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. 2022 Jul 12;2022(7):CD010834. doi: 10.1002/14651858.CD010834.pub4

Bjermer 2016.

Study characteristics
Methods Parallel, double‐blind RCT with a 16‐week treatment phase
Participants 315 participants (42 male) with moderate‐severe asthma, with airway reversibility, blood eosinophilia, ACQ score of at least 1.5, and taking ICS
  1. Main inclusion/exclusion criteria:

    1. blood eosinophils ≥ 400 cells/μL during 2 to 4‐week screening period

    2. ACQ‐7 score ≥ 1.5

    3. maintenance treatment with medium‐dose ICS (maintenance OCS not allowed)

  2. Mean age, years: reslizumab 0.3 mg/kg, 44.5; reslizumab 3 mg/kg, 43.0; placebo, 44.2

  3. Male, n: reslizumab 0.3 mg/kg, 43; reslizumab 3 mg/kg, 42; placebo, 41

  4. Baseline mean FEV1 % predicted: reslizumab 0.3 mg/kg, 69; reslizumab 3 mg/kg, 70; placebo, 71

  5. Allocation, n: reslizumab 0.3 mg/kg, 104; reslizumab 3 mg/kg, 106; placebo, 105

Interventions IV infusion of reslizumab 0.3 mg/kg, reslizumab 3.0 mg/kg, or placebo once every 4 weeks (total of 4 doses)
Outcomes Primary outcome
  1. pre‐bronchodilator spirometry (FEV1)


Secondary outcomes
  1. FVC, FEF 25%‐75%

  2. Asthma symptoms (ACQ, ACQ‐6, ACQ‐5), ASUI, AQLQ

  3. Rescue inhaler use

  4. Blood eosinophil levels

Notes 68 locations across 13 countries
Funded by Teva Branded Pharmaceutical Products R&D, Inc
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated, no clarification available from study authors
Allocation concealment (selection bias) Unclear risk Not stated, no clarification available from study authors
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated, no clarification available from study authors
Incomplete outcome data (attrition bias)
All outcomes Low risk Slightly more withdrawals in placebo group (20/105, 19%) than treatment arms (12‐17%)
Selective reporting (reporting bias) Low risk All outcomes reported