Real-World Effectiveness of Adalimumab in Patients With Moderate to Severe Hidradenitis Suppurativa

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• In this prospective, observational, study from 23 Canadian centers, 165 adults with moderate to severe hidradenitis suppurativa (HS) were treated with adalimumab. At week 24, 68.9% of patients achieved Hidradenitis Suppurativa Clinical Response (HiSCR) and this was maintained at week 52. The proportion of responders was higher in patients with an abscess and inflammatory nodule (AN) count >5 at baseline. Male responders were 4-times more likely than female responders to achieve HiSCR at week 24. Earlier onset of HS was associated with improved response.

• The effectiveness of adalimumab in the treatment of HS is maintained at 52 weeks, and patients with the highest AN count derive the greatest benefit from treatment.

–  Katherine M. Stiff, MD

Written by

 

 

Steven Daveluy MD, FAAD

Hidradenitis suppurativa (HS) is a debilitating skin disease that is typically difficult to manage. Adalimumab is currently the only FDA-approved treatment for HS. As clinical trials have stringent criteria for participation, the results may not match the experience we see in the real world, across a more diverse patient population. This real-world, 1-year, prospective, observational study with 120 adult patients from 23 centers across Canada provides insight into the efficacy of adalimumab in HS. 

The HiSCR is the standard measure of efficacy in HS, representing a 50% improvement in abscess and nodule count. At week 24, about 60% of patients achieved a HiSCR, which is higher than the 50.6% from PIONEER I and II, the adalimumab phase III trials. This may be explained by the fact that this study had about 15% to 20% more patients with moderate (Hurley stage 2) disease and fewer severe patients. Males had four times the odds of responding compared with females, which was not observed in prior adalimumab trials. The odds of responding decreased by 5% for each additional year in the age at disease onset. Patients with more inflammatory nodules and abscesses at baseline were more likely to respond. The response at 24 weeks was maintained at 52 weeks.

These findings indicate that, among patients with HS treated with adalimumab, the patients who see the largest benefit are those with a high inflammatory burden and high numbers of nodules and abscesses. They also support the concept of a "window of opportunity" in controlling HS. As adalimumab aims to suppress the inflammation driving HS, it has the most benefit in patients experiencing heavy inflammation before the inflammation leads to scarring and tunnel formation. Patients who respond to adalimumab at week 24 can be counseled to expect to maintain that response long-term. A limitation of this study is the high proportion of white participants (82.6%), which limits generalizability of the results to a more diverse population.

Abstract 

BACKGROUND

Long-term, real-word data are needed to help manage patients with hidradenitis suppurativa (HS) through this recurrent, painful and debilitating disease.

OBJECTIVES

To primarily measure real-world effectiveness of adalimumab in HS and to secondarily observe clinical course of HS in the light of patients' response.

METHODS

In SOLACE, adults with moderate-to-severe HS in need for change in ongoing therapy were treated with adalimumab for up to 52 weeks as per physician's medical practice. Treatment effectiveness was measured by Hidradenitis Suppurativa Clinical Response (HiSCR). Inflammatory nodules, abscesses and draining fistulas were counted, Hurley stage was assessed, and disease severity was rated using the International HS Severity Scoring System (IHS4). A post hoc analysis further explored the HiSCR response by abscess and inflammatory nodule (AN) count at baseline (low, medium and high) and gender. Spontaneously reported safety events were collected.

RESULTS

From 23 Canadian centres, 69% of the 138 patients achieved HiSCR at week 24, which increased to 82% and 75% at week 52 in patients with medium and high AN counts, respectively. Gender (4 times the odds for female) and age at HS onset (5% decrease with each additional year) had an effect on achieving HiSCR. Treatment with adalimumab led to an important decrease in number of lesions in responders, with most gains observed in inflammatory nodules, more frequently in the lower body area of patients in the high AN count group. The IHS4 scores of responders were substantially lowered, with a larger decrease in patients of the high AN count group. No new safety signal was detected.

CONCLUSIONS

The effectiveness of adalimumab was maintained during this 1-year period, and an optimal gain was documented for patients with medium and high AN counts. These real-world data support a prompt treatment of HS patients and the use of IHS4 to monitor treatment.

Journal of the European Academy of Dermatology and Venereology: JEADV

Real-world effectiveness of adalimumab in patients with moderate-to-severe hidradenitis suppurativa: the 1-year SOLACE study

J Eur Acad Dermatol Venereol 2021 Aug 11;[EPub Ahead of Print], W Gulliver, A Alavi, MC Wiseman, MJ Gooderham, J Rao, MS Alam, KA Papp, O Desjardins, C Jean 

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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