PsA is a long-term immune disease that causes painful inflammation in the joints, tendons, and sometimes the spine, along with characteristic skin changes. Studies have shown that up to 30% of people with plaque psoriasis may develop PsA. Although it usually starts in adults between the ages of 30 and 50, PsA can occur at any age, with symptoms like stiffness and swelling of the joints, including in the fingers and toes. Many people also experience ongoing fatigue and may have other health problems like obesity, heart disease, anxiety, or depression.
Tremfya is lab-made, dual-acting antibody that reduces inflammation by targeting interleukin-23 (IL-23), a protein that fuels inflammation. It works by binding to the p19 subunit of IL-23, reducing the signals that drive inflammatory responses and easing symptoms.
This label update matters as Tremfya is the only FDA-approved IL-23 inhibitor that can slow or stop joint damage in active PsA.
Why Was It Approved?
The label update is based on results from a 24-week study involving patients with active PsA who hadn’t used biologics before (patients who were biologic-naive) and whose PsA did not respond adequately to standard treatments. The patients receiving Tremfya showed an improvement in joint symptoms and a slowing of joint damage compared with those receiving placebo, as measured by imaging scores.
In patients who switched from placebo to Tremfya at week 24, the rate of joint damage progression was reduced by 57% between weeks 24 and 48. Overall, the study confirmed the known safety profile of Tremfya, with no new safety concerns identified.
The most common side effects of Tremfya in people with PsA include upper respiratory infections, headaches, reactions at the injection site, joint pain, bronchitis, diarrhea, stomach flu or intestinal infections, fungal skin infections, and herpes simplex infections. Severe allergic reactions, including anaphylaxis, have been reported.
What Do I Need to Know?
For PsA, you take Tremfya as a shot under the skin at Week 0 and Week 4, then every eight weeks. Your health care provider should use the lowest dose that works for you. If you or a caregiver will give injections at home, get training first.
Before starting Tremfya, your health care provider will check you for infections, including tuberculosis (TB) and will regularly monitor you for signs of TB during and after treatment.
Tell your health care provider if you are being treated for an active infection (including TB) or have an infection that does not go away or keeps coming back. If a serious infection develops, your health care provider may pause treatment until it improves. You should not get live vaccines while using Tremfya. Try to complete your schedule of routine vaccines before starting this medicine. Do not use Tremfya if you have had a serious allergy to Tremfya or to any of its ingredients.
Tell your health care provider about all the medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements, you take. Tremfya may change how some medicines are broken down in your body. If you take a medicine with a narrow safety window that is metabolized by the liver enzyme called CYP2D6, you may need closer monitoring or a dose change when starting Tremfya.
Contact your health care provider right away if you notice signs of allergic reactions such as trouble breathing; swelling of your face, eyelids, lips, mouth, tongue, or throat; or skin rashes, itching, or hives or signs of infection such as fever, chills, stomachache, muscle pain, cough, or pain while urinating.
