Efficacy of adalimumab in recalcitrant hidradenitis suppurativa

ARTICLE

Auteur(s) : Elena Sotiriou, Zoe Apalla, Eustratios Vakirlis, Demetrios Ioannides

First Dermatologic Department, Medical School, Aristotle University Thessaloniki, 8, Papakyriazi str, 54645 Thessaloniki, Greece

Hidradenitis suppurativa (HS) is a recurrent, chronic inflammatory disease, localized in apocrine gland-bearing areas of the body [1]. Treating HS is challenging as common therapeutic approaches do not achieve complete remissions, or lead to relapses after their discontinuation [1].

Based on previous reports of HS management with anti-TNF agents [1-4], we attempted a small clinical study to evaluate the efficacy and safety of adalimumab in recalcitrant HS. Adalimumab was chosen because antibody formation to it is less likely and because of the home administration convenience [4].

Three female patients-one with axillary, 2 with inguinal involvement-were treated with adalimumab for 3 months. Written informed consent was obtained in all cases. The mean patient age was 35.3 years, and mean disease duration 4.3 years. Previous treatments, discontinued at least 2 weeks before treatment initiation, included antibiotics, oral contraceptives and isotretinoin.

Haematological and biochemical profiles, purified protein derivative testing, ANA panel and chest radiography were normal in all three patients. At the time of the initial administration, patients were free from acute or chronic infections.

Adalimumab was administered at a dose of 40 mg, subcutaneously, every other week. Clinical evaluations were performed at baseline, at months 1, 2, 3 and 3 months after treatment discontinuation. Baseline was defined as the day of the first adalimumab administration. At each visit, disease severity was evaluated according to a scoring system described by Sartorious et al. [5]. A visual analogue scale (VAS) was used to evaluate the degree of disease activity as perceived by the patient at baseline, at month 3 and at the last follow-up visit (0 = no disease activity, 10 = very severe disease activity). At baseline and at month 3 patients completed a DLQI (Dermatology Life Quality Index) questionnaire. Haematological and biochemistry tests were performed at each visit. The treatment was well tolerated. Patients nos 2 and 3 experienced mild pain at injection sites during infusions.

Marked improvement, including reduction of inflammation, induration, purulence, drainage and tenderness, was observed at the first clinical evaluation with mean disease severity scores decreasing from 24.3 to 12.6. Further disease severity reduction, reaching a > 50% decrease of pre-treatment disease severity, was noted at months 2 and 3. At the last follow-up visit, relapse was observed in all patients. However, the mean disease severity score was 16.6, remaining lower than that evaluated at baseline for all patients. Mean disease activity decreased from 9.3 at baseline to 3.6 at 3 months and raised again to 6.3 at 3 months after treatment discontinuation.

DLQI questionnaires showed mean reduction of 78% (range 75-80%). Table 1 lists patients’ characteristics and changes in VAS. Disease severity score changes are shown in table 2. The aetiopathogenesis of HS remains obscure. Recent studies lead to the hypothesis that follicular occlusion is the primary process, followed by inflammatory reactions. As TNF-α is found increased within and around granulomas in HS tissues [6], it may play an important role in the disease. Rapid improvement in disease activity after treatment with immunosuppressives underscores its inflammatory pathogenesis. TNF-α antagonists may lead to improvement in HS by inhibiting the generalized pro-inflammatory effects of TNF-α [4].

Adalimumab is a fully human monoclonal IgG1 antibody specific for TNF-α. It binds to both soluble and membrane bound TNF. It is hoped that it will be less immunogenic than infliximab, while providing a comparable effect [6]. Given its strong anti-inflammatory properties and its convenient dosing regimen, adalimumab may represent an effective treatment for HS. However, the rapid recurrences observed after treatment discontinuation may limit its potential for a long-term disease control. Further controlled trials are needed to determine optimal dosing schedules, long-term efficacy, safety and the true therapeutic benefit of adalimumab in the disease.

Acknowledgements

References

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5 Sartorious K, Lapins J, Emtestam L, Jemec GB. Suggestions for uniform outcome variables when reporting treatment effects in hidradenitis supputativa. Br J Dermatol 2003; 149: 211-3.

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