No Adverse Events Reported in RA Drug Study

Rheumatoid arthritis patients using adalimumab don’t face higher risks for adverse health events, researchers said in a recent study. The medication is still considered safe, and no new adverse health events were discovered in association with its use. The new study also reinforces the benefit for these patients of receiving the flu vaccine.

The study appears in the June 23, 2016, issue of the Annals of the Rheumatic Diseases.

Tumor necrosis factor inhibitors are commonly used to improve clinical outcomes in rheumatoid arthritis patients.  But, their safety levels are a concern, and they’re frequently associated with an increased risk of infection. Adalimumab’s safety profile is well established, but there have been few global clinical trials that review its impact on rheumatoid arthritis patients or that pay close attention to any serious adverse events – those that were fatal, life-threatening, or lead to hospitalizations.

In this cohort study, researchers reviewed and updated any adverse health events of special interest among rheumatoid arthritis patients using adalimumab. These problems included: serious infectious events, tuberculosis, opportunistic infections, herpes zoster, and hepatitis B reactivation.  

Led by Gerd R. Burmester, M.D. professor of medicine in the rheumatology and clinical immunology department at Charité-University Medicine Berlin in Germany, investigators determined rheumatoid arthritis patients taking adalimumab faced no higher risk for a myriad of adverse events than did rheumatoid arthritis patients who didn’t take the medication or those who were healthy. They also face no additional safety risk for laboratory abnormalities, hepatitis B reactivation, spontaneous abortions or birth defects.

“Our focus was on safety aspects that have not been broadly published with adalimumab or other anti-TNFs,” researchers wrote. “Limiting this analysis to clinical trial experience may not fully reflect clinical practice, due to selection bias of trial populations, survival of completers and co-morbidities.”

Researchers culled data from 28 global clinical trials data between Feb. 1, 2004, and Nov. 5, 2013. Information on pregnant patients was gleaned from the Adalimumab Pregnancy Exposure Registry.

During the study, researchers reviewed data on 15, 132 patients who had been exposed to adalimumab through Dec. 31, 2012, accounting for roughly 24, 810 patient years of exposure.

Results revealed serious infections and tuberculosis occurred at a rate of 4.7 and 0.3 events/100 patient years, respectively; pneumonia occurred at 0.7 events/100 patient years; cellulitis occurred in 0.3 events/100 patient years; and bacterial arthritis and sepsis occurred in 0.2 events/100 patient years.

From all the studies, 40 opportunistic infections – excluding oral candidiasis, herpes zoster, and tuberculosis – were reported in 35 patients at a rate of 0.2 events/100 patient years. The most frequently reported such infections included: oesophageal candidiasis, coccidiomycosis, cytomegalovirus infection, mycobacterium arium complex infection.

According to study data, researchers also evaluated how the flu vaccine impacted rheumatoid arthritis patients who received more than 1 dose of adalimumab for up to 10 years.  All total, 351 out of 553 rheumatoid arthritis patients received flu vaccines. Five percent of those vaccinated and 14 percent of those unvaccinated experienced adverse events. However, awareness of the beneficial impact of receiving the flu vaccine remains low, researchers said.

Laboratory results also revealed patients treated with adalimumab and methotrexate for both early-stage and long-standing rheumatoid arthritis experienced fewer incidents of moderate anemia.

Overall, the study updates and confirms adalimumab’s known safety profile. There is a recent increased increase, they said, in how adalimumab impacts a rheumatoid arthritis patient’s risk of herpes zoster. Data indicates, though, that using tumor necrosis factor inhibitors doesn’t actually up the risk, making further research into the risk-benefit of vaccination prior to using the medication compelling.

References:

Burmester, Gerd R., et. al. “Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis.” Annals of the Rheumatic Diseases. Published online June 23, 2016. doi: 10.1136/annrheumdis-2016-209322

Burmester, Gerd R., et. al. “Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis.” Annals of the Rheumatic Diseases. Published online June 23, 2016. doi: 10.1136/annrheumdis-2016-209322