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. 2024 Jun 7;10(2):e152.
doi: 10.1097/JW9.0000000000000152. eCollection 2024 Jun.

Data wobbles in hidradenitis suppurativa clinical trials and potential contributing factors: a retrospective review

Corey L Snyder  1   2 , Ruby S Gibson  1 , Stella X Chen  1   3 , Martina L Porter  1   4 , Alexa B Kimball  1   4
Affiliations

Data wobbles in hidradenitis suppurativa clinical trials and potential contributing factors: a retrospective review

Corey L Snyder et al. Int J Womens Dermatol. .

Abstract

Background: In some hidradenitis suppurativa (HS) clinical trial study arms, there is an unexpected decline in efficacy between the penultimate visit and the prespecified primary endpoint week, which we have termed a "wobble."

Objective: We aimed to establish how often study arms in HS programs wobble.

Methods: In a retrospective review, we identified HS clinical trials listed on ClinicalTrials.gov testing systemic, nonantibiotic medications that utilized Hidradenitis Suppurativa Clinical Response (HiSCR) as an outcome measure. We identified study arms demonstrating greater improvement in a visit prior to the primary endpoint week. Baseline subject characteristics were compared between studies with HiSCR wobble and no HiSCR wobble.

Results: A total of 21 studies (randomized control trial [RCT], n = 14; open-label, n = 7) with 35 study drug arms (RCT, n = 27; open-label, n = 8) and 14 placebo arms were identified. HiSCR wobble occurred significantly more often in RCT compared to open-label study drug arms (11/27 [40.7%] vs 0/8 [0%]). In RCT study arms with HiSCR wobble, baseline draining fistula counts were significantly lower (2.3 vs 3.2), and numerically fewer Hurley stage 3 patients (33.2% vs 42.5%), lower weighted total abscess and nodule counts (12.1 vs 12.6), lower weighted dermatology life quality index scores (12.5 vs 14.5), and a higher proportion of female patients (63.9% vs 58.3%) were observed.

Limitations: Include low number of HS clinical trials and insufficient data reported in many studies to assess for wobble, degree of wobble, and to compare all baseline characteristics.

Conclusion: Nonlinear improvement in study arm response occurs in some HS RCTs. Potential contributing factors include a higher proportion of less severe patients at baseline and more female patients.

Keywords: acne inversa; biological products; clinical trial protocol; hidradenitis suppurativa; randomized controlled trial.

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Conflict of interest statement

The authors made the following disclosures: A.B.K.’s institution received grants from Abbvie, Admirx, Anapyts Bio, Aristea, Bristol Myers Squibb, Chemocentryx, Eli Lilly, Incyte, Janssen, Moonlake, Novartis, Pfizer, Prometheus, UCB; Sonoma Bio. she received consulting fees from Abbvie, Alumis, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Moonlake Novartis, Pfizer, Priovant, Sonoma Bio, Sanofi, UCB; Target RWE, Ventyx; and serves on the board of directors of Almirall. M.L.P. is a consultant and/or investigator for Abbvie, Alumis, Anaptys Bio, Aristea, Bayer, Bristol Meyers Squibb, Janssen, Eli Lilly, Moonlake, Novartis, Pfizer, Prometheus, Trifecta Clinical, UCB, Regeneron, Innovoderm, Bayer, Prometheus, and Incyte. S.X.C. is an investigator for Novartis, Moonlake, Prometheus, and UCB. R.S.G.’s fellowship was funded through the National Psoriasis Foundation. R.S.G. is an investigator for Abbvie, Janssen, Regeneron, Eli Lilly, Novartis, UCB, Aristea, Incyte, Innovoderm, Bayer, and Moonlake. C.L.S. declares no conflicts of interest.

Figures

Fig. 1.
Fig. 1.
Inclusion/exclusion algorithm. HiSCR, Hidradenitis Suppurativa Clinical Response; RCT, randomized control trial.
See this image and copyright information in PMC

References

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