Table 3.
Published clinical trials of immunomodulatory therapy to prevent or delay the first clinically-apparent inflammatory arthritis in high-risk individuals
| Study | Reference | Inclusion Criteria |
Intervention | Primary Finding |
|---|---|---|---|---|
| Dutch Dexamethasone | Bos et al Ann Rheum Dis 2010(65) | RF and/or ACPA shared epitope positive arthralgia | Dexamethasone 100 mg x 2 doses vs. placebo | Overall, 17/83 (21%) participants developed IA over a median follow-up of 26 months. In the dexamethasone-treated group 9/42 (21%) developed IA demonstrating no difference in progression to IA over placebo-treated participants; dexamethasone was associated with decreased autoantibody levels. |
| PRAIRI | Gerlag et al Ann Rheum Dis 2019(66) | RF and ACPA Arthralgia | Rituximab 1000 mg x 1 dose (with concomitant corticosteroid) vs placebo for rituximab (but received corticosteroid) | Overall, 30/81 (37%) developed IA over a median follow-up 29 months. In the rituximab-treated arm 14/41 (34%) developed IA at a median of 16.5 months compared in the placebo group to 14/40 (40%) developing IA at a median 11.5 months. There was no significant difference in overall progression to IA; however, rituximab associated with delay of onset of IA ~12 months. |
| StapRA | Van Boheemen et al RMDOpen 2021(67) | RF and ACPA or high ACPA Arthralgia Calculated risk 55% of IA/RA within 3 years | Atorvastatin 40 mg daily x 3 years vs placebo | Overall, 15/62 (24%) participants developed IA during a median follow-up of 14 months. In the atorvastatin group, 9/31 (29%) developed IA at a median 9 months compared to the placebo group where 6/31 (19%) developed IA at a median of 4 months. There was no statistical difference in progression to IA. |