A review of adherence to nice criteria for initiation and continuation of treatment of dupilumab in atopic dermatitis

Abstract

Abstract Introduction Atopic dermatitis is a chronic, recurrently flaring, generalised skin condition that can be life-limiting, debilitating and isolating. A typical treatment pathway involves emollients and topical corticosteroids (first line), topical calcineurin inhibitors (second line), phototherapy (third line) and systemic immunosuppressant therapies (fourth line. Dupilumab is recommended by NICE1 as an option for treating moderate to severe atopic dermatitis in adults, only if the disease has not responded to at least one other systemic therapy, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil, or these are contraindicated or not tolerated, and the company provides dupilumab according to the commercial arrangement. Dupilumab should be stopped at 16 weeks if the atopic dermatitis has not responded adequately i.e. at least a 50% reduction in the Eczema Area and Severity Index score (EASI, ranges from 0 to 72, with higher scores indicating greater severity) from when treatment started and at least a 4-point reduction in the Dermatology Life Quality Index (DLQI) from when treatment started. Aim To ascertain whether dupilumab (a payments by results excluded drug, commissioned by integrated care systems) was used in a teaching district general hospital according to the stated criteria within the NICE technology appraisal. Methods Patients prescribed and supplied with dupilumab for more than 16 weeks were identified and Dermatology letters were scrutinised by a pharmacy team member. Ethical review was not required as this was a service evaluation. Results Eighty-eight patients had received dupilumab and the records of 30 (mean age 44, range 18-73, 18 male) were reviewed. Most entries were from when NICE first approved dupilumab, though some were chosen from late 2021/early 2022. All but one had been on at least one prior systemic therapy. This one patient was admitted urgently with severe dermatitis and so was referred for dupilumab as it is quicker acting than immunosuppressant therapy and no need to wait for blood tests. One patient did not have a starting EASI score (under a tertiary hospital). Twenty-nine of the 30 patients experienced both the required 50% or more reduction in EASI score at the review meeting and the at least a 4-point reduction in DLQI. The one patient who did not respond had treatment ceased. At approximately week 16, for all patients the ASI score changed from a mean of 29.7 (range 3-66.7) to 3.6 (range 0-27.9), and DLQI from a mean of 18.9 (range 7-30) to 4.4 (range 0-28). Discussion/Conclusion This study found that all but one of 30 patients had been on prior systemic therapy, and all but one patient met the NICE criteria at the review period (treatment then ceased). This was a sample of approximately one-third of the patients who had received dupilumab. Acknowledging that the dupilumab NHS price is about £16,000 per patient per year, these reassuring results of NICE compliance have been shared with Dermatology. We recognise the limitations of a single centre, very small-scale study. We do not report prolonged follow up of patients in relation to any improvement in their atopic dermatitis other than what we observed documented in Dermatology letters at commencement and review of treatment.