Real-world Study Reveals Side Effects Linked to Cosentyx

Researchers examine a therapy approved for ankylosing spondylitis

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by Lindsey Shapiro |

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Diarrhea, cold-like symptoms, itchy skin, and rash are the most common real-world side effects associated with Cosentyx, an approved treatment for ankylosing spondylitis (AS), a study has found.

Such side effects typically emerge in the first month of using the medication, according to the analysis, which included information from a large multinational database.

Other, less common, but notable side effects included yeast infections, inflammatory bowel disease, and loss of smell.

The study, “Toxicity signals associated with secukinumab: A pharmacovigilance study based on the United States Food and Drug Administration Adverse Event Reporting System database,” was published in the British Journal of Clinical Pharmacology.

Novartis‘ Cosentyx acts by blocking a protein called interleukin-17a (IL-17a) that drives inflammation in the body’s tissues. Delivered via under-the-skin injections, the treatment is widely prescribed for a number of inflammatory conditions.

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Cosentyx is approved in the U.S. and several other countries for conditions that include plaque psoriasis, psoriatic arthritis, AS and active non-radiographic axial spondyloarthritis (nr-axSpA), of which AS is a severe type.

Approvals for AS were based largely on findings from the MEASURE 1 (NCT01358175) and (MEASURE 2 (NCT01649375) Phase 3 clinical trials, in which participants saw significant improvements in measures of disease severity compared with a group of participants taking placebo.

But Cosentyx has been associated with some side effects, in particular infections, allergic reactions, gastrointestinal problems, and nervous system disorders, across its several indications.

However, most side effect data is from clinical trials, which “do not reflect the situation of the ‘real-world’ population,” the researchers wrote.”In order to achieve a comprehensive understanding of [Cosentyx] toxicities, research based on post- marketing world data is essential.”

The research team, all from the Naval Medical University in Shanghai, China, sought to assess the real-world side effects associated with Cosentyx — called a pharmacovigilance study.

Data spanning 2015–2021 were obtained from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. This large database contains information about medication use and adverse events across several countries, and is used commonly for pharmacovigilance assessments.

Data mostly from US sources

A total of 300,665 records were extracted from FAERS that were related to Cosentyx. These reports came mostly from the U.S (67.2%), but also from Canada, Germany, the United Kingdom, France, and other locations.

The medication was used most often by women (59.6%) and those 45–60 years old. Cosentyx usually was indicated for psoriasis (57.6%), followed by psoriatic arthritis (27.8%), and AS (10.63%). It usually was administered at 300 mg or 150 mg doses.

Of the four main toxicities, infections and infestations were the most commonly reported type of side effect, occurring in 29,372 reports. This most often manifested as cold-like symptoms (nasopharyngitis).

In terms of allergic reactions (20,952 reports), itchy skin and rash were the most typical manifestations, and among the 19,134 reports of gastrointestinal issues, diarrhea, unspecified gastrointestinal disorder, and Crohn’s disease were frequent.

Nervous system problems, including symptoms such as migraine, burning sensations or movement disorders, were seen less frequently than the other main toxicities, occurring in 13,560 reports.

The team noted that infectious and gastrointestinal symptoms are in line with the known role of IL-17a in fighting infection and maintaining gut health, but that “the effects of IL-17 on the brain have not yet been clarified and require further exploration.”

Across all four domains, diarrhea, nasopharyngitis, itchy skin and rash were the most common side effects related to Cosentyx, all of which are known side effects mentioned on Cosentyx’s prescribing label.

Other side effects were observed in each category that, although less common, occurred more frequently than expected and should be deemed side effects of concern, the team noted. These included yeast infections (candidiasis), dermatitis psoriasiform (red, itchy patches of skin), inflammatory bowel disease, and loss of smell.

Onset of nervous system symptoms was the fastest, occurring a median of 20 days after starting Cosentyx treatment, followed by gastrointestinal disorders (21 days), and allergic reactions (23 days).

Detect symptoms early

About a quarter of patients with allergic reactions developed symptoms within a day. “Clinicians should therefore pay particular attention during the first day of treatment,” the researchers wrote.

Infections showed the longest time to onset, taking a median of 57 days after starting treatment to emerge.

The four types of toxicities showed considerable overlap, with 675 patients exhibiting side effects in all four categories.

“The mechanisms underlying these overlaps require further investigation. In the real world, when a patient has one [adverse event], the clinicians should carefully monitor for other [adverse events],” the team wrote.

Other side effects that did not belong to these four main categories also were  observed, and included pain, joint stiffness, skin plaques, and skin discoloration.

Overall, “[t]his comprehensive pharmacovigilance analysis based on post-marketing data contributes to a further understanding of the safety of [Cosentyx],” the researchers wrote.

They noted that missing or incomplete data and a lack of investigation of other medications also being used limit the analysis.

“The real relationship between [adverse events] and [Cosentyx] should be followed-up and validated in prospective studies.”