Browsing by Subject "dupilumab"

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  • Cork, Michael J.; Eckert, Laurent; Simpson, Eric L.; Armstrong, April; Barbarot, Sebastien; Puig, Luis; Girolomoni, Giampiero; de Bruin-Weller, Marjolein; Wollenberg, Andreas; Kataoka, Yoko; Remitz, Anita; Beissert, Stefan; Mastey, Vera; Ardeleanu, Marius; Chen, Zhen; Gadkari, Abhijit; Chao, Jingdong (2020)
    Background: Atopic dermatitis (AD) profoundly affects quality of life (QoL). Dupilumab significantly improves clinical outcomes, is well tolerated, and approved to treat inadequately controlled moderate-to-severe AD in adults; however, its effect on patient-reported outcomes (PROs) is not fully characterized. Objective: To evaluate the impact of dupilumab on patient-reported AD symptoms and QoL. Methods: Pooled data were analyzed from two identically designed phase 3 studies, LIBERTY AD SOLO 1 (NCT02277743) and SOLO 2 (NCT02277769), assessing the following PROs: Peak Pruritus Numerical Rating Scale (NRS), Pruritus Categorical Scale, SCORing AD (SCORAD), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), five-dimension EuroQoL questionnaire (EQ-5D), and patient-assessed disease status and treatment effectiveness. Results: Dupilumab rapidly improved (vs. placebo) Peak Pruritus NRS scores by day 2 (p <.05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 (p <.0001). At week 16, more dupilumab-treated than placebo-treated patients reported improvement in SCORAD itch and sleep, and no pain/discomfort (EQ-5D) (p <.0001). Limitations: Cultural differences of translated PROs. Conclusion: Dupilumab had a significant, positive impact on AD symptoms, including itch, sleep, pain, anxiety and depression, and QoL in adults with moderate-to-severe AD.
  • Agache, Ioana; Song, Yang; Rocha, Claudio; Beltran, Jessica; Posso, Margarita; Steiner, Corinna; Alonso-Coello, Pablo; Akdis, Cezmi; Akdis, Mubeccel; Canonica, Giorgio Walter; Casale, Thomas; Chivato, Tomas; Corren, Jonathan; del Giacco, Stefano; Eiwegger, Thomas; Firinu, Davide; Gern, James E.; Hamelmann, Eckard; Hanania, Nicola; Mäkelä, Mika; Martin, Irene Hernandez; Nair, Parameswaran; O'Mahony, Liam; Papadopoulos, Nikolaos G.; Papi, Alberto; Park, Hae-Sim; de Llano, Luis Perez; Quirce, Santiago; Sastre, Joaquin; Shamji, Mohamed; Schwarze, Jurgen; Canelo-Aybar, Carlos; Palomares, Oscar; Jutel, Marek (2020)
    Dupilumab, a fully human monoclonal antibody against interleukin-4 receptor alpha, is approved as add-on maintenance treatment for inadequately controlled type 2 severe asthma. This systematic review evaluated the efficacy, safety and economic impact of dupilumab compared to standard of care for uncontrolled severe asthma. PubMed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important asthma-related outcomes were evaluated. The risk of bias and the certainty of the evidence were assessed using GRADE. Three RCTs including 2735 subjects >12 years old and 24-52 weeks of follow-up were included. Dupilumab reduced with high certainty severe asthma exacerbations (Incidence rate ratio 0.51; 95% CI 0.45-0.59) and the percentage use of oral corticosteroid use (mean difference (MD) -28.2 mg/d; 95% CI -40.7 to -15.7). Asthma control (ACQ-5), quality of life (AQLQ) and rescue medication use [puffs/d] improved, without reaching the minimal important clinical difference: ACQ-5 MD -0.28 (95% CI -0.39 to -0.17); AQLQ MD +0.28 (95% CI 0.20-0.37); and rescue medication MD -0.35 (95% CI -0.73 to +0.02). FEV1 increased (MD +0.15; 95% CI +0.11 to +0.18) (moderate certainty). There was an increased rate of dupilumab-related adverse events (AEs) (moderate certainty) and of drug-related serious AEs (low certainty). The incremental cost-effectiveness ratio of dupilumab versus standard therapy was 464 000$/QALY (moderate certainty). More data on long-term safety are needed both for children and for adults, together with more efficacy data in the paediatric population.