Atorvastatin is unlikely to prevent rheumatoid arthritis in high risk individuals: Results from the prematurely stopped STAtins to Prevent Rheumatoid Arthritis (STAPRA) trial

Laurette van Boheemen*, Samina Turk, Marian Van Beers-Tas, Wouter Bos, Diane Marsman, Ed N. Griep, Mirian Starmans-Kool, Calin D. Popa, Alper van Sijl, Maarten Boers, Michael T. Nurmohamed, Dirkjan van Schaardenburg

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Objectives Persons at high risk of rheumatoid arthritis (RA) might benefit from a low-risk pharmacological intervention aimed at primary prevention. Previous studies demonstrated disease-modifying effects of statins in patients with RA as well as an association between statin use and a decreased risk of RA development. A randomised, double-blind, placebo-controlled trial investigated whether atorvastatin could prevent arthritis development in high-risk individuals. Methods Arthralgia patients with anticitrullinated protein antibody (ACPA) >3 xULN or ACPA and rheumatoid factor, without (a history of) arthritis, were randomised to receive atorvastatin 40 mg daily or placebo for 3 years. The calculated sample size was 220 participants. The primary endpoint was clinical arthritis. Cox regression analysis was used to determine the effect of atorvastatin on arthritis development. Results Due to a low inclusion rate, mainly because of an unwillingness to participate, the trial was prematurely stopped. Data of the 62 randomised individuals were analysed. Median follow-up was 14 (inner quartiles 6-35) months. Fifteen individuals (24%) developed arthritis: 9/31 (29%) in the atorvastatin group; 6/31 (19%) in the placebo group: HR 1.40, 95% CI 0.50 to 3.95. Conclusions In this small set of randomised high-risk individuals, we did not demonstrate a protective effect of atorvastatin on arthritis development. The main reason for the low inclusion was unwillingness to participate; this may also impede other RA prevention trials. Further research to investigate and solve barriers for prevention trial participation is needed.
Original languageEnglish
Article numbere001591
JournalRMD Open
Issue number1
Publication statusPublished - 7 Mar 2021

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