Patients with moderate-to-severe hidradenitis suppurativa (HS) who are being treated with adalimumab do not need to stop the medication before surgery, according to new findings.
In a press release the study’s authors say that while the anti-inflammatory medication adalimumab is used to improve symptoms of HS, it has been unclear whether it was necessary to discontinue the medication prior to HS-related surgeries.
To address this question, an international research group coordinated by Professor Falk Bechara from the Department of Dermatosurgery at the Bochum University Clinic for Dermatology in Bochum, Germany conducted a four-year, worldwide multicentre study.
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. To be eligible, patients had to be between 18 and 65 years of age, have moderate to severe HS that required radical surgery in an axillary or inguinal region and had two other anatomical regions affected, with one or more regions at Hurley stage II or III.
A total of 206 participants were randomized 1:1 to receive either continuous adalimumab 40 mg or a placebo during a 12-week pre-surgery period, two weeks perioperative, and 10 weeks postoperative.
At week 12, significantly more patients in the adalimumab group achieved HS clinical response across all body regions compared to those in the placebo group—48% vs. 34%; p=0.049.
Treatment-emergent adverse events were reported in 74 of the patients in the adalimumab group and in 69 of those in the placebo group. The investigators note that there was no increased risk of postoperative wound infection, complication, or hemorrhage in either study group. There were two deaths in the adalimumab group, but the authors write that neither was considered as having a reasonable possibility of being related to the medication.
In the release, lead author Dr. Bechara said: “This is a milestone for patients with moderate and severe hidradenitis suppurativa, who have to undergo surgery.”
The study was published online ahead of print in the journal JAMA Surgery (Aug. 18, 2021).
“The study shows that adalimumab doesn’t need to be discontinued even when hidradenitis suppurativa surgery is performed,” said Dr. Bechara. “It is effective and safe both before and after surgery.”
He noted that further studies are needed to determine to what extent these positive results of the study can be transferred to other diseases that also require surgery, yet: “The outlook is certainly quite promising.”