Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa : The SHARPS Randomized Clinical Trial
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.
| Errataetall: |
CommentIn: JAMA Surg. 2022 Jun 1;157(6):552-553. - PMID 35262636 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:156 |
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| Enthalten in: |
JAMA surgery - 156(2021), 11 vom: 01. Nov., Seite 1001-1009 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bechara, Falk G [VerfasserIn] |
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| Links: |
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| Themen: |
Adalimumab |
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| Anmerkungen: |
Date Completed 24.01.2022 Date Revised 10.07.2022 published: Print ClinicalTrials.gov: NCT02808975 CommentIn: JAMA Surg. 2022 Jun 1;157(6):552-553. - PMID 35262636 Citation Status MEDLINE |
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| doi: |
10.1001/jamasurg.2021.3655 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM329498886 |
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| 100 | 1 | |a Bechara, Falk G |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa |b The SHARPS Randomized Clinical Trial |
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| 500 | |a Date Revised 10.07.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02808975 | ||
| 500 | |a CommentIn: JAMA Surg. 2022 Jun 1;157(6):552-553. - PMID 35262636 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Importance: Surgery is a mainstay in the management of hidradenitis suppurativa (HS). Adalimumab is the first drug approved for HS | ||
| 520 | |a Objective: To investigate the efficacy and safety of adalimumab in combination with wide-excision surgery followed by secondary intention healing | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a Main Outcomes and Measures: The primary end point was the proportion of patients achieving HS clinical response across all body regions at week 12 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a Trial Registration: ClinicalTrials.gov Identifier: NCT02808975 | ||
| 650 | 4 | |a Clinical Trial, Phase IV | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
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| 650 | 7 | |a Adalimumab |2 NLM | |
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| 700 | 1 | |a Giamarellos-Bourboulis, Evangelos J |e verfasserin |4 aut | |
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| 700 | 1 | |a Szepietowski, Jacek C |e verfasserin |4 aut | |
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| 700 | 1 | |a Jemec, Gregor B E |e verfasserin |4 aut | |
| 700 | 1 | |a Zouboulis, Christos C |e verfasserin |4 aut | |
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