You are here
Mease et al has reported in the NEJM the results of a phase 3 trial showing tofacitinib (Tofa) to be significantly more effective than placebo in active psoriatic arthritis (PsA) patients who previously failed to respond to tumor necrosis factor inhibitor (TNFi) therapies.
In a 6 mont trial, 395 PsA patients were randomized to receive either ofa 5 mg bid, Tofa 10 mg bid or placebo (PBO) patients who were switched to either 5 mg or 10 mg bid after 3 months. THe primary enpoints were ACR20 response and change in HAQ-DI at 3 months.
The ACR20 responses at 3 months were
- PBO 24%
- Tofa 5 mg 50%
- Tofa 10 mg 47% P<0.001 for both comparisons vs PO
- HAQ-DI score decreased −0.39 and −0.35, as compared with −0.14 (P<0.001)
Serious adverse events occurred in 4% of the patients who received the 5-mg dose of tofacitinib continuously and in 6% who received the 10-mg dose continuously. Over the course of 6 months, there were four serious infections, three herpes zoster infections, one myocardial infarction, and one ischemic stroke among the patients who received tofacitinib continuously.
These data were presented to the FDA and the Arthritis Advisory Committee in August 2017 and in part, lead to unanimous backing from the committee for drug approval.