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THU0119 Lack of effect of secukinumab treatment on the lipid profile in patients with rheumatoid arthritis: Results from a randomized, double-blind, placebo-controlled, phase II study
  1. P. Durez1,
  2. M. Genovese2,
  3. H. Kellner3,
  4. C. Codding4,
  5. G. Ligozio5,
  6. H. Richards6,
  7. C. Escrig6,
  8. S. Mpofu6
  1. 1Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
  2. 2Stanford University, California, United States
  3. 3Centre for Inflammatory Joint Diseases, Munich, Germany
  4. 4Health Research of Oklahoma, Oklahoma
  5. 5Novartis Pharmaceuticals Corporation, East Hanover, United States
  6. 6Novartis Pharma AG, Basel, Switzerland

Abstract

Background Rheumatoid Arthritis (RA) is a chronic, inflammatory, systemic autoimmune disease of unknown etiology characterized by symmetric synovitis leading to cartilage damage1. Chronic and severe RA is associated with a 50% higher risk of death from cardiovascular disease (CVD) compared with healthy controls2. Moreover, Active RA is associated with an unfavorable lipid profile resulting in a higher atherogenic index3. Secukinumab, a fully human anti-IL-17A monoclonal antibody has shown to improve signs and symptoms of patients with active RA in this phase II trial4. Evaluation of the effect of secukinumab on lipids is potentially relevant as current guidelines recommend treatment if hypercholesterolemia is associated with elevated CV risk5.

Objectives To report the effect of secukinumab on the lipid profile and atherogenic indexes in patients with active RA despite stable methotrexate (MTX) treatment.

Methods Adult RA patients (n=237) on MTX were randomized equally to receive monthly s.c injections of secukinumab 25mg, 75mg, 150mg, 300mg or placebo. After Week (wk) 16, responders on secukinumab remained on the same dose whereas doses were escalated in non-responders at wk20 (except patients initially on 300mg who remained on the same dose). All placebo patients were switched to secukinumab 150mg. Patients were followed up to wk52. Primary endpoint was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at wk16.

Results Demographics, baseline characteristics and lipid parameters were normal and comparable across all treatment groups. There was no effect of secukinumab on the lipid profile (Total Cholesterol, HDLc, LDLc, TG, Apo A-I and Apo B) during the first 16 wks of treatment in all treatment groups when compared to placebo. Atherogenic indices (TC/HDLc and Apo B/Apo A-I ratio also remained unchanged during first 16 wks of therapy (Table 1). In patients who switched from placebo to secukinumab 150mg at wk20, TC/HDLc and Apo B/Apo A-I ratios remained unchanged throughout the duration of the study (wk0-52). The efficacy and safety of this study group has been reported previously and did not report any CV event3.

Conclusions Treatment with secukinumab was not associated with changes in the lipid profile or the atherogenic risk in patients with RA.

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  2. Avina-Zubieta JA. Arthritis Rheum. 2008; 59: 1690-7.

  3. Myasoedova E et al. Ann Rheum Dis. 2010; 69:1310-4.

  4. Mark C. Genovese. Arthritis Rheum. 2011;63(10[suppl]):S149-S150.

  5. Peters MJL et al. Int J Clin Prac 2010; 64:1440-3.

Disclosure of Interest P. Durez: None Declared, M. Genovese Grant/Research support from: Novartis, H. Kellner: None Declared, C. Codding: None Declared, G. Ligozio Employee of: Novartis Pharmaceuticals Corporation, H. Richards Employee of: Novartis Pharma AG, C. Escrig Shareholder of: Novartis Pharma AG, Employee of: Novartis Pharma AG, S. Mpofu Shareholder of: Novartis Pharma AG, Employee of: Novartis Pharma AG

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