Artikel
Secukinumab for the treatment of ankylosing spondylitis: comparative effectiveness results versus adalimumab using a matching-adjusted indirect comparison
Suche in Medline nach
Autoren
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Steffen Jugl
- Novartis Pharma AG, Basel, Schweiz
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Walter Maksymowych
- University of Alberta, Edmonton, Canada
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Dominique Baeten
- Academic Medical Center/University of Amsterdam, Clinical Immunology and Rheumatology, Amsterdam, The Netherlands
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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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Hanno B. Richards
- Novartis Pharma AG, Basel, Switzerland
| Veröffentlicht: | 29. August 2016 |
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Gliederung
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Background: The MEASURE (M2) trial showed superiority for secukinumab over placebo. Efficacy was sustained up to 2 years. The ATLAS trial compared adalimumab 40 mg with placebo, but there is no head-to-head trial. Placebo patients could switch to active treatment at week 12 in ATLAS and 16 in M2. MAIC can assess comparative effectiveness by re-weighting PLD resulting in a 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 Secukinumab arm in M2 (n=72) was re-weighted to match baseline characteristics of the adalimumab arm in ATLAS (n=208). Logistic regression was used to determine weights for age, sex, mean BASFI score, mean CRP level, and prior biologic use. Sensitivity analyses including adjustment for BASDAI score were performed. Correlation analyses of baseline characteristics with ASAS20/40 responses were not available before the regression analyses. Both trials reported NRI results until week 24; beyond which ATLAS used LOCF with n=311, including placebo switchers. Weighted outcomes from M2 (ESS n=34) were compared with outcomes from ATLAS. Pairwise comparisons using RR were performed. Results are presented as probability of response (95% CI) and RR (95% CI).
Results: Secukinumab treatment led to statistical significantly higher ASAS responses at week 24 vs. adalimumab for ASAS20 (72.3% [62–83]; RR 1.43 [1.12–1.84] p=0.004) and ASAS40 (61.4% [50–73]; RR 1.56 [1.14–2.14] p=0.006). The ASAS20 and 40 response rates for adalimumab were 50.5% (44–57) and 39.4% (33–46). At week 52, secukinumab led to higher ASAS responses. The ASAS20 and 40 response rates were 78.9% (69–89) and 57.6% (46–69) (secukinumab), and 65.4% (60–71) and 47.1% (42–53) (adalimumab). The comparison at ASAS20 approached significance (RR 1.21 [0.996–1.461] p=0.055).
Figure 1 [Fig. 1]
Conclusion: Secukinumab demonstrated statistically significant higher symptomatic improvement in terms of ASAS20 and 40 responses at week 24 in this first MAIC (similar trend noted up to week 52). Differences in study designs and the small ESS (n=34) for secukinumab may result in potential limitations, warranting further MAIC analyses.
