Dual IL-17 blockade yields efficacy on joints and skin

A current analysis of phase 3 data evaluated patients with both psoriatic arthritis (PsA) and moderate-to-high grades of skin involvement. Favourable results for bimekizumab were not only seen for American College of Rheumatology (ACR) 50 but also Psoriasis Area and Severity Index (PASI) and swollen joint count (SJC).

Prof. Diamant Thaçi (University of Lübeck, Germany) presented results on the assessment of the IL-17 A/F inhibitor bimekizumab as a treatment for patients suffering from both PsA and active psoriasis up to 1 year [1]. The new analysis used data from the phase 3 trials BE OPTIMAL (NCT03895203) with patients naïve to biologic DMARDs and BE COMPLETE (NCT03896581) assessing patients with an inadequate prior response to TNF inhibitors.

BE OPTIMAL (BO) included 852 participants who received either placebo, adalimumab as a reference, or bimekizumab at a dose of 160 mg every 4 weeks. BE COMPLETE (BC) enrolled 400 participants who were randomised to placebo or bimekizumab at the same regimen. Both trials comprised a double-blind period to week 16 with a primary endpoint of ACR50 and an open-label extension up to week 52. Their inclusion criteria required a skin involvement of at least 3% of body surface area (BSA) at baseline.

At week 16, bimekizumab was superior to placebo in joint, radiographic, and skin outcomes in both trials [2,3]. At week 52, the overall results in BO showed ACR50 responses over 60% irrespective of starting on placebo up to week 16 [1]. In BC, the ACR50 response rates in the non-responder imputation (NRI) population were 47.7%/56.3% depending on being on the study drug since week 16 or from the start.

Prof. Thaçi pointed out that the analysis particularly looked at the subgroups with moderate (≥3 to ≤10%) and severe (≥10%) BSA involvement, as these patients are of special interest to dermatologists. ACR50 was achieved in 60.9%/56.3% (BO) and 41.3%/55.0% (BC) of patients with moderate BSA involvement. The corresponding values for BSA ≥10% were 64.6%/69.9% (BO) and 64.0%/58.2% (BC), respectively.

The target of ≤1 SJC was reached in BO and BC by overall 70–80%. In both trials, PASI scores of 1 or less were observed in 73–82% in the subgroups with a BSA ≥3 to ≤10% and 65.7–81.3% with a BSA of at least 10. The analysis also looked at the very high bar of ACR50 plus PASI100 response at week 52. “Roughly 50% of bDMARD-naïve patients in BO achieved that, while the TNF-experienced are also showing a very good response,” Prof. Thaçi revealed. For the subgroups with moderate and severe BSA involvement this combined response was achieved, for example in BO, in over 40% and over 50%.

For both trials, the safety profile was consistent with known results. Prof. Thaçi additionally indicated that all cases of candidiasis were mild or moderate.

1. 
   
   1. Thaçi D. Bimekizumab efficacy and safety in patients with active psoriatic arthritis and psoriasis: 52-week results from the BE OPTIMAL and BE COMPLETE phase 3 randomised, placebo-controlled studies. 4, EADV Congress 2023, 11–14 October, Berlin, Germany.
   2. McInnes IB, et al. Lancet. 2023;401:25–37.
   3. Merola JF, et al. Lancet. 2023;401:38–48.

 

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Posted on 28 November, 202328 November, 2023