The study, which was conducted by an international team of investigators and presented at the Congress of Clinical Rheumatology (CCR) West 2019 annual meeting, found the median time to 30% or greater improvement in pain in the 5 mg twice daily was 55 days, which was almost half of the 110 days noted in the placebo group.
In an effort to assess the time to clinically meaningful pain improvement in patients, investigators conducted retrospective analysis of 2 randomized, placebo-controlled, double-blind Phase 3 studies of tofacitinib—OPAL Beyond and OPAL Broaden. Assessment of pain were measured through arthritis pain severity reported by patients using a 0 to 100 mm visual analogue scale.
Assessments were performed at baseline, week 2, months 1, 2, 3, 4 and 6 for both studies. Investigators noted because OPAL Broaden was 6 months longer than OPAL Beyond, they included assessments from months 9 and 12 in OPAL BROADEN.
Investigators choose thresholds of 30% or more, 50% or more, and 70% or more to assess time to improvement in patients. Initial improvement was defined as time to the first post-baseline day a a patient reached an improvement threshold relative to baseline and established improvement was defined as time to a pain improvement threshold that was sustained for at least 2 consecutive visits.
Upon analyses, investigators found approximately 45% of patients in both studies receiving tofacitinib experienced 30% or greater improvement of pain by month 1 and that number increased to 55% at month 2. Investigators noted this number was greater than those in the placebo group.
In patients who switched from placebo to tofacitinib at month 3, the proportion of patients who reached a pain improvement threshold relative to baseline was similar to those who received tofacitinib at baseline by month 6 in both studies.
A Kaplan-Meier nonparametric model applied to data from both studies found that patients who received tofacitinib appeared to achieve initial and established pain improvements more quickly than patients who received placebo.
“In patients with active PsA, clinically meaningful improvement were achieved faster in patients who received tofacitinib 5 mg BID, compared with patients who received placebo,” investigators wrote.
This study, “Median time to pain improvement in patients with psoriatic arthritis treated with tofacitinib,” was presented at CCR West 2019.