Artikel
Secukinumab for the treatment of psoriatic arthritis: comparative effectiveness results versus adalimumab up to 48 weeks using a matching-adjusted indirect comparison
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Autoren
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Steffen Jugl
- Novartis Pharma AG, Basel, Schweiz
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Iain McInnes
- University of Glasgow, Glasgow, England
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Philip Mease
- Department of Rheumatology, Swedish Medical Center, and University of Washington, Seattle, WA, USA
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H. Thom
- University of Bristol, Bristol, Großbritannien
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Sandrine Cure
- MAPI group, Uxbridge, United Kingdom
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Eirini Palaka
- Novartis Ireland Ltd, Dublin, Ireland
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Kunal Gandhi
- Novartis Pharmaceuticals Corporation, East Hanover, USA
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Shephard Mpofu
- Novartis Pharma AG, Basel, Switzerland
| Veröffentlicht: | 29. August 2016 |
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Gliederung
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Background: The FUTURE 2 (F2) trial showed superiority of Secukinumab 150 mg and 300 mg over placebo (efficacy sustained to week 52). The ASEPT trial compared adalimumab 40 mg wih placebo in biologic-naive patients. There is no head-to-head-trial. Patients could switch from placebo (F2: week 16 or 24; ADEPT: week 24). MAIC can compare effectiveness by re-weighting PLD resulting in reduced ESS, to match the baseline patient characteristics and simulate head-to-head comparisons.
Objectives: To assess the relative efficacy of secukinumab vs. adalimumab
Methods: PLD from the F2 trial (n=200) were weighted to match baseline characteristics (age, body weight, sex, race, methotrexate use, presence of psoriasis [≥3% body surface area], mean PASI score, dactylitis, enthesitis, mean HAQ-DI and previous biologic therapy) of ADEPT (n=151). Weighted outcomes from F2 (ESS: 150 mg, n=36; 300 mg, n=38) were compared with data from ADEPT. Pairwise comparisons using RRs were performed and presented as RR (95% CI) and probability of response (95% CI) for ACR20, 50 and 70 at week 48. For PASI75 and 90, adalimumab week 48 results are compared with secukinumab week 52 data.
Results: Both Secukinumab doses had higher mean ACR20, 50 and 70 responses than adalimumab, with statistical significance for 150 mg (1.41 [1.14–1.76], p=0.002) and 300 mg (1.31 [1.03–1.66], p=0.027) at ACR20 and for 300 mg (1.41 [1.03–1.92], p=0.032) at ACR50. The ACR20, 50 and 70 response rates were 79.6% (72–88), 57.1% (47–67) and 32.4% (23–42) for 150 mg; 73.5% (64–83), 61.4% (51–71) and 42.9% (33–53) for 300 mg; and 56.3% (48–64), 43.7% (36–52) and 29.8% (23–37) for adalimumab. Findings were consistent across sensitivity analyses which also showed significance for secukinumab 300 mg at ACR70. PASI 75 and 90 response rates were numerically better for secukinumab 300 mg: 71.1% (57–86) and 52.2% (36–68) than adalimumab: 58.0% (46–70) and 46.4% (35–58). Secukinumab150 mg rates were 51.2% (38–64) and 40.8% (28–54).
Figure 1 [Fig. 1]
Conclusion: Secukinumab was associated with numerically higher response rates for joint and skin outcomes with statistically significantly higher responses vs. adalimumab for ACR endpoints at week 48.
