‘Inconclusive’ trial results on statins for rheumatoid arthritis prevention
medwireNews: Findings from the STAPRA trial suggest no protective effect of atorvastatin against the development of rheumatoid arthritis (RA) in high-risk individuals.
However, the investigators say that their study “suffered severe difficulties” with recruitment and retention, resulting in small participant numbers and “inconclusive” results.
Laurette van Boheemen (Amsterdam Rheumatology and Immunology Center, the Netherlands) and colleagues explain that previous studies have demonstrated disease-modifying effects of statins in patients with established RA, and at “the population level an association between statin use and a decreased risk of RA development has been demonstrated.”
Moreover, they note that the risk for cardiovascular disease is already elevated at the time of RA diagnosis, which supports “the rationale for exploring statins as a potential tool for RA prevention.”
To investigate further, the team identified 175 eligible people with arthralgia and high risk for developing RA, defined as anticitrullinated protein antibodies (ACPA) above three times the upper limit of normal or ACPA of at least 7 kU/L and rheumatoid factor of at least 5 kU/L, but no previous history of clinical arthritis.
In all, 62 of these individuals agreed to participate in the trial and were randomly assigned to receive atorvastatin 40 mg/day or placebo for 3 years. The main reasons for non-participation were unwillingness to take the trial medication and perceived high study burden, and the trial was terminated early due to the low inclusion rate.
As reported in RMD Open, 29% of 31 participants developed clinical arthritis (≥1 swollen joint) during a median follow-up of 17 months in the atorvastatin group, compared with 19% of 31 individuals in the placebo arm, a nonsignificant difference. There was also no significant difference in time to arthritis development between the two groups.
van Boheemen and team say that there was a high drop-out rate in the atorvastatin (19%) and placebo arms (36%), mainly due to adverse events including muscle symptoms.
They point out that the low recruitment and retention rates in STAPRA are in line with other ongoing and completed RA prevention trials, which “contrasts with the relative ease with which early RA trials recruit patients.”
The researchers conclude that “barriers for participation need to be explored and addressed” in order “for RA prevention to move forward.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group