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.
- [Show abstract] [Hide abstract]
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. · 3.59 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: Abnormal liver biochemical tests are present in up to 30% of patients with inflammatory bowel disease (IBD), and therefore become a diagnostic challenge. Liver and biliary tract diseases are common extraintestinal manifestations for both Crohn's disease and ulcerative colitis (UC), and typically do not correlate with intestinal activity. Primary sclerosing cholangitis (PSC) is the most common hepatobiliary manifestation of IBD, and is more prevalent in UC. Approximately 5% of patients with UC develop PSC, with the prevalence reaching up to 90%. Cholangiocarcinoma and colon cancer risks are increased in these patients. Less common disorders include autoimmune hepatitis/PSC overlap syndrome, IgG4-associated cholangiopathy, primary biliary cirrhosis, hepatic amyloidosis, granulomatous hepatitis, cholelithiasis, portal vein thrombosis, liver abscess, and non-alcoholic fatty liver disease. Hepatitis B reactivation during immunosuppressive therapy is a major concern, with screening and vaccination being recommended in serologically negative cases for patients with IBD. Reactivation prophylaxis with entecavir or tenofovir for 6 to 12 mo after the end of immunosuppressive therapy is mandatory in patients showing as hepatitis B surface antigen (HBsAg) positive, independently from viral load. HBsAg negative and anti-HBc positive patients, with or without anti-HBs, should be closely monitored, measuring alanine aminotransferase and hepatitis B virus DNA within 12 mo after the end of therapy, and should be treated if the viral load increases. On the other hand, immunosuppressive therapy does not seem to promote reactivation of hepatitis C, and hepatitis C antiviral treatment does not influence IBD natural history either. Most of the drugs used for IBD treatment may induce hepatotoxicity, although the incidence of serious adverse events is low. Abnormalities in liver biochemical tests associated with aminosalicylates are uncommon and are usually not clinically relevant. Methotrexate-related hepatotoxicity has been described in 14% of patients with IBD, in a dose-dependent manner. Liver biopsy is not routinely recommended. Biologics-related hepatotoxicity is rare, but has been shown most frequently in patients treated with infliximab. Thiopurines have been associated with veno-occlusive disease, regenerative nodular hyperplasia, and liver peliosis. Routine liver biochemical tests are recommended, especially during the first month of treatment. All these conditions should be considered in IBD patients with clinical or biochemical features suggestive of hepatobiliary involvement. Diagnosis and management of these disorders usually involve hepatologists and gastroenterologists due to its complexity.World Journal of Gastroenterology 11/2013; 19(42):7327-7340. · 2.43 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: Abstract Background. Adalimumab (ADA), an antitumor necrosis factor (anti-TNF) monoclonal antibody, is effective in treating moderate-to-severely active Crohn's disease (CD). ADA has been associated with a variety of adverse events (AE). The purpose of this study is to determine the safety and efficacy of ADA in CD patients in clinical practice. Methods. A retrospective analysis was performed on CD patients treated with ADA. Data extracted and analyzed included patient and CD demographics, remission and response rates with ADA, and safety and tolerability of ADA. Results. A total of 149 ADA-treated CD patients were included. The mean duration of therapy with ADA was 20 months with 32% of patients discontinuing treatment. Anti-TNF-naïve and anti-TNF-exposed patients on ADA achieved clinical remission in 45% and 32%, had a clinical response in 23% and 23%, and had no clinical response in 32% and 45%, respectively. Anti-TNF-naïve and anti-TNF-exposed patients maintained remission in 82% and 67%, respectively. Fistulas healed in 19% and improved in 19%. AE occurred in 38% of patients with infection being the most common (20%). Serious infections lead to death in one (<1%). Logistic regression of AE did not identify statistically significant predictors except for colonic disease location (odds ratio [OR] = 0.31, 95% CI = 0.12-0.82, p = 0.018) and the rate of ADA discontinuation (OR = 3.24, 95% CI = 1.58-6.64, p = 0.0013). Conclusion. ADA is an effective treatment for CD. AE can occur commonly leading to discontinuation of medication and may be influenced by disease location. Although serious complications are rare, close monitoring of all patients on ADA is needed.Scandinavian Journal of Gastroenterology 12/2013; 49(3). · 2.33 Impact Factor