Safety, Efficacy of Tacrolimus for Ulcerative Colitis Not Impacted by Age

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Patients ≥ 65 years of age experienced similar rates of remission and adverse events compared to their younger counterparts, with no significant difference in change in renal function observed between the 2 groups.

Tacrolimus may be a safe and effective treatment option for patients ≥ 65 years of age with moderate to severe ulcerative colitis (UC), with findings from a retrospective cohort study highlighting similar rates of remission and adverse events among older and younger patients.

Older patients’ estimated glomerular filtration rate (eGFR) was significantly lower at all time points before, during, and after treatment compared to their younger counterparts, although investigators noted there was no statistically significant difference in the overall change in eGFR between the groups.1

An immunosuppressive agent typically used for prophylaxis of organ rejection post-transplantation, tacrolimus also acts as a calcineurin inhibitor for the treatment of steroid-refractory UC and has been demonstrated to have strong therapeutic efficacy without an increased risk of severe adverse effects. However, the optimal duration and safety of tacrolimus maintenance therapy in this patient population is largely unknown, especially in older adults, a growing number of which represent the overall UC population.2

“Among various ulcerative colitis treatments, tacrolimus, a calcineurin inhibitor, has been shown to be effective in the treatment of severe and refractory ulcerative colitis,” wrote Katsutoshi Tokushige, MD, professor and divison head in the department of internal medicine at Tokyo Women’s Medical University, and colleagues.1 “To date, limited information is available on older patients with UC.”

To compare the safety and efficacy of tacrolimus as well as its impact on renal function in younger and older adult patients with UC, investigators retrospectively examined patient data for those who received tacrolimus from April 2009 through December 2022 and eventually achieved remission. Patients were stratified into younger (age < 65 years; n = 116) and older (age ≥ 65 years; n = 21) groups based on their age at treatment initiation.1

Investigators additionally collected information for participants’ age at disease onset, laboratory values, eGFR, use of 5-aminosalicylic acid (5-ASA), biologic experience, colonoscopy scores, remission at 1 month after treatment initiation, and adverse events. Further assessment of treatment duration and renal function was conducted in patients with available follow-up data (n = 110 younger patients; n = 19 older patients).1

Compared to the younger group, participants in the older group had a greater age at onset (59.8 years vs 32 years; P <.0001) and treatment initiation (68.9 years vs 39.4 years; P <.0001) but less 5-ASA use (66.7% vs 87.9%; P = .022) and biologic experience (14.2% vs 31.9%; P = .102). Before treatment, hemoglobin (P = .035), albumin (P = .012), and eGFR (P <.001) were significantly lower in the older group, although CRP was significantly higher (P = .035).1

Investigators also called attention to significant differences in the presence of underlying diseases, noting that apart from liver diseases, all other diseases, including cancer, were significantly more common in the older patient group (P <.05).1

Remission, defined by investigators as Lichtiger clinical activity index ≤ 4, was 80.1% in the younger group and 66.6% in the older group, although this difference was not statistically significant. Adverse events were similar in both groups (34% in younger vs 38% in older), all of which improved after treatment discontinuation, dose reduction, or intravenous fluid infusion. Treatment duration was significantly shorter in the older patient group (156.6 days vs 254.4 days; P = .0489).1

Additionally, participants in this group experienced significantly less change in renal function, as determined by eGFR, across all time points measured in the study. At weeks 2, 4, 12, and 24 after treatment initiation, eGFR was significantly lower in the older patient group, indicating worse renal function, with the same result observed at week 48 after tacrolimus discontinuation. However, investigators noted there were no significant differences in the change in eGFR from treatment initiation across any of these time points.1

“During treatment with [tacrolimus], older adults must be carefully monitored for signs of infection, including physical findings, such as fever and tachycardia, results of blood tests, and diagnostic imaging. If these parameters are carefully followed, [tacrolimus] is an effective drug and is an important treatment option for moderate and severe UC in older patients,” investigators concluded.1


  1. Ito A, Murasugi S, Omori T, et al. Efficacy and safety of tacrolimus in older adults with ulcerative colitis: a retrospective study. BMC Gastroenterol.
  2. Wu B, Tong J, Ran Z. Tacrolimus Therapy in Steroid-Refractory Ulcerative Colitis: A Review. Inflamm Bowel Dis. 2020;26(1):24-32. doi:10.1093/ibd/izz068