Evidence for a ‘window of opportunity’ in hidradenitis suppurativa treated with adalimumab: a retrospective, real‐life multicentre cohort study*

Introduction: There are an increasing number of biologic drugs in the pipeline for treating hidradenitis suppurativa (HS). Clinical trials for these drugs usually share the same clinical selection criteria. Objectives: (a) To describe the clinical profile of HS patients receiving first-line biologic treatment in an HS clinic setting, (b) to assess how this population would meet clinical criteria to participate in a clinical trial, and (c) to assess treatment effectiveness at week 16 in eligible vs non-eligible patients. Methods: Prospective observational study. Patients were grouped according to their eligibility for clinical trials. The effectiveness of adalimumab was assessed by HiSCR, IHS4-category-change and a-50%-reduction on IHS4 at week 16. Results: Thirty-eight patients were included in the study: eight (21.05%) were eligible for clinical trials and 30 (78.95%) were not. The main reason for non-eligibility was not having an AN count ≥5. Both groups presented similar number of draining tunnels. Effectiveness at week 16 was lower in non-eligible than eligible patients when evaluated by HiSCR-response but similar if evaluated by the IHS4-category-change or the 50%-reduction in IHS4. Conclusion: In our population, the external validity of current eligibility criteria for clinical trials is low. Most patients receiving adalimumab in real-life setting would not be eligible for clinical trials.

Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 91%

Clinical selection criteria in new clinical trials of hidradenitis suppurativa: External validity and implications on the daily clinical practice

Montero‐Vílchez

Salvador‐Rodríguez

Sánchez‐Díaz

et al. 2020

“…A recent real‐life multicenter study on 389 patients with HS treated with adalimumab confirmed the tolerability of the TNF‐α inhibitor; mild upper respiratory tract infections were reported and a case of serious infections pneumonia sustained by Aspergillus fumigatus probably related to the treatment was described 3 …”

Section: Factors Treated Group N (%)mentioning

confidence: 90%

“…Since the end of February, when the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic had already spread in most of Italy, a task force comprised of four dermatologists, one infectious disease specialist, one A recent real-life multicenter study on 389 patients with HS treated with adalimumab confirmed the tolerability of the TNF-α inhibitor; mild upper respiratory tract infections were reported and a case of serious infections pneumonia sustained by Aspergillus fumigatus probably related to the treatment was described. 3 In addition, similar to psoriasis, recent studies demonstrated that HS is associated with several comorbidities including smoking history, metabolic syndrome (including hypertension and diabetes), obesity, cardiovascular complications, dyslipidemia, and inflammatory bowel disease. 4 Emerging data demonstrate that risk factors for severe COVID-19 infection are strikingly similar to HS comorbidities specifically obesity, cardiovascular diseases, diabetes, hypertension, and smoking history.…”

Section: Sars-cov-2 Skin Diseasesmentioning

confidence: 99%

Management of patients with hidradenitis suppurativa during the COVID‐19 pandemic: Risk and benefit of immunomodulatory therapy

Molinelli

Diotallevi

Simonetti

et al. 2020

“…Data on golimumab are very limited. Golimumab has been used successfully in a patient suffering from concomitant HS/AI and pyostomatitis vegetans in ulcerative colitis 37 . Golimumab failed in another patient with concomitant HS/AI and psoriatic arthritis 38 …”

Section: Treatment With Biologicsmentioning

confidence: 99%

Immunomodulatory drugs alone and adjuvant to surgery for hidradenitis suppurativa/acne inversa—A narrative review

Wollina

Brzeziński

Koch

et al. 2020

Hidradenitis suppurativa/acne inversa (HS/AI) is one of the most debilitating dermatoses with a strong negative impact on every dimension of quality of life. Treatment is dependent on the severity of clinical manifestations and comorbidities. While antiinflammatory and antimicrobial approaches are recommended for mild and moderate stages, immunomodulatory drugs have gained increasing interest in all stages of HS/AI. We reviewed the available data on this subject in a narrative review and included not only substances with published final outcome but those where either the ongoing trials or experience from case report. Furthermore, we investigated combined surgical therapy and immunomodulatory drugs and raised specific questions to be answered in controlled settings. This aspect seems to be underrepresented. The first approved medical treatment for HS/AI is adalimumab. Other cytokine, interleukin, Janus kinase and C5a inhibitors and antagonists are under investigation. IL-1 inhibitors and antagonists may become an option for mild to moderate HS/AI, while most of the other medical compounds target moderate to severe HS/AI. Despite medical efforts with immunomodulatory agents, surgery remains a cornerstone of efficient HS/AI therapy. Better outcome in advanced disease might be achieved by combining drug therapy and surgery, but more systematic clinical trials are necessary for the optimal combination.