Long-term safety of tofacitinib in patients with rheumatoid arthritis

This study investigated the long-term safety of tofacitinib (Xelijanz) in rheumatoid arthritis (RA).

They found that this treatment was effective and well tolerated by patients with RA.

Rheumatoid arthritis (RA) is caused by inflammation. It is an auto-immune disease. This means the body’s immune cells attack joint tissue. This leads to pain, swelling and tissue degeneration. To treat RA, patients are prescribed drugs that reduce inflammation. They are called disease-modifying anti-rheumatic drugs (DMARDs). Conventional synthetic DMARDs (csDMARDs) are the first-line of therapy in RA. These drugs are non-specific. They reduce inflammation in a number of ways. Over time, patients may not respond as well to csDMARDs. The development of more selective drugs is important in managing RA long-term. 

Tofacitinib is a relatively new DMARD. It blocks enzymes called Janus kinases or JAKs. JAK inhibitors block a cellular pathway involved in inflammation. Tofacitinib prevents the activation of immune cells that cause inflammation in RA. It is an effective treatment for RA on the short-term. It is unclear if tofacitinib is safe for the long-term management of RA.

This study was a long-term extension study. Patients initially took part in clinical trials with tofacitinib. 4481 patients were allowed to continue tofacitinib treatment indefinitely if required. Patients were taking either 5 mg or 10 mg tofacitinib. The study lasted 9.5 years. 

Side effects due to any cause were generally mild (59%) or moderate (36%) in severity. The rate of side effects that led to halting tofacitinib treatment was similar throughout the trial. Infections were the main cause for halting tofacitinib treatment. Serious side effects included pneumonia (2.1%) and osteoarthritis (1.9%). The risk of side effects was high in tofacitinib-treated patients. 88 people died during the study. 84 of these deaths were linked to serious side effects.

The effectiveness of tofacitinib was maintained for over 8 years. 

The authors concluded that tofacitinib was effective and well tolerated in the long-term by patients with RA.

If you have any concerns regarding RA please consult with your physician.