What Is Cosentyx, and Why Does It Matter?
Cosentyx (secukinumab) is a fully human biologic medicine that targets and blocks interleukin‑17A (IL‑17A), a naturally occurring protein in the body that helps regulate the immune system and manage inflammation. The FDA has expanded the use of Cosentyx for treating children 12 and older with moderate-to-severe hidradenitis suppurativa (HS) who weigh at least 30 kilograms (66 pounds).
HS is a painful, long‑lasting inflammatory skin condition that worsens over time. One of the major underlying mechanisms in HS involves abnormal activity of the immune system, with IL‑17A playing a key role in driving the inflammation. HS causes frequent, painful boil-like lumps and draining sores, often in sensitive areas of the body, that may leave permanent scars. HS often begins around puberty and can cause lasting scarring and disabilities, adversely affecting patients’ emotional well-being, social interactions, and daily activities during a crucial phase of their life. This condition may affect as many as 1 in 100 people worldwide, with more than half noticing their symptoms during their teen years, emphasizing the need for early treatment.
This approval matters because Cosentyx is the only IL‑17A blocker to be approved in nearly a decade, offering a novel treatment option with a different mechanism of action for children 12 and older having moderate-to-severe HS, with dosing that can be tailored according to the affected individual’s weight.
First approved in 2015, Cosentyx is also used to treat several other inflammatory conditions, including psoriatic arthritis in adults and children, ankylosing spondylitis and non-radiographic axial spondyloarthritis in adults, enthesitis-related arthritis in children, and moderate-to-severe plaque psoriasis in adults and children who are candidates for whole‑body (systemic) treatment or light‑based therapy (phototherapy).
Why Was It Approved?
The FDA based its decision on controlled studies in adults with HS, plus analyses that linked expected drug levels in teens to those seen in adults. Pediatric data from other approved uses of Cosentyx were also included. Modeling studies predicted that dosing by weight in adolescents would produce blood levels similar to adults with HS. Taken together, this supported use in children 12 and older with moderate to severe HS who meet a minimum weight of 66 pounds (30 kilograms).
Common side effects include cold symptoms, diarrhea, and infections of the upper airway. Because Cosentyx affects your immune system, your risk for infections may increase. Serious side effects include severe allergic reactions; serious bacterial, viral, or fungal infections that may be life-threatening; reactivation of tuberculosis (TB); and severe skin reactions that look like eczema. New cases of inflammatory bowel disease (IBD) such as ulcerative colitis or Crohn disease or worsening of previously existing IBD (flare-ups) have also been reported.
What Do I Need to Know?
Cosentyx is given as an injection under the skin in your thighs or stomach area (abdomen), avoiding a 2-inch area around your belly button. If your health care provider decides you can take it at home, you or a caregiver should be trained on how to prepare and inject it properly. Avoid injecting in the areas where the skin is sore, bruised, red, or hard.
Before starting Cosentyx, tell your health care provider if you have an infection or are being treated for an infection, have an infection that does not go away or keeps returning, have tuberculosis (TB) or have been in close contact with someone with TB, or have or previously had hepatitis B. Also tell your provider about all your medical conditions, especially if you have IBD such as Crohn disease or ulcerative colitis, and if you are allergic to latex or to Cosentyx or any of its ingredients.
Before starting Cosentyx, your health care provider will check you for TB. In case you’re at risk, you may need TB medicines before and during treatment. Your health care provider will also closely monitor you for any signs of TB or other infections while you’re taking Cosentyx.
Be sure to share a list of all medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements, you take to avoid possible interactions. Inform your health care provider about your updated vaccination status before starting the treatment. You should avoid taking live vaccines right before or during treatment. If you are sensitive or allergic to latex, it’s important to know that the removable needle cap on some prefilled devices contains latex. Do not use Cosentyx if you have had a serious allergic reaction to secukinumab or any of its ingredients.
It is not known if Cosentyx harms a fetus or passes into breast milk. Tell your health care provider if you are pregnant or planning to become pregnant or are breastfeeding.
Get emergency help right away if you have signs and symptoms of a serious allergic reaction, such as trouble breathing; swelling of the face, lips, mouth, tongue, or throat; dizziness or lightheadedness; itching; hives; or a skin rash.
Tell your health care provider immediately if you think you may have an infection or have symptoms such as fever, chills, sweating, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, red or painful skin or sores, diarrhea or stomach pain, or burning during urination or frequent urination.