Guselkumab brings active psoriatic arthritis into ‘stringent’ control through 2 years
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Key takeaways:
- Patients with active PsA met disease control endpoints with guselkumab at 100 weeks.
- Across subgroups, 50% to 70% had complete skin clearance, while 65% to 85% had enthesitis/dactylitis resolution.
Guselkumab for psoriatic arthritis led to major improvements in joint disease activity, complete skin clearance and other “stringent” endpoints that were maintained through 2 years, according to data published in Clinical Rheumatology.
“In the phase 3, randomized, placebo-controlled DISCOVER-1 (1 year) and DISCOVER-2 (2 years) studies, guselkumab demonstrated significantly greater efficacy in improving PsA signs and symptoms across multiple domains versus placebo,” Christopher T. Ritchlin, MD, MPH, of the University of Rochester Medical Center, and colleagues wrote. “Additionally, the proportions of guselkumab-treated patients achieving meaningful responses across PsA domains were sustained or increased through up to 2 years.
“Of note, post hoc analyses of DISCOVER-2 found that among patients who achieved70% improvement in the ACR response criteria (ACR70), or met the composite minimal disease activity (MDA) criteria at 1 year, over 70% and 80%, respectively, maintained this response at 2 years,” they added. “Post hoc analyses of the pooled DISCOVER-1 and -2 studies further demonstrated that the efficacy of guselkumab through 1 year was consistent across assessed PsA patient subgroups defined by baseline clinical characteristics.”
To examine the extent of PsA disease control over a period of 2 years with guselkumab (Tremfya, Janssen) treatment, across multiple domains and patient-reported outcomes, Ritchlin and colleagues conducted a post-hoc analysis of data from the DISCOVER-2 trial. The analysis included 493 patients randomly assigned to receive guselkumab, 90% (n = 442) of whom completed 100 weeks of treatment.
Endpoints included ACR50/ACR70 improvement, a score of zero on the Investigator’s Global Assessment, resolution of dactylitis/enthesitis, at least a four-point improvement on the FACIT-Fatigue response, low disease activity on the PsA Disease Activity Score (PASDAS), and minimal disease activity. Patients were analyzed in subgroups based on sex, baseline medication use, BMI, PsA duration, number of swollen or tender joints, C-reactive protein levels and psoriasis severity and extent.
According to the researchers, guselkumab demonstrated significant multi-domain efficacy in “adequately sized patient subgroups.” Across the subgroups, the following were achieved at week 100:
- 65% to 85% demonstrated enthesitis/dactylitis resolution;
- 50% to 70% achieved IGA complete skin clearance;
- 60% to 80% reported meaningful improvements in function or fatigue;
- 40% to 65% achieved PASDAS low disease activity; and
- 35% to 50% achieved minimal disease activity.
“Substantial portions of adults with active PsA, who received up to 2 years of guselkumab in DISCOVER-2, showed durable achievement of stringent endpoints across key PsA disease domains and [patient-reported outcomes],” Ritchlin and colleagues wrote. “... Results of these analyses lend further support to guselkumab as an effective means of tailoring treatment to achieve low levels of disease activity across key domain involvement in individual patients.”
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