Safety and Effectiveness of Tacrolimus Adjuvant Therapy for Rheumatoid Arthritis Patients with Inadequate Response to Biological Disease-modifying anti-rheumatic drugs

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Safety and Effectiveness of Tacrolimus Adjuvant Therapy for Rheumatoid Arthritis Patients with Inadequate Response to Biological Disease-modifying anti-rheumatic drugs
Key Take-Away: 

Non-adherence to disease-modifying antirheumatic drugs (DMARDs) hinders the objectives of rheumatoid arthritis (RA) treatment, achieving low disease activity and limiting radiological progression. This study explored the potential and efficacy of Tacrolimus as an adjunct therapy to the patients showing low-adherence to biological DMARDs. The investigators successfully established Tacrolimus as a useful adjuvant therapy in patients with RA.

Rheumatoid arthritis is characterized by pain, aching, stiffness and swelling of the joints. It is the leading cause of pain and affects nearly 0.5% to 1% of the population worldwide. Tacrolimus is an immunomodulator that acts by inhibiting T-cell activation and has been suggested as a promising adjuvant therapy in patients with insufficient response to biological disease-modifying anti-rheumatic drugs (DMARDs).

ABSTRACT: 
Background: 

Rheumatoid arthritis is characterized by pain, aching, stiffness and swelling of the joints. It is the leading cause of pain and affects nearly 0.5% to 1% of the population worldwide.

Tacrolimus is an immunomodulator that acts by inhibiting T-cell activation and has been suggested as a promising adjuvant therapy in patients with insufficient response to biological disease-modifying anti-rheumatic drugs (DMARDs). Post-marketing surveillance (PMS) was conducted to assess the safety and effectiveness of tacrolimus (TAC) add-on therapy for patients with rheumatoid arthritis (RA) and an inadequate response to DMARDs.

Methods: 

Patients with RA from 180 medical sites across Japan were registered centrally with an electronic investigation system.

The observational period was 24 weeks from the first day of TAC administration concomitantly with biological DMARDs.

Results: 

Safety and effectiveness was studied in 624 and 566 patients, respectively. Patients were predominantly female (81.1%), with a mean age of 61.9 years.

Overall, 125 adverse drug reactions (ADRs) occurred in 94 patients (15.1%), and 15 serious ADRs occurred in 11 patients (1.8%). These incidences were lower when compared with previously reported incidences after TAC treatment in PMS, and all the observed ADRs were already known. A statistically significant improvement was observed in the primary efficacy variable of Simplified Disease Activity Index after TAC treatment; 62.7% of patients achieved remission or low disease activity at week 24.

 

Conclusion: 

TAC is well tolerated and effective treatment when used as an add-on to biological DMARDs in Japanese patients with RA who do not achieve an adequate response to biological DMARDs in a real-world clinical setting.

 

Source:

Mod Rheumatol. 2017 Jun 26:1-10.

Link to the source:

http://www.ncbi.nlm.nih.gov/pubmed/28649878

The original title of the 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.

Authors:

Takeuchi T et al

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