Spesolimab for Hidradenitis Suppurativa: A Proof-of-Concept Study
Bibliographic record
Abstract
Introduction: Hidradenitis suppurativa (HS) is a chronic, inflammatory disorder characterized by painful inflammatory nodules (N), abscesses (A) and draining tunnels (dT), primarily affecting intertriginous areas. Interleukin-36 (IL-36) signaling has been notably expressed within HS inflammatory lesions. To address the need for targeted therapies, this Phase IIa proof-of-clinical-concept (PoCC) study (NCT04762277) explored the effect of spesolimab, an anti-IL-36 receptor monoclonal antibody, in patients with moderate-to-severe HS. Methods: Eligible patients (N=52) were randomized (2:1) to receive spesolimab or placebo (1200 mg intravenous dosing once weekly for three weeks [loading dose], followed by 1200 mg subcutaneous dosing every 2 weeks for 12 weeks). No formal statistical tests were performed, as this was an exploratory study. Of patients who completed the study, 45 were enrolled in an ongoing open-label extension (OLE) study (NCT04876391) with spesolimab. For each study, endpoints included change from baseline at Weeks 12 and 24 in total A, N and dT (ANdT) counts, and adverse events (AEs). Results: Mean changes from baseline at Week 12 in dT, A and total ANdT counts were -1.30, -0.53 and -4.87 in the spesolimab arm, and 1.07, 3.07 and -0.86 in the placebo arm, respectively. Mean changes in N count were numerically similar between the spesolimab (-3.00) and placebo (-5.00) arms. Of patients with ≥1 dT at baseline, a numerically greater proportion had a decrease in dT count at Week 12 in the spesolimab (16/24, 66.7%) versus the placebo (5/13, 38.5%) arm. Least squares mean changes from baseline in total AN count at Week 12 were -38.8% and -34.7% in the spesolimab and placebo arms, respectively, which may have been affected by higher baseline AN and N counts in the spesolimab versus placebo arm. In the OLE, patients originally randomized to spesolimab (n=30) achieved sustained reductions in dT count and in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 24. The safety profile of spesolimab was similar to that reported in other trials; among the 52 patients enrolled in the PoCC study, 77.8% (spesolimab) and 87.5% (placebo) of patients reported ≥1 AE. No patients receiving spesolimab reported serious AEs, and no new safety concerns were identified by Week 24. No deaths were reported. Conclusion: Our findings show that spesolimab was well tolerated and decreased all HS lesions. These results support the development of spesolimab in HS. This study was supported and funded by Boehringer Ingelheim.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".