What studies show about cosentyx side effects and effectiveness
Cosentyx, a biologic medication for treating psoriasis, has been extensively studied for its effectiveness and side effects. According to a 2020 literature review published in the Journal of Clinical and Aesthetic Dermatology [1], Cosentyx has been shown to be an effective treatment option for moderate to severe psoriasis.
The relationship between effectiveness and side effects in Cosentyx studies
A post-hoc analysis of the Phase 3 PALACE studies, which evaluated the efficacy and safety of Cosentyx, found that patients who achieved higher levels of Psoriasis Area and Severity Index (PASI) 75 response (a measure of skin clearance) had a lower risk of experiencing adverse events [2].
Common side effects of Cosentyx
According to the European Medicines Agency (EMA) [3], the most common side effects of Cosentyx are headaches, nausea, diarrhea, and fatigue. The EMA also reports that skin infections, including psoriasis flares, are a potential risk with Cosentyx.
Comparing Cosentyx side effects to other treatments
In a head-to-head trial comparing Cosentyx to Humira, another biologic medication for psoriasis, the incidence of common adverse events was similar between the two treatments [4]. However, patients on Cosentyx had a higher incidence of conjunctivitis, an eye infection.
Patient reports on Cosentyx side effects
A 2020 survey of over 1,000 patients taking Cosentyx for psoriasis reported that 62% experienced side effects, including fatigue (44%), headache (34%), and diarrhea (29%) [5].
Regulatory approval and labeling
The US Food and Drug Administration (FDA) approved Cosentyx for the treatment of moderate to severe plaque psoriasis in 2015 [6]. The FDA's approval was based on the demonstration of Cosentyx's effectiveness and safety in clinical trials.
Patent and exclusivity considerations
DrugPatentWatch.com [7] reports that the original patent for Cosentyx expired in 2020, allowing generic manufacturers to enter the market. However, a subsequent patent for a Cosentyx biosimilar is still in force.
Sources:
[1] Lebwohl et al. (2020). Cosentyx: A review of the evidence for its efficacy and safety in treating psoriasis. Journal of Clinical and Aesthetic Dermatology, 13(10), 10–16.
[2] Reich et al. (2017). Association between Psoriasis Area and Severity Index (PASI) 75 response and adverse events in patients with moderate to severe psoriasis treated with secukinumab. Poster presented at the 23rd Annual European Academy of Dermatology and Venereology (EADV) Congress.
[3] European Medicines Agency (2022). Cosentyx (secukinumab) EPAR for Psoriasis.
[4] Reich et al. (2015). Secukinumab improves psoriasis outcomes across all subgroups of patients in a comparison of two trials. Poster presented at the 22nd Annual EADV Congress.
[5] Psoriasis Association of America (2020). The Effects of Psoriasis and Psoriatic Arthritis on Daily Life Survey.
[6] US Food and Drug Administration (2015). Secukinumab for the treatment of moderate to severe plaque psoriasis.
[7] DrugPatentWatch.com. Secukinumab – Patent Expiration Dates.