Is Tremfya a biological?

Yes, Tremfya is a biological medicine approved to treat adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.

A biological medicine is a large complex molecule made from living organisms using specialized technology.

Tremfya (guselkumab) is classified as a monoclonal antibody and works by blocking Interleukin-23 (IL-23), a cytokine protein that plays a key role in inflammation and immune response.

Examples of other prescription biologic treatments used for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis or Crohn's disease include:

• Humira (adalimumab) treats plaque psoriasis, psoriatic arthritis and ulcerative colitis and blocks Tumor Necrosis Factor (TNF).
• Cosentyx (secukinumab) treats plaque psoriasis and psoriatic arthritis and blocks IL-1.
• Enbrel (etanercept) treats plaque psoriasis and psoriatic arthritis and blocks Tumor Necrosis Factor (TNF).
• Stelara (ustekinumab) is used to treat certain types of Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis, all considered autoimmune conditions. It blocks the activity of IL-12 and IL-23, which reduces inflammation, pain, swelling, and skin symptoms.

Related: See a full list of Interleukin (IL) Inhibitors

How is Tremfya used?

Plaque psoriasis

For plaque psoriasis, Tremfya is used in patients who are eligible for systemic therapy (injections or pills) or phototherapy (treatment using ultraviolet light).

• In clinical studies, at least 70% of patients (7 out of 10) saw at least 90% clearer skin after 16 weeks of treatment with Tremfya.
• More than 80% of patients were clear or almost clear. Most patients (90%) who had 90% clearer skin at 28 weeks continued to see it at 48 weeks.
• In one study, 70% of patients still had 90% clearer skin at 5 years.

Improvement in skin itching, pain, stinging, burning and skin tightness were observed when compared to a placebo.

Tremfya was approved by the FDA for treatment of plaque psoriasis in July 2017.

Psoriatic arthritis

Tremfya is also approved to treat active psoriatic arthritis in adults. It can help relieve joint pain, stiffness and swelling, and allow a person to perform everyday tasks, such as bathing, reaching up, eating and walking, a bit easier. Fatigue may be reduced as well.

• In studies of patients with psoriatic arthritis, greater than 50% (more than 5 out of 10) of patients who received Tremfya had a 20% improvement in psoriatic arthritis symptoms at 24 weeks.
• At 24 weeks, an improvement in skin plaques was also seen.

Tremfya was approved by the FDA for treatment of psoriatic arthritis in July 2020.

Ulcerative colitis

In September 2024 the FDA approved Tremfya for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Ulcerative colitis (UC) is a chronic disease of the large intestine in which the lining of the colon becomes inflamed. Symptoms may include: diarrhea (possibly with blood or pus), stomach pain and cramping, weight loss, fever, fatigue, rectal pain, urgent need to defecate.

• In studies, results showed that 50% of patients receiving Tremfya 200 mg subcutaneous (SC) maintenance every 4 weeks and 45% of patients receiving Tremfya 100 mg SC every 8 weeks achieved clinical remission at week 44 compared to 19% of placebo-treated patients (p<0.001).
• In addition, over one-third of patients achieved endoscopic remission at one year with Tremfya vs. 15% of placebo-treated patients (p<0.001).

Related questions

• What does psoriasis look like?
• How do you get psoriasis and is it contagious?
• How does Tremfya work?

Crohn's disease

In March 2025, the FDA approved Tremfya for the treatment of adults with moderately to severely active Crohn’s disease (CD). It is the first IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, allowing the flexibility of patient SC self-administration from the start of treatment.

Crohn’s disease is a long-term (chronic) inflammatory bowel disease with disruptive stomach symptoms such as abdominal pain and tenderness, frequent bowel movements, rectal bleeding, weight loss and bowel urgency. Crohn's disease typically begins between ages 15 and 40, and there is no cure at this time.

• Approval was based on data from the placebo-controlled Phase 3 GRAVITI and GALAXI studies in over 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy (i.e. corticosteroids or immunomodulators) or biologics.
• Pooled data from the GALAXI clinical program showed Tremfya was superior to Stelara in all pooled endoscopic endpoints.

Dosing

Tremfy is given as a subcutaneous injection, usually every 4 or 8 weeks, after initial starter doses. Your doctor will determine your dose and schedule based on your condition.

It is available as a self-administered injection. You, or your caregiver, can learn how to inject the medicine yourself, after training from your healthcare provider.

Related: Tremfya dosing (in more detail)

Side effects

Tremfya may cause serious side effects, like serious allergic reactions and infections. Your doctor will check for tuberculosis (TB) before you start treatment. Avoid getting a live vaccine while using Tremfya. Live vaccines examples include the chicken pox vaccine, measles, mumps and rubella (MMR), rotavirus, smallpox and yellow fever.

Common side effects reported with Tremfya in people using it for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, injection site reactions, and joint pain (arthralgia), gastroenteritis, diarrhea, fungal skin infections, herpes simplex infections, and bronchitis.

Common side effects reported with Tremfya in people using it for ulcerative colitis include: respiratory / upper respiratory tract infections, injection site reactions, and joint pain (arthralgia).

Reported common side effects in people using it to treat Crohn’s Disease (≥3%) include: respiratory tract infections, abdominal pain, injection site reactions, headache, fatigue, arthralgia, diarrhea, and gastroenteritis.

This is not all the information you need to know about Tremfya (guselkumab) for safe and effective use and does not take the place of your doctor's recommendations. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.