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SAT0390 Secukinumab for The Treatment of Ankylosing Spondylitis: Comparative Effectiveness Results versus Currently Licensed Biologics from A Network Meta-Analysis
  1. D. Baeten1,
  2. P. Mease2,
  3. V. Strand3,
  4. I. McInnes4,
  5. H. Thom5,
  6. S. Kanters6,
  7. E. Palaka7,
  8. K. Gandhi8,
  9. H. Richards9,
  10. S. Jugl9
  1. 1Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
  2. 2Swedish Medical Center and University of Washington, WA
  3. 3Stanford University, Palo Alto, CA, United States
  4. 4University of Glasgow, Glasgow
  5. 5University of Bristol, Bristol, United Kingdom
  6. 6Redwood Outcomes, Vancouver BC, Canada
  7. 7Novartis Ireland Ltd, Dublin, Ireland
  8. 8Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States
  9. 9Novartis Pharma AG, Basel, Switzerland

Abstract

Background Secukinumab 150 mg (SEC) is approved for the treatment of active AS in adults who have responded inadequately to conventional therapy. The MEASURE 1 (M1) and MEASURE 2 (M2) RCTs, which included biologic-naïve and biologic-experienced patients, demonstrated superiority of SEC over placebo. In AS no direct trial comparisons of SEC with licensed biologics are currently available.

Objectives To use network meta-analysis (NMA) to compare SEC vs licensed biologics in the short term.

Methods A systematic literature review (January 2015) identified RCTs of licensed biologics in adults with active AS in whom conventional therapy had failed. NMAs were conducted in accordance with health technology assessment guidance using Bayesian fixed-effects models. To analyse ASAS and BASDAI50 response rates, a standard NMA model with logit link function was used. Analyses of changes from baseline (CFBs) in BASDAI and BASFI used a linear model with identity link and normal distribution. Pairwise comparisons were conducted using relative risks and mean differences. SEC results are presented as the probability of response (95% credible interval [CrI]) for ASAS and BASDAI50, and as CFB (95% CrI); CrIs can be interpreted similarly to CIs. Non-responder imputation data were used, if available; otherwise, LOCF data were used. For infliximab 5 mg/kg (INF) only data from an open label trial was available. Analyses were run at week 12 for biologic-naïve (M1, n=92; M2, n=44) and mixed (naïve or experienced; M1, n=125; M2, n=72) populations.

Results In the biologic-naïve population, ASAS20 results for SEC were similar to those for adalimumab (ADA), etanercept (ETN) 50 mg BIW/QW, golimumab (GOL) 50/100 mg, and INF. The SEC response rates were 58% (46–68) for ASAS20, 42% (31–55) for ASAS40 and 39% for BASDAI50 (28–50); BASFI CFB was −1.99 (−2.39 to −1.60). For BASDAI CFB, SEC [−2.11 (−2.60 to −1.63)] was similar to all other biologics except INF, which had a statistically significantly greater CFB than SEC.

In the mixed population, SEC had similar efficacy to ADA, certolizumab pegol (CZP) 200/400 mg QW, ETN and GOL for ASAS20 [SEC response, 53% (43–63)]. SEC was also similar to ADA, CZP, ETN, GOL and INF for ASAS40 [39% (29–51)], BASDAI50 [35% (25–46)] and BASFI CFB [−1.89 (−2.24 to −1.53)]. SEC was statistically significantly superior to ADA, CZP and ETN for BASDAI CFB [−3.43 (−3.82 to −3.05)].

Conclusions This NMA shows that SEC has similar efficacy to most licensed biologics at most endpoints investigated, with the exception of INF for BASDAI CFB in the biologic-naïve population and ASAS20 in the mixed population. SEC also demonstrated statistically significant superiority over ADA, ETN and CZP for BASDAI CFB in the mixed population. The short-term nature of this study is a limitation (long-term data [≥52 weeks] are available for SEC).

Disclosure of Interest D. Baeten Grant/research support from: Pfizer, MSD, AbbVie, UCB, Novartis, Janssen and Boehringer Ingelheim, Consultant for: Pfizer, MSD, AbbVie, UCB, Novartis, Janssen, Boehringer Ingelheim, Eli Lilly, Roche, BMS and Glenmark, P. Mease Grant/research support from: Corrona, Speakers bureau: Corrona, Merck and Novartis, V. Strand Consultant for: Abbvie, Amgen Corporation, AstraZeneca, BMS, Celgene, Celltrion, CORRONA, Genentech/Roche, GlaxoSmithKline, Janssen, Jazz Pharmaceuticals, Lilly, Novartis, Pfizer, Regeneron, Sandoz, Sanofi and UCB, I. McInnes Consultant for: Novartis, Janssen, Abbvie, Pfizer and UCB, H. Thom Consultant for: Novartis Pharma AG and for a short time in 2015 for Eli Lilly, S. Kanters Consultant for: Novartis, E. Palaka Employee of: Novartis, K. Gandhi Shareholder of: Novartis, Employee of: Novartis, H. Richards Shareholder of: Novartis, Employee of: Novartis, S. Jugl Shareholder of: Novartis, Employee of: Novartis

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