Tacrolimus Add-on Therapy found Efficacious for Rheumatoid Arthritis Patients

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Tacrolimus Add-on Therapy found Efficacious for Rheumatoid Arthritis Patients

A recent study revealed that tacrolimus was found safe and efficacious as an add-on to biological DMARDs in patients with RA. The Disease-modifying anti-rheumatic drugs (DMARDs) are used to manage the condition of rheumatoid arthritis to reduce joint inflammation. However, doctors used specific biological modifiers such as tacrolimus with DMARDs.

  Tacrolimus is a class of imunosupressents which is used along with other medications to manage the condition of disease more effectively. However, the efficacy of tacrolimus and its action on DMARDs is unclear.

Therefore, scientists conducted Post-marketing surveillance (PMS) to evaluate tacrolimus add-on therapy efficacy and safety among RA patients and also an inadequate response to biological DMARDs actions. For the study, RA patients were registered centrally from 180 medical sites across Japan with an electronic investigation system. A total of 624 and 566 patients involved in evaluating Safety and efficacy, respectively. Among participants, a significant percentage was of a female with a mean age of 61.9 years.  The whole observational course from the first day of tacrolimus administration simultaneously with DMARDs was of 24 weeks.

After treatment, a total 125 adverse drug reactions (ADRs) were noticed among 94 patients and 15 severe ADRs among 11 patients. However, the frequency of these adverse effects was lesser after tacrolimus treatment in PMS as compared to previously reported incidences. Moreover, all these all ADRs were already recognised. Further, the primary efficacy variable of the Simplified Disease Activity Index after TAC treatment also shown a  statistically significant recovery from disease. About a 62.7% of patients, remission or low disease activity, was noticed at 24th week.

Therefore, the overall study explains that tacrolimus as an add-on to biological DMARDs is significantly effective and well tolerated among patients with RA who do not obtain an incompetence response to DMARDs in a real-world clinical setting.


Mod Rheumatol. 2017 Jun 26:1-10.

Link to the source:


Original title of article:

Safety and effectiveness of tacrolimus add-on therapy for rheumatoid arthritis patients without an adequate response to biological disease-modifying anti-rheumatic drugs (DMARDs): Post-marketing surveillance in Japan.


Takeuchi T; et al.

Therapeutic, Tacrolimus, Rheumatoid arthritis, Hands, Feet, Biological DMARDs, Post-marketing surveillance, Add-on therapy, Efficacy, Safety
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