Safety of drugs used for the treatment of Crohn’s disease

Pudipeddi, Aviv; Kariyawasam, Viraj C.; Haifer, Craig; Baraty, Brandon; Paramsothy, Sudarshan; Leong, Rupert W.

doi:10.1080/14740338.2019.1612874

Cited by 28 publications

(15 citation statements)

References 89 publications

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“…Although AEs are associated with both AZA and thalidomide, the incidence of AEs reported in the current study was similar to that of previous studies (5,14,29,49); indicating that the combination of AZA and thalidomide may not increase the risk of AEs. Teratogenicity is the most well-known AE of thalidomide (50), but it is also the most preventable one.…”

Section: Discussionsupporting

confidence: 89%

Thalidomide Combined With Azathioprine as Induction and Maintenance Therapy for Azathioprine-Refractory Crohn's Disease Patients

Qiu

et al. 2020

Front. Med.

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The combination therapy of thalidomide and azathioprine (AZA) offers an alternative in clinical practice for Crohn's disease (CD) patients experiencing a loss of response to AZA monotherapy. However, little is known about the efficacy and safety of this combination therapy for patients with CD. This was a retrospective study of 122 consecutive CD patients who lost response to AZA therapy and had switched to a combination therapy of thalidomide and AZA. The primary outcomes were clinical response and clinical remission rates at week 24. Patients who had an initial response to combination therapy were continued on the treatment for remission maintenance. The secondary outcomes were the proportion of clinical relapse throughout maintenance. The Kaplan-Meier method was used to calculate cumulative rates, and Cox regression analysis was used for multivariate analysis. During induction, 80.3% (98/122) patients achieved clinical response within a median duration of 6.5 weeks, (interquartile range, 4.3-8.1 weeks). The rate of clinical remission at 24 weeks was 70.5%. During follow-up, 22.4% (22/98) of the patients that were maintained on combination therapy experienced clinical relapse. The proportions of patients in remission status at 12, 24, and 36 months were 85.1, 78.3, and 70.1%, respectively. Multivariate analysis revealed C-reactive protein >10 mg/L at disease relapse on AZA monotherapy [adjusted hazard ratio (HR), 4.72; 95% CI, 1.19-18.75, P = 0.027] and 6-thioguanine nucleotides level ≥235 pmol/8 × 10 8 erythrocytes at AZA monotherapy (adjusted HR, 5.32; 95% CI, 1.40-20.14, P = 0.014) were associated with disease relapse on combination therapy. The endoscopic remission rate was 63.6%. Mucosal healing was achieved in 23.6% of the patients. Both Crohn's Disease Endoscopic Index of Severity (13.4 ± 4.92 vs. 6.12 ± 5.24, P < 0.001) and Rutgeerts scores (3.23 ± 0.73 vs. 1.77 ± 1.59, P = 0.003) were significantly decreased with the use of combination therapy. Adverse events occurred in 62 (50.8%) patients, but only 13 (10.7%) necessitated therapy discontinuation. Thalidomide combined with AZA was effective in inducing clinical remission and sustaining long-term steroid-free remission in CD patients who lost response to AZA monotherapy.

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Section: Discussionsupporting

confidence: 89%

Thalidomide Combined With Azathioprine as Induction and Maintenance Therapy for Azathioprine-Refractory Crohn's Disease Patients

Qiu

et al. 2020

Front. Med.

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“…Prediction, prevention and management techniques for main drug class-specific complications associated with the use of maintenance IBD drugs [7][8][9][10] are listed in Table 1. Prediction is currently limited to the detection of a genetic predisposition to thiopurine-induced myelosuppression.…”

Section: Drug Class-specific Complicationsmentioning

confidence: 99%

Predicting, Preventing, and Managing Treatment-Related Complications in Patients With Inflammatory Bowel Diseases

Beaugerie

Rahier

Kirchgesner

2020

Clinical Gastroenterology and Hepatology

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“…Drugs for treating CD include aminosalicylic acid preparations, corticosteroids, immunosuppressive agents and biological agents (Zalieckas, 2017;Pudipeddi et al, 2019). Aminosalicylic acids are mainly used for remission of CD in mild active stage and corticosteroid for moderate or severe CD or patients who are ineffective with aminosalicylic acid, immunosuppressive agents for the maintenance therapy and biological agents are considered as redemption for patients who have failed in traditional treatment (Akobeng et al, 2016;Rutgeerts et al, 2004;Lémann et al, 2006;Ng et al, 2011;Zheng et al, 2011;Yang et al, 2012).…”

Section: Introductionmentioning

confidence: 99%

Thalidomide Prevented and Ameliorated Pathogenesis of Crohn’s Disease in Mice via Regulation of Inflammatory Response and Fibrosis

Chen

Luo

et al. 2019

Front. Pharmacol.

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Crohn's disease (CD) is a chronic, relapsing form of inflammatory bowel disease, seriously threatening human health. Thalidomide has been used for the treatment of CD. However, the effects and the possible mechanisms of thalidomide on CD are still unclear. Herein, our study demonstrated that thalidomide protected colon mucosa against trinitrobenzene-sulfonic acid (TNBS)-induced injury, diminished inflammatory infiltration and levels of IFN-γ, IGF-1, IL-6, IL-17, TNF-α, while increased the levels of IL-10 and TGF-γ. Moreover, it reversed the intestinal fibrosis and inhibited the accumulated infiltration, down-regulated the expression of col1a2, col3a2, MMP-3, MMP-9, MMP-1, TGF-γ, α-SMA, but up-regulated the expression of TIMP-1 and Vimentin. Although it could be observed that the effect of thalidomide administration in modeling was better than after modeling, there was no statistical difference between the two groups. The present study provided evidence that the therapeutic effect of thalidomide alleviated the inflammatory response and damage of colon tissue, mainly by restoring the imbalance of TH17/Treg cells and inhibiting intestinal fibrosis in TNBS-induced mice colitis.

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Safety of drugs used for the treatment of Crohn’s disease

Cited by 28 publications

References 89 publications

Thalidomide Combined With Azathioprine as Induction and Maintenance Therapy for Azathioprine-Refractory Crohn's Disease Patients

Thalidomide Combined With Azathioprine as Induction and Maintenance Therapy for Azathioprine-Refractory Crohn's Disease Patients

Predicting, Preventing, and Managing Treatment-Related Complications in Patients With Inflammatory Bowel Diseases

Thalidomide Prevented and Ameliorated Pathogenesis of Crohn’s Disease in Mice via Regulation of Inflammatory Response and Fibrosis

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