PMID- 19581281 OWN - NLM STAT- MEDLINE DCOM- 20100716 LR - 20161125 IS - 1468-2060 (Electronic) IS - 0003-4967 (Linking) VI - 69 IP - 6 DP - 2010 Jun TI - Adverse events and factors associated with toxicity in patients with early rheumatoid arthritis treated with methotrexate tight control therapy: the CAMERA study. PG - 1044-8 LID - 10.1136/ard.2008.106617 [doi] AB - OBJECTIVE: To evaluate toxicity profiles in patients with rheumatoid arthritis (RA) treated either according to an intensive or a conventional treatment strategy approach with methotrexate (MTX) and to study factors associated with MTX-related toxicity. METHODS: Data were used from the Computer-Assisted Management in Early Rheumatoid Arthritis (CAMERA) study, in which clinical efficacy of an intensive treatment strategy with MTX was more beneficial than a conventional treatment strategy approach. In this study, data on adverse events (AEs) were compared between the two strategy groups. Logistic regression analyses were used to identify possible associations between factors assessed at baseline and withdrawal due to MTX-related AEs or liver toxicity at follow-up. RESULTS: Although significantly more patients in the intensive strategy group experienced MTX-related AEs than in the conventional strategy group, all recorded AEs were relatively mild. A higher body mass index (BMI) was significantly associated with withdrawal due to MTX-related AEs in the multiple regression analyses (odds ratio=1.207, 95% confidence interval 1.02 to 1.44, p=0.033). There was a trend towards an association between diminished creatinine clearance and MTX withdrawal. For liver toxicity, increased serum liver enzymes at baseline were associated with liver toxicity during follow-up. CONCLUSION: Although the occurrence of AEs in the intensive strategy group was higher than in the conventional strategy group, the previously observed clinical efficacy of an intensive treatment strategy seems to outweigh the observed toxicity profiles. When starting MTX, attention should be given to patients with a high BMI and those with increased levels of liver enzymes and decreased renal function. FAU - Verstappen, S M M AU - Verstappen SM AD - University Medical Center Utrecht, Department of Rheumatology and Clinical Immunology, F02.127, PO Box 85500, 3508 GA Utrecht, The Netherlands. FAU - Bakker, M F AU - Bakker MF FAU - Heurkens, A H M AU - Heurkens AH FAU - van der Veen, M J AU - van der Veen MJ FAU - Kruize, A A AU - Kruize AA FAU - Geurts, M A W AU - Geurts MA FAU - Bijlsma, J W J AU - Bijlsma JW FAU - Jacobs, J W G AU - Jacobs JW CN - Utrecht Rheumatoid Arthritis Cohort Study Group LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20090705 PL - England TA - Ann Rheum Dis JT - Annals of the rheumatic diseases JID - 0372355 RN - 0 (Antirheumatic Agents) RN - 0 (Immunosuppressive Agents) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM MH - Adult MH - Aged MH - Antirheumatic Agents/administration & dosage/*adverse effects MH - Arthritis, Rheumatoid/*drug therapy MH - Chemical and Drug Induced Liver Injury/etiology MH - Drug Administration Schedule MH - Drug Therapy, Computer-Assisted/methods MH - Epidemiologic Methods MH - Female MH - Humans MH - Immunosuppressive Agents/administration & dosage/*adverse effects MH - Male MH - Methotrexate/administration & dosage/*adverse effects MH - Middle Aged EDAT- 2009/07/08 09:00 MHDA- 2010/07/17 06:00 CRDT- 2009/07/08 09:00 PHST- 2009/07/08 09:00 [entrez] PHST- 2009/07/08 09:00 [pubmed] PHST- 2010/07/17 06:00 [medline] AID - ard.2008.106617 [pii] AID - 10.1136/ard.2008.106617 [doi] PST - ppublish SO - Ann Rheum Dis. 2010 Jun;69(6):1044-8. doi: 10.1136/ard.2008.106617. Epub 2009 Jul 5.