Sanofi and Regeneron presented analyses from the ongoing open-label RELIEVE-AD study of Dupixent (dupilumab) at the American Academy of Dermatology (AAD). RELIEVE-AD is an ongoing, prospective, longitudinal study evaluating the patient experience through the administration of an online patient survey at baseline and at specific time points over the course of 36 months, with a goal to assess disease control, health-related quality-of-life, treatment satisfaction, and symptoms for patients with moderate-to-severe atopic dermatitis (AD) treated with Dupixent. The companies presented two posters at AAD from the RELIEVE-AD study, one that highlighted patient satisfaction and disease control and another that evaluated a reduction in concomitant therapy use with Dupixent treatment.
In poster 33120, this analysis highlighted patient-reported outcomes (PROs), with a focus on patient satisfaction and disease control in moderate-to-severe AD patients. Disease control was assessed using the AD Control Tool (ADCT; range, 0–24), where a total score under seven indicates disease control, and treatment satisfaction was evaluated using a seven-point Likert scale from ‘extremely satisfied’ to ‘extremely dissatisfied’. Adequate control of disease is supported by patient satisfaction ratings, which show that 75.5% of patients treated with Dupixent are very satisfied or extremely satisfied with their AD treatment.
Poster 32929 evaluated the use of concomitant therapy among adults with AD being treated with Dupixent. The analysis showed that concomitant AD medication use was significantly reduced following Dupixent treatment, with the reduction seen as rapidly as the first month post-treatment. Moreover, a significant reduction in concomitant AD medication use was reported from baseline to the first month, then to months 30–36 across all medication categories (prescription topical medications, systemic steroids and systemic immunosuppressants).
Although Dupixent is expected to maintain its market advantage for the treatment of moderate-to-severe patients, there are several recently approved systemic therapies such as Leo Pharma’s Adtralza/Adbry (tralokinumab), AbbVie’s Rinvoq (upadacitinib) and Pfizer’s Cibinqo (abrocitinib), which will be competing with the IL-4/13 inhibitor. Leo Pharma has begun a long-term extension study, ECZTEND (NCT03587805), but this study is not assessing any PROs so is not comparable to RELIEVE-AD. The company has, however, listed an observational ECZTEND real-world extension study with the German Clinical Trials Registry, where PROs are expected to be an outcome.
AbbVie and Pfizer have yet to list long-term real-world use studies for Rinvoq and Cibinqo assessing PROs, but they have completed sub-group analyses of their Phase III trials as presented during the European Academy of Dermatology and Venereology (EADV) conference. At EADV 2021, AbbVie presented PRO data from its pivotal trials Measure-Up 1 (NCT03569293), Measure-Up 2 (NCT03607422), and AD-Up (NCT03568318), which demonstrated improvements in psychosocial measures and rapid skin clearance. Similarly, Pfizer presented patient-level analysis assessing efficacy and PROs from its active comparator study, JADE Compare (NCT03720470). Although both companies have highlighted PROs, this data is not long term and cannot be extrapolated to understand real-world use patterns.
Sanofi and Regeneron could utilise PROs on disease control and patient satisfaction for their direct-to-consumer marketing of Dupixent in the US, highlighting that Dupixent is a patient-centred and effective product with a high level of satisfaction among AD sufferers. The reduction in concomitant therapy use, meanwhile, could be a key message for marketing to prescribers, highlighting that dupilumab has the ability to simplify the AD treatment regimen. With an influx of novel therapies expected in the near-term and long-term results, using PROs will allow Sanofi and Regeneron to defend and differentiate their gold-standard biologic against increased competition in the AD space, allowing the company to draw on benefits shown in RELIEVE-AD.