Abstract | OBJECTIVE: The aim of this international multicentric randomized phase 3 clinical trial was to compare prospectively radiosynoviorthesis (RSO) with rhenium-186-sulfide (186Re) to intra-articular corticotherapy in patients with clinically controlled rheumatoid arthritis (RA), but in whom one or a few medium-sized joints remained painful or swollen. METHODS: One hundred and twenty-nine joints in 81 RA patients [stratified into 2 groups: wrists (group 1, n = 78) and all the other joints (group 2, n = 51, including 18 elbows, 21 shoulders and 12 ankles)] were randomized to receive intra-articular injections of either 186Re-sulfide (64 +/- 4 MBq), or cortivazol (Altim) 3.75 mg. Clinical assessment was performed before and then at 3, 6, 12, 18 and 24 months after local therapy, using a 4-step verbal rating scale (VRS) and a 100 mm visual analog scale for pain, a 4-step VRS for joint swelling and mobility and a 2-step VRS for the radiological stage. The Mantel-Haenszel test was used for qualitative variables, analysis of variance (ANOVA) for quantitative pain analysis and Kaplan-Meyer survival test for relapse analysis. RESULTS: 186Re was observed to be statistically superior to cortivazol at 18 and 24 months while no statistical difference was seen for any criterion at 3, 6 and 12 months post injection. At 24 months, the difference in favor of 186Re was significant for pain (p = 0.024), joint swelling (p = 0.01), mobility (p = 0.05, non-wrists only), pain and swelling (p = 0.03) and pain or swelling (p = 0.02). "Survival" studies (Kaplan-Meyer) demonstrated a greater relative risk of relapse in corticoid treated joints, but only from the second year of follow-up. No serious side effect was observed in any patient, with only light and transient local pain and/or swelling occurring in 24% of cases, regardless of the treatment used. CONCLUSION: 186Re-sulfide and cortivazol had similar efficacy up to 12 months post-injection, but 186Re became clearly more effective at 18 and 24 months, for all criteria monitored and for RA outcome. Therefore, 186Re RSO can be recommended for routine clinical use.
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Authors | J G Tebib, L M Manil, G Mödder, P Verrier, Y De Rycke, A Bonmartin, J Y Devaux, F Chossat, C J Menkes, A Kahan |
Journal | Clinical and experimental rheumatology
(Clin Exp Rheumatol)
2004 Sep-Oct
Vol. 22
Issue 5
Pg. 609-16
ISSN: 0392-856X [Print] Italy |
PMID | 15485015
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antirheumatic Agents
- Pregnatrienes
- Radioisotopes
- Rhenium
- cortivazol
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Topics |
- Adult
- Antirheumatic Agents
(therapeutic use)
- Arthritis, Rheumatoid
(therapy)
- Female
- Follow-Up Studies
- Humans
- Injections, Intra-Articular
- Male
- Middle Aged
- Pregnatrienes
(therapeutic use)
- Prospective Studies
- Radioisotopes
(therapeutic use)
- Rhenium
(therapeutic use)
- Treatment Outcome
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