TABLE 1.
Results of indirect comparisons using Bucher's test for dupilumab versus mepolizumab and dupilumap versus omalizumab for treatment of severe type 2 asthma
| Outcome | Unit of measurement | MCID | Dupilumab # versus mepolizumab ¶ | Dupilumab versus omalizumab + | ||
| Difference in absolute values (95% CI) | Difference in relative value (95% CI) | Difference in absolute values (95% CI) | Difference in relative value (95% CI) | |||
| Exacerbation rate | Mean reduction of annual exacerbations, n | 0.5 exacerbation per year | B: −0.19 (−0.53–0.32), p=0.39 | B: 0.85 (0.57–1.26), p=0.43 | B: −0.11 (−0.27–0.11), p=0.26 | B: 0.85 (0.61–1.17), p=0.33 |
| Percentage of patients without exacerbations | 10% | B: −10.6 (−21.9–4.5), p=0.12 | B: 0.80 (0.60–1.08), p=0.14 | B: 2.6 (−5.6; 12.2), p=0.58 | B: 1.05 (0.90–1.21), p=0.53 | |
| OCS maintenance treatment | Mean % reduction of daily OCS dose | 20% (at least 2.5 mg prednisolone equivalent) | ||||
| Percentage of patients able to eliminate daily OCS treatment | 5% | C: −0.5 (−9.9–27.6), p=0.94 | C: 0.97 (0.31–2.91), p=0.96 | |||
| Percentage of patients with a reduction of OCS daily dose≥50% | 10% | C: −1.4 (−21.0–29.9), p=0.92 | C: 0.97 (0.61–1.57), p=0.91 | |||
| Lung function, FEV1 | Mean difference in FEV1 | 200 mL | A: +100 (13–188), p=0.025 B: +189 (62–316), p=0.004 C: +106 (−122–334), p=0.37 |
B: +96 (11–182), p=0.028 | ||
| Percentage of patients who achieved an improvement in FEV1 ≥200 mL | 15% | |||||
| ACQ | Mean difference in ACQ | 0.5 | A: −0.02 (−0.22–0.18), p=0.86 C: 0.05 (−0.41–0.51), p=0.84 |
A: −0.11 (−0.42–0.20), p=0.50 | ||
| AQLQ | Mean difference in AQLQ | 0.5 | A: −0.13 (−0.32–0.06), p=0.18 C: −0.01 (−0.41–0.40), p=0.96 |
A: −0.08 (−0.30–0.15), p=0.50 | ||
| SAEs | Total incidence of SAEs | 5% | A: 6.5 (−1.6–27.5), p=0.39 B: 2.0 (−5.7–17.6), p=0.75 C: 26.0 (1.5–257.1), p=0.013 |
A: 1.97 (0.76–5.13), p=0.16 B: 1.15 (0.57–2.35), p=0.71 C: 19.55 (2.10–184.6), p=0.009 |
A: 3.0 (−1.8–14.9), p=0.49 B: 0.2 (−2.7–5.3), p=0.93 |
A: 1.61 (0.64–4.05), p=0.32 B: 1.04 (0.60–1.80), p=0.90 |
| Specific subtypes of SAEs, e.g. anaphylaxis | No analysis | No analysis | ||||
All estimates are for dupilumab compared to mepolizumab and omalizumab. MCID: minimal clinically important difference; OCS: oral corticosteroids; FEV1: forced expiratory volume in 1 s; ACQ: Asthma Control Questionnaire; AQLQ: Asthma quality of life Questionnaire; SAE: serious adverse events. A: severe asthma, 24–32 weeks treatment; B: severe asthma, 48–52 weeks treatment; C: OCS-dependent asthma, 24 weeks treatment. #: dupilumab studies: [10–14]; ¶: mepolizumab studies: [15–18]; +: omalizumab studies: [19–40].