Secukinumab demonstrates efficacy, safety, and tolerability upon administration by 2 ml autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial

Bárður Sigurgeirsson, John Browning, Stephen Tyring, Jacek C. Szepietowski, Raquel Rivera-Díaz, Isaak Effendy, Deborah Keefe, Gerard Bruin, Bertrand Paguet, Rong Fu, Isabelle Hampele, Maximilian Reinhardt, Manmath Patekar

Rannsóknarafurð: Framlag til fræðitímaritsGreinritrýni

Útdráttur

Convenient administration is an important factor for treatment adherence in patients with psoriasis. MATURE study reports the efficacy, safety, tolerability, and pharmacokinetics (PKs) of secukinumab 300 mg 2 ml autoinjector (AI) from MATURE trial (NCT03589885). Eligible patients were randomized to secukinumab 300 mg 2 ml AI or 2× 1 ml prefilled syringe (PFS) or placebo. The co-primary endpoints were psoriasis area and severity index (PASI) 75 and investigator's global assessment (IGA) 0/1 response rates at Week 12 versus placebo. Other endpoints included PASI90/100 response, dermatology life quality index (DLQI) 0/1, PKs, 2 ml AI usability rated using self-injection assessment questionnaire (SIAQ), and safety. The study met both co-primary and secondary endpoints (p < 0.0001). Secukinumab 300 mg 2 ml AI and 2× 1 ml PFS treatments led to superior PASI75/90/100 (2 ml AI: 95.1%/75.6%/43.9%; 2× 1 mL PFS: 83.2%/62.6%/37.5% and placebo: 10%/5.0%/0.0%, respectively), IGA, and DLQI 0/1 responses compared with placebo, and efficacy was sustained through 52 weeks. SIAQ results showed high usability of self-injection with 2 mL AI device. No new safety signals were observed. Study design may bias the interpretation of safety profile after Week 12, due to different exposure of secukinumab versus placebo. Secukinumab 300 mg administered with the 2 mL AI demonstrated superior efficacy over placebo, good tolerability, and convenient administration.

Upprunalegt tungumálEnska
FræðitímaritDermatologic Therapy
Snemmbirting á neti21 des. 2021
DOI
ÚtgáfustaðaÚtgefið - mar. 2022

Athugasemd

Funding Information:
This investigation was sponsored by Novartis Pharma AG, Basel, Switzerland. Funding information

Publisher Copyright:
© 2021 Wiley Periodicals LLC.

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