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Abstract Number: 2765

A Double-Blind Randomized Placebo-Controlled Trial Of Lovastatin in Patients with Rheumatoid Arthritis

Cynthia Aranow1, John J. Cush2, Marcy B. Bolster3, Christopher C. Striebich4, Maria Dall'era5, Meggan Mackay6, Ewa Olech7, Tracy M. Frech8, J. Box9, Richard M. Keating10, Mary Chester M. Wasko11, E. William St Clair12, Alan Kivitz13, Betty Diamond14, Anne Davidson15, Meagan Spychala16, Ellen A. Goldmuntz17 and Autoimmunity Centers of Excellence18, 1Feinstein Institute for Medical Research, Manhasset, NY, 2Baylor Research Institute and Baylor University Medical Center, Dallas, TX, 3Medicine, Medical University of South Carolina, Charleston, SC, 4University of Colorado Denver, Aurora, CO, 5Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, 6Autoimmune & Musculoskeletal Disease, Feinstein Institute for Medical Research, Manhasset, NY, 7Clinical Pharmacology, Oklahoma Medical Research Foundation, Oklahoma City, OK, 8Internal Medicine-Division of Rheumatology, University of Utah School of Medicine, SLC, UT, 9Carolina Bone and Joint, Charlotte, NC, 10Rheumatology Section, The University of Chicago, Chicago, IL, 11West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, PA, 12Medicine, Duke Unversity Medical Center, Durham, NC, 13Altoona Center for Clinical Research, Duncansville, PA, 14Autoimmune & Musculoskeletal, Feinstein Institute for Medical Research, Manhasset, NY, 15Autoimmunity and Musculoskeletal Diseases, Feinstein Institute for Medical Research, Manhasset, NY, 16Rho, Inc., Chapel Hill, NC, 17DAIT, NIAID/NIH, Bethesda, MD, 18NIAID, National Institutes of Health, Bethesda, MD

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: clinical trials, rheumatoid arthritis (RA) and statins

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Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy: Efficacy of Approved Biologics I

Session Type: Abstract Submissions (ACR)

Background/Purpose: HMG -CoA reductase inhibitors (statins) are standard treatment for hyperlipidemia. In addition to lipid lowering abilities, statins exhibit multiple anti-inflammatory effects.   The objectives of this study were to determine if treatment of patients with Rheumatoid Arthritis (RA) with lovastatin decreased CRP or reduced disease activity.

Methods: We conducted a randomized double blind placebo controlled 12 week trial.  64 patients with mildly active RA (defined as 2-8 tender joints and 1-6 swollen joints) and an elevated CRP (> 5mg/L) were randomized (1:1) to receive lovastatin 80mg or placebo.   Patients could be on stable prednisone ≤ 10 mg, DMARDs and/or biologic therapy.  The primary efficacy endpoint was the reduction in mean log CRP.  Secondary endpoints included disease activity, RF and anti-CCP antibody titers.  Safety was a co-primary endpoint; hepatic and muscle toxicities were of particular interest.

Results: Baseline features of the treatment groups were similar.  The mean baseline CRP was 12.2 mg/L in the lovastatin arm and 12.6 mg/L in the placebo arm; mean baseline DAS-28 CRP was 3.5 and 3.6 in the lovastatin and placebo arms, respectively.  No significant differences in mean log CRP reduction or % change in CRP from baseline between the two treatment arms were observed.  No significant difference between the lovastatin and placebo arms was observed in a longitudinal model of the estimated mean log CRP.  Disease activity assessed by DAS28 did not change from baseline in either lovastatin or placebo treated groups (-0.42 and -0.58, respectively, ns).  At week 12, clinical responses were comparable in subjects receiving lovastatin or placebo:  ACR 20 (29% vs. 40%) and Good/Moderate EULAR response (42% vs. 44%).  Autoantibody titers were stable during the course of the study with no group differences.  Although not statistically different, the frequency of subjects receiving biologic therapy was greater in the lovastatin treated group than placebo (59% vs. 38%).  A post-hoc analysis of subjects not using biologic therapy (n=32) demonstrated a significantly greater proportion achieving ≥15% reduction in CRP from baseline in the lovastatin treated group (83%) compared to placebo (33%; p = 0.019).  No analogous difference was observed in subjects receiving biologics (47% vs. 60%).  The mean change from baseline CRP in subjects not using biologics was also numerically greater in subjects taking lovastatin (-4.75) than placebo (-2.00).   Lovastatin was well tolerated with no serious safety concerns.  Several subjects experienced transient reversible elevations of transaminases. Clinical myositis was not observed.

Conclusion: Statins were well tolerated in our patient population.   This study showed no anti-inflammatory or clinical effects after 12 weeks of treatment with lovastatin.  However, we observed a potential modest effect of lovastatin in subjects not using biologics, suggesting statins may be anti-inflammatory in selected patients.

Sponsored by NIAID Autoimmunity Centers of Excellence:  U19 AI056362, U19AI056363; NCT00710021


Disclosure:

C. Aranow,
None;

J. J. Cush,
None;

M. B. Bolster,
None;

C. C. Striebich,
None;

M. Dall’era,
None;

M. Mackay,
None;

E. Olech,
None;

T. M. Frech,
None;

J. Box,
None;

R. M. Keating,
None;

M. C. M. Wasko,
None;

E. W. St Clair,
None;

A. Kivitz,
None;

B. Diamond,
None;

A. Davidson,
None;

M. Spychala,
None;

E. A. Goldmuntz,
None;

A. Centers of Excellence,
None.

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