Severe side effects are rare with biologics, study says

| Melissa Leavitt

People taking biologics for their psoriasis can breathe a little easier. A recent study suggests that the drugs are generally safe, and do not often result in serious side effects that force patients to stop treatment.

The study, which was published in May 2015 in the Journal of the American Academy of Dermatology, analyzed the health records of psoriasis patients on biologics, looking for the number of times patients had to stop biologic treatment because of side effects.

According to the results, side effects — which researchers call "adverse events" — led patients to stop taking their biologics in about 4 percent of cases, a rate described by the researchers as “very low.”

Most of what is known about the safety of biologics comes from clinical trial data, the researchers noted. Although clinical trials offer a good source of information about side effects, they don’t always reflect what will happen when patients take these drugs in the "real world," according to the researchers. Clinical trials sometimes screen out patients who don’t meet certain criteria, and they may not follow patients on biologics for very long. 

However, this study followed patients for up to nine years, looking to see how these drugs affected their health and treatment decisions.

A closer look at adverse events

Researchers studied the health records of patients in two clinics in Canada, identifying 398 patients on biologics. The biologics included in the study were Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab) and Stelara (ustekinumab).

The most common adverse events that led patients to stop their treatment were infections, reactions at the site of the infusion, and malignancies, or cancer, according to the study. Five patients developed an infection that led them to stop their biologic, and four developed malignancies, according to the results.

Five patients on Remicade stopped their treatment because of reactions at the site of the infusion. Remicade is the only therapy out of the ones studied that is delivered through intravenous infusion, the researchers noted.

Results from the study suggest that adverse events do not occur more often in the real world than in clinical trials, and are uncommon for the biologics studied, the researchers concluded.

 


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