OP-0041 – A 3 Week Course of IM Steroid Injections May Prevent the Progression of Very Early Inflammatory Polyarthritis: Results of the STIVEA Trial.
Verstappen, McCoy, Roberts, Dale, Hassel and Symmons. Manchester, UK
Objectives
The aim of this study (Steroids in Very Early Arthritis; STIVEA) was to determine whether treatment of recent onset inflammatory polyarthritis (IP) with 3 weekly injections of intramuscular methylprednisolone would suppress evolution to RA.
Methods
This was a double-blind, placebo-controlled multicenter trial of methylprednisolone 80 mg IM weekly times 3 doses versus placebo injections in patients with > 2 swollen/tender joints of 4-11 weeks duration. Patients were followed for 12 months after randomization. The primary outcome was the start (by the internist), or referral to a rheumatologist for start, of second line therapy by six months post-randomization. The odds ratios (OR) for the need to start second line therapy and for the diagnosis of RA were calculated, adjusting for relevant confounders. The primary outcome was assessed by an intention to treat analysis.
Results
265 patients were enrolled (132 in the placebo group; 133 in the steroid group). There were no significant differences in demographic features of the two groups at baseline (mean age 55; 69% women, mean disease duration 8 wks). 20 and 21 patients were lost from the placebo and steroid groups, respectively, over the course of the study. At 6 months, 78% of the placebo group and 62% of the steroid group had either started or been referred for second line therapy (OR 2.29, 95% CI 1.21, 4.30). At 12 months, 60% of the placebo group, compared to 50% of the steroid group, achieved a diagnosis of RA (OR 1.49, 95% CI 0.81, 2.75).
Conclusion
Treatment of patients with very early IP with intramuscular steroids appears to postpone prescription of second line therapy and prevents patients from progressing to RA.
Editorial Comment
This study is very reminiscent of the PROMPT trial which showed that treatment of very early IP with methotrexate will slow the progression from undifferentiated early IP to definite or probable RA, especially in anti-CCP positive patients. It would be of interest to know in the current (STIVEA) study if anti-CCP status also influenced the outcomes. One would expect so.
The STIVEA study has significant weaknesses. The patient evaluations, decisions to treat, and diagnosis of RA were made by general internists, not rheumatologists, and the diagnosis of RA was not based on published criteria. Thus, one wonders how many of the “RA” patients truly had RA. Nonetheless, the results seem intuitive – that giving potent anti-inflammatory therapy to patients with a few swollen joints will delay additional of more swollen painful joints. If patients fail to respond to steroids, and or flare after discontinuation of steroids, then a disease modifying drug is indicated. The dose of methylprednisolone used in this study is quite high, and would likely not be embraced by US rheumatologists who tend to use lower doses of oral prednisone.
