Guselkumab sustains skin, joint improvements in biologic-naïve PsA through 2 years
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Guselkumab is associated with durable improvements in multiple psoriatic disease domains through 2 years, with no new safety findings, in patents who are biologic-naïve, according to data published in Arthritis & Rheumatology.
“Psoriatic arthritis is a heterogeneous disease that is life long and currently has no cure,” Iain B. McInnes, PhD, FRCP, of the University of Glasgow, in the United Kingdom, told Healio Rheumatology. “Despite recent successful developments across a range of modes of action, we remain in a position of unmet need as we try to optimize the management of PsA and maximize the number of patients in minimal disease activity or remission.”
To analyze the long-term efficacy and safety of guselkumab (Tremfya, Janssen) in patients with active PsA, McInnes and colleagues reported on the 2-year results of the phase 3 DISCOVER-2 trial. In that study, patients with active PsA despite prior nonbiologic therapy — enrolled from 118 sites in 13 countries — were randomized 1:1:1 to receive 100 mg of guselkumab every 4 weeks, 100 mg of guselkumab at week 0, week 5 and subsequently every 8 weeks, or placebo. Those in the placebo group ultimately switched to guselkumab 100 mg every 4 weeks at week 24.
Efficacy endpoints included ACR20, ACR 50 and ACR70 improvement measures, an Investigator’s Global Assessment of psoriasis (IGA) score of 0, enthesitis and dactylitis resolution, and changes in PsA-modified van der Heijde-Sharp (vdH-S) radiographic scores. For this analysis, the researchers analyzed clinical and radiographic data through week 100, with safety assessments continued through week 112.
According to the researchers, among the 739 patients randomized and treated in DISCOVER-2, 652 participated through week 100. Among the participants who received guselkumab, including those who switched from placebo, rates of ACR20/50/70 response ranged from 68% to 76%, 48% to 56% and 30% and 36% at week 100, respectively. Additionally, among these same groups, 55% to 67% achieved an IGA score of 0, with enthesitis and dactylitis resolution rates ranging from 62% to 70% and 72% to 83%, respectively.
Mean changes in PsA-modified vdH-S scores from week 52 to 100 ranged from 0.13 to 0.75 among the groups that received guselkumab. According to the researchers, this indicated that the low rates of radiographic progression reported among patients who used the drug at earlier times extended through week 100.
Among the 731 analyzed patients who received guselkumab through week 112, 8% demonstrated a serious adverse event, while 3% had a serious infection. There was one death, attributed to a traffic accident.
“This study increases our understanding of the potential that guselkumab can play in the treatment of PsA,” McInnes said. “In particular, it reports data that suggest that guselkumab is a well-tolerated therapeutic that can offer benefits across a range of tissue domains that are characteristic of the heterogeneous clinical presentation of PsA. In addition, the safety profile remains satisfactory, although clearly longer and larger follow up is essential in this regard.”
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