WIthdrawal of DUpilumab in Severe Asthma : a randomised non-inferiority-controlled trial

Prior treatment

• Alcohol and/or drug misuse as determined by the investigator
• Patients treated by an oral corticosteroid dose ≥ 10 mg/day (in prednisolone equivalent)

Other illness

• Patients who have to discontinue dupilumab for a reason other than controlled asthma, such as an adverse drug reaction, a planned or current pregnancy, a medical condition requiring the discontinuation of dupilumab (e.g. in a context of the occurrence of helminthiasis), a planned or current vaccination with live and/or live- attenuated vaccine, or a planned switch to another biologic indicated in severe asthma
• Patients with any condition that would prevent participation in the study and completion of the study procedures, including language limitation

Other

• Patients who refuse to discontinue dupilumab, for any reason
• Pregnancy or breastfeeding
• Patient unwilling to sign the informed consent form
• Patient placed under juridical protection
• Patients with FEV1 ≤ 30% of predicted values
• Patients who have to continue dupilumab for the treatment of comorbidities apart from nasal polyposis
• Active smoking
• Patients whose compliance to asthma treatment is considered poor or doubtful by the investigator
• Patients participating in another interventional research study

• Adult patients ≥ 18 years old
• Patients treated with dupilumab, prescribed by a pneumologist, for at least 36 months for severe asthma
• Well controlled asthma defined by an ACT score ≥ 18 and 0 or 1 exacerbation within the year prior to randomization
• Affiliated person or beneficiary of a social security scheme
• Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)
• Effective contraception for women of childbearing age