Methotrexate is one of the immunosuppressants used in chronic inflammatory bowel disease (IBD). It is indicated as monotherapy for induction and maintenance treatment of Crohn's disease (CD), or in combination with anti-tumor necrosis factor (TNF) agents for prevention of immunization. The main objective is to assess the persistence rate of methotrexate treatment in patients followed for chronic inflammatory bowel disease (IBD).
Methotrexate is one of the immunosuppressants used in chronic inflammatory bowel disease (IBD). It is indicated as monotherapy for induction and maintenance treatment of Crohn's disease (CD), or in combination with anti-tumor necrosis factor (TNF) agents for prevention of immunization Thiopurines are the most commonly used immunosuppressants in IBD, which contrasts with rheumatology data where methotrexate is the first-line immunosuppressant. Thiopurines and methotrexate have equivalent efficacy in CD 4. Methotrexate is available in injectable (intramuscular (IM) or subcutaneous (SC)) or tablet form. In IBD, only parenteral administration has been shown to be effective. There is no consensus on the optimal maintenance dosage. Tolerance problems remain an obstacle to its use, even if the side effects are not severe. In this context, the objectives of this study are to describe the use of methotrexate in current practice in patients followed for IBD, its persistence, compliance, tolerance, as well as the factors associated with the persistence of treatment.
Study Type
OBSERVATIONAL
Enrollment
1,282
CHRU of Nancy
Vandœuvre-lès-Nancy, Grand Est, France
Persistence rate of methotrexate treatment in chronic inflammatory bowel disease patients
Persistence is measured as the time between starting treatment and stopping the drug or switching to another drug.
Time frame: minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022
Assess the effectiveness of induction therapy with methotrexate for Crohn's patient
Clinical response defined as a decrease of at least 3 points in the Harvey-Bradshaw Index (HBI) for CD assessed at 6 months of methotrexate therapy. The Harvey-Bradshaw Index consists of a few questions (n=5) to quickly categorize the severity of Crohn's disease and detect remission. Harvey-Bradshaw Index Score: Remission: \<5 Mild Disease: 5 to 7 Moderate Disease: 8 to 16 Severe Disease: \>16
Time frame: minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022
Assess the effectiveness of induction therapy with methotrexate for Ulcerative colitis patient
Clinical response defined as a decrease of at least 3 points in the partial Mayo score for Ulcerative colitis (UC) assessed at 6 months of methotrexate therapy Mayo score composed by 4 items: stool frequency; rectal bleeding, mucosal appearance at endoscopy and physician rating of disease activity. Mayo score: Score \<2 : no activity Score between 3 and 5: mild activity Score between 6 and 10 :moderate activity Score \>11 : severe activity
Time frame: minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022
Assess the safety of methotrexate therapy
Adverse reactions associated with methotrexate treatment: hematological, hepatic, pulmonary, renal toxicity, allergic reaction, abdominal pain, nausea, vomiting.
Time frame: minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022
Describe the reasons for discontinuation of methotrexate therapy
Reasons for discontinuing methotrexate: inefficiency and intolerance
Time frame: minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022
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