乌鸦传媒

People taking adalimumab (Humira) for moderate-to-severe hidradenitis suppurativa (HS) saw better results across the board when the drug was combined with a surgical intervention.

That's according to the results of a randomized controlled trial published in the .

The real-world clinical effectiveness trial compared a combination therapy of adalimumab and surgery (deroofing, limited or wide excision) with adalimumab monotherapy in adults with moderate-to-severe HS; 31 patients were included in each arm. The mean International Hidradenitis Suppurativa Severity Score System (IHS4) score at baseline was 23.9±10.7 in the combination-therapy group and 20.9±16.4 in the monotherapy group. After 12 months, the surgery group saw significantly greater reductions in IHS4 scores compared with monotherapy (-19.1±11.3 vs -7.8±11.8, P<.001).

The combination group also saw a greater reduction in Dermatology Life Quality Index after treatment than the monotherapy group (-8.2±6.2 vs -4±7.7, P=.02).

The study by a group of Dutch researchers, was led by Pim Aarts, MD, a dermatologist and researcher with Erasmus University Medical Center in The Netherlands. The following study excerpts have been lightly edited for length and clarity.

What unanswered question was this trial was designed to address?

The advent of adalimumab has improved the management of HS in recent years. Still, this treatment only yields a response in up to 60% of patients.

Prior study data suggest that adalimumab monotherapy is insufficient in reducing disease burden in many patients with HS, and that additional therapeutic measures are required.

Surgery is one such measure. Although concerns have been raised about the safety of continuing biologics before and during surgery, earlier data demonstrated that adalimumab use did not lead to increased peri-surgical adverse events (AE).

Before this investigation, the added value of surgical intervention in people with HS who are receiving adalimumab had not been evaluated in a controlled study.

The Dutch researchers aimed to compare the real-world effectiveness of adalimumab and adjuvant surgery with adalimumab monotherapy in patients with moderate-to-severe HS in a pragmatic, phase IV, randomized controlled trial.

What were the key findings?

Combining adalimumab with surgery resulted in a significantly greater clinical response and a significantly improved quality of life compared with adalimumab monotherapy after 12 months.

At the end of treatment, more patients in the surgery group achieved a ≥2 point change in Hidradenitis Suppurativa Physician's Global Assessment scale (58%, 18/31) compared with the monotherapy group (18%, 4/31), P<.001.

Further, patients in the surgery group achieved the IHS4-55 threshold significantly more often than people in the monotherapy group (87% vs 32%, P<.001).

At the end of treatment, only the surgery group showed a significant decrease in pain scores (P=.044, monotherapy P=.103). Patients in the surgery group (93%) were also more satisfied with their treatment strategy than those in the monotherapy group (65%), P=.02.

Finally, 71% of patients from the monotherapy group opted for surgery during or within 3 months after study completion.

What were the findings on adverse events?

AEs were reported in 94% of patients of the monotherapy group compared with 68% of patients in the surgery group (P=.01).

In total, 79 AEs were reported in the monotherapy group and 49 in the surgery group; 73% were potentially related to treatment in each case. The latter were: HS flares, infections, hematoma at the injection site, mild bleeding at the surgical site, and postoperative pain.

In the monotherapy group, HS flares were reported 27 times versus 11 times in the surgery group.

What are the study's clinical implications?

The benefit of additional surgery was striking. There were significant reductions in IHS4 scores as well as improvements in quality of life with fewer AEs.

Aarts and colleagues recommend that the option of adalimumab with surgery always be proposed to patients with moderate-to-severe HS.

Key points:

• Adalimumab (Humira) was found to be more effective against HS when combined with surgical interventions.
• Patients receiving both treatments experienced better response, improved quality of life, greater overall satisfaction.
• The option of combining adalimumab with surgery should be discussed with patients who have moderate-to-severe HS.