The new data examines delivery system efficacy of either 1 secukinumab 300-mg dose in an autoinjector vs 2 doses of secukinumab 150-mg 1 mL pre-filled syringes.
Data from MATURE (NCT03589885), a phase 3b study investigating secukinumab (Cosentyx; Novartis) 300-mg in a 2mL autoinjector (UnoReady pen), today was presented at the European Academy of Dermatology and Venereology (EADV) 30th anniversary congress held virtually September 29 to October 2.1
Secukinumab is a biologic that reduces inflammation by blocking interleukin (IL)-17A. The MATURE study found that the 300-mg injections achieved a high efficacy and provided a convenient administration in adult patients with moderate to severe plaque psoriasis, which was measured with the Psoriasis Area and Severity Index (PASI) 75 and 90 vs placebo. The trial compared 1 secukinumab 300-mg in an autoinjector vs 2 doses of secukinumab 150-mg 1 mL pre-filled syringes and placebo.
“Chronic diseases like psoriasis can often be difficult to manage and adherence to treatments can be a challenge for patients,” said Bardur Sigurgeirsson, MD, University of Iceland, in Reykjavik, and lead author of the MATURE study. “This study shows that a 300-mg dose of Cosentyx can be delivered in 1 injection, making it more convenient and simpler for patients to use, without compromising efficacy or safety.”
The study enrolled 122 patients, 41 into secukinumab 300-mg/ 2 mL autoinjector, 41 in secukinumab in 2 150-mg/ 1 mL pre-filled syringe, and 40 into placebo and they were treated for 52 weeks. The PASI 90 non-responders in the placebo group were switched to secukinumab treatment at week 12.
At week 12, 95.1% of patients in the 300-mg autoinjector arm achieved PASI 75 compared to 83.3% of 150-mg syringes arm and 10% of the placebo arm. Similar results were shown for PASI 90 at week 12, with 75.6% of patients in the 300-mg autoinjector arm compared to 62.6% of 150-mg pre-filled syringes arm and 10% of placebo achieving.
The results at week 52 showed that for PASI 75 and PASI 90 patients on 300-mg of secukinumab via autoinjector achieved 92.7% and 73.2% respectively, vs 90.4% and 68.3% of patients treated with 150-mg pre-filled syringes, and 26.8% and 0% of placebo patients.
The study also demonstrated a high patient satisfaction, with all the patients in the secukinumab 300-mg autoinjector group reported being “very satisfied” and “satisfied” at week 28. The safety profile was consistent with previous studies and no new safety signals were observed.1
Also, higher quality of life (QOL) scores were reported in those in both groups treated with secukinumab, 71.1% with the autoinjector and 72.5% with the pre-filled syringe, vs placebo (8.1%) at week 12 and the high scores continued up to week 52 in both secukinumab groups.
“We’re always looking for ways to improve usability and adherence of all our therapies, so people get the most benefit and treatments are convenient to administer,” said Todd Fox, global head of medical affairs for immunology, hepatology, and dermatology, Novartis, Switzerland. “With the Cosentyx 300-mg autoinjector, people with psoriasis can better manage their symptoms with fewer injections. It’s great to know that all adults who trialed the Cosentyx UnoReady autoinjector said they were satisfied with how it worked.”
The UnoReady pen was approved for use in Europe in November 2020 for all patients requiring a 300-mg dose of secukinumab.
1. Sigurgeirsson B, Browning J, Tyring S, et al. High efficacy, safety, and tolerability of secukinumab injection with 2 mL auto-injector (300 mg) in adult patients with moderate to severe plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial. Presented at EADV 30th Annual Congress 2021. Abstract A2325.