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Dermatology

Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis SuppurativaThe SHARPS Randomized Clinical Trial

Educational objective To determine the efficacy and safety of adalimumab in conjunction with surgery in adults with moderate to severe hidradenitis suppurativa.

1 Credit CME

JAMA Surgery

Published Online: August 18, 2021

Original Investigation

Article Information and Disclosures

Falk G. Bechara, MD¹;

Maurizio Podda, MD²;

Errol P. Prens, MD, PhD³;

Barbara Horváth, MD, PhD⁴;

Evangelos J. Giamarellos-Bourboulis, MD, PhD⁵;

Afsaneh Alavi, MSc, MD⁶;

Jacek C. Szepietowski, MD, PhD⁷;

Joslyn Kirby, MD, MS, MEd⁸;

Ziqian Geng, PhD⁹;

Christine Jean, PhD⁹;

Gregor B. E. Jemec, MD, DMSc¹⁰;

Christos C. Zouboulis, MD, PhD^11,12,13,14

Author Affiliations

¹Department of Dermatology, Venereology, and Allergology, St Josef Hospital, Ruhr-University Bochum, Bochum, Germany
²Department of Dermatology, Medical Center Klinikum Darmstadt, Teaching Hospital Goethe-University Frankfurt, Darmstadt, Germany
³Department of Dermatology, Erasmus University Medical Center, Rotterdam, the Netherlands
⁴Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
⁵4th Department of Internal Medicine, National and Kapodistrian University of Athens Medical School, Athens, Greece
⁶Division of Dermatology, Women’s College Hospital, University of Toronto, Toronto, Ontario, Canada
⁷Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland
⁸Department of Dermatology, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania
⁹AbbVie Inc, North Chicago, Illinois
¹⁰Department of Dermatology, Zealand University Hospital, Roskilde, Denmark
¹¹Department of Dermatology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany
¹²Department of Venereology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany
¹³Department of Allergology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany
¹⁴Department of Immunology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany

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Key Points

Question What is the efficacy and safety of adalimumab in conjunction with surgery in adult patients with moderate to severe hidradenitis suppurativa (HS)?

Findings In this randomized clinical trial of 206 patients, significantly more patients receiving adalimumab achieved HS clinical response across all body regions vs placebo at week 12 and improvements in quality of life.

Meaning Adalimumab was efficacious in patients with HS, with no need to interrupt treatment prior to surgery; these findings may help to guide medical treatment decisions for patients with HS who are candidates for surgery.

Abstract

Importance Surgery is a mainstay in the management of hidradenitis suppurativa (HS). Adalimumab is the first drug approved for HS.

Objective To investigate the efficacy and safety of adalimumab in combination with wide-excision surgery followed by secondary intention healing.

Design, Setting, and Participants The Safety and Efficacy of Adalimumab for Hidradenitis Suppurativa Peri-Surgically (SHARPS) trial was a phase 4, randomized, double-blind, placebo-controlled study of adalimumab in conjunction with surgery. Patients were enrolled in 45 sites across 20 countries from July 18, 2016, to February 2, 2019, with the last patient visit on October 16, 2019. Eligible patients (aged 18-65 years) had moderate to severe HS that required radical surgery in an axillary or inguinal region and had 2 other anatomical regions affected, with 1 or more regions at Hurley stage II or III. Analysis was conducted in November 2019.

Interventions Patients were randomized 1:1 to receive continuous adalimumab, 40 mg, or placebo during presurgery (12 weeks), perioperative (2 weeks), and postoperative (10 weeks) periods.

Main Outcomes and Measures The primary end point was the proportion of patients achieving HS clinical response across all body regions at week 12.

Results Overall, 103 patients were randomized to adalimumab and 103 to matching placebo. Among all patients, 51% (n = 106) were women, 94% (n = 193) were White, and the mean (SD) age was 37.6 (11.3) years. At week 12, significantly more patients receiving adalimumab (49 of 103 [48%]) vs placebo (35 of 103 [34%]; P = .049) achieved HS clinical response across all body regions (treatment difference, 14% [95% CI, 0%-27%]). Treatment-emergent adverse events were reported in 74 of 103 patients (72%) and 69 of 103 patients (67%) in the adalimumab and placebo groups, respectively. No increased risk of postoperative wound infection, complication, or hemorrhage was observed with adalimumab vs placebo. Two deaths occurred in the adalimumab group; neither was considered as having a reasonable possibility of relationship to study drug.

Conclusions and Relevance Adalimumab was efficacious in conjunction with wide-excision surgery followed by secondary intention healing, with no need to interrupt treatment prior to surgery. These data support further investigation of adalimumab as an adjuvant therapy to surgery in patients with moderate to severe HS.

Trial Registration ClinicalTrials.gov Identifier: NCT02808975

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Article Information

Corresponding Author: Falk G. Bechara, MD, Department of Dermatology, Venereology, and Allergology, St Josef Hospital, Ruhr-University Bochum, Gudrunstr. 56, 44791, Bochum, Germany (f.bechara@klinikum-bochum.de).

Accepted for Publication: May 25, 2021.

Published Online: August 18, 2021. doi:10.1001/jamasurg.2021.3655

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2021 Bechara FG et al. JAMA Surgery.

Author Contributions: Dr Bechara had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Bechara, Podda, Prens, Horváth, Alavi, Geng, Jean, Jemec, Zouboulis.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Bechara, Horváth, Geng, Jean.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Geng.

Administrative, technical, or material support: Podda, Prens, Giamarellos-Bourboulis, Alavi, Jemec.

Supervision: Bechara, Podda, Prens, Horváth, Giamarellos-Bourboulis, Alavi, Kirby, Jean, Jemec, Zouboulis.

Conflict of Interest Disclosures: Dr Bechara received honoraria from AbbVie, Novartis, and Janssen for advisory board and speaker services, and his department received grants from AbbVie, Novartis, UCB, InflaRx, Incyte, and Janssen for his participation as an investigator. Dr Podda reported personal fees from AbbVie and grants from AbbVie paid to Klinikum Darmstadt during the conduct of the study; personal fees and grants paid to Klinikum Darmstadt from Beiersdorf, Bristol Myers Squibb, CSL Behring, Galderma, Janssen-Cilag, Leo Pharma, Novartis, MSD, USB, Boehringer Ingelheim, Eli Lilly and Company, and InflaRx outside the submitted work. Dr Prens received honoraria from AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen-Cilag, Galderma, InflaRx, Novartis, UCB, Regeneron, and Pfizer for speaker and advisory board services and received investigator-initiated grants (paid to the Erasmus MC) from AbbVie, Celgene, Janssen-Cilag, and UCB. Dr Horváth reported grants from Janssen-Cilag, AbbVie, Novartis, UCB Pharma, and Leo Pharma paid to their institution during the conduct of the study; grants from Solenne BV, Celgene, Akari Therapeutics, Philips, Roche, Regeneron, and Sanofi paid to their institution outside the submitted work; and personal fees from Janssen-Cilag, AbbVie, Novartis Pharma, UCB Pharma, Leo Pharma, Solenne BV, Celgene, Akari Therapeutics, Philips, Roche, Regeneron, and Sanofi paid to their institution. Dr Giamarellos-Bourboulis reported grants from AbbVie for the SHARPS study to the National and Kapodistrian University of Athens during the conduct of the study; grants from Abbott, InflaRx, XBiotech, Astellas Pharma, Axis Shield, Horizon 2020 ImmunoSep, bioMérieux, FrameWork 7 HemoSpec, and Horizon 2020 Marie Curie ITN European Sepsis Academy; personal fees from Abbott, XBiotech, Angelini Pharma, Pfizer, and ThermoFisher outside the submitted work; and honoraria from MSD. Dr Alavi reported grants from AbbVie during the conduct of the study; personal fees from Novartis, Janssen, Kymera Therapeutics, and AbbVie outside the submitted work; and has acted as a consultant, advisor, and/or received research funding from Asana, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Galderma, Genentech, Glenmark, Incyte, InflaRx, Leo Pharma, Novartis, Regeneron, UCB, and Valeant. Dr Szepietowski is an advisory board member of AbbVie, Leo Pharma, Novartis, Pierre Fabre, Menlo Therapeutics, Sienna Biopharmaceuticals, and Trevi; principal investigator for AbbVie, Novartis, Menlo Therapeutics, Trevi, Janssen, Merck, Regeneron, Amgen, Boehringer Ingelheim, Galapagos, Galderma, InflaRx, Kymab, Pfizer, UCB, Helm, and Incyte; speaker for AbbVie, Novartis, Janssen, Eli Lilly, Sanofi Genzyme, Sun Pharma, and Berlin-Chemie Menarini; and reported personal fees from AbbVie during the conduct of the study and outside the submitted work. Dr Kirby reported personal fees from AbbVie, ChemoCentryx, Incyte, Novartis, Janssen, and UCB Pharma outside the submitted work. Dr Geng reported owns AbbVie stock as an employee. Dr Jean reported being a former employee of AbbVie and owns stock or stock options. Dr Jemec reported grants from AbbVie, InflaRx, Novartis, Janssen-Cilag, CSL Behring, Afyx, Regeneron, and Leo Pharma; personal fees from UCB Pharma, Incyte, and ChemoCentryx during the conduct of the study; personal fees from Coloplast, Novartis, and Leo Pharma outside the submitted work; a patent for a probiotic pending; is editor in chief of Dermatology; advisor at Miiskin and Henlez; honoraria from Kymera and VielaBio. Dr Zouboulis reported grants from AbbVie paid to the Dessau Medical Center during the conduct of the study; grants from AbbVie paid to the Dessau Medical Center outside the submitted work; personal fees from AbbVie outside the submitted work; personal consultation/lecture/advisory board honoraria from Almirall, Bayer, Celgene, Galderma, GlaxoSmithKline/Stiefel, Idorsia, Incyte, InflaRx, Janssen, Novartis, Pierre Fabre, PPM Pharma, Regeneron, Sobi, UCB; and fees paid to the Dessau Medical Center for participation at clinical studies from Advanced Oxygen Therapy Inc, AstraZeneca, Galderma, InflaRx, NAOS-Bioderma, Novartis, PPM Pharma, Relaxera, and UCB Pharma.

Funding/Support: AbbVie funded this study.

Role of the Funder/Sponsor: AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.

Meeting Presentation: Findings from the SHARPS study were previously presented at the 9th Conference of the European Hidradenitis Suppurativa Foundation; February 6, 2020; Athens, Greece.

Additional Contributions: AbbVie and the authors thank the patients, study sites, and investigators who participated in this clinical study. Medical writing support was provided by Madhura Mehta, PhD, and Janet Matsuura, PhD, of ICON and was funded by AbbVie.

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.