Background
Dupilumab has been shown to improve clinical outcomes long term while reducing oral corticosteroid (OCS) dose in patients with severe OCS-dependent asthma. This post hoc analysis assesses the impact of OCS dose at baseline (≤10 or >10 mg·day−1) on long-term outcomes of dupilumab treatment.
Methods Annualised severe asthma exacerbation rates, forced expiratory volume in 1 s (FEV1), measures of asthma control and quality of life (QoL), and OCS dose were evaluated in patients from the phase 3 VENTURE trial with severe OCS-dependent asthma, further categorised by OCS dose ≤10 or >10 mg·day−1 at parent study baseline (PSBL), who enrolled in TRAVERSE.
Results Dupilumab reduced the annualised exacerbation rate in VENTURE, and it remained low throughout TRAVERSE (0.202–0.265 [OCS ≤10 mg·day−1 at PSBL] and 0.221–0.366 [OCS >10 mg·day−1 at PSBL]). Improvements in pre-bronchodilator FEV1, asthma control and QoL observed in VENTURE dupilumab patients were sustained throughout TRAVERSE. Patients on placebo during VENTURE showed rapid improvements in FEV1 upon initiating dupilumab in TRAVERSE, which were sustained to the end of TRAVERSE. Reductions in OCS dose observed in VENTURE were maintained throughout TRAVERSE, with more than two-thirds of patients achieving reductions in OCS doses to ≤5 mg·day−1 by TRAVERSE Week 48.
Conclusions Improvements in clinical outcomes and reductions in OCS dose with dupilumab observed in VENTURE were maintained throughout TRAVERSE, regardless of baseline disease severity. Patients who switched from placebo in VENTURE to dupilumab in TRAVERSE had improved clinical outcomes and reductions in OCS dose comparable to those given dupilumab in VENTURE.
Footnotes
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Conflict of interest: C. Domingo reports travel and speaker fees from ALK, Allergy Therapeutics, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline (GSK), HAL Allergy, ImmunoTek, Menarini, Novartis, Pfizer, sanofi-aventis, Stallergenes Greer, and Teva.
Conflict of interest: K.F. Rabe reports consultant and speaker fees from AstraZeneca, Boehringer Ingelheim, Novartis, Sanofi and Teva.
Conflict of interest: D. Price reports advisory board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mundipharma, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi, Teva Pharmaceuticals, Thermo Fisher Scientific and Viatris; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance Biopharma and Viatris; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, Teva Pharmaceuticals, Theravance Biopharma, UK National Health Service and Viatris; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GSK, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, Teva Pharmaceuticals and Viatris; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Circassia, Mundipharma, Novartis, Teva Pharmaceuticals and Thermo Fisher Scientific; funding for patient enrolment or completion of research from Novartis; stock or stock options from AKL Research and Development and Timestamp; owns 74% of Optimum Patient Care (Australia and UK) and 74% of Observational and Pragmatic Research Institute (Singapore); is a peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme and Health Technology Assessment; and was an expert witness for GSK.
Conflict of interest: G. Brusselle reports consultant and speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Sanofi and Teva. M.E. Wechsler reports personal fees from Amgen, AstraZeneca, Boehringer Ingelheim, CytoReason, Equillium, Genentech, Genzyme, Novartis, Pulmatrix, Regeneron Pharmaceuticals, Inc., resTORbio, Sentien Biotechnologies and Teva; and grants and personal fees from GSK and Sanofi. C. Xia, R. Gall, Y. Deniz and A. Radwan are employees of and shareholders in Regeneron Pharmaceuticals, Inc. N. Pandit-Abid, P.J. Rowe and J.A. Jacob-Nara are employees of Sanofi, and may hold stock and/or stock options in the company.
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- Received January 27, 2023.
- Accepted August 29, 2023.
- Copyright ©The authors 2023
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