A V Marzano1,2, G Genovese1,2, G Casazza3, C Moltrasio1,2, P Dapavo4, G Micali5, R Sirna6, P Gisondi7, A Patrizi8, V Dini9, D Bianchini10, L Bianchi11, L Fania12, F Prignano13, A Offidani14, L Atzori15, V Bettoli16, S P Cannavò17, M Venturini18, M R Bongiorno19, A Costanzo20, G Fabbrocini21, K Peris22. 1. Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. 2. Department of Physiopathology and Transplantation, Università degli Studi di Milano, Milan, Italy. 3. Dipartimento di Scienze Biomediche e Cliniche 'L. Sacco', Università degli Studi di Milano, Milan, Italy. 4. Department of Medical Sciences, University of Turin, Turin, Italy. 5. Dermatology Clinic, University of Catania, Catania, Italy. 6. Dermatology Unit, Department of Surgery, Misericordia Hospital, Grosseto, Italy. 7. Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy. 8. Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy. 9. Department of Dermatology, University of Pisa, Pisa, Italy. 10. Dermatologic Clinic, Department of Internal Medicine and Medical Specialties, 'La Sapienza' University, Rome, Italy. 11. Department of Dermatology, University of Rome 'Tor Vergata', Rome, Italy. 12. First Dermatology Clinic and Clinical Epidemiology Unit, Istituto Dermopatico dell'Immacolata, IDI-IRCCS, Rome, Italy. 13. Department Health Science Section of Dermatology, University of Florence, Florence, Italy. 14. Dermatological Clinic Department of Clinical and Molecular Sciences, Polytechnic University of the Marche Region, Ancona, Italy. 15. Unit of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. 16. Department of Medical Sciences, Section of Dermatology, University of Ferrara, Ferrara, Italy. 17. Department of Clinical and Experimental Medicine, Section of Dermatology, University of Messina, Messina, Italy. 18. Department of Dermatology, ASST Spedali Civili di Brescia, Brescia, Italy. 19. Section of Dermatology, Department of Health Promotion, Maternal-Infant, Internal Medicine and Specialization, University of Palermo, Palermo, Italy. 20. Dermatology Unit, IRCCS Humanitas Clinical and Research Center, Rozzano (Milan), Italy. 21. Department of Dermatology, University of Naples Federico II, Naples, Italy. 22. Institute of Dermatology, Università Cattolica - Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.
Abstract
BACKGROUND: The anti-tumour necrosis factor (TNF)-α adalimumab is the only licenced biologic for moderate-to-severe hidradenitis suppurativa (HS). No predictors of response have been identified so far. OBJECTIVES: To identify clinical parameters predicting response to adalimumab and confirm its efficacy/safety. METHODS: The data of 389 patients with HS treated with adalimumab in 21 Italian centres were reviewed. Sex, age at onset/diagnosis/baseline, body mass index, smoking, phenotype, previous treatments, concomitant antibiotics and 'therapeutic delay', defined as the time from HS onset to adalimumab initiation, were assessed. Response to adalimumab and its impact on quality of life (QoL) were evaluated using the Hidradenitis Suppurativa Clinical Response (HiSCR) and the Dermatology Life Quality Index (DLQI) or the Visual Analogue Scale for pain (VAS pain), respectively. Logistic regression analysis was performed. RESULTS: The therapeutic delay correlated to lack of response to adalimumab at week 16 [odds ratio (OR) 1·92 for therapeutic delay > 10 years; 95% confidence interval (CI) 1·28-2·89; P = 0·0016). HiSCR was achieved in 43·7% and 53·9% patients at week 16 and 52, respectively. Significant reductions in both DLQI and VAS pain were found between week 16 vs. baseline (P < 0·0001 for both) and week 52 vs. baseline (P < 0·0001 for both). Previous immunosuppressants inversely correlated to HiSCR at week 52 (OR = 1·74, 95% CI 1·04-2·91, P = 0·0342). CONCLUSIONS: Inverse correlation between therapeutic delay and clinical response was found, supporting early adalimumab use and providing evidence for a 'window of opportunity' in HS treatment. Adalimumab efficacy and safety were confirmed, along with patients' QoL improvement. Immunosuppressants could negatively influence the response to adalimumab inducing a switch to non-TNF-α-driven pathways.
BACKGROUND: The anti-tumour necrosis factor (TNF)-α adalimumab is the only licenced biologic for moderate-to-severe hidradenitis suppurativa (HS). No predictors of response have been identified so far. OBJECTIVES: To identify clinical parameters predicting response to adalimumab and confirm its efficacy/safety. METHODS: The data of 389 patients with HS treated with adalimumab in 21 Italian centres were reviewed. Sex, age at onset/diagnosis/baseline, body mass index, smoking, phenotype, previous treatments, concomitant antibiotics and 'therapeutic delay', defined as the time from HS onset to adalimumab initiation, were assessed. Response to adalimumab and its impact on quality of life (QoL) were evaluated using the Hidradenitis Suppurativa Clinical Response (HiSCR) and the Dermatology Life Quality Index (DLQI) or the Visual Analogue Scale for pain (VAS pain), respectively. Logistic regression analysis was performed. RESULTS: The therapeutic delay correlated to lack of response to adalimumab at week 16 [odds ratio (OR) 1·92 for therapeutic delay > 10 years; 95% confidence interval (CI) 1·28-2·89; P = 0·0016). HiSCR was achieved in 43·7% and 53·9% patients at week 16 and 52, respectively. Significant reductions in both DLQI and VAS pain were found between week 16 vs. baseline (P < 0·0001 for both) and week 52 vs. baseline (P < 0·0001 for both). Previous immunosuppressants inversely correlated to HiSCR at week 52 (OR = 1·74, 95% CI 1·04-2·91, P = 0·0342). CONCLUSIONS: Inverse correlation between therapeutic delay and clinical response was found, supporting early adalimumab use and providing evidence for a 'window of opportunity' in HS treatment. Adalimumab efficacy and safety were confirmed, along with patients' QoL improvement. Immunosuppressants could negatively influence the response to adalimumab inducing a switch to non-TNF-α-driven pathways.
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