For adults with moderately to severely active Crohn’s disease
WHY CHOOSE
TREMFYA®?
Some goals of managing Crohn’s disease are to visibly improve intestinal lining and to treat symptoms—TREMFYA® can help with both.
Results with SC initial
and maintenance dosing
(no intravenous infusion)
Results with SC initial and maintenance dosing (no intravenous infusion)
In a 48-week trial, all patients received TREMFYA® as subcutaneous (SC) injections (under the skin), which started with 400 mg at weeks 0, 4, and 8, followed by either 100 mg every 8 weeks or 200 mg every 4 weeks.*
RESULTS WITH SC INITIAL AND MAINTENANCE
DOSING (NO IV)
FAST ACTING
AND
LONG LASTING
Rapid results at 12 weeks
All patients started with SC doses of 400 mg.
PATIENTS WHO ACHIEVED CLINICAL REMISSION
PATIENTS WHO ACHIEVED ENDOSCOPIC RESPONSE†‡
Decreases in abdominal pain and bowel movements were observed as early as 4 weeks.
Lasting results at 1 year
After initial SC doses, patients received 200 mg every 4 weeks or 100 mg every 8 weeks.
PATIENTS WHO ACHIEVED CLINICAL REMISSION
Also, 59% of patients on TREMFYA® 100 mg SC maintenance doses achieved clinical remission.
PATIENTS WHO ACHIEVED ENDOSCOPIC RESPONSE†‡
Also, 39% of patients on TREMFYA® 100 mg SC maintenance doses achieved endoscopic response.
†Endoscopic response is based on areas visualized by endoscopy.
‡Endoscopic response means visible improvement of the intestinal lining.
RESULTS WITH SC INITIAL AND
MAINTENANCE
DOSING (NO IV)
SOME PATIENTS SAW
VISIBLE HEALING
OF THE INTESTINAL LINING§
After initial SC doses, patients received
200 mg every 4 weeks or 100 mg every 8 weeks.
PATIENTS WHO WERE IN
ENDOSCOPIC REMISSION
Visible healing of the intestinal lining means endoscopic remission.
§Endoscopic remission is based on areas visualized on colonoscopy, which may not represent the deeper bowel layer or entire GI tract.
*Results are from a clinical trial of patients with moderately to severely active Crohn’s disease: 225 patients started with TREMFYA® 400 mg SC doses followed by 114 patients receiving TREMFYA® 100 mg SC and 111 patients receiving TREMFYA® 200 mg SC maintenance doses, and 115 patients received placebo.
Individual results may vary.
Results from two trials starting with intravenous dosing
Results from two trials
starting with
intravenous dosing
TREMFYA® was also studied in two identical trials (Trial 1 and Trial 2), which started with 200 mg administered intravenously (IV) through a vein in the arm.*
RESULTS FROM TWO TRIALS STARTING WITH
IV DOSING
RAPID RELIEF
AT WEEK 12
Patients who achieved
clinical remission at week 12
Patients who achieved clinical remission at week 12
All patients started with IV doses of 200 mg every 4 weeks
TRIAL 1
TRIAL 2
Patients who achieved
endoscopic Visible improvement of the intestinal lining on endoscopy. response†‡
at week 12
Patients who achievedendoscopic responseVisible improvement of the
intestinal lining on endoscopy.†‡
at week 12
All patients started with IV doses of 200 mg every 4 weeks
TRIAL 1
TRIAL 2
†Based on areas visualized by endoscopy.
‡Endoscopic response means visible improvement of the intestinal lining.
*Results are from two identical clinical trials of patients with moderately to severely active Crohn’s disease. Trial 1: 285 patients started with TREMFYA® 200 mg IV doses and 76 patients received placebo. Trial 2: 288 patients started with TREMFYA® 200 mg IV starter doses and 72 patients received placebo.
Individual results may vary.
The results below are based on data combined from trial 1 and trial 2 to compare TREMFYA® vs STELARA® (ustekinumab).
All patients on TREMFYA® received the same initial IV dosing as in trial 1 and trial 2. Following these initial doses, patients received subcutaneous (SC) injections of 200 mg every 4 weeks or 100 mg every 8 weeks.
All patients on STELARA® received the recommended dosage for Crohn’s disease: a one-time weight-based intravenous (IV) infusion followed by 90 mg subcutaneous (SC) injections every 8 weeks.*
TREMFYA® demonstrated superiority vs STELARA® across 4 key measures.
Patients who achieved endoscopic response†Visible improvement of the
intestinal lining on endoscopy. at 1 year
Visible improvement of the intestinal lining on endoscopy.
Also, 48% of patients on TREMFYA® 100 mg SC maintenance doses achieved endoscopic response† at 1 year.
Patients who achievedclinical remission and endoscopic response†Remission of symptoms and visible improvement of the intestinal lining on endoscopy. at 1 year
Remission of symptoms and
visible improvement of the
intestinal lining on endoscopy.
Also, 42% of patients on TREMFYA® 100 mg SC maintenance doses achieved clinical remission and endoscopic response† at 1 year.
Patients who achievedvisible
healing of the intestinal lining†Visible healing of the intestinal lining means endoscopic remission.
at 1 year
Visible healing of the intestinal lining means endoscopic remission.
Also, 33% of patients on TREMFYA® 100 mg SC maintenance doses achieved visible healing of the intestinal lining† at 1 year.
Patients who achievedclinical remission and visible healing of
the intestinal lining†Remission of symptoms and the intestinal lining.at 1 year
Remission of symptoms and the intestinal lining.
Also, 30% of patients on TREMFYA®
100 mg SC maintenance doses achieved clinical remission and visible healing of the intestinal lining†at 1 year.
Patients who achieved
endoscopic response†Visible improvement of the
intestinal lining on endoscopy.
at 1 year
Visible improvement of the
intestinal lining on endoscopy.
Patients who achieved
clinical remission and
endoscopic response† Remission of symptoms and
visible improvement of the
intestinal lining on endoscopy.
at 1 year
Remission of symptoms and
visible improvement of the
intestinal lining on endoscopy.
Patients who achieved
visible healing of the
intestinal lining† at 1 yearVisible healing of the intestinal lining means endoscopic remission.
Visible healing of the
intestinal lining means
endoscopic remission.
Patients who achieved
clinical remission and
visible healing of the
intestinal lining†
at 1 year Remission of symptoms and the intestinal lining.
Remission of symptoms
and the intestinal lining.
Also, 48% of patients on
TREMFYA® 100 mg SC
maintenance doses
achieved endoscopic
response† at 1 year.
Also, 42% of patients on
TREMFYA® 100 mg SC
maintenance doses achieved
clinical remission and
endoscopic response† at 1 year.
Also, 33% of patients on
TREMFYA® 100 mg SC
maintenance doses
achieved visible healing of
the intestinal lining†
at 1 year.
Also, 30% of patients on
TREMFYA® 100 mg SC
maintenance doses
achieved clinical remission
and visible healing of the
intestinal lining† at 1 year.
Subsequent endpoints in the planned testing process did not show significant results, so they are not included here.
†Endoscopic remission and endoscopic response are based on areas visualized on colonoscopy, which may not represent the deeper bowel layer or entire GI tract.
*Results are based on data combined from trial 1 and trial 2 of patients with moderately to severely active Crohn’s disease: 286 patients started with TREMFYA® 200 mg IV doses followed by 100 mg SC maintenance doses every 8 weeks, 296 patients started with TREMFYA® 200 mg IV doses followed by 200 mg SC maintenance doses every 4 weeks, and 291 patients started with a STELARA® weight-based IV dose followed by 90 mg SC every 8 weeks. The number of patients used to measure the effect of TREMFYA® compared to STELARA® at 1 year is different than that at Week 12 due to the types of treatment assessments.
STELARA® is indicated for the treatment of adults with moderately to severely active Crohn’s disease. For more information on STELARA®,
please read the full Prescribing Information and Important Safety Information below.
Talk to your doctor to see if TREMFYA®
is right for you.
TREMFYA®
LEGACY
14+
YEARS
of combined clinical research*
6+
YEARS
on the market across multiple indications
*Based on a clinical trial of TREMFYA® initiated in 2009.
TREMFYA® Safety Information
TREMFYA® may cause serious side effects, including:
- Serious allergic reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
- fainting, dizziness, feeling lightheaded (low blood pressure)
- swelling of your face, eyelids, lips, mouth, tongue or throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
- itching
- Infections. TREMFYA® is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
- fever, sweats, or chills
- cough
- shortness of breath
- blood in your phlegm (mucus)
- muscle aches
- warm, red, or painful skin or sores on your body different from your psoriasis
- weight loss
- diarrhea or stomach pain
- burning when you urinate or urinating more often than normal
- Liver problems. With the treatment of Crohn’s disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:
- unexplained rash
- vomiting
- tiredness (fatigue)
- yellowing of the skin or the whites of your eyes
- nausea
- stomach pain (abdominal)
- loss of appetite
- dark urine
These are not all the possible side effects of TREMFYA®.
Please read the Important Safety Information located at the bottom of the screen and the Medication Guide for TREMFYA® to learn more about these and other risks for TREMFYA®. Discuss any questions you have with your doctor.
TREMFYA® may cause serious side effects, including:
- See “What is the most important information I should know about TREMFYA®?”
The most common side effects of TREMFYA® include:
- respiratory tract infections
- joint pain (arthralgia)
- fungal skin infections
- headache
- diarrhea
- herpes simplex infections
- injection site reactions
- stomach flu (gastroenteritis)
- stomach pain
- bronchitis
These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
TREMFYA® may cause serious side effects, including:
- Serious allergic reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
- fainting, dizziness, feeling lightheaded (low blood pressure)
- swelling of your face, eyelids, lips, mouth, tongue or throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
- itching
- Infections. TREMFYA® is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
- fever, sweats, or chills
- cough
- shortness of breath
- blood in your phlegm (mucus)
- muscle aches
- warm, red, or painful skin or sores on your body different from your psoriasis
- weight loss
- diarrhea or stomach pain
- burning when you urinate or urinating more often than normal
- Liver problems.With the treatment of Crohn’s disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:
- unexplained rash
- vomiting
- tiredness (fatigue)
- yellowing of the skin or the whites of your eyes
- nausea
- stomach pain (abdominal)
- loss of appetite
- dark urine
These are not all the possible side effects of TREMFYA®.
Please read the Important Safety Information located at the bottom of the screen and the Medication Guide for TREMFYA® to learn more about these and other risks for TREMFYA®. Discuss any questions you have with your doctor.
TREMFYA® may cause serious side effects, including:
- See “What is the most important information I should know about TREMFYA®?”
The most common side effects of TREMFYA® include:
- respiratory tract infections
- joint pain (arthralgia)
- fungal skin infections
- headache
- diarrhea
- herpes simplex infections
- injection site reactions
- stomach flu (gastroenteritis)
- stomach pain
- bronchitis
These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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