Guselkumab Reduces Fatigue in Psoriatic Arthritis Patients

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In a study that examined the effects of guselkumab (Tremfya, Janssen) on fatigue in patients with psoriatic arthritis, the treatment reduced fatigue through one year, according to researchers reporting at the annual meeting of the American College of Rheumatology on Friday.

Guselkumab is an interleukin-23 inhibitor that is approved in psoriatic arthritis. Two phase 3 trials, DISCOVER 1 & 2, have shown that treatment with guselkumab led to improvement in American College of Rheumatology 20 (ACR20) clinical response up 24 weeks in 1,078 patients with psoriatic arthritis. This improvement was maintained through one year.

This study, which analyzed data from the DISCOVER 1 & 2 trials, was led by Proton Rahman, M.D., F.R.C.P.C., professor of medicine at theMemorial University of Newfoundland in St John's, Canada. It included patients with active psoriatic arthritis who were randomized to receive subcutaneous guselkumab 100 mg every four weeks or every eight weeks, or placebo. At week 24, patients receiving placebo were switched to guselkumab 100 mg every four weeks.

Fatigue was assessed by the patient reported outcome FACIT-Fatigue score.At baseline, the mean FACIT-Fatigue scores were 30.4 and 29.7 for DICOVER 1 & 2, respectively, indicating that patients with psoriatic arthritis experienced fatigue worse than the general population.

At 24 weeks, treatment with guselkumab

led to significant improvements in FACIT-Fatigue scores (≥4 points) compared with placebo (54 percent to 63 percent versus 35 percent to 46 percent, P≤0.003). Improvements in fatigue were similar between the two guselkumab doses and were maintained through one year.

After switching to guselkumab at weeks 24, placebo patients achieved FACIT-Fatigue scores that were comparable to those of guselkumab patients. At one year, 61 percent to 70 percent of both guselkumab and placebo-to-guselkumab groups achieved clinically meaningful improvement in FACIT-Fatigue.

Further evaluation, after adjustment for ACR20 response, at week 24 showed guselkumab had independent positive treatment effects on fatigue, of 12 percent to 36 percent in the eight weekly dosing group and 69 percent to 70 percent in the four weekly dosing group.

“Using mediation analysis and questionnaires specifically developed for fatigue, it was shown that guselkumab can improve fatigue scores for one year and this improvement was independent from improvement in the joint scores,” Dr. Rahman said.

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REFERENCE

ABSTRACT: 0347.“In Two Phase-3 Trials, Guselkumab Reduced Fatigue over 52 Weeks in Patients with Psoriatic Arthritis and Demonstrated Independent Treatment Effects on Fatigue After Adjustment for Clinical Response (ACR20).”The annual meeting of the American College of Rheumatology. 11:00 AM, Friday, Nov. 6, 2020.