The efficacy of adalimumab in the treatment of hidradenitis suppurativa

Dicle Tıp Dergisi / Dicle Med J (2018) 45 (1) : 19 - 27 Özgün Araştırma / Original Article The efficacy of adalimumab in the treatment of hidradenitis suppurativa Ali Balevi1, Pelin Ustuner2, Mustafa Özdemir3 1 Pelin Üstüner, Istanbul Medipol University Medical Faculty, Dermatology Department, Istanbul, Turkey ORCID: 0000-0002-7885-0537 2 Ali Balevi, Istanbul Medipol University Medical Faculty, Dermatology Department, Istanbul, Turkey ORCID: 0000-0001-5057-0405 3 Mustafa Özdemir, Istanbul Medipol University Medical Faculty, Dermatology Department, Istanbul, Turkey ORCID: 0000-0002-7022-913X Received: 10.08.2017; Revised: 15.12.2017; Accepted: 28.12.2017 Abstract Objectives: Hidradenitis suppurativa is seen as a result of the occlusion, constriction and bacterial infection of the apocrine glands in bilateral axillas, submammarian areas, neck, inguinal regions, flexural surfaces of the thighs and anogenital areas. Among the biological agents adalimumab is a recombinant human IgG1 monoclonal antibody; TNF-α antagonist approved to be used in the treatment of hidradenitissuppurativa. Methods: In this study, 12 patients resistant to conventional treatments with moderate severity, Hurley stage 2 or 3 were started subcutaneous adalimumab treatment. The disease activities upon the hidradenitis suppurativa, clinical severity index and life quality index of the patients were examined both before and 1 year after the treatment. Results: Twelve patients were recruited. In the examination of the hidradenitis suppurativa clinical severity scores, significant clinical responses were noted in 9 (75%) patients. While the mean value of the life quality index was 14.4±6.9 before the treatment, it was determined to be significantly decreased to 4.3±3.8 after the treatment. Conclusion: We concluded that adalimumab; the unique biological agent approved to be used in the treatment of treatment-resistant, moderate-severe hidradenitis suppurativa is efficient and safe in similar ratios with the previous clinical studies in the literature. Keywords: Adalimumab, eccrine glands, hidradenitis DOI: 10.5798/dicletip.407240 Yazışma Adresi / Correspondence: Pelin Ustuner, Istanbul Medipol University, School of Medicine, Department of Dermatology TEM Avrupa OtoyoluGöztepe Çıkışı No: 1 Bağcılar 34214 İstanbul, Turkey e-mail: 19 Balevi A., Ustuner P., Özdemir M. Hidradenitissüpürativa tedavisinde adalimumabın etkinliği Özet Amaç: Hidradenitis suppurativa; her iki koltuk altı, göğüs altları, boyun, kasıklar, bacakların birbirine sürten yüzünde ve anogenital bölgelerde apokrin bez kanalında tıkanma, daralma ve bakteriyel enfeksiyon sonucu görülmektedir. Biyolojik ajanlar arasında adalimumab; hidradenitis süpürativa tedavisinde kullanımı onaylanmış TNF-α antagonisti rekombinant insan IgG1 monoklonal antikorudur. Yöntemler: Bu çalışmada klasik tedavilere dirençli, orta-şiddetli tutulumlu, Hurley stage 2 veya 3, klasik tedavilere direnç/yetersizlik olan 12 hastaya adalimumab tedavisi uygulandı. Hastaların tedavi öncesi ve 1 yıllık tedavi sonrası hidradenitis süpürativa klinik şiddet indeksine göre hastalık aktiviteleri ve yaşam kalite indeksleri incelendi. Bulgular: Oniki hasta çalışmaya alındı. 7 hastada Hurley 3, geriye kalan 5 hastada Hurley 2 seviyesinde tutulum mevcuttu. Hidradenitis süpürativa klinik şiddet skorlaması incelendiğinde 9 hastada (%75) anlamlı klinik yanıt tespit edildi. Tedavi öncesi yaşam kalite indeksi ortalamasının 14.4±6.9 iken, tedavi sonrası anlamlı oranda gerileyerek 4.3±3.8’a düştüğü saptandı. Sonuç: Tedaviye dirençli orta-şiddetli hidradenitis süpürativa tedavisinde kullanımı onay almış tek biyolojik ajan olan adalimumabın literatürdeki önceki klinik çalışmalarla benzer oranda etkin ve güvenilir olduğu sonucuna vardık. Anahtar kelimeler: Adalimumab, ekrin ter bezleri, hidradenit INTRODUCTION Hidradenitis suppurativa (HS) is a chronic, recurrent, inflammatory disease of the apocrine glands. The prevelance of HS is not known, but according to the epidemiological studies the disease has been reported in 0.05-0.2% of the population. The disease is seen in nearly 4% of the young adult females. Hidradenitis suppurativa is diagnosed according to the clinical signs. In the etiopathogenesis; folicular hyperkeratosis iniciates that the disease is followed by the follicular occlusion and apocrin glands participates secondaryly1. Comedones, inflammatory/non-inflammatory nodules, sinus tracts and abscess forming scars are commonly seen. These lesions occur in axillary, inguinal, pubic, gluteal areas and in submammarian areas in females. For the define diagnosis the development of these painful and purulent nodules should be seen at least for 2 times in 6 months. The disease usually starts at the age of tweenties after the puberty2. Up to now; lots of different treatments have been recommended for the treatment of HS and no medical cure is present. Different treatment options are planned simultaneously and combined with surgery. Topical and systemic antibiotics, dapson, systemic/intralesional corticosteroids, immunosuppressives (azotyopurine, methotrexate, cyclosporine), colchicine, retinoids, hormonal treatment and biologic agents (adalimumab, infliximab, etc) are some of the medical treatment options3. In the lesional skin areas of patients with HS the increase in the levels of lots of cytokines such as; tumour necrosis factor (TNF-α), interleukin (IL)-12, IL-23, IL-10 and IL-17 has been shown. Up to now, of the biologicals; infliximab and adalimumab have been reported to have efficacy in the treatment of HS. Adalimumab, TNF- α antagonist; recombinant monoclonal IgG1 antibodyblocks the TNF 1 and 2 receptors (p55 and p75, respectively) on the cellular surface and avoids the production of cyctokines that provides the enchancement of inflammatory cascade4. Adalimumab is a systemic agent that has been approved by FDA for the treatment of moderate and severe HS. Significant clinical improvement has been reported with adalimumab in HS lesions. However, variable clinical results exist about the the treatment duration, clinical response rates and remission rates of biological agents 20 Dicle Tıp Dergisi / Dicle Med J (2018) 45 (1) : 19 - 27 including adalimumab. Herein, in this study we aimed to assess the efficacy of adalimumab in HS patients. METHODS Our study was performed retrospectively by the investigation of the policlinic records of the patients treated with adalimumab for HS between 2014 and 2016 inour University Medical Faculty Dermatology Clinic. Whether or not the patients were diagnosed with HS was recorded from the medical records and via mobile questionaires. The records of the patients about the age, sex, body mass index, smooking habits, disease duration, family history, previous treatments, comorbidities, localization of the lesions and informations about treatments were examined. The HS clinical stages of the patients were recorded. According to this; stage 1- solitar (...truncated)