PONENTE (ongoing) | Open-label, single-arm | >36 weeks (variable personalised OCS tapering period) + 4 weeks follow-up | Aim: ∼600 | Benralizumab | ≥5 mg·day−1 of prednisone (or equivalent) | Dose-reduction phase: variable depending on baseline OCS dosage Maintenance phase: ∼24–32 weeks Follow-up: 4 weeks (Week 36) | OCS dosages will be reduced by 5 mg either weekly or every 2 weeks or by 2.5 mg every 4 weeks depending on baseline OCS use/loss of asthma control until reaching ≤5 mg·day−1 Following 4 weeks at ≤5 mg·day−1, further OCS reduction depends on cortisol concentration and AI status (evaluated by HPA axis integrity) assessed by ACTH stimulation testing |
ZONDA [18] | RCT | 28 weeks + 8 weeks follow-up | 220 | Benralizumab | 7.5–40.0 mg·day−1 of prednisone (or equivalent) 5–35 mg·day−1 of prednisone (or equivalent) | Dose-reduction phase: 20 weeks (Week 4–24) Maintenance phase: 4 weeks Follow-up: 8 weeks (Week 36) | OCS dosage reduced by 2.5–5 mg·day−1 every 4 weeks (until reaching a dosage of 7.5 mg·day−1, then further reduced to 5 mg·day−1, 1.25 mg·day−1, and 0 mg·day−1; only patients with OCS dosage of ≤12.5 mg·day−1 at the end of the run-in phase were eligible for a 100% dose reduction) |
SIRIUS [28] | RCT | 24 weeks | 135 | Mepolizumab | 5–35 mg·day−1 of prednisone (or equivalent) | Run-in optimisation phase: 3–8 weeks Dose-reduction phase: 16 weeks (Week 4–20) Maintenance phase: 4 weeks (Week 24) | Run-in OCS optimisation phase: OCS reduced weekly until asthma worsening Dose-reduction phase: OCS dosage reduced by 1.25–10 mg·day−1 every 4 weeks (based on asthma control and symptoms of AI); reduction only allowed for patients with stable ACQ-5 scores and for whom the investigator deemed appropriate |
VENTURE [29] | International RCT | 24 weeks | 210 | Dupilumab | 5–35 mg·day−1 of prednisone (or equivalent) | Dose-reduction phase: 16 weeks (Week 4–20) Maintenance phase: 4 weeks Follow-up: 12 weeks | OCS dosage reduced every 4 weeks (protocol-specified algorithm; reduction range 2.5–25 mg·day−1, depending on baseline OCS dosage); no dose adjustments allowed after Week 20 |