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Posted by on Feb 28, 2019 in Rheumatoid Arthritis | 0 comments

In a nutshell

This study investigated the safety of tofacitinib (TFB; Xeljanz) in the treatment of rheumatoid arthritis (RA).

They found that patients taking TFB alone had a reduced risk of infections.

Some background

Rheumatoid arthritis (RA) is a chronic condition caused by inflammation. This leads to painful swelling in the joints and disability. RA is treated with medication to reduce inflammation. These drugs are called anti-rheumatic disease-modifying drugs or DMARDs. There are different types of DMARDs. The ‘classic’ DMARDs are also known as conventional synthetic or csDMARDs. 

Recent evidence suggests that combining csDMARDs with new RA drugs may improve treatment. Tofacitinib (TFB) is a drug with a specific target – Janus kinase (JAK) enzymes. TFB is effective as a stand-alone treatment (monotherapy, MT). It is also effective in combination therapy (CMBT) with csDMARDs. It is unclear if the safety of TFB is better in MT or CMBT. 

Methods & findings

This study analyzed data from 6 clinical trials including 3881 patients. 2 studies investigated TFB MT. 4 studies compared CMBT to MT with TFB. The authors analyzed all reported adverse events (AEs) and serious AEs (SAEs). Patients were taking either 5 or 10 mg TFB twice daily. 

The risk of AEs was numerically lower in MT patients. Overall, the safety profile of TFB in MT and CMBT was similar. The most frequently reported AE was upper respiratory tract infections. This affected 7.6% of MT patients and 9.9% of CMBT patients. The most frequent SAE in CMBT patients was pneumonia (0.7%).

The most frequent SAE in MT patients was chronic obstructive pulmonary disease, COPD (0.3%). The SAEs that led to stopping TFB treatment was pneumonia (CMBT – 0.5% patients) and impaired kidney function (MT – 0.5% patients). MT patients had a significantly lower risk of herpes zoster and serious infections. 

The bottom line

The authors concluded that patients taking TFB alone had a reduced risk of infections.

The fine print

This study looked back at medical records and some relevant information was not available. Further studies are needed to compare the safety of TFB treatment strategies. 

What’s next?

If you have any concerns regarding RA treatment, please discuss this with your physician. 

Published By :

Seminars in Arthritis and Rheumatism

Date :

Dec 01, 2018

Original Title :

A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population.

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