Targeted treatment with a combination of traditional DMARDs produces excellent clinical and radiographic long-term outcomes in early rheumatoid arthritis regardless of initial infliximab. The 5-year follow-up results of a randomised clinical trial, the NEO-RACo trial
Autor: | Markku Korpela, Markku J Kauppi, Kari Laiho, Hannu Kautiainen, M Hakola, Anna Karjalainen, Vappu Rantalaiho, Pekka Hannonen, Timo Möttönen, Marjatta Leirisalo-Repo, Ritva Peltomaa, Oili Kaipiainen-Seppänen, Leena Laasonen |
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Rok vydání: | 2013 |
Předmět: |
Adult
Male medicine.medical_specialty Prednisolone Immunology Placebo-controlled study Placebo Severity of Illness Index General Biochemistry Genetics and Molecular Biology Arthritis Rheumatoid 03 medical and health sciences 0302 clinical medicine Double-Blind Method Rheumatology Sulfasalazine Internal medicine Humans Immunology and Allergy Medicine 030212 general & internal medicine 030203 arthritis & rheumatology Tumor Necrosis Factor-alpha business.industry Remission Induction Antibodies Monoclonal Hydroxychloroquine Middle Aged medicine.disease Infliximab 3. Good health Surgery Radiography Clinical trial Treatment Outcome Antirheumatic Agents Rheumatoid arthritis Disease Progression Drug Therapy Combination Female business Follow-Up Studies medicine.drug |
Zdroj: | Annals of the Rheumatic Diseases. 73:1954-1961 |
ISSN: | 1468-2060 0003-4967 |
DOI: | 10.1136/annrheumdis-2013-203497 |
Popis: | Objective To study whether adding initial infliximab to remission-targeted initial combination-DMARD treatment improves the long-term outcomes in patients with early rheumatoid arthritis (RA). Methods Ninety-nine patients with early, DMARD-naive RA were treated with a triple combination of DMARDs, starting with methotrexate (max 25 mg/week), sulfasalazine (max 2 g/day), hydroxychloroquine (35 mg/kg/week), and with prednisolone (7.5 mg/day), and randomised to double blindly receive either infliximab (3 mg/kg; FIN-RACo+INFL) or placebo (FIN-RACo+PLA) infusions during the first 6 months. After 2 years the treatment strategies became unrestricted, but the treatment goal was strict ACR remission. At 5 years the clinical and radiographic outcomes were assessed. Results Ninety-one patients (92%) were followed up to 5 years, 45 in the FIN-RACo+INFL and 46 in the FIN-RACo+PLA groups. At 5 years, the respective proportions of patients in strict ACR and in disease activity score 28 remissions in the FIN-RACo+INFL and FIN-RACo+PLA groups were 60% (95% CI 44% to 74%) and 61% (95% CI 45% to 75%) (p=0.87), and 84% (95% CI 71% to 94%) and 89% (95% CI 76% to 96%) (p=0.51). The corresponding mean (SD) total Sharp/van der Heijde scores at 5 years were 4.3 (7.6), and 5.3 (7.3), while the respective mean Sharp/van der Heijde scores changes from baseline to 5 years were 1.6 (95% CI 0.0 to 3.4) and 3.7 (95% CI 2.2 to 5.8) (p=0.13). Conclusions In early RA, targeted treatment with a combination of traditional DMARDs and prednisolone induces remission and minimises radiographic progression in most patients up to 5 years; adding initial infliximab for 6 months does not improve these outcomes. |
Databáze: | OpenAIRE |
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