Secukinumab gives early, sustained enthesitis resolution in PsA
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Patients with psoriatic arthritis treated with secukinumab demonstrated early and sustained resolution of enthesitis, with 300 mg doses providing higher resolution than 150 mg in more severe cases, according to data published in Arthritis Research & Therapy.
“This study provides more granular detail on responses specifically for enthesitis, which is typically only a secondary endpoint in most PsA trials,” Laura C. Coates, MBChB, PhD, of the University of Oxford, told Healio Rheumatology. “Enthesitis is an important feature of PsA and evidence on the treatments for enthesitis, including different doses, is helpful for clinicians in choosing therapy.”
Researchers conducted post hoc analyses of the FUTURE2 and FUTURE3 studies. According to the researchers, FUTURE 2 was a 5-year, randomized, double-blind, placebo-controlled study of 397 patients with active PsA. Participants were assigned 1:1:1 to receive either 300 mg, 150 mg or 75mg of secukinumab (Cosentyx, Novartis), or placebo, at baseline and weeks 1, 2, 3 and 4, and once every 4 weeks thereafter. In FUTURE 3, a 3-year study, 414 participants were randomly assigned 1:1:1 to receive either self-administered subcutaneous secukinumab 300 mg or 150 mg, or a placebo. Treatments were administered at baseline and weeks 1, 2, 3 and 4, and every 4 weeks thereafter.
In both studies, participants in the placebo group were re-randomized to receive 300 mg or 150 mg of secukinumab at week 16, for nonresponders, or week 24, for responders. In addition, the researchers used the Leeds Enthesitis Index to assess enthesitis in participants through week 104.
Coates and colleagues analyzed resolution of enthesitis count, median time to first resolution and shift analysis of baseline count to either full resolution, stable count or worse count. In addition, they evaluated multiple efficacy outcomes among participants with and without enthesitis.
According to the researchers, among the 712 patients included in their analysis, 65% had baseline enthesitis. In the overall population, 65% of participants who received 300 mg and 56% of those treated with 150 mg of secukinumab demonstrated full resolution by week 16, compared with 44% of those who were given placebo. Those figures later improved to 91% in the 300 mg secukinumab group and 88% in the 150 mg group at week 104. In addition, 89% of participants without baseline enthesitis maintained their status at week 104.
The median number of days to resolution of enthesitis count was shorter in both secukinumab groups — 57 in the 300 mg group and 85 for the 150 mg group — compared with 167days among patients treated with placebo. In participants with an enthesitis count of 1 or 2, shift analysis from baseline to week 24 demonstrated that more patients achieved full resolution with either secukinumab regimen compared with placebo. However, there was no difference between secukinumab and placebo among the more severe patients with counts of 3 to 6.
Increases in the proportions of patients achieving full resolution were observed with secukinumab no matter of the severity from baseline to week 104. Improvements in efficacy outcomes were similar across patients with or without enthesitis in the 300 mg group.
“We showed a very good response of enthesitis to secukinumab at both 150 and 300 mg doses over an extended study period of 2 years,” Coates said. “Both doses of secukinumab were fast acting to control enthesitis and the majority of individuals who responded maintained that response. We showed that slightly higher responses seemed to be seen with the higher dose, but the study was not planned for a direct comparison.”– by Jason Laday
Disclosure: The researchers report study funding from Novartis. Coates reports grant support from AbbVie, Pfizer, Novartis, Eli Lilly, Celgene and Janssen, as well as consulting fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Gilead, Galapagos, Pfizer, UCB, Novartis, Eli Lilly and Janssen. Please see the study for all other authors’ relevant financial disclosures.
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