New data from the phase 3 OPAL BROADEN clinical trial (ClinicalTrials.gov Identifier: NCT01882439) and the OPAL Beyond clinical trial (ClinicalTrials.gov Identifier: NCT01877668) showed statistically significant improvements in psoriatic arthritis (PsA) disease activity, as measured by American College of Rheumatology 20 (ACR20), with tofacitinib treatment at 3 months vs placebo.
The OPAL studies evaluated the safety and efficacy of tofacitinib citrate, a Janus kinase (JAK) inhibitor, in adults with active PsA with inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or to tumor necrosis factor inhibitors (TNFis), respectively.
OPAL Broaden, a 12-month trial with 3-month placebo-controlled period, evaluated the safety and efficacy of tofacitinib 5mg (n=107) and 10mg (n=104) twice daily vs. placebo in adults with active PsA who had an inadequate response to at least 1 csDMARD and who were TNF-inhibitor naive. It also included an active control arm of adalimumab 40mg (n=106) given every 2 weeks.
In this study, 50.5% of patients in the tofacitinib 5mg and 60.6% of patients in the 10mg group achieved ACR20 response vs. 33.3% of patients in the placebo group. Patients in the adalimumab group achieved ACR20 response at a rate of 51.9%.
OPAL Beyond, a 6-month duration trial with a 3-month placebo-controlled period, evaluated the safety and efficacy of tofacitinib 5mg (n=131) and 10mg (n=132) twice daily vs. placebo (n=131) in adults with active PsA with an inadequate response to at least 1 TNF inhibitor.
In this study, 49.6% in the tofacitinib 5mg group and 47.0% in the tofacitinib 10mg group achieved ACR20 response at 3 months, vs. 23.7% of patients in the placebo group.
For both studies, the changes from baseline in HAQ-DI score were statistically significantly greater with tofacitinib 5mg and 10mg twice daily compared to placebo at 4 months.
The study authors reported that the most common adverse events (AEs) in OPAL Broaden and OPAL Beyond over 12 and six months, respectively, were upper respiratory tract infection, nasopharyngitis and headache.
Multiple study authors disclosed financial relationships to Pfizer, the manufacturer of tofacitinib.
Gladman DD, Rigby W, Azevedo VF, Behrens F, Blanco R, Kaszuba A, Kudlacz E, Wang C, Menon S, Hendrikx T, Kanik KS. Efficacy and safety of tofacitinib in patients with active psoriatic arthritis and an inadequate response to tumor necrosis factor inhibitors: OPAL Beyond, a Randomized, Double Blind, Placebo-Controlled, Phase 3 Trial [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-of-tofacitinib-an-oral-janus-kinase-inhibitor-in-patients-with-active-psoriatic-arthritis-and-an-inadequate-response-to-tumor-necrosis-factor-inhibitors-opal-beyond-a-randomize/. Accessed November 19, 2016.
This article originally appeared on MPR