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.
Bárdur SigurgeirssonJohn BrowningStephen TyringJacek Cezary SzepietowskiRaquel Rivera-DíazIsaak EffendyDeborah KeefeGerard BruinBertrand PaguetRong FuIsabelle HampeleMaximilian ReinhardtManmath PatekarPublished in: Dermatologic therapy (2022)
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.
Keyphrases
- double blind
- placebo controlled
- phase iii
- artificial intelligence
- ankylosing spondylitis
- open label
- clinical trial
- phase ii
- study protocol
- rheumatoid arthritis
- emergency department
- end stage renal disease
- newly diagnosed
- metabolic syndrome
- prognostic factors
- cross sectional
- chronic kidney disease
- skeletal muscle
- weight loss
- disease activity
- ultrasound guided
- preterm birth