Long-term Outcomes in Steroid-refractory Ulcerative Colitis Treated with Tacrolimus Alone or in Combination with Purine Analogues

Schmidt, Karl; Müller, Niklas F.; Dignaß, Axel; Baumgart, Daniel C.; Lehnert, Hendrik; Stange, E. F.; Herrlinger, K; Fellermann, Klaus; Büning, Jürgen

doi:10.1093/ecco-jcc/jjv175

Cited by 21 publications

(23 citation statements)

References 28 publications

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“…The long‐term safety and efficacy of tacrolimus could not be evaluated in this study. Several retrospective studies suggest that long‐term tacrolimus therapy is safe and effective in refractory IBD . Nevertheless, RCTs are necessary to rigorously assess the safety and efficacy of tacrolimus as maintenance therapy.…”

Section: Discussionmentioning

confidence: 99%

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Tacrolimus vs. anti‐tumour necrosis factor agents for moderately to severely active ulcerative colitis: a retrospective observational study

Yamamoto

Shimoyama

Umegae

et al. 2016

Aliment Pharmacol Ther

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Section: Discussionmentioning

confidence: 99%

“…These studies suggest that tacrolimus is useful as an alternative option for steroid‐refractory UC. Furthermore, a recent study reported that tacrolimus was useful for the long‐term management of steroid‐refractory UC.…”

Section: Introductionmentioning

confidence: 99%

Tacrolimus vs. anti‐tumour necrosis factor agents for moderately to severely active ulcerative colitis: a retrospective observational study

Yamamoto

Shimoyama

Umegae

et al. 2016

Aliment Pharmacol Ther

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“…Previous studies in UC have reported the possible benefit of combining thiopurines with tacrolimus, as purine analogues were shown to be associated with a higher rate of clinical remission and longer time to colectomy. 25 Nevertheless, these factors have not been previously described in patients with CD. Importantly, the relationship between blood drug concentrations during induction and clinical disease activity are relevant findings that may help to increase the likelihood of response in these cases.…”

Section: Ta B L E 3 (Continued)mentioning

confidence: 99%

Tacrolimus induces short‐term but not long‐term clinical response in inflammatory bowel disease

Rodríguez‐Lago¹,

Castro‐Poceiro²,

Fernández-Clotet³

et al. 2020

Aliment Pharmacol Ther

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Background: Tacrolimus is a calcineurin inhibitor commonly used for prophylaxis of rejection in renal and liver transplantation. There are limited but favourable data regarding its possible use in patients with inflammatory bowel disease (IBD). Aims:To evaluate the efficacy and safety of tacrolimus in patients with IBD in clinical practice. Methods:We performed a retrospective, multicentre study in 22 centres in Spain. All adult patients who received oral tacrolimus for luminal or perianal IBD were included.Clinical response was assessed by Harvey-Bradshaw index and partial Mayo score after 3 months. Perianal disease was evaluated by fistula drainage assessment. Results:One hundred and forty-three patients were included (mean age 38 years; 51% male; median disease duration 110 months). In ulcerative colitis (UC) (n = 58), the partial Mayo score decreased after 3 months from median 6 to 3 (P = 0.0001), whereas in Crohn's disease (CD) (n = 85), the Harvey-Bradshaw index decreased after 3 months from median 9 to 7 (P = 0.011). In CD patients, blood tacrolimus concentrations during induction (>10 ng/mL vs <10 ng/mL; odds ratio 0.23, 95% CI 0.05-0.87) and the concomitant use of thiopurines (odds ratio 0.18, 95% CI 0.04-0.81) were associated with lower clinical disease activity at 3 months. Of 62 patients with perianal disease, complete closure was observed in 8% (n = 5) of patients with perianal fistulas, with 34% (n = 21) showing partial response. Treatment was maintained for a median of 6 months (IQR,(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16). After a median clinical follow-up of 24 months (IQR, 15-57), the rate of treatment-related adverse events was 34%, correlating with blood drug concentrations (P = 0.021). Finally, 120 patients (84%) discontinued tacrolimus, | 871 RODRÍGUEZ-LAGO Et AL.

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“…[52][53][54][55] Like patients treated with CsA, steroid-refractory UC patients who achieve remission with TAC treatment would require immunomodulators to maintain remission and prevent colectomy. Recently, Schmidt et al 56 reported the effect of purine analogs (PAs) on the long-term clinical outcomes of 156 moderately to severely active steroid-refractory UC patients treated with TAC. The Kaplan-Meier curve for colectomy-free survival after month 3 showed a benefit in the PA group.…”

Section: ) Cyclosporine Amentioning

confidence: 99%

Optimizing the Use of Current Treatments and Emerging Therapeutic Approaches to Achieve Therapeutic Success in Patients with Inflammatory Bowel Disease

Nakase

2020

Gut and Liver

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The current goal of inflammatory bowel disease (IBD) treatment is a symptom-free everyday life accompanied by mucosal healing with minimal use of corticosteroids. Recent therapeutic advances, particularly, the emergence of antitumor necrosis factor (anti-TNF) antibodies, have changed the natural history of IBD. Additionally, these advances also led to the emergence of the therapeutic concept of the "treat to target" strategy. With the development of new drugs and clinical trials, not only biologics but also small molecules have been applied to clinical practice to better individualize and optimize therapy. However, if newer drugs, including anti-TNF therapies, are recommended for all patients diagnosed with IBD, a significant number of patients will be overtreated. The basic goal of IBD treatment is still to make the best use of conventional treatments based on IBD pathophysiology. Thus, physicians should be familiar with the modes of action of the available drugs. In this review, the author discusses the existing data for many approved drugs and provide insights for optimizing current treatments for the management of patients with IBD in the era of biologics.

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Long-term Outcomes in Steroid-refractory Ulcerative Colitis Treated with Tacrolimus Alone or in Combination with Purine Analogues

Abstract: Our study supports the efficacy of tacrolimus in steroid-refractory UC. Purine analogues appear to be beneficial for the long-term outcome of these patients.

Cited by 21 publications

References 28 publications

Tacrolimus vs. anti‐tumour necrosis factor agents for moderately to severely active ulcerative colitis: a retrospective observational study

Tacrolimus vs. anti‐tumour necrosis factor agents for moderately to severely active ulcerative colitis: a retrospective observational study

Tacrolimus induces short‐term but not long‐term clinical response in inflammatory bowel disease

Optimizing the Use of Current Treatments and Emerging Therapeutic Approaches to Achieve Therapeutic Success in Patients with Inflammatory Bowel Disease

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