Trial reportAnais brasileiros de dermatologia
Efficacy and safety of risankizumab versus methotrexate in patients with moderate-to-severe plaque psoriasis: results from IMMbrace, a randomized, double-blind, phase 3 study with an open-label extension period in Brazil.
Trial report in Anais brasileiros de dermatologia. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- New Tuberculosis Infection and Reactivation of Tuberculosis in Patients with Psoriasis or Psoriatic Arthritis Receiving IL-23 Inhibitors: A Systematic Literature Review.Dermatology and therapy · 2026Pooled it
- Evaluating Risankizumab's Long-Term Effects in Psoriasis Using Optical Coherence Tomography.Dermatology and therapy · 2026Article
- IL-23 Inhibitors in Psoriasis: What Have We Learnt so Far?Journal of inflammation research · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPsoriasis, a chronic, inflammatory skin disease, requires long-term therapy. Risankizumab is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit.
objectiveThe authors assessed the efficacy and safety of risankizumab compared with methotrexate in adults with moderate-to-severe plaque psoriasis.
methodsIMMbrace was a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study. Patients received subcutaneous risankizumab 150 mg at weeks 0, 4, and 16 plus oral placebo weekly, or oral methotrexate 5 mg weekly (with dose escalation up to 25 mg based on response and tolerability) plus subcutaneous placebo at weeks 0, 4, and 16. Primary efficacy endpoints were the proportions of patients who achieved ≥ 90% improvement in Psoriasis Area and Severity Index (PASI90) and static Physician's Global Assessment of clear/almost clear (sPGA 0/1) at week 28. Safety was also assessed.
resultsAmong 98 patients randomized (risankizumab, n = 50; methotrexate, n = 48), 95 completed the double-blind period. At week 28, significantly higher proportions of patients treated with risankizumab versus methotrexate achieved PASI90 (84.0% vs. 35.4%; p < 0.001); sPGA 0/1 was achieved by 90.0% and 64.6% of patients in the risankizumab and methotrexate groups (p ≤ 0.001). Risankizumab efficacy was maintained throughout week 112. Adverse event rates were similar in the two groups. STUDY LIMITATIONS: The sample size was small due to the difficulty of recruiting patients without methotrexate use.
conclusionsRisankizumab demonstrated superior efficacy over methotrexate at week 28; efficacy was maintained, and no new safety findings were observed through week 112.
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