Article Text

PDF
AB0738 Secukinumab Reduces Hscrp Levels in Subjects with Moderate-To-Severe Plaque Psoriasis and Concomitant Psoriatic Arthritis: A Sub-Analysis from the Phase 3 Erasure Study
  1. A. Gottlieb1,
  2. B. Sigurgeirsson2,
  3. A. Blauvelt3,
  4. Y. Gong4,
  5. C. Papavassilis5,
  6. S. Mpofu5
  1. 1Tufts Medical Center, Boston, United States
  2. 2Department of Dermatology, University of Iceland, Iceland, Iceland
  3. 3Oregon Medical Research Center, Oregon, United States
  4. 4Novatis Pharma Co. Ltd., Shanghai, China
  5. 5Novartis Pharma AG, Basel, Switzerland

Abstract

Background Secukinumab has been shown to significantly improve plaque psoriasis and physical functioning in subjects with psoriasis and concomitant psoriatic arthritis (PsA) [1]. High sensitivity C-reactive protein (hsCRP) is an indicator of skin and joint inflammation and hsCRP levels >3 mg/L are indicative of increased cardiovascular risk [2].

Objectives To evaluate the effect of secukinumab (a fully human anti–interleukin 17A monoclonal antibody) on serum hsCRP levels in subjects with psoriasis and concomitant PsA.

Methods A total of 738 subjects aged ≥18 years with moderate-to-severe plaque psoriasis (incl. Psoriasis Area and Severity Index (PASI) score ≥12) were randomized 1:1:1 to subcutaneous secukinumab 150 mg or 300 mg or placebo given at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter through week 48. At week 12, subjects in the placebo group not achieving a PASI 75 response were re-randomized 1:1 to secukinumab 150 mg or 300 mg. An analysis of change in hsCRP levels from baseline to week 52 in subjects with concomitant PsA is reported here.

Results In 171 (23.2%) subjects with concomitant PsA, baseline median hsCRP levels were in the high cardiovascular risk range at 5.2 mg/L, 4.0 mg/L, and 4.4 mg/L in the secukinumab 150 mg (n=46), 300 mg (n=57) and placebo (n=68) groups, respectively. At week 12, median hsCRP levels were reduced by ≥50% to 2.2 mg/L and 2.0 mg/L in the secukinumab 150 mg and 300 mg groups, and reductions were sustained to week 52. At week 12, the median hsCRP level increased slightly (4.7 mg/L) in the placebo group. Baseline median hsCRP levels were more elevated in subjects with greater baseline disability/reduced physical functioning (defined as Health Assessment Questionnaire–Disability Index [HAQ-DI] >0.5): 7.4 mg/L, 9.9 mg/L, and 5.0 mg/L in the secukinumab 150 mg (n=19), 300 mg (n=26) and placebo (n=38) groups, respectively. At week 12, median hsCRP levels were reduced by approximately 70% to 2.3 mg/L and 3.0 mg/L in the secukinumab 150 mg and 300 mg groups, with reductions sustained to week 52 (Fig. 1). In the placebo group, the median hsCRP level at week 12 was 5.4 mg/L. Secukinumab was well tolerated with no unexpected safety findings.

Figure 1.

Median hsCRP levels from baseline to week 52 in patients with HAQ-DI >0.5.

Conclusions In subjects with psoriasis and concomitant PsA, secukinumab was associated with pronounced and sustained reductions in serum hsCRP levels indicating a reduction in inflammatory burden during secukinumab therapy.

References

  1. Gottlieb AB et al. Secukinumab shows substantial improvement in both psoriasis symptoms and physical functioning in moderate-to-severe plaque psoriasis subjects with psoriatic arthritis: a subanalysis of a phase 3, multicenter, double-blind, placebo-controlled study. Presented at ACR2013, Oct, 25-30, San Diego, USA, Poster no. 319.

  2. Pearson TA, Mensah GA, Alexander RW et al. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: a statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation 2003; 107:499–511.

Disclosure of Interest A. Gottlieb Grant/research support: Abbott Laboratories, Amgen, Celgene Corporation, Coronado Biosciences, Immune Control, Janssen-Ortho Inc., Lerner Medical Devices, Lilly ICOS LLC, Novartis Pharmaceutical Corporation, Novo Nordisk A/S, Pfizer Inc., UCB, Consultant for: Abbott Laboratories, AbbVie, Amgen, Canfite, Celgene Corporation, CSL Behring Biotherapies for Life, Glaxo Smith Kline, Incyte Corporation, Lilly ICOS LLC, Merck & Co., Novartis Pharmaceutical Corporation, Teva, Vertex Pharmaceuticals, B. Sigurgeirsson Grant/research support: Novartis Pharma AG, Consultant for: Novartis Pharma AG, A. Blauvelt Grant/research support: Novartis Pharmaceutical Corporation, Consultant for: Novartis Pharmaceutical Corporation, Speakers bureau: Novartis Pharmaceutical Corporation, Y. Gong: None declared, C. Papavassilis Shareholder of: Novartis Pharma AG, Employee of: Novartis Pharma AG, S. Mpofu Employee of: Novartis Pharma AG

DOI 10.1136/annrheumdis-2014-eular.1109

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.