Serious adverse events with disease-modifying anti-rheumatic drugs in axial spondyloarthritis: a retrospective cohort study from a South African rheumatology centre
This retrospective cohort study of South African patients with axial spondyloarthritis found that those treated with biologic DMARDs, particularly monoclonal TNF inhibitors, experienced a significantly higher incidence of infective serious adverse events compared to those on conventional synthetic DMARDs, highlighting the need for enhanced infection surveillance in African settings.
Original paper licensed under CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/). This is an AI-generated explanation of the paper below. It is not written or endorsed by the authors. For technical accuracy, refer to the original paper. Read full disclaimer
Chronic inflammation can quietly reshape the human body, turning the spine and joints into sites of persistent pain and stiffness. This is the reality for people living with axial spondyloarthritis, a condition where the immune system mistakenly attacks the spine and the joints connecting the spine to the pelvis. While the disease often strikes younger adults, it carries a hidden weight: the same inflammatory processes that damage joints also accelerate the hardening of arteries, putting these patients at a higher risk for heart disease. To calm this internal fire, doctors prescribe medications known as disease-modifying anti-rheumatic drugs. Some are older, synthetic compounds, while others are newer, biologic drugs made from living cells that target specific parts of the immune system. These treatments can be life-changing, but because they suppress the body's natural defenses, they also carry the risk of letting infections take hold. In wealthy nations, the safety of these drugs is well-documented, but in sub-Saharan Africa, where tuberculosis is common and healthcare resources differ, the picture remains hazy. Understanding how these powerful medicines behave in this specific environment is not just a matter of academic interest; it is a question of keeping patients safe where they live.
In a private rheumatology centre in Stellenbosch, South Africa, a team of researchers set out to fill this gap by looking back at the medical records of ninety-two patients treated between 2014 and 2021. They wanted to see what actually happened to these individuals when they took these medications. The study divided the patients into two groups: those treated with the older, conventional synthetic drugs and those treated with the newer biologic drugs. The researchers tracked every serious event that occurred, defining a serious event as a death, a hospitalization for a severe infection, a new cancer, or a major heart problem like a heart attack or stroke. They followed the patients for a total of over 450 years of combined observation time, a method that allows doctors to calculate how often these bad events happen relative to how long people are on the treatment.
The results painted a clear, though cautious, picture of the risks involved. The group receiving the newer biologic drugs experienced more serious infections than the group on the older drugs. Specifically, the biologic group had a higher rate of infections that required hospitalization, with respiratory infections being the most common culprit. In contrast, the older drug group had fewer such events. When the researchers looked at the total number of serious problems, including heart issues and cancers, the difference between the two groups was not statistically significant, meaning the data did not show a clear winner or loser for overall safety. However, the signal for infection was strong enough to be noticed, particularly among patients taking a specific type of biologic drug known as a monoclonal tumor necrosis factor inhibitor. These patients faced a notably higher risk of infection compared to those on the older medications.
One of the most reassuring findings concerned tuberculosis, a major health threat in South Africa. Before starting the newer biologic drugs, all patients were rigorously screened for a hidden, dormant form of tuberculosis. Ten patients who tested positive were treated with antibiotics to clear the infection before they began their rheumatism medication. Throughout the entire eight-year study, none of these ten patients experienced a reactivation of the disease, and no new cases of active tuberculosis appeared in the study group. This suggests that the strict screening and preventive treatment protocols used in this South African clinic are working effectively, even in a region where the disease is widespread. The study also noted that three patients in the biologic group suffered major heart events, reinforcing the need for doctors to keep a close watch on heart health in these patients, given their underlying risk.
The researchers were careful to point out that their findings come with limitations. The study was small, involving fewer than one hundred people, and it was conducted at a single private clinic, which means the results might not apply to every patient in the country. The group taking the newer drugs also had the disease for a longer time on average, which could have influenced their risk of infection independently of the medication. Because of these factors, the authors describe their conclusions as a starting point for further investigation rather than a final verdict. They emphasize that while the newer drugs carry a higher risk of infection, the benefits of controlling the disease often outweigh the risks, provided that doctors remain vigilant. The study underscores the importance of checking for hidden infections before starting treatment, keeping vaccinations up to date, and managing heart health, ensuring that the powerful tools available to treat this painful condition are used as safely as possible in the South African context.
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