Date: Monday, November 9, 2020
Session Type: Poster Session D
Session Time: 9:00AM-11:00AM
Background/Purpose: Persons at high risk of developing rheumatoid arthritis (RA) may benefit from a low-risk pharmacological intervention aimed at primary prevention. Previous studies demonstrated disease-modifying effects of statins in RA patients1 as well as an association between statin use and a decreased risk of RA development2. We designed a multi-center, randomized, double-blind, placebo-controlled trial to investigate if atorvastatin use for 3 years could prevent arthritis. Subsequently, we conducted qualitative research to determine barriers and facilitators for prevention trial participation.
Methods: Individuals at high risk of RA, i.e. arthralgia without arthritis and anti-citrullinated protein antibody (ACPA) >3xULN or both ACPA and rheumatoid factor (RF), were randomized to atorvastatin 40 mg daily or placebo for 3 years. The primary endpoint was clinical arthritis development. The pre-calculated sample size was 220 participants. After trial inclusions were stopped, we conducted focus group interviews with individuals who participated or declined participation in the STAPRA trial or the Arthritis Prevention In the Pre-clinical Phase of RA with abatacept (APIPPRA) trial3.
Results: Sixty-seven individuals were included in the STAPRA trial (figure 1). Inclusion was stopped after 38 months due to the low inclusion rate, and analyses were performed 1 year later. Mean age was 48 years, 74% was female, mean follow up was 18 (0-36) months. Fifteen individuals (24%) developed clinical arthritis: 9/31 (29%) in the atorvastatin group and 6/31 (19%) in the placebo group after a median period of 9 (IQR 5.5-26.5) months (atorvastatin) and 4 (0-14.8) months (placebo): HR 0.71, 95% CI 0.3-2.0. In our center, 4 out of 14 eligible individuals participated in the APIPPRA trial. Eighteen individuals participated in the focus group discussions, 3 were asked for APIPPRA of which 1 participated, 15 were asked for STAPRA of which 8 participated. Seven barriers or facilitators for prevention trial participation emerged: (1) trial medication, (2) symptom severity, (3) treatment options, (4) study burden, (5) feeling of acknowledgement (6) own risk assessment and (7) altruism.
Conclusion: The results of the STAPRA trial are inconclusive due to severe difficulties with patient inclusion and low treatment adherence. The focus group study revealed several themes that play an important role in at-risk individuals’ decision whether or not to participate in a prevention trial. These should be taken into account when designing preventive trials and will be important in optimizing acceptance and adherence to preventive treatment.
1 McCary et al. Lancet. 2004; 19;363(9426):2015-21
2 Chodick G et al. PLoS Med. 2010;7(9):e1000336
3 Al-Laith M et al. Trials. 2019;20(1):429.
To cite this abstract in AMA style:van Boheemen L, ter Wee M, Turk S, van Beers M, Bos W, Marsman D, Griep E, Starmans M, Popa C, van Sijl A, Seppen B, Boers M, Nurmohamed M, van Schaardenburg D. The STAtins to Prevent Rheumatoid Arthritis (STAPRA) Trial: Clinical Results and Subsequent Qualitative Study, a Mixed Method Evaluation [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/the-statins-to-prevent-rheumatoid-arthritis-stapra-trial-clinical-results-and-subsequent-qualitative-study-a-mixed-method-evaluation/. Accessed June 22, 2021.
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