(RxWiki News) Clinicians are generally familiar with the side effects of most prescribed medications. However, the safety of newer medications such as golimumab, an anti-TNF drug to treat autoimmune disorders, is still being examined.
Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis are all chronic autoimmune disorders that may require patients to take medications for extended periods of time. Therefore, studying the safety of these medications over long periods of administration is important.
Golimumab (Simponi), a newer medication of the anti-TNF type, was FDA approved in 2009. Anti-TNF medications inhibit the substances (TNF) responsible for inflammation.
This recent study assessed the adverse effects of golimumab in patients who have been using it for up to three years. The authors found that golimumab has similar long-term side effects as other anti-TNF drugs, but the study on the safety of golimumab will continue for another two years.
"Ask your doctor about all your medication options."
This study on the safety profile of golimumab was led by Jonathan Kay, MD, from the Division of Rheumatology of the University of Massachusetts Medical School and colleagues.
Data was obtained from five clinical trials on 2,225 participants receiving golimumab as an injection under the skin and 639 receiving a placebo (fake medicine).
From the participants who received golimumab, 1,249 received a 50 mg dose and 1,501 received a 100 mg dose every four weeks for up to 160 weeks (three years and four months). At least 1,119 patients were taking golimumab for more than 156 weeks. Some participants were also taking methotrexate — a commonly prescribed type of disease-modifying antirheumatic drugs (DMARD).
The participants were adults around 49 years of age of which 1,532 had rheumatoid arthritis, 405 had psoriatic arthritis and 356 had ankylosing spondylitis. Overall, the participants presented inflammation and moderate functional impairment due to their condition.
During the first 16 weeks of treatment, the researchers did not find a difference in the number of patients (around 65 percent) who experienced adverse events across the three groups of participants (placebo, golimumab 50 mg, golimumab 100 mg).
During the first 160 weeks of treatment, the researchers reported that only 73 percent of patients in the placebo group experienced adverse events compared to 85 percent in the golimumab at 50 mg group and 86 percent in the golimumab at 100 mg group.
Infections such as upper respiratory tract infections, nasopharyngitis and nausea were the most common type of adverse events experienced by all the participants.
The researchers calculated that the number of deaths estimated to occur in 1,000 patients per year was:
- 2.8 for placebo
- 3 for golimumab at 50mg
- 4.1 for golimumab at 100mg
The number of patients estimated to develop lymphoma (blood cancer) if 1,000 patients were followed for one year were:
- 0 for placebo
- 0.4 for golimumab at 50 mg
- 1.8 for golimumab at 100 mg
And the number of serious infections estimated to occur in 100 patients per year was:
- 5.3 for placebo
- 3 for golimumab at 50 mg
- 5 for golimumab at 100 mg
The researchers noted that within the participants taking golimumab, those who had rheumatoid arthritis were more prone to serious infections (9.1 percent) than those who had psoriatic arthritis (2.5 percent) or ankylosing spondylitis (4.8 percent).
Although there was a possible increased risk for serious infection and lymphoma for golimumab at 100 mg, the authors concluded that the safety of golimumab is comparable to other anti-TNF medications such as etanercept (Enbrel), infliximab (Remicade), adalimumab (Humira), and certolizumab (Cimzia).
This study was published on December 16 in the Annals of Rheumatic Diseases and the clinical trials were funded by Janssen and Merck/Schering-Plough.