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Studies confirm improvement achieved and maintained through one year of active treatment with similar scores for patients switching from placebo to guselkumab.
Guselkumab (Tremfya, Janssen Pharmaceutical Companies of Johnson & Johnson) improved fatigue in adult patients with active psoriatic arthritis (PsA) and maintained response through 52 weeks of active treatment, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale, according to data from 2 phase 3 trials.
Guselkumab improved fatigue during the placebo-controlled periods of both the DISCOVER-1 and DISCOVER-2 studies at week 24, and through one year of active treatment. In both studies, guselkumab had positive effects on fatigue, in addition to other clinical outcomes, including ACR20 response. Guselkumab is FDA-approved for administration as a 100 mg subcutaneous (SC) injection every eight weeks (q8w), following two starter doses at weeks 0 and 4.
· At week 24 in both studies, treatment with guselkumab led to greater improvements in FACIT-Fatigue scores compared with placebo, as early as week 16 in DISCOVER-1 and week 8 in DISCOVER-2, with 54%-63% of guselkumab patients achieving clinically meaningful improvement (≥4 points) in FACIT-Fatigue compared with 35%-46% of placebo patients (unadjusted P≤0.003).
FACIT-Fatigue least squares (LS) mean changes from baseline were 5.6 and 5.8 for q8w and every 4weeks (q4w), respectively, compared with 2.2 for placebo in DISCOVER-1, and 7.6 and 7.1 for q8w and q4w, respectively, compared with 3.6 for placebo in DISCOVER-2.
In both studies, guselkumab was well-tolerated through study completion, and adverse events (AEs) were generally consistent with previous studies of guselkumab and current prescribing information. Serious AEs and serious infections occurred in 4% and 1% of guselkumab-treated patients, respectively, in both DISCOVER-1 and DISCOVER-2.
"Data from the DISCOVER-1 and DISCOVER-2 studies demonstrating guselkumab reduced fatigue through 52 weeks provide evidence of an additional treatment benefit for patients with active PsA," said Alyssa Johnsen, MD, PhD, Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. "The positive outcomes in fatigue assessment add to the body of data for guselkumab, which has shown improvements in multiple clinical outcomes including joint symptoms, skin symptoms, soft tissue inflammation, and physical function."
Guselkumab was approved in July 2020 by the U.S. FDA for adult patients with active PsA, a chronic progressive disease characterized by painful joints and skin inflammation and is the first and only therapy approved for active PsA to have improvement in fatigue as measured by FACIT-F in the product label. (PsA) is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. Studies show that up to 30% of people with psoriasis also develop PsA. The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50 but can develop at any time. Nearly half of patients with PsA experience moderate fatigue and about 30 percent suffer from severe fatigue. Though the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.