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Guselkumab Response Durable in Psoriatic Arthritis

— Skin and joint improvements persisted through 2 years of follow-up

MedpageToday

The efficacy of the monoclonal antibody guselkumab (Tremfya) persisted through 2 years of follow-up among patients with active psoriatic arthritis (PsA), a researcher reported at the virtual American College of Rheumatology (ACR) annual meeting.

Among patients who continued on treatment with guselkumab through week 100, 20% improvements on the ACR's response criteria (ACR20) were observed in 76% of patients who were given the medication in doses of 100 mg every 4 weeks and in 74% of those treated every 8 weeks, noted Iain McInnes, MD, PhD, of the University of Glasgow in Scotland.

In addition, ACR50 responses were seen at week 100 in 56% and 55% of the groups receiving guselkumab every 4 weeks and every 8 weeks, respectively, while ACR70 responses were seen in 35% and 36%, he said during a poster session.

"Psoriatic arthritis is a heterogeneous disease that requires lifelong treatment, so the durability of response is an important consideration," he noted.

Guselkumab targets the p19 subunit of interleukin (IL)-23, which is approved for use in plaque psoriasis and PsA. The T helper 17 cell line has been implicated in the pathogenesis of both conditions, and IL-23 promotes the proliferation of T helper cells in psoriatic lesions.

The phase III trial, which was known as DISCOVER-2, initially randomized 739 patients who were biologic-naive to one of the two dose regimens or placebo for 24 weeks. At week 24, participants in the placebo group were switched to guselkumab 100 mg every 4 weeks. Ninety-six percent of patients remained in the study at week 24, 93% were still enrolled at week 52, and 88% at week 100.

Improvements on skin scores were observed at all time points. At week 24, 75% improvements in Psoriasis Area and Severity Index (PASI) scores were seen in 78% of the 4-week group and in 79% of the 8-week group, but in only 23% of the placebo group. But by week 100, the corresponding numbers were 83%, 82%, and 80%. PASI 100 scores at week 100 were observed in 59%, 53%, and 61%.

Radiographic progression, assessed by changes in Sharp-van der Heijde scores, was 0.75 during weeks 52 to 100 in the 4-week group and 0.46 in the 8-week group. In the placebo group, the scores were 1.24 by week 24, 0.51 from weeks 24 to 100 (after switching to guselkumab every 4 weeks), and 0.13 from weeks 52 to 100.

Physical function and quality-of-life measures also showed benefits through week 100.

Serious adverse events were reported throughout the study period in 9% of both guselkumab groups and in 7% of the placebo/4-week group, while serious infections occurred in 2%, 3%, and 3%, respectively. One patient in the placebo/4-week group died in a traffic accident.

"Thus, based on the totality of data, guselkumab shows a favorable risk-benefit ratio through 2 years of follow-up," McInnes concluded.

  • author['full_name']

    Nancy Walsh earned a BA in English literature from Salve Regina College in Newport, R.I.

Disclosures

The study was supported by Janssen.

McInnes reported financial relationships with Janssen, AbbVie, Amgen, Bristol Myers Squibb, Causeway, Eli Lilly, Gilead, Novartis, Pfizer, Sanofi Regeneron, and UCB.

Primary Source

American College of Rheumatology

McInnes I, et al "Efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through 2 years: results of a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naive patients with active psoriatic arthritis" ACR 2021; Abstract 1336.