TABLE 1

Comparison of PONENTE study features with published oral corticosteroid (OCS)-sparing studies of other biological treatments for severe asthma

Study nameStudy typeTrial durationPatientsBiologicOCS inclusion criteriaOCS tapering
Time frameDosage reduction
PONENTE (ongoing)Open-label, single-arm>36 weeks (variable personalised OCS tapering period) + 4 weeks follow-upAim: ∼600Benralizumab≥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]RCT28 weeks + 8 weeks follow-up220Benralizumab7.5–40.0 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]RCT24 weeks135Mepolizumab5–35 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 RCT24 weeks210Dupilumab5–35 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

RCT: randomised controlled trial; AI: adrenal insufficiency; HPA: hypothalamic–pituitary–adrenal; ACTH: adrenocorticotropic hormone; ACQ-5: five-item Asthma Control Questionnaire-5.