In short
Reslizumab is a biologic medicine used as an add-on treatment for severe asthma with an eosinophilic phenotype. It is a protein-based substance authorised as a medicine under the brand name CINQAERO. One Phase 3 clinical trial is currently authorised to investigate whether the interval between reslizumab doses can be gradually prolonged in 142 people with severe asthma.
Key points
- Reslizumab is a biologic medicine for severe eosinophilic asthma, sold as CINQAERO.
- It is given as a solution for infusion, normally into a vein, though the current trial lists subcutaneous injection.
- The authorised Phase 3 trial BIO-GRAIL includes 142 participants with severe asthma.
- The trial tests whether the interval between biologic doses can be gradually prolonged over about one year.
- Asthma control is measured by exacerbation frequency and the ACQ symptom score.
- Reslizumab is classified under ATC code R03DX08, a group of other systemic drugs for obstructive airway diseases.
What is reslizumab?
Reslizumab is a protein-based biologic medicine used as an add-on treatment for severe asthma with an eosinophilic phenotype. It belongs to the drug class of interleukin inhibitors, which block specific signalling proteins involved in inflammation. The substance is authorised as a medicine in the United Kingdom under the product name CINQAERO 10 mg/mL concentrate for solution for infusion, with Teva UK Limited as the authorisation holder. In the Anatomical Therapeutic Chemical classification it carries the code R03DX08, placing it among other systemic drugs for obstructive airway diseases. Reslizumab is also known by the brand name Cinqair in some regions.
How does reslizumab work?
Reslizumab works by targeting interleukin-5, a signalling protein that promotes the growth, activation and survival of eosinophils, a type of white blood cell involved in allergic inflammation. By blocking interleukin-5, reslizumab can reduce the number of eosinophils in the blood, which may help reduce the airway inflammation that drives severe eosinophilic asthma. The medicine is used together with other asthma medicines for the maintenance treatment of severe asthma in people with an eosinophilic phenotype, meaning their disease is associated with elevated eosinophil levels.
Which conditions is reslizumab used or studied for?
- Severe eosinophilic asthma — the main condition reslizumab is authorised to treat, used as add-on therapy when inhaled corticosteroids do not provide adequate control.
- Refractory asthma — asthma that remains poorly controlled despite standard treatment, discussed in a peer-reviewed article on reslizumab as add-on therapy.
- Severe asthma — the condition studied in the authorised BIO-GRAIL trial, which includes people already receiving biologic treatment.
How is reslizumab given?
Reslizumab is manufactured as a solution for infusion, a liquid preparation normally given into a vein. The product information describes it as a concentrate for solution for infusion. In the BIO-GRAIL trial, the intervention is listed with subcutaneous injection as the route of administration, reflecting how the medicine is being used in that specific study. Reslizumab is given only by or under the supervision of a healthcare professional.
What do the clinical trials show?
One clinical trial involving reslizumab is currently authorised in the EU Clinical Trials Information System. The trial, called BIO-GRAIL, is a Phase 3 interventional study with 142 participants and has the status Authorised. It investigates whether the interval between doses of biologic treatments, including reslizumab, can be gradually prolonged over approximately one year in people with severe asthma. The trial compares several biologic medicines used in severe asthma: Nucala, CINQAERO (reslizumab), Dupixent, Fasenra and Tezspire. The primary outcome is maintained asthma control after about one year with at least one step of interval prolongation. Asthma control is defined as not more than one additional exacerbation compared with baseline frequency and an Asthma Control Questionnaire (ACQ) score below 2.0 at the last study visit. An exacerbation is defined as an acute worsening of symptoms lasting more than 48 hours, as assessed by the treating physician. Participants are people with severe asthma already receiving biologic treatment.
What side effects are known?
The most serious side effect reported for reslizumab is anaphylaxis, a severe and potentially life-threatening allergic reaction. In placebo-controlled clinical studies, anaphylaxis was observed in 0.3% of patients receiving reslizumab infusion, and it was reported as early as the second dose. Patients are observed for a period after administration by a healthcare professional prepared to manage anaphylaxis, and the infusion should be stopped immediately if signs or symptoms of anaphylaxis appear. Common side effects are not listed in the available source. The medicine is not indicated for use in children, as safety and efficacy have not been established in the paediatric population.