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Novel selective IL-23 blocker highly effective over 2 years

Conference
WCD 2019
Trial
Phase 3, IMMhance
Results of the phase B of the IMMhance study show that more than 80% of patients continuously treated with the IL-23 inhibitor risankizumab reach complete or almost complete clearance of their psoriasis after two years [1].

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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