Guselkumab Demonstrates Efficacy in Biologic-Naive or TNFi-Treated Patients With Psoriatic Arthritis

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ATLANTA — Guselkumab may demonstrate efficacy at 4 and 8 weeks for physical function, joint and skin symptoms, and quality of life among patients with psoriatic arthritis, according to research results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia.

The safety and efficacy of guselkumab was assessed in DISCOVER-1 (ClinicalTrials.gov Identifier: NCT03162796), a phase 3, double-blind, placebo-controlled trial. The study included data from adult patients with active PsA despite standard therapies (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], nonbiologic disease-modifying antirheumatic drugs [DMARDs], or apremilast) who were biologic-naive or with prior TNFi treatment. Active PsA was defined as having ≥3 swollen+≥3 tender joints and C-reactive protein (CRP) ≥0.3mg/dL. Patients were randomly assigned 1:1:1 to guselkumab 100 mg every 4 weeks, guselkumab 100 mg at week 0, 4, every 8 weeks, or placebo. Patients were stratified by week 0 DMARD use or nonuse and prior TNFi use or nonuse. Stable concomitant use of oral corticosteroids, nonbiologic DMARDs, and NSAIDs was allowed. Patients with <5% improvement in tender+swollen joints could increase or initiate the dose of permitted medications while continuing study treatment.

The primary study end point was week 24 ACR20. Major secondary end points included Investigator’s Global Assessment (IGA) psoriasis response (IGA=0/1 + ≥2-grade reduction) at week 24 in patients with ≥3% body surface area (BSA) psoriasis and IGA ≥2 at week 0; changes in Disease Activity Score 28-CRP, Short Form 36 Physical Component Score (SF-36 PCS), Health Assessment Questionnaire Disability Index (HAQ-DI) scores, and ACR50/70 response at week 24; and ACR20/50 response at week 16.

Among the data of 381 patients treated and analyzed, baseline characteristics were consistent with moderate-to-severe psoriasis (mean BSA involved with psoriasis, 13.4%; patients with IGA=3-4, 42.5%; mean swollen/tender joint counts, 9.8/19.3). Compared with placebo, significantly more patients who received guselkumab every 4 weeks and every 8 weeks achieved ACR20 response at week 24 (22.2%, 58.6%, and 52.8%, respectively), with consistent response rates observed in the subgroups with or without prior TNFi use. Significantly greater HAQ-DI and SF-36 PCS score improvements were seen in the guselkumab vs placebo group from week 0 to week 24.

Of the 249 patients with ≥3% BSA psoriasis and IGA ≥2 at week 0, significantly more patients treated with guselkumab than placebo achieved IGA response. A higher percentage of patients achieved ACR20 response at week 16, ACR50 response at week 16/24, ACR70 response at week 24, and PASI75/90/100 responses at week 24. More patients treated with guselkumab every 4 and 8 weeks vs placebo achieved MDA response at week 24.

Serious infections, adverse events, and death occurred in 2 (0.5%), 9 (2.4%), and 1 (0.3%) patient/s, respectively.

“In [patients] with active PsA who were biologic-naive or had been treated with TNFi, both [guselkumab every 4 and 8 weeks] demonstrated efficacy for joint and skin symptoms, physical function, and quality of life relative to [placebo]. Observed [adverse events] were consistent with [guselkumab] safety established in psoriasis.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Reference

Deodhar A, Helliwell P, Boencke W-H, et al. Guselkumab, an anti-interleukin-23p19 monoclonal antibody, in patients with active psoriatic arthritis who were biologic-naïve or prior TNFα inhibitor-treated: Week 24 results of a phase 3, randomized, double-blind, placebo-controlled study. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 807.

This article originally appeared on Rheumatology Advisor