Bimekizumab Efficacy by Prior Biologic Treatment in Patients with Moderate to Severe Hidradenitis Suppurativa: 48-Week Pooled Data from the Randomized, Double-Blind, Placebo-Controlled, Multicenter BE HEARD I and II Phase 3 Trials

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that presents with painful nodules and abscesses, purulent drainage, and scars. 1 • Prior biologic use may influence or be predictive of response to subsequent biologics in inflammatory conditions of skin, 2 but there is a lack of research investigating this influence in HS specifically.• BKZ, a humanized IgG1 monoclonal antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated clinically meaningful improvements in patients with HS. 3,4 • Here, we present efficacy of BKZ by prior biologic treatment in patients with moderate to severe HS. ObjectiveTo investigate the impact of prior biologic use on the efficacy of BKZ in patients with moderate to severe HS. Methods• BE HEARD I and II 5,6 were identically-designed, randomized, double-blind, placebo (PBO)-controlled phase 3 studies comprising initial (Weeks 0-16) and maintenance (Weeks 16-48) treatment periods (Figure 1).• Here, we report proportions of patients achieving a 50/75/90% HS Clinical Response (HiSCR50/75/90) and Dermatology Life Quality Index Minimal Clinically Important Difference (DLQI MCID; ≥4-point reduction in those with a score of ≥4 at baseline) for individuals who received prior biologic treatment for any indication vs those who were biologic-naïve across initial randomization groups from baseline through Week 48.• All prior biologic treatments received by patients were for HS; two patients initially included in the "prior biologic use" subgroup were switched to the "biologic-naive" subgroup, as they had not received true biologic therapy.• Data are reported using modified non-responder imputation (mNRI) and observed case (OC). Results Baseline Demographics• Of the 1,014 patients randomized at baseline, 18.8% (n=191) of patients had previously received biologic therapy and 81.2% (n=823) were biologic-naïve.• Sex, age and weight were similar across patients with prior biologic use and patients who were biologic-naïve (Table 1).• More patients with prior biologic use had Hurley Stage III compared to biologic-naïve patients (62.8% vs 40.0%;Table 1). Response by Prior Biologic Use• Among patients with a history of prior biologic use in the BKZ Q4W/Q4W, BKZ Q2W/Q4W, BKZ Q2W/Q2W, and PBO/BKZ Q2W groups, 49.0%, 49.4%, 56.2%, and 27.6% achieved HiSCR50 at Week 16, respectively (Figure 2A).-In biologic-naïve patients, responses with BKZ (57.5%, 57.4%, and 58.4%) were higher vs. PBO (34.5%) at Week 16, respectively (Figure 2B).• At Week 48, levels of HiSCR50 response were maintained or higher across treatment regimens vs. at Week 16 (Figure 2A-B).• HiSCR75/90 responses were also maintained through Week 48 across treatment regimens for both patients who had received prior biologic use and biologic-naïve patients (Tables 2 and3).• High proportions of DLQI MCID responders at Week 16 were also observed in both subgroups across treatment regimens, with responses maintained to Week 48 (Figure 2C-D). ConclusionsBKZ demonstrated consistent efficacy in the achievement and maintenance of HiSCR and DLQI MCID clinical responses to Week 48 regardless of prior biologic use in patients with moderate to severe HS.Greater levels of HiSCR clinical responses were observed for BKZ-treated patients vs. PBO-treated patients across prior biologic subgroups at Week 16.

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