Anti-IL-5/5R versus anti-IL4R switching strategies for uncontrolled severe asthma treated by anti-IL5/5R : A target trial emulation (RAMSES-Switch)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105375
• EU PAS number:
  EUPAS105374
• Study ID:
  105375
• Official title and acronym:
  Anti-IL-5/5R versus anti-IL4R switching strategies for uncontrolled severe asthma treated by anti-IL5/5R : A target trial emulation (RAMSES-Switch)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Severe asthma, affects for 5 to 10% of asthma patients.Biologic therapies have emerged as effective treatments for severe asthma, and five monoclonal antibodies (mAbs) are now available in France to target different subtypes of severe asthma. Intensity of clinical response varies from patient to patient: therefore, for patients with insufficient response, a switch to another drug is possible, since most of the biologics target similar populations of patients with severe asthma. Although response to a biologic given as a second or third line of treatment has been documented, the best strategy to switch from a molecule to another one has not been evaluated yet. In case of failure of anti-IL5 or anti IL5R drugs, two main strategies are used: switching to dupilumab, an anti IL4/13R mAb that also targets eosinophilic asthma or switching to another anti IL5 drug. This study aimed to compare the efficacy of the two switching strategies on asthma control in patients with severe eosinophilic asthma with insufficient clinical response to a first-line anti-IL5/5R mAb treatment. We planned an emuation of a target trial using the data of the Research on severe asthma cohort (RAMSES-cohort). We planned to use a propensity score framework to deal with potential cofounders to the observational nature of the data.
• Study status:
  Ongoing

Research institution and networks

Institutions

Assistance Publique - Hôpitaux de Paris (AP-HP)

France

yon-HC de Lyon - La Croix Rousse (9) Clamart-HIA Percy (33)Colmar-Hôpitaux Civils de Colmar (4) Paris-APHP - Cochin (16)-Saint-Denis-Centre Cardiologique du Nord - Moulins Gémeaux (25) Antony-Hôpital Privé d'Antony (47)andoeuvre-lès-Nancy-CHRU de Nancy - Brabois (53)Brest-CHU de Brest, Paris-APHP - Bichat (1) Montfermeil-GHI Le Raincy Montfermeil (10), Lille-CHRU de Lille - Albert Calmette (8) Reims-CHU de Reims - Maison Blanche (21), Montpellier-CHU de Montpellier - Arnaud de Villeneuve (11) Orléans-CHR d'Orléans - La Source (15), Marseille-APHM - Nord (37) Pierre-Bénite-HC de Lyon - Sud (19), Dijon-CHRU de Dijon - François Mitterrand (34) Pringy-CHR d'Annecy (20), Créteil-CHI Créteil (5) Suresnes-Hôpital Foch (57), La Tronche-CHU de Grenoble - La Tronche (6) Caen-CHU de Caen - Côte de Nacre (3), Le Kremlin-Bicêtre-APHP - Bicêtre (7 Amiens-CHU d'Amiens Sud (46), Besançon-CHU de Besançon - Jean Minjoz (39) Paris-GH Paris Saint Joseph (51

Networks

RAMSES Study Group, CRISALIS (Clinical Research Initiative in Severe Asthma : a Lever for Innovation & Science)

Study timelines

Date when funding contract was signed

Actual: 10/12/2018

Study start date

Planned: 01/09/2019

Actual: 30/09/2022

Data analysis start date

Planned: 01/03/2023

Actual: 01/05/2023

Date of final study report

Planned: 15/09/2023

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Astrazeneca, GlaxoSmithKLine, Sanofi, Boston Scientific, Novartis, French Society of Pneumology

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable