Efficacy and safety of mirikizumab in psoriasis: results from a 52-week, double-blind, placebo-controlled, randomized withdrawal, phase III trial (OASIS-1).
Andrew BlauveltAlexa B KimballMatthias AugustinYukari OkuboMichael M WitteClaudia Rodriguez CaprilesAngelina SontagVipin AroraOlawale OsuntokunBruce E StroberPublished in: The British journal of dermatology (2022)
Mirikizumab was superior to placebo at week 16 and maintained efficacy through week 52, with no new safety signals. What is already known about this topic? Interleukin (IL)-23 is a key cytokine in the pathogenesis of psoriasis. Drugs targeting the p19 subunit of IL-23 have recently been approved for the treatment of adult patients with moderate-to-severe plaque psoriasis. Patients with moderate-to-severe plaque psoriasis achieved significantly greater improvements in skin measures and patient-reported quality-of-life measures after 16 weeks when treated every 8 weeks with mirikizumab compared with placebo in a phase II clinical trial. What does this study add? Compared with placebo, mirikizumab demonstrated high levels of efficacy at week 16 in a large phase III trial; safety profiles were similar between the mirikizumab and placebo arms. After week 16, patients maintained on doses of mirikizumab 250 mg every 8 weeks (Q8W) or 125 mg Q8W showed similar efficacy and favourable safety profiles over 52 weeks, whereas patients switched to placebo gradually lost efficacy over time.
Keyphrases
- placebo controlled
- phase iii
- double blind
- phase ii
- clinical trial
- open label
- study protocol
- patient reported
- phase ii study
- newly diagnosed
- end stage renal disease
- ejection fraction
- coronary artery disease
- patient reported outcomes
- prognostic factors
- chronic kidney disease
- squamous cell carcinoma
- high intensity
- randomized controlled trial
- radiation therapy
- drug induced
- preterm birth