Safety and efficacy of mirikizumab versus secukinumab and placebo in the treatment of moderate-to-severe plaque psoriasis (OASIS-2): a phase 3, multicentre, randomised, double-blind study

Papp, K; Warren, RB; Green, L; Reich, K; Langley, RG; Paul, C; Asahina, A; Johnson, L; Arora, V; Osuntokun, O; Lebwohl, M

doi:10.1016/s2665-9913(23)00120-0

Safety and efficacy of mirikizumab versus secukinumab and placebo in the treatment of moderate-to-severe plaque psoriasis (OASIS-2): a phase 3, multicentre, randomised, double-blind study

Lancet RheumatolPublished 21 Aug 2023Randomised controlled trial

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Authors' conclusion

This trial showed superiority of mirikizumab at a dose of 250 mg over placebo in patients with moderate-to-severe plaque psoriasis, with a safety profile consistent with that of the IL-23 class.

Study context

Population: Adults with chronic plaque psoriasis ≥6 months, ≥10% body surface area (BSA), Psoriasis Area and Severity Index (PASI) ≥12 and Static Physician's Global Assessment (sPGA) ≥31,738 screened
Participants: 1,465 adults

Comparison: Mirikizumab 250 mg induction vs placebo
Mirikizumab 250/250 mgn = 454
Mirikizumab 250/125 mgn = 451
Secukinumab 300 mgn = 448
Placebon = 112reference
Primary endpoint: Co-primary: sPGA 0 or 1 with ≥2-point improvement, and PASI 90, mirikizumab 250 mg induction vs placebo (ITT)
Follow-up: Up to week 16

Methodological detailsphase 3, multicentre, double-blind, placebo-controlled, active comparator (secukinumab)

Phase 3
Multicentre
Double-blind
Placebo-controlled
Active comparator (secukinumab)

Primary result

As reported in the abstract

sPGA 0 or 1

Mirikizumab 250/250 mg79.7%721

Placebo6.3%7 of 112

P < 0.0001 for superiority

Further findings

Outcome	Mirikizumab 250/250 mg	P value
Co-primary: PASI 90 · up to week 16Mirikizumab 250/250 mg vs Placebo · mirikizumab figure is pooled mirikizumab groups, 673 of 905 · intention-to-treat	74.4% (95% CI 71.5–77.2)	P < 0.0001 for superiority

Co-primary: PASI 90: pooled mirikizumab groups: 673 of 905

Safety

Events

Outcome	Mirikizumab 250/250 mg	Secukinumab 300 mg	Placebo
MACE · up to week 16Mirikizumab count is for the mirikizumab groups combined	4	0	0

MACE — One fatal acute MI with mirikizumab, considered related to study drug: 1

Treatment-emergent adverse events · weeks 0-52

Reported with similar frequency across treatment groups

Reference

Authors: Papp K, Warren RB, Green L, Reich K, Langley RG, Paul C, et al.
All 11 authors
Papp K, Warren RB, Green L, Reich K, Langley RG, Paul C, Asahina A, Johnson L, Arora V, Osuntokun O, Lebwohl M
Journal: The Lancet Rheumatology
Published: 21 Aug 2023
DOI: 10.1016/s2665-9913(23)00120-0
PubMed: 38251498
Registration: NCT03535194

Intervention details

Mirikizumab 250/250 mg: 250 mg mirikizumab every 4 weeks for 16 weeks, then every 8 weeks from week 16 to week 52
Mirikizumab 250/125 mg: 250 mg mirikizumab every 4 weeks for 16 weeks, then 125 mg every 8 weeks from week 16 to 52
Secukinumab 300 mg: 300 mg secukinumab once weekly up to week 4, then every 4 weeks
Placebo: placebo every 4 weeks for 16 weeks, then 250 mg mirikizumab every 4 weeks from week 16 to 32 and every 8 weeks from week 32 to 52

Key notes

Intention-to-treat
Pooled mirikizumab 250 mg induction groups: 721 of 905

More notes

Mirikizumab figure is pooled 250 mg induction groups (both mirikizumab groups), 721 of 905

Original publication

Safety and efficacy of mirikizumab versus secukinumab and placebo in the treatment of moderate-to-severe plaque psoriasis (OASIS-2): a phase 3, multicentre, randomised, double-blind study. Lancet Rheumatol. Published 21 August 2023. doi:10.1016/s2665-9913(23)00120-0

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