The Safety and Tolerability of Methotrexate for Treating Patients With Crohn's Disease
ABSTRACT To determine the safety and tolerance of methotrexate for treating patients with Crohn's disease in clinical practice.
Methotrexate is effective for treating patients with Crohn's disease. However, concerns about potential toxicity, particularly to the liver, have limited its use.
A retrospective chart review was performed of Crohn's disease patients in our practice treated with methotrexate. Data related to the safety and tolerance of methotrexate was extracted and analyzed.
Of 92 patients treated with methotrexate, there was enough data for 79 patients for analysis (49 women and 30 men; mean age 28.8 y). Forty-two patients (53%) had previously received azathioprine. Overall, 40 patients (51%) achieved and maintained remission on methotrexate, including 13 of 30 (43%) who concomitantly received anti-tumor necrosis factor therapy. The mean total accumulated dose of methotrexate was 1727 mg [SD 1572 mg], with a mean total duration of methotrexate use of 25.4 months (SD 43.1 mo). The most common adverse events were nausea (22%) and elevated liver enzymes (10%). Only 6% of patients stopped methotrexate therapy because of persistently abnormal liver enzymes. No patients underwent liver biopsy.
This retrospective study showed that methotrexate is safe and well-tolerated in treating patients with Crohn's disease in clinical practice.
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ABSTRACT: Compared with solid waste landfill, cleaner production is an effective way to reduce solid waste all over the world. In this study, a modified flue gas desulfurization residue (MFGDR) was prepared and used to ameliorate acidic soil. The MFGDR was prepared by calcining a mixture of dry/semi-dry flue gas desulfurization residue, potassium feldspar and/or limestone powder in a definite molar ratio. The MFGDR, rich in K, Ca, Mg, Si and other micronutrients, which are lack in acidic soil. Application of the MFGDR was effective in raising soil pH, increasing soil available P, K, Ca, Mg and Si, and decreasing available Cd and Pb concentrations in soil. Growth of rice was significantly increased by the MFGDR application, comparing with the untreated control, straw yield and grain yield of rice were increased by 11.2–29.2% and 16.9–26.0%, respectively. Concentrations of Hg, As and Pb in rice grain were significantly decreased, after the MFGDR application. The MFGDR can be used as an ideal soil ameliorant to ameliorate acidic soil, especially for acidic soil wildly distributing in South China. The agricultural application of the MFGDR can effectively solve the FGD residue landfill problem, and the relevant regenerative purpose was also realized.Journal of Cleaner Production 03/2012; 24:159–167. DOI:10.1016/j.jclepro.2011.11.065 · 3.84 Impact Factor
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ABSTRACT: Methotrexate is useful in inflammatory bowel disease (IBD), but its role is secondary because of its limited experience and a supposedly unfavorable safety profile. To describe the efficacy and safety of methotrexate in a long-term real clinical practice. Retrospectively reviewed records of IBD patients treated with methotrexate in eight hospitals of Madrid (Spain). A total of 77 patients were included (80% Crohn's disease); 94% received methotrexate because of steroid dependency. Overall, 82% of the patients initially responded (28% remission). Eighty-eight percent of the patients followed maintenance treatment for a mean of 17 (range: 1-108) months. Forty percent of the patients lost response at a mean of 57 weeks after starting methotrexate. No statistically significant differences were found in the response rates in terms of the disease type, route of administration, or the Montreal Classification category. The mean methotrexate cumulative dose was 1108 mg (range: 25-6480). The main adverse events included 10 cases of gastrointestinal symptoms, four of myelotoxicity, and 10 of abnormal liver function tests, and led to methotrexate withdrawal in four (5%) patients. Transient elastography, performed in 46 patients, detected six additional cases with significant fibrosis and normal liver function tests. Methotrexate is useful in inducing a response in IBD, although its efficacy decreases frequently through the follow-up. Although methotrexate seems safe in the long term, in addition to biochemical controls, a more accurate method to detect liver damage should be considered.European journal of gastroenterology & hepatology 06/2012; 24(9):1086-91. DOI:10.1097/MEG.0b013e3283556db5 · 2.15 Impact Factor
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ABSTRACT: BACKGROUND & AIMS: Methotrexate is an immunosuppressant that is used to treat patients with Crohn's disease (CD). However, there are few data on the long-term effects of methotrexate maintenance therapy for these patients. We assessed the sustained clinical benefits and tolerability of methotrexate monotherapy following thiopurine therapy in patients with CD. METHODS: We analyzed data from 3 hospitals on 174 consecutive patients with CD (35±12 years old) who received methotrexate monotherapy following thiopurine therapy (23% also did not respond to anti-tumor necrosis factor-therapy) from 2000 to 2010. We assessed patient characteristics and the tolerability and sustained clinical benefits of the treatment. Sustained clinical benefit was defined as ongoing use of methotrexate or intentional discontinuation of successful therapy before the end-of-study point. RESULTS: The number of patients with sustained clinical benefits from methotrexate monotherapy were 98 (86%), 50 (63%), 27 (47%), and 3 (20%), at 6, 12, 24, and 60 months, respectively. Forty-five patients (26%) discontinued methotrexate because of intolerance, particularly within 6 months after therapy began. Adverse responses were generally mild; only 1 patient required admission to the hospital, for infection with cytomegalovirus, and no drug-related deaths were reported. Intolerance of preceding thiopurine therapy was associated with adverse events during methotrexate therapy. CONCLUSION: In a large cohort study of patients who received methotrexate monotherapy following thiopurine therapy for CD, 47% continued to receive the therapy or intentionally discontinued successful therapy within 2 years, and 20% did so within 5 years. Long-term use of methotrexate was well tolerated and relatively safe.Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association 01/2013; 11(6). DOI:10.1016/j.cgh.2012.12.026 · 6.53 Impact Factor