The IMMhance study consisted of 2 phases: results from the first phase were previously reported, and showed that after 16 weeks of treatment, the selective IL-23 inhibitor risankizumab (n=407) met the co-primary endpoints Psoriasis Area and Severity Index (PASI) improvement by 90% and complete or almost complete clearance of skin lesions according to physicians global assessment (sPGA 0/1) vs placebo (n=100) (P<0.001). The second phase (week 28 through week 104) of this trial evaluated the efficacy and safety of continuous therapy with risankizumab vs randomised withdrawal, as well as re-treatment.
Patients who achieved sPGA 0/1 at week 28 with risankizumab were re-randomised to continue either risankizumab (n=111) every 12 weeks or to withdrawal (n=225). The primary endpoint in the second phase of the study was percentage of patients that reached sPGA 0/1 at 1 year; ranked secondary endpoint was achievement of sPGA 0/1 at week 104 (2 years) among re-randomised patients.
Both the primary and secondary endpoints were achieved for risankizumab compared with placebo (P<0.001; see Figure). Median time to relapse (sPGA >3) was significantly different between patients re-randomised to risankizumab compared with those re-randomised to placebo (placebo 295 days vs risankizumab not determinable due to low number of relapses in this group; P<0.01). In addition, an increasing proportion of patients treated with continuous risankizumab achieved PASI 100 and sPGA 0 over time during the treatment period in part B.
Figure: Primary and secondary efficacy endpoints of sPGA 0/1 at 1 and 2 years [1]
RZB, risankizumab; PB, placebo; sPGA, physician´s global assessment.
After 2 years, 81.1% of patients achieved sPGA 0/1. Among 153 patients re-randomised to placebo who relapsed, 83.7% regained sPGA 0/1 after re-treatment with risankizumab (re-treatment was started after the sPGA score regressed to ≥3 during withdrawal). Treatment-emergent adverse events were comparable across treatment groups at week 16 and in re-randomised arm from weeks 16-104. Most frequent treatment-emergent adverse events in all groups were infections. No new safety signals emerged over 2 years.
1. Blauvelt A, et al. Poster presented at 24th World Congress of Dermatology, 10-15 June 2019, Milan, Italy.
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Table of Contents: WCD 2019
Featured articles
Letter from the Editor
Insights into pathogenesis of AD define novel therapeutic targets
Treating Psoriasis in 2019
Choosing the right biologic in psoriasis
Registries – an important research tool in biologics
Atopic Dermatitis – What is New
Insights into pathogenesis of AD define novel therapeutic targets
Combinations are hot in AD treatment
Dermal Reactions to Systemic Drugs
Cutaneous adverse events due to EGFR inhibitors
Management strategies for drug-induced mucositis
Skin toxicity of immune checkpoint inhibitors
Lupus Erythematosus Today
New targets and biologics for cutaneous lupus erythematosus
Novel lupus classification will aid future research
Hidradenitis Suppurativa
Various guidelines with much overlap
Antibiotics in hidradenitis suppurativa
Biologicals beyond TNF blockade
Small Molecules – What to Expect
Novel treatment options for many dermatologic indications
Long awaited oral therapy for moderate-to-severe AD
Novel treatment options in alopecia areata and vitiligo
Optimising the Management of Keloids
Keloids: a faulty switch in wound healing?
What the future of keloid treatment could hold
Malignant Melanoma – Advances in Management
Will malignant melanoma become a curable disease?
Best of the Posters
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