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A double-blind, placebo-controlled, phase II, randomized study of lovastatin therapy in the treatment of mildly active rheumatoid arthritis

Author

Aranow C1, Cush J2, Bolster MB3, Striebich CC4, Dall'era M5, Mackay M1, Olech E6, Frech T7, Box J8, Keating R9, Wasko MC10, St Clair W11, Kivitz A12, Huang W1, Ricketts P1, Welch B13, Callahan S13, Spychala M14, Boyle K14, York K14, Keyes-Elstein L14, Goldmuntz E13, Diamond B1, Davidson A1. Rheumatology (Oxford). 2019 Oct 18. pii: kez471. doi: 10.1093/rheumatology/kez471. [Epub ahead of print]

Author Information

1The Feinstein Institute for Medical Research, Manhasset, USA.

2 Division of Rheumatology, Baylor University Medical Center, Dallas, USA.

3 Division of Rheumatology, Massachusetts General Hospital, Boston, USA.

4 Division of Rheumatology, University of Colorado, Denver, USA.

5 Division of Rheumatology, University of California, San Francisco, USA.

6 Department of Internal Medicine, University of Nevada School of Medicine, Las Vegas, USA.

7 Department of Internal Medicine, University of Utah, Internal Medicine, Salt Lake City, USA.

8 Box Arthritis & Rheumatology of the Carolinas, Charlotte, USA.

9 Division of Rheumatology, Scripps Green Hospital, La Jolla, USA.

10 Division of Rheumatology, Western Pennsylvania Hospital, Pittsburgh, USA.

11 Division of Rheumatology and Immunology, Duke University School of Medicine, Durham, USA.

12 Altoona Center for Clinical Research, Duncansville, USA.

13 National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.

14 Rho Federal Systems Division, Chapel Hill, USA.

Abstract

OBJECTIVES: 

3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins) are standard treatment for hyperlipidaemia. In addition to lipid-lowering abilities, statins exhibit multiple anti-inflammatory effects. The objectives of this study were to determine whether treatment of patients with RA with lovastatin decreased CRP or reduced disease activity.

METHODS: 

We conducted a randomized double-blind placebo-controlled 12 week trial of lovastatin vs placebo in 64 RA patients with mild clinical disease activity but an elevated CRP. The primary efficacy end point was the reduction in mean log CRP. Secondary end points included disease activity, RF and anti-CCP antibody titres. Mechanistic end points included levels of serum cytokines. Safety was assessed; hepatic and muscle toxicities were of particular interest.

RESULTS: 

Baseline features were similar between groups. No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group. Mechanistic analyses did not reveal significant changes in any biomarkers. A post hoc analysis of subjects not using biologic therapy demonstrated a significantly greater proportion achieving ?20% reduction in CRP from baseline in the lovastatin group compared with placebo (P-value = 0.007). No difference was observed in subjects receiving biologics. Lovastatin was well tolerated with no serious safety concerns.

CONCLUSION: 

This study showed no anti-inflammatory or clinical effects on RA disease activity after 12 weeks of treatment with lovastatin. Lovastatin had a modest effect on CRP in subjects not using biologics, suggesting statins may be anti-inflammatory in selected patients.

TRIAL REGISTRATION: 

ClinicalTrials.gov, http://clinicaltrials.gov, NCT00302952.