Table 2.
Clinical effect of investigational agents currently evaluated in Phase I and II RCTs for the treatment of asthma compared to PCB on efficacy outcomes for which the MCID values are currently available. The investigational agents reported in this table also elicited statistically significant improvement vs. PCB (p < 0.05).
| Outcome | Treatment | Drug Class | Delta Effect | Suggested MCID [103] | Beneficial Clinically Relevant Effect |
|---|---|---|---|---|---|
| Trough FEV1 | Itepekimab 300 mg Q2W | Anti-IL-33 mAb | 140 mL (10–270) | >100 mL | Yes |
| Indacaterol maleate 150 μg QD | LABA | 186 mL (129–243) | >100 mL | Yes | |
| Peak FEV1 | Itepekimab 300 mg Q2W + dupilumab 300 Q2W | Anti-IL-33 mAb + anti IL-4/IL-13 mAb | 130 mL (10–250) | ≥12% and ≥200 mL | No |
| PEF | Indacaterol maleate 150 μg QD | LABA | 33.00 L/min (25.60–40.30) | >5.39% | ? |
| Morning PEF | Velsecorat 720 μg QD | SGRM | 16.60 L/min (8.03–25.17) | >5.39% | ? |
| Evening PEF | Velsecorat 720 μg QD | SGRM | 11.99 L/min (3.57–20.42) | >5.39% | ? |
| ACQ | Itepekimab 300 mg Q2W | Anti-IL-33 mAb | −0.42 points (−0.73–−0.12) | >0.5 points | Borderline |
| Itepekimab 300 mg Q2W + dupilumab 300 mg Q2W | Anti-IL-33 mAb + anti IL-4/IL-13 mAb | −0.32 points (−0.63–−0.01) | >0.5 points | No | |
| Velsecorat 720 μg QD | SGRM | −0.27 points (−0.43–−0.10) | >0.5 points | No | |
| CJM112 300 mg QW | IL-17A mAb | −0.23 points (−0.40–−0.06) * | >0.5 points | No | |
| Exacerbations | Velsecorat 720 μg QD | SGRM | 0.11 rate (0.04–0.25) | >−20% rate | Yes |
| AQLQ | Itepekimab 300 mg Q2W | Anti-IL-33 mAb | 0.45 points (0.14–0.77) | >0.5 points | Borderline |
| Itepekimab 300 mg Q2W + dupilumab 300 mg Q2W | Anti-IL-33 mAb + anti IL-4/IL-13 mAb | 0.43 points (0.11–0.75) | >0.5 points | Borderline |
* 80% Confidence Interval. ACQ: asthma control questionnaire; AQLQ: asthma quality of life questionnaire; FEV1: forced expiratory volume in the 1st second; IL-n: interleukin-n; LABA: long-acting β2-adrenoceptor agonist; mAb: monoclonal antibody; MCID: Minimal Clinical Important Difference; NA: not available; PCB: placebo; PEF: peak expiratory flow; Q2W: once every 2 weeks; QD: quaque die, once daily; RCT: randomised controlled trial; SGRM: selective glucocorticoid receptor modulator; TSLP: thymic stromal lymphopoietin.