Oral tacrolimus benefits haemodialysis patients with uraemic pruritus

A study from Iran presented at ERA 2024 demonstrated the potential of oral tacrolimus to deliver an antipruritic effect in haemodialysis patients with uraemic pruritus.

“In patients undergoing haemodialysis, [pruritus] is a highly prevalent complication that affects their quality of life,” noted one of the study investigators, Fatemeh Masjedi, PhD, from the Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

Uraemic pruritus is a serious symptom in patients with end-stage kidney disease (ESKD) and those undergoing chronic dialysis. It causes skin damage, discomfort, sleep disturbance, and impaired quality of life. [Nephrol Dial Transplant 2011;26:3338-3344; Nephrol Dial Transplant 2004;19:1895-1901] Over 40 percent of haemodialysis patients suffer from chronic pruritus, with half having generalized pruritus. [Int J Nephrol Renovasc Dis 2017;10:11-26]

Since uraemic pruritus is deemed part an immune-mediated inflammatory process, immunosuppressive drugs such as tacrolimus may be beneficial. However, there is conflicting evidence to support the efficacy of tacrolimus ointment for relief of uraemic pruritus. [Perit Dial Int 2000;20:802-803; J Am Acad Dermatol 2005;52:519-521] Moreover, evidence supporting the benefits of oral tacrolimus on dermatologic concerns such as pruritus during haemodialysis is lacking.

Given the condition of haemodialysis in patients with ESKD, and the potential presence of oral tacrolimus in their future treatment plan, the investigators conducted this trial to evaluate the antipruritic effect of oral tacrolimus and compare it against placebo.

The study comprised 75 patients (mean age 58.18 years) who were undergoing haemodialysis. They were randomized 1:1 to receive either tacrolimus 1 mg/day or placebo treatment for 8 weeks. A 2-week observational period ensued thereafter. Visual Analogue Scale (VAS), % affected body surface area, and 12 Pruritus Severity Scale questionnaire (12-PSS) were measured before and after the treatment periods. Sleep quality and the effect of sex were also assessed.

Following the intervention, tacrolimus trumped placebo as reflected by the mean changes in VAS (-3.21 vs -1.38), % body surface area (-19.10 vs 4.64), and 12-PSS score (-4.59 vs 2.08; p<0.05).

Over half (52.6 percent) of tacrolimus-treated patients reported improvement in sleep quality following treatment as opposed to those who had received placebo (p<0.01). [ERA 2024, abstract 3142]

Moreover, tacrolimus appeared to be more beneficial in women compared with men (p<0.016), the investigators added.

Current treatment options not good enough

Despite several medications currently used for the treatment of uraemic pruritus, these are not satisfactory, said Masjedi and colleagues. [Iran J Kidney Dis 2017;11:50-55]

“Based on the preliminary results of this study, tacrolimus can be introduced as an effective drug for the management of pruritus and can be an add-on therapy in uraemic patients,” they concluded.