Περίληψη:
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, 40mg, 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.
Συγγραφείς:
Bechara, Falk G.
Podda, Maurizio
Prens, Errol P.
Horvath,
Barbara
Giamarellos-Bourboulis, Evangelos J.
Alavi, Afsaneh and
Szepietowski, Jacek C.
Kirby, Joslyn
Geng, Ziqian
Jean,
Christine
Jemec, Gregor B. E.
Zouboulis, Christos C.
