Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research
Identifieur interne : 000278 ( France/Analysis ); précédent : 000277; suivant : 000279Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research
Auteurs : C. Salliot [France] ; D. Van Der Heijde [Pays-Bas]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2009-07.
English descriptors
- Teeft :
- Adverse event, Adverse events, American college, Antirheumatic drugs, Arthritis, Arthritis rheum fries, Arthritis rheum kremer, Average dose, Cardiovascular diseases, Cardiovascular mortality, Cohort, Control groups, Cytopenia, Dmards, Dose methotrexate, Exclusion criteria, Folic, Folic acid, General population, Herpes zoster, Incidence rate, Incidence rates, Literature search, Liver damage, Liver enzymes, Liver toxicity, Lymphoma, Malignancy, Many patients experience, Methotrexate, Methotrexate therapy, Methotrexate treatment, Monotherapy, Online, Other dmards, Permanent discontinuation, Predefined inclusion, Prospective studies, Prospective study, Rheum, Rheumatoid, Rheumatoid arthritis, Rheumatoid arthritis patients, Rheumatol, Rheumatol weinblatt, Risk factor, Sequential liver biopsies, Serious infections, Severe fibrosis, Side effects, Study design, Supplemental table, Survival benefit, Systematic literature research, Systematic literature search, Total number, Toxicity, Toxicity index, Upper limit.
Abstract
Objective: To perform a systematic literature review of the long-term safety of methotrexate (MTX) monotherapy in rheumatoid arthritis (RA). Methods: A search was performed in Medline, Cochrane and EMBASE. Adults with RA who had received MTX monotherapy for more than 2 years were studied. Results: 88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, d-penicillamine and higher than for hydroxychloroquine (level of evidence 2a–2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b–4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b–4). Conclusion: This systematic literature search on MTX monotherapy with relatively low-dose use during at least 2 years shows favourable long-term safety.
Url:
DOI: 10.1136/ard.2008.093690
Affiliations:
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Methods: A search was performed in Medline, Cochrane and EMBASE. Adults with RA who had received MTX monotherapy for more than 2 years were studied. Results: 88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, d-penicillamine and higher than for hydroxychloroquine (level of evidence 2a–2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b–4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b–4). Conclusion: This systematic literature search on MTX monotherapy with relatively low-dose use during at least 2 years shows favourable long-term safety.</div></front></TEI><affiliations><list><country><li>France</li><li>Pays-Bas</li></country><region><li>Hollande-Méridionale</li><li>Île-de-France</li></region><settlement><li>Leyde</li><li>Paris</li></settlement></list><tree><country name="France"><region name="Île-de-France"><name sortKey="Salliot, C" sort="Salliot, C" uniqKey="Salliot C" first="C" last="Salliot">C. Salliot</name></region></country><country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Van Der Heijde, D" sort="Van Der Heijde, D" uniqKey="Van Der Heijde D" first="D" last="Van Der Heijde">D. 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