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[PubMed] [Google Scholar] 4. and 75% (EASI-75) improvement in EASI, respectively at 16+/- 4 TRV130 HCl (Oliceridine) weeks. IGA scores improved by at least two categories for 75% patients. DLQI scores decreased by a mean of 9.0 points, with 80% patients demonstrating a MCID 4-point improvement. For 85% patients, clinicians rated the treatment response as being either better (19%) or much better (65%). CONCLUSIONS Dupilumab is usually associated with a significant and clinically relevant improvements in AD as measured by patient- and physician-reported outcome measures. Importantly, the clinical efficacy, despite the refractory disease of this EAMS cohort, is comparable to that previously reported in clinical trials. INTRODUCTION Systemic therapy is typically considered in atopic dermatitis (AD) resistant to topical therapy and where phototherapy is usually ineffective or contraindicated1,2. Traditionally used systemic brokers include azathioprine, methotrexate and ciclosporin. Of these, only ciclosporin is usually licensed in AD and the EMA licence limits use up to 12 Rabbit polyclonal to UBE3A months. Dupilumab, a monoclonal antibody against interleukin (IL)-4 receptor alpha that inhibits IL-4/IL-13 signalling is usually indicated in dermatology for the treatment of moderate-to-severe atopic dermatitis (AD) in adult and adolescent patients 12 years and older and severe AD in children 6-11 years, who are candidates for systemic therapy. In the TRV130 HCl (Oliceridine) United Kingdom (UK) the Early Access to Medicines Scheme (EAMS) aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. Promising Innovative Medicine (PIM) status was granted to dupilumab in December 2015 and EAMS TRV130 HCl (Oliceridine) positive scientific opinion in March 2017. Dupilumab was made available to adult patients with severe AD who had failed to respond, or who are intolerant of, or ineligible for all those approved therapies with or without corticosteroids. The efficacy and safety of dupilumab has been evaluated in pivotal randomised, double-blind, placebo-controlled studies (SOLO 1, SOLO 2, CAF and CHRONOS) 4,7. It is hypothesised that treatment of AD via EAMS would match that shown previously in large RCTs. Therefore, the aim of this analysis was to assess the efficacy in EAMS a prelicense access scheme in the UK. PATIENTS AND METHODS Patients Patient inclusion and exclusion criteria have been listed in Table 1. Table 1 In-/exclusion criteria Inclusion criteria: ?-Signed written informed consent br / ?- em Adult patients 18 years with severe atopic dermatitis who have failed to respond, or who are intolerant of or ineligible for all those approved therapies (ciclosporin) /em br / ?-Patient has received treatment with dupilumab for 3 months before the date of data collection as part of the Early Access to Medicines Scheme br / ?-Patient has returned for at least one follow-up visit since initiation of treatment Exclusion criteria: ?-Patient has been on dupilumab 3 months before the date of data collection br / ?-Patient has not attended any follow-up visits br / ?-Patient has received treatment with dupilumab prior to EAMS e.g. previous enrolment in a dupilumab clinical trial br / ?- em The patient has active chronic or acute contamination requiring systemic treatment TRV130 HCl (Oliceridine) with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 1 week before the first anticipated date for dupilumab administration /em br / ?- em The patient has known or suspected immunodeficiency, including a history of invasive opportunistic infections (e.g. tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) TRV130 HCl (Oliceridine) despite contamination resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the treating physician /em br / ?- em The patient has used any of the following treatments within 5 half-lives (if known) or 12 weeks before the first anticipated date for dupilumab administration (if half-life is not known or not applicable) /em ??- em Immunosuppressive/immunomodulating.