VIENNA – In a head-to-head match-up of anti-psoriasis treatments, more patients treated with guselkumab (Tremfya) reached the primary endpoint of achieving almost clear skin as assessed by the Psoriasis Area and Severity Index (PASI) compared to treatment with secukinumab (Cosentyx), researchers reported here.
After 48 weeks, 84.5% of the 534 patients assigned to received guselkumab had been assessed as achieving a PASI 90 compared with 70.0% of the 514 patients assigned to treatment with secukinumab (P<0.001), reported Robert Langley, MD, of Dalhousie University, Halifax, Nova Scotia.
In the major secondary endpoint of PASI 75 achievement at week 12 and at Week 48, Langley said 84.6% of guselkumab patients achieved this endpoint compared to 80.2% of patients who were taking secukinumab. That meant guselkumab was non-inferior to secukinumab (P<0.001).
However, it fell short of showing significance for superiority for reaching PASI 75 (P=0.062).
In his oral late-breaker presentation at the biennial Inflammatory Skin Disease Summit, Langley called ECLIPSE “the first head-to-head study” to compare long-term results with the IL-23 inhibitor guselkumab against secukinumab, an IL-17 inhibitor.
“As there are limits to cross-trial comparisons, head-to-head trials of biologics may be required for regulatory purposes, are of interest to clinicians, and provide direct efficacy and safety comparisons,” he said.
As the trial progressed, each drug appeared superior to the other at some point. Secukinumab held an advantage in the first 12 weeks of the trial. But by week 20, its effectiveness appeared to wane somewhat while there was a plateau effect among patients on guselkumab that continued out to week 48.
Langley said that in the hierarchy of secondary endpoints, the failure to achieve superiority at PASI 75 meant that other secondary endpoints have to be considered “nominal.” Among those endpoints was achievement of PASI 100, or complete clearance of plaques. He said 58.2% of the patients taking guselkumab achieved that milestone compared with 48.4% of patients on secukinumab (P<0.001 for both non-inferiority and superiority).
In other secondary endpoints, the Investigator’s Global Assessment score of cleared lesions at week 48 was 62.2% of the patients on guselkumab and 50.4% of patients on secukinumab (P<0.001 for non-inferiority and superiority).
The patients in the study had a mean weight of 89 kg; their mean PASI score at baseline was 20; about 29% of the patients had been on biologic agents before entering the study. About 76% of the patients in both groups were diagnosed with moderate plaque psoriasis; about 23% were diagnosed with severe plaque psoriasis.
Guselkumab was given at 100 mg subcutaneously on weeks 1 and 4 and then once every other month. The secukinumab patients received 300 mg subcutaneously every week for the first 5 weeks and then once monthly through week 48. Guselkumab patients received placebo injections to maintain blinding.
Adverse events were similar between the two drugs. Langley said that 6.2% of patients on guselkumab experienced one or more serious adverse events compared with 7.2% of the patients assigned to secukinumab.
Incidence of infections was lower in the patients on guselkumab, with 12 of those patients experiencing superficial Candida infections and nine patients developing Tinea infections compared with 39 Candida and 23 Tinea infections among the secukinumab patients.
“Both molecules are highly efficacious with excellent safety profiles,” Langley said.
In commenting on the trial, session co-moderator Erwin Tschachler, MD, professor of dermatology at the Medical University of Vienna, told MedPage Today, that there was a message between the lines of the study. “What we see is that in the future we will have combination therapy, because you see this quick rise with the anti-IL-17 molecule secukinumab and the long-lasting effect with the anti-IL-23 molecule guselkumab.”
“So hidden in this data might be the future that we can combine some of these agents,” he said.
The study was supported by Janssen.
Langley disclosed relevant relationships with AbbVie, Amgen, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Lilly, Merck, Novartis, and Pfizer.
Tchachler disclosed no relevant relationships with industry.