novel oral Janus kinase inhibitor, tofacitinib, is associated with reduced symptoms when used as monotherapy or in addition to background methotrexate.
The clinical benefits of tofacitinib in combination with methotrexate are sustained over 2 years among patients with rheumatoid arthritis (RA), according to a study published online January 22 in Arthritis & Rheumatology.
Tofacitinib is superior to methotrexate in treating rheumatoid arthritis, but increased side effects were seen with tofacitinib, including development of herpes zoster.
A total of 18.5% patients taking tofacitinib experienced a remission of their condition in 8 weeks compared to just 8.2% of patients receiving placebo.
The researchers found that significantly more patients receiving tofacitinib 5mg and tofacitinib 10mg versus placebo achieved a ≥50% reduction in the Nail Psoriasis Severity Index (NAPSI) score from baseline (NAPSI50)
Tofacitinib slows the progression of joint damage and improves disease activity in patients with rheumatoid arthritis (RA).
ACR/ARHP Annual Meeting 2015
Clinical efficacy of the oral Janus kinase inhibitor tofacitinib at Month 6 was greater than placebo and "appeared similar regardless of methotrexate dose" in patients with rheumatoid arthritis a post-hoc analysis presented at the 2015 ACR/ARHP Annual Meeting has found.