TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema

A long‐term prospective observational safety study is essential to characterize fully the safety profile of systemic immunomodulating therapies for patients with atopic eczema. The TREatment of ATopic eczema (TREAT) Registry Taskforce offers a large platform to conduct such research using national registries that collect the same data using a predefined core dataset.

[1]  J. Giovannelli,et al.  Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort. , 2019, Journal of the American Academy of Dermatology.

[2]  C. Flohr,et al.  TREatment of ATopic eczema (TREAT) Registry Taskforce: consensus on how and when to measure the core dataset for atopic eczema treatment research registries , 2019, The British journal of dermatology.

[3]  C. Flohr,et al.  TREatment of ATopic eczema (TREAT) Registry Taskforce: an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema photo‐ and systemic therapy registries , 2018, The British journal of dermatology.

[4]  I. Pavord,et al.  Dupilumab Efficacy and Safety in Moderate‐to‐Severe Uncontrolled Asthma , 2018, The New England journal of medicine.

[5]  C. Flohr,et al.  The International TREatment of ATopic Eczema (TREAT) Registry Taskforce: An Initiative to Harmonize Data Collection across National Atopic Eczema Photo- and Systemic Therapy Registries. , 2017, The Journal of investigative dermatology.

[6]  G. Yancopoulos,et al.  Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial , 2017, The Lancet.

[7]  C. Flohr,et al.  Treatment of moderate‐to‐severe atopic eczema in adults within the U.K.: results of a national survey of dermatologists , 2017, The British journal of dermatology.

[8]  C. Flohr,et al.  TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries , 2017, Trials.

[9]  J. Silverberg,et al.  Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. , 2016, The New England journal of medicine.

[10]  E. R. Sutherland,et al.  Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial , 2016, The Lancet.

[11]  J. Vandenbroucke,et al.  Point: Incident Exposures, Prevalent Exposures, and Causal Inference: Does Limiting Studies to Persons Who Are Followed From First Exposure Onward Damage Epidemiology? , 2015, American journal of epidemiology.

[12]  P. Spuls,et al.  Ten years experience with oral immunosuppressive treatment in adult patients with atopic dermatitis in two academic centres , 2015, Journal of the European Academy of Dermatology and Venereology : JEADV.

[13]  S. Feldman,et al.  Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents. , 2014, Journal of the American Academy of Dermatology.

[14]  J. Schmitt,et al.  Efficacy and safety of systemic treatments for moderate-to-severe atopic dermatitis: a systematic review. , 2014, The Journal of allergy and clinical immunology.

[15]  K. Schmiegelow,et al.  Use of azathioprine and the risk of cancer in inflammatory bowel disease. , 2013, American journal of epidemiology.

[16]  M. El-Khalawany,et al.  Methotrexate versus cyclosporine in the treatment of severe atopic dermatitis in children: a multicenter experience from Egypt , 2013, European Journal of Pediatrics.

[17]  B. Fingleton,et al.  Cytokine stimulation of epithelial cancer cells: the similar and divergent functions of IL-4 and IL-13. , 2012, Cancer research.

[18]  J. Ring,et al.  Guidelines for treatment of atopic eczema (atopic dermatitis) Part II , 2012, Journal of the European Academy of Dermatology and Venereology : JEADV.

[19]  J. Ring,et al.  Guidelines for treatment of atopic eczema (atopic dermatitis) Part I , 2012, Journal of the European Academy of Dermatology and Venereology : JEADV.

[20]  C. Flohr,et al.  The European treatment of severe atopic eczema in children taskforce (TREAT) survey , 2012, The British journal of dermatology.

[21]  F. Vanaclocha,et al.  Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials. , 2012, Archives of dermatology.

[22]  R. Agans,et al.  Systemic Treatment of Pediatric Atopic Dermatitis with Azathioprine and Mycophenolate Mofetil , 2011, Pediatric dermatology.

[23]  R. Schlienger,et al.  Incidence of cancer in the general population and in patients with or without atopic dermatitis in the U.K. , 2010, The British journal of dermatology.

[24]  Zhiguang Li,et al.  Paradoxical Roles of IL-4 in Tumor Immunity , 2009, Cellular and Molecular Immunology.

[25]  C. Chow,et al.  Efficacy and tolerability at 3 and 6 months following use of azathioprine for recalcitrant atopic dermatitis in children and young adults , 2009, The Journal of dermatological treatment.

[26]  Sylvie Chevret,et al.  Sample size formula for proportional hazards modelling of competing risks , 2004, Statistics in medicine.

[27]  D. Atherton,et al.  A retrospective evaluation of azathioprine in severe childhood atopic eczema, using thiopurine methyltransferase levels to exclude patients at high risk of myelosuppression , 2002, The British journal of dermatology.

[28]  A. Finlay,et al.  Cyclosporin for severe childhood atopic dermatitis: short course versus continuous therapy , 2000, The British journal of dermatology.

[29]  P. Krupp,et al.  The risk of neoplasms in patients treated with cyclosporine A. , 1989, Journal of autoimmunity.

[30]  D. Macdonald,et al.  Skin cancer and cyclosporine therapy. , 1985, The New England journal of medicine.

[31]  J. Thompson,et al.  Hypertrichosis and Multiple Cutaneous Squamous Cell Carcinomas in Association with Cyclosporin a Therapy 1 , 1983, Journal of the Royal Society of Medicine.

[32]  D. Schoenfeld,et al.  Sample-size formula for the proportional-hazards regression model. , 1983, Biometrics.

[33]  K. Kragballe,et al.  Methotrexate induced liver cirrhosis , 1980, The British journal of dermatology.

[34]  W. Tom,et al.  Oral azathioprine for recalcitrant pediatric atopic dermatitis: clinical response and thiopurine monitoring. , 2013, Journal of the American Academy of Dermatology.

[35]  K. Schäkel,et al.  Systemic treatment of severe atopic eczema: a systematic review. , 2007, Acta dermato-venereologica.

[36]  I I Lelis,et al.  [Atopic dermatitis]. , 1980, Vestnik dermatologii i venerologii.