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Ustekinumab - Uses, Side Effects, Steps and Precautions

Published on Apr 27, 2022 and last reviewed on Jul 06, 2022   -  20 min read

Abstract

Ustekinumab is a drug that was long-established in treating Crohn’s disease. The below article is classified on Ustekinumab.

Overview:

Ustekinumab is a monoclonal antibody drug developed by Janssen Pharmaceuticals. This drug is used to treat moderate to severe Crohn's disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis, etc. It is an injectable drug and is usually prescribed in adults after being unresponsive to other medications. Ustekinumab does not treat or cure these diseases entirely; however, it helps minimize and manage their symptoms.

As per reports, Ustekinumab has been effective in more than 45,000 Crohn's disease patients. It is recorded as the first and exclusively approved drug of choice for ulcerative colitis treatment as it has shown improvements in the colon. Ustekinumab had received the U.S Food and Drugs Administration approval for treating adults with moderate to severe plaque psoriasis in September 2009. Followed approval for treating other diseases, and on October 21, 2019, received approval for treating adults with moderate to severe ulcerative colitis. On July 30, 2020, U.S Food and Drugs Administration approved the use of Ustekinumab for the age group between 6 years to 11 years, suffering from moderate to severe plaque psoriasis.

How Does Ustekinumab Work?

Those suffering from conditions like Crohn's disease, plaque psoriasis, etc., will have higher levels of cytokines (small proteins) in the body. Ustekinumab acts by attaching to these proteins and blocking their activity. The molecular mechanism of action of Ustekinumab is that it actsby preventing the human interleukins IL-12 (interleukin-12) and IL-23 from binding to IL-12rB receptor chain of IL-12 receptor complexes on the surface of natural killer (NK) cells and T cells (Lymphocytes). It prevents IL-12 and IL-23 mediated gene activation, cytokine production, and downstream signaling.

Uses:

  1. Crohn's Disease: It is one of the chronic inflammatory bowel diseases. Ustekinumab is indicated in treating moderate to severe Crohn's disease, especially in patients who were intolerant, showed poor or no response to either immunomodulators, corticosteroids and TNF blockers.

  2. Psoriasis: In psoriatic patients, it is used in treating adult patients with moderate to severe plaque psoriasis.

  3. Psoriatic Arthritis: Ustekinumab is used alone or in combination with Methotrexate to treat psoriatic arthritis in adult patients.

  4. Ulcerative Colitis: Ustekinumab is used to treat moderate to severe ulcerative colitis.

Dosage:

After the first dose, Ustekinumab is given four weeks later, which is then followed every 12 weeks. It is initially injected into the veins (intravenous), followed by injection under the skin (subcutaneous) in Crohn's disease.

For Subcutaneous Injection:45 mg/0.5 ml or 90 mg/ml in a single-dose prefilled syringe or 45 mg/0.5 ml in a single-dose vial. The dose of Ustekinumab in patients weighing less than 100 kgs is 45 mg and in those weighing more than 100 kgs is 90 mg.

For Intravenous Infusion:130 mg/26 ml solution in a single-dose vial.

Warning:

1) Infections:Ustekinumab increases the risk of infections and could reactivate recent infections. Serious infections by bacteria, viruses, and fungi have occurred to this drug. Therefore, it is necessary to consider the risks and side effects before taking the medication. Treatment with Ustekinumab should not be initiated in patients with an active infection until it is treated completely. If the patients are genetically deficient in IL-12 or IL-23, it increases their risk for certain infections. But there is no known information on the incidence of infections due to suppressed levels of IL-12 and IL-23 from Ustekinumab.

2) Tuberculosis: Patients should be examined for tuberculosis before administering Ustekinumab. If the patient is tuberculosis positive, refrain from administering this drug immediately and start with anti-tubercular therapy before giving Ustekinumab.

3) Malignancies:Studies have proven an increase in the risk of malignancies in patients taking Ustekinumab, as it is an immunosuppressive drug (stops the body's immune cells from damaging healthy cells and tissues). Patients who are 60 years old and more, patients under long-time immunosuppressants, those under PUVA (psoralen and ultraviolet A) therapy if taking this drug should be constantly checked for any signs of malignancies.

4) Hypersensitivity reactions: Ustekinumab has shown hypersensitivity (allergic) reactions such as anaphylaxis in a few cases. If anaphylaxis occurs, the drug should be discontinued.

5) Immunizations: Considering the patient's age, all the recommended vaccines should be taken, as it is not recommended to take live vaccines while taking this drug.

6) Posterior Reversible Encephalopathy Syndrome (PRES): It is a neurological condition that affects the brain with symptoms such as headaches, altered mental state, seizures, defects in vision, etc. Although the cause is unclear, a few patients have reported PRES after taking the drug; Ustekinumab should be discontinued in patients suspected of this condition.

7) Pneumonia:It is an infection in the lungs caused due to microbes. Non-infectious pneumonia has been reported in a few patients after taking this drug.

For Patients:

What Do You Need to Know About Crohn’s Disease?

Crohn's disease is a long-term inflammatory bowel disease that affects the stomach lining by making it inflamed and irritated. Its symptoms include stomach pain, diarrhea, constipation, diet changes, fatigue, urge to excrete frequently, etc. Crohn's disease can affect any part of the gastrointestinal system, including the organs from the mouth to the anus. The most commonly affected areas are the small intestine and colon. Unfortunately, it is an entirely non-curable disease. Medications like corticosteroids and immunosuppressants are used to slow this condition's progression.

What Are the Causes of Crohn’s Disease?

There is no accurately known cause of Crohn's disease. However, family history, genes, a weak immune system, and certain environmental factors such as smoking are considered the major causes of Crohn's disease.

What Happens in Crohn’s Disease?

Crohn's disease affects any organ involved in digestion, starting from the mouth to the anus.

This disease does not necessarily affect the digestive system as a whole; it can affect a few parts while the rest are entirely normal and healthy. It is an autoimmune disease (the immune system mistakes the healthy cells to be harmful and attacks them) in which the immune cells attack the healthy cells of the digestive lining.

How Does Crohn’s Disease Vary From Ulcerative Colitis?

Both these conditions belong to inflammatory bowel diseases (IBD). While the symptoms are similar in both, a few criteria differentiate Crohn's disease from ulcerative colitis, which includes,

  1. Ulcerative colitis only affects the large intestine, but Crohn's disease can affect any part of the digestive system from the mouth to the anus.

  2. Crohn's disease does not affect the involved part as a whole. There are still healthy parts left. But ulcerative colitis does not leave a single part and affects the colon (large intestine) as a whole.

Learn More About Ustekinumab

Facts to Know Before Starting Ustekinumab:

When and Why Switch to Ustekinumab?

Ustekinumab is not the first medicine of choice for Crohn's disease. When all the other medications have failed to show results or if the patient could not tolerate the drugs used otherwise, Ustekinumab is considered. It has shown noticeable effects in minimizing the symptoms and keeping the condition in check. Most importantly, the positive effects of Ustekinumab are more than its side effects.

How Effective Is Ustekinumab?

Ustekinumab showed a good clinical response in more than 70 % of the patients who were under the drug for a year. It has shown a reduction in the severity of the symptoms and kept the symptoms in check.

Things to Inform Your Doctor Before They Prescribe You Ustekinumab:

  1. Treated for any infections if the patients have an active infection or open wounds.

  2. Getting infections frequently and if a particular infection keeps recurring.

  3. Experiencing symptoms of infection such as fever, muscle aches, chills, body aches, weight loss, cough, shortness of breath, diarrhea, etc.

  4. Positive for tuberculosis or have been in close contact with someone who suffers from tuberculosis.

  5. Inform if you are pregnant, planning for pregnancy, or a breastfeeding mother. Ustekinumab passes in small amounts through breast milk; consult with the doctor to know the right way to feed the baby.

  6. If any other medications were taken for the condition previously or if you are getting a prescription for this condition for the first time.

  7. Allergic to any drugs or anything in general, like latex.

  8. If the patient or any close living family members have taken any recent vaccinations, it is not advisable as there is a serious risk of infections.

  9. Taking medications for any other conditions or have taken treatments like phototherapy.

Starting Ustekinumab:

How to Take Ustekinumab?

Ustekinumab is available as single-dose prefilled syringes and single-dose vials. The first dose of Ustekinumab is given in the veins at the doctor's clinic or hospital. The second dose should be taken four weeks later and then taken every 12 weeks. The doses can be self-injected, or a family member can help inject it for you at home when recommended to be administered under the skin (subcutaneously). The dosage depends upon the weight of the individual. If you are under any other medications, ask your doctor's opinion if you can continue taking them simultaneously.

Using Prefilled Syringes:

Dos and Don'ts While Using Prefilled Syringes:

  1. Inform your doctor if you are allergic to latex or Ustekinumab, as the needle cover is made up of latex.

  2. Read the instructions carefully before using the syringes.

  3. Check the expiration date before opening the carton.

  4. Store the prefilled syringes in a refrigerator between 36℉ to 46℉.

  5. The syringes should be stored by positioning them upwards and straight.

  6. Avoid shaking the syringes.

  7. Do not freeze the prefilled syringe.

  8. Each syringe is only for a single-use and should be discarded after use.

  9. The syringes should be stored in their original carton to prevent exposure to light.

  10. Do not inject through clothes.

  11. Avoid using a damaged or pre-opened pen.

  12. It can be stored at room temperature inside the carton for upto 30 days and should be discarded after. Do not refrigerate after storing it at room temperature.

  13. Keep the syringes out of reach for children.

Instructions for the Patient or the Caregiver on Using Prefilled Syringes:

Necessities to Inject the Prefilled Syringe:

  • Antiseptic wipes to clean the injection site.

  • Cotton balls and gauze.

  • Prescribed dose prefilled syringe.

  • Adhesive band-aid.

  • Disposal sharps container.

Steps to Inject Ustekinumab - Prefilled Syringe:

Prepare the Injection Site and the Injection:

  • Wash your hands clean using antiseptic soap or handwash.

  • Clean the injection site using antiseptic wipes and see that the injecting surface is placed flat.

  • Do not touch the cleaned injection site and let it dry on its own.

  • The tip of the needle is designed with a cut portion that should be facing upwards while injecting.

  • The site of injection could be buttocks, thighs, stomach, or the outer area in the upper part of the arms if the caregiver is injecting.

  • The injection site should be free of redness, swelling, or skin patches.

Injecting the Drug:

  • Remove the needle cap right before injecting.

  • Hold the prefilled syringe using one hand and remove the cap using the other hand.

  • Avoid touching the plunger (the part of the syringe used to push the medicine into the skin, usually present at the lower end) before injecting or while removing the cap.

  • Avoid getting anything in contact with the needle and do not touch the needle.

  • Using the other hand, pull the skin a little and hold it tight.

  • Inject the needle in 45° angulation in one go.

  • Push the plunger using the thumb as much as it goes in.

  • Inject the liquid slowly and completely.

  • After injecting the liquid, slowly pull the needle out.

  • Release the plunger.

  • After pulling out the needle, it is normal to bleed, do not panic.

  • Place cotton on the site and give mild pressure, Do not rub the injection site.

Select a different injection site every time you inject to prevent developing a lump that is rare and to give the site time to heal. If you inject more than the recommended dose accidentally, seek immediate medical help.

How to Safely Dispose of the Prefilled Syringes?

It is important to follow proper disposal protocols for syringes. The used and expired syringes should be disposed of in the FDA-approved sharps container. Do not throw them in the normal household trash. If a sharps container is not available, dispose of it in a closely sealed, leak-proof heavy duty plastic container and dispose of it periodically as per the local community guidelines. Dispose of the left medicines after injecting, following the same guidelines.

Contact your doctor or pharmacist to clear doubts regarding the disposal protocols.

Using Single-Dose Vials:

Do and Don'ts While Using Single-Dose Vials:

  1. Self-injection or injection by a caregiver using a vial is advised if they are taught by a healthcare professional how to do it. If you are not sure about how to inject, seek help from the health care professional or someone who is trained to inject.

  2. Check the carton for the expiration date dosage and make sure you are using the correct dosage and the vial is not expired.

  3. Read the instructions carefully before using the vials.

  4. The vial should be colorless to light yellow with a few white particles; anything other than this is considered discolored and should be discarded.

  5. Avoid using a cloudy, frozen vial and vial with large particles.

  6. Store the vials in a refrigerator between 36℉ to 46℉.

  7. The vials should be stored by positioning them upwards and straight.

  8. Avoid shaking the vials.

  9. Do not freeze the vials.

  10. Each vial is only for a single-use and should be discarded after use.

  11. The vial should be stored in its original carton to prevent exposure to light.

  12. Do not inject through clothes.

  13. Avoid using a damaged or pre-opened carton of vials.

  14. It can be stored at room temperature inside the carton for upto 30 days and should be discarded after. Do not refrigerate after storing it at room temperature.

  15. Keep the vials out of reach for children.

  16. Discard the remaining solutions following the protocols designed for drug disposals.

  17. Do not put the needle cap back to prevent injury (needle-stick injury).

Instructions for the Patient or the Caregiver on Using Vials:

Necessities to Inject From the Vials:

  • Antiseptic wipes to clean the injection site.

  • Cotton balls and gauze.

  • Prescribed dose vial.

  • Adhesive band-aid.

  • Disposal sharps container.

  • A syringe with a needle as prescribed by the doctor.

Steps to Inject From Single-Dose Vials:

Prepare the Injection Site and the Injection:

  • Wash your hands clean using antiseptic soap or hand wash.

  • Clean the injection site using antiseptic wipes and see that the injecting surface is placed flat.

  • Do not touch the cleaned injection site and let it dry on its own.

  • The tip of the needle is designed with a cut portion that should be facing upwards while injecting.

  • The site of injection could be buttocks, thighs, stomach, or the outer area in the upper part of the arms if the caregiver is injecting.

  • The injection site should be free of redness, swelling, or skin patches.

Preparing the Vial and the Needle:

  • Remove the vial's cap but not the rubber stopper. Clean the rubber, stop using antiseptic wipes and avoid touching it after cleaning.

  • Take a syringe with a needle attached to it and remove the cap. Do not touch the needle or let anything else touch it. Dispose of the needle cap and the vial cap.

  • Pull the plunger in the syringe to the level prescribed by the physician.

  • Hold the vial on the non-dominant hand and the syringe on the other hand.

  • Insert the needle through the center of the rubber stopper.

  • Push the plunger to remove air from the syringe and prevent air bubbles from forming.

  • Now, hold the vial upside down and see that the needle is immersed in the liquid.

  • Pull the plunger until the level of the liquid in the syringe reaches the prescribed level.

  • Make sure to remove the air bubbles in the syringe before removing it from the vial.

  • Once there are no more air bubbles, remove the syringe from the vial.

  • Do not place the syringe down and avoid touching the needle.

Injecting the Drug:

  • The syringe should be held in the dominant hand between the index and the thumb, do not pull or push the plunger.

  • Avoid getting anything in contact with the needle and do not touch the needle.

  • Using the other hand, pull the skin a little and hold it tight.

  • Inject the needle in 45° angulation in one go.

  • Push the plunger using the thumb as much as it goes in.

  • Inject the liquid slowly and completely.

  • After injecting the liquid, slowly pull the needle out slowly.

  • After pulling out the needle, it is normal to bleed, do not panic.

  • Place cotton on the site and give mild pressure, do not rub the injection site.

For 90 mg dose, two 45 mg vials are used. Give the second injection in a different site, following the first one. Follow the same instructions as the first injection. A different injection site is selected every time you inject to prevent developing a lump that is rare and to give the site time to heal. If you inject more than the recommended dose accidentally, seek immediate medical help.

How to Safely Dispose of the Vials and Syringes?

  • It is important to follow proper disposal protocols for syringes and vials. The used and expired syringes and vials should be disposed of in the FDA-approved sharps container. Do not throw them in the normal household trash. If a sharps container is not available, dispose of it in a closely sealed, leak-proof heavy duty plastic container and dispose of it periodically as per the local community guidelines. Dispose of the left medicines after injecting, following the same guidelines.

  • Contact your doctor or pharmacist to clear out doubts regarding the disposal protocols.

What Are the Steps To Be Followed After Taking Ustekinumab?

Keep Track of the Symptoms and Changes:

When you start using the drug, look for any changes or improvement in symptoms and note them down and mention it to your physician in the next visit so that they can see how you respond to the drug. If you face any adverse reactions like allergies or worsening of symptoms, inform your physician about it immediately. The improvement in symptoms does not happen overnight; stay patient and take the injections as recommended.

Diet Modifications:

Unless specified by your physician, follow your regular diet but make sure that your diet is clean, healthy, and balanced. If you notice that a specific food triggers the symptoms, inform your doctor and avoid consuming it per their instructions.

Look for Any Side Effects:

Ustekinumab injections can cause side effects that could be mild or severe. There are several other symptoms as well, and they vary with the person.

Mild side-effects include;

  1. Headache, nausea, vomiting.

  2. Sneezing.

  3. Irritation or signs of inflammations (redness, swelling, etc.) at the injection site.

  4. Tiredness

  5. Headache.

  6. Body pain.

  7. Joint pain.

Some serious side effects include;

  1. Rashes, itching, or hives.

  2. Swollen face, lips, tongue, throat, etc.

  3. Breathing difficulty.

  4. Seizures.

  5. Confused mental state.

  6. Lung inflammation.

There is also a chance of developing cancer as an adverse effect of this drug, but that does not mean everybody will get cancer by taking this drug.

Avoid Self-medication:

Do not take Ustekinumab without a professional's prescription. It is usually prescribed only after trying other drugs. Do not encourage anyone else to take the same medications you are taking even if they face similar symptoms; advise others to seek medical help and get a prescription before taking any drugs.

Staying on Ustekinumab:

Tips to Stay on Track:

The improvement in the condition after taking Ustekinumab does not happen overnight. The time to make a difference varies with persons; in some cases, results can occur in weeks, and in some, it takes months to show results. Stick to proper dosage forms and avoid altering them yourself. If you have any side effects after taking the drug, seek medical help. As per the physician's advice, adjust the dosage or stop the medication completely. Confirm with your physician when to take the next dose if you skip once.

For Doctors:

Indications:

Ustekinumab is prescribed when all the other drugs fail to respond or the patient is intolerant to the other drugs.

Pharmacology:

Mechanism of Action:

Ustekinumab is an IgG1k monoclonal antibody that binds specifically to the protein p40 used by IG-12 and IG-23, which are naturally occurring cytokines secreted by macrophages and dendritic cells. IG-12 and IG-23 are involved in inflammatory and immune responses. It acts by inhibiting the activity of IG-12 and IG-23 by preventing p40 from binding to the IL-12RB1 receptor. It cannot bind to the IG-12 and IG-23 that are already bound to the receptor. The abnormal regulation of IL-12 and IL-23 has been associated with immune-mediated conditions such as psoriasis, psoriatic arthritis, ulcerative colitis, Crohn's disease, etc. The chronic inflammation in Crohn's disease is mainly due to the cytokines IG-12 and IG-23.

Pharmacodynamics:

  • Ustekinumab is a targeted antibody therapy that functions by suppressing immune responses.

  • It normalizes the formation of CYP enzymes.

  • Enhance the CYP-mediated metabolism of drugs.

  • Decrease in mRNA expressions of the IG-12 and IG-23 cytokines.

Chemical Taxonomy:

Chemical Taxonomy

Ingredients:

Active Ingredient:

Ustekinumab.

Inactive Ingredients:

  • In the Single-dose of the prefilled syringe (Subcutaneous administration): L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and sucrose.

  • In the Single-dose vial (Subcutaneous administration): L-histidine, L-histidine hydrochloride monohydrate, Polysorbate 80, and sucrose.

  • In Single-dose vial (intravenous): EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80, and sucrose.

Absorption:

  • The peak serum concentration of Ustekinumab in Crohn's disease and ulcerative colitis patients receiving the recommended intravenous induction dose was 125.2 x 33.6 mcg/ml. When given subcutaneously, no accumulation of Ustekinumab in serum was noted.

  • The median time it took for subjects with psoriasis to reach maximum serum concentrations (Tmax) was 13.5 days after a subcutaneous injection of 45 mg and seven days after a 90 mg injection.

  • The median Cmax is 2.4 microgram/mL for 45 mg and 5.3 microgram/mL for patients taking 90 mg ustekinumab.

Distribution:

In Crohn's disease, the total volume of distribution of Ustekinumab was 4.62 L, and in ulcerative colitis, it is 4.4 L. After the intravenous administration in psoriatic patients, the median volume of distribution is 57 to 83 ml/kg, and in subcutaneous injection, the volume ranges from 76 to 161ml/kg.

Metabolism:

The metabolism of Ustekinumab is still unclear and is considered to be degraded into small peptides and amino acids.

Clearance:

After subcutaneous administration, clearance of 2.7 to 5.3 ml/day/kg was observed in psoriatic patients, and a clearance of 0.19 L/day was observed in patients treated for Crohn's disease and ulcerative colitis.

Elimination:

Ustekinumab's mode of excretion still stands unclear; there is a prediction that it has renal excretion. In Crohn's disease patients, Ustekinumab has a clearance of 0.19 L/day with an estimated median terminal half-life of approximately 19 days.

Warning and precautions:

1) Severe Infection Risk - Avoid prescribing Ustekinumab in patients with active or incompletely healed infections. Serious infections (bacterial, viral, and fungal infections) have occurred to this drug. Also, patients on Ustekinumab are prone to severe infections. Hence, it is necessary to consider the risks and side effects before prescribing the medication.

2) Increased Cancer Risk- Certain studies have proven an increase in the risk of cancers in patients taking Ustekinumab, as it is an immunosuppressive drug. Therefore caution should be taken while prescribing Ustekinumab in patients who are 60 years old and more, patients under long-time immunosuppressants, those under PUVA therapy, etc.

3) Hypersensitivity Reactions- Guide the patients about the possible side effects such as rash, itching, redness, etc., in the injection site and advise them to seek immediate medical help if they suffer such symptoms.

4) Live Vaccines- Live vaccines should be avoided while the patient is on this drug due to an increased risk of infections. It is also suggested that they take all the vaccines for the specific age before taking this drug.

5) Evaluation of Tuberculosis Before Starting Ustekinumab Therapy - Patients with active tuberculosis infections should be given anti-tubercular therapy first before prescribing them Ustekinumab.

6) Posterior Reversible Encephalopathy Syndrome (PRES) - Although the cause is unclear, a few patients have reported PRES after taking the drug; Ustekinumab should be discontinued in patients suspected of this condition. The case history should be focused on knowing the neurological state of the patient as well.

7) Pneumonia -Non-infectious pneumonia has been reported in a few patients after taking this drug.

Indications and Uses:

1) Crohn's disease: Ustekinumab is indicated in treating moderate to severe Crohn's disease, especially in patients who were intolerant or showed poor or unresponsiveness to either immunomodulators and corticosteroids or TNF blockers.

2) Psoriasis: It is used in treating adult patients with moderate to severe plaque psoriasis.

3) Psoriatic Arthritis: Ustekinumab is used alone or combined with Methotrexate to treat psoriatic arthritis in adult patients.

4) Ulcerative colitis: Ustekinumab is used to treat moderate to severe ulcerative colitis.

Dosage Strength and Forms:

  • Initially, Ustekinumab is given intravenously and then is subcutaneously injected.

  • It is available in prefilled syringes and vials, which can be self-injected.

  • The medicine looks colorless to pale yellow.

Dosage and Administration:

  • After the first dose, Ustekinumab is given four weeks later, which is then followed every 12 weeks.

  • For Subcutaneous injection: 45 mg/ 0.5 ml or 90 mg/ml in a single-dose prefilled syringe or 45 mg/0.5 ml in a single-dose vial. The dose of Ustekinumab in patients weighing less than 100 kgs is 45 mg, and in those weighing more, than 100 kgs is 90 mg.

  • For intravenous infusion: 130 mg/26 ml solution in a single-dose vial.

Considerations for Administration:

Do not prescribe Ustekinumab in patients with:

  • An active infection.

  • Recently received BCG vaccination.

  • Tuberculosis and have not started anti-tubercular therapy.

  • Posterior reversible encephalopathy syndrome.

Before prescribing Ustekinumab, remember to;

  • Test patients for latent tuberculosis (TB). Treat TB before starting the Ustekinumab.

  • Advice getting the necessary vaccinations except for BCG.

Contraindication:

Do not prescribe Ustekinumab for patients with known hypersensitivity to Ustekinumab or inactive ingredients.

Results from Clinical Trials:

Various studies have been performed to assess the response and remission of Ustekinumab in Crohn's disease patients.

One such study is the following:

  • Ustekinumab safety was assessed by three randomized trial studies using 1409 patients who had moderate to severe Crohn's disease. The study was done for a total of 52 weeks involving eight-week intravenous injections followed by 44 weeks of subcutaneous injections as a maintenance phase. After assessing the efficacy data of the studies, a greater population of patients showed a clinical response when compared to the placebo. Responses were very evident in week three and continued to improve till week 8.

  • A maintenance study involving 338 patients with 100 points clinical response at the end of week eight was conducted. The clinical remission and response were 53 % and 59 % in patients who took 90 mg for eight weeks and 49% and 58% in patients who took 90 mg for 12 weeks, which was significantly higher than the placebo's 36 % and 44 %.

Drug Interactions:

Interactions With Other Drugs:

Knowing the history of drug intake is a crucial part in deciding if the drug could be administered to a particular patient.

  • Concomitant Methotrexate (MTX) usage in psoriatic arthritis patients did not affect the safety and efficacy of Ustekinumab.

  • The use of immunomodulators and corticosteroids in patients with Crohn's disease and ulcerative colitis concomitantly did not affect the safety and efficacy of Ustekinumab.

Interactions With CYP450 Substrates:

Increased levels of cytokines are seen in chronic inflammations, which alter the formation of CYP450. Ustekinumab, an antagonist of IL-12 and IL-23, is seen to normalize its formation. In patients receiving concomitant CYP450 substrates and Ustekinumab, the drug dosage should be adjusted accordingly.

Interactions With Live Vaccines:

Due to the increased risk of infection, ask the patients not to take any live vaccines during treatment with Ustekinumab.

Interactions With Allergen Immunotherapy:

Though the interactions with allergen immunotherapy have not been evaluated much, Ustekinumab is suspected to decrease the protective effect of the allergen immunotherapy, thereby increasing the risk of allergic reactions. Caution should be taken in patients under allergen immunotherapy.

Other Specifications:

Ustekinumab During Pregnancy:

There is not enough data about the effects of Ustekinumab on pregnant women. So far, animal study data performed in monkeys gives no evidence of fetal malformations and miscarriages when exposed to Ustekinumab in vitro. It should be prescribed in pregnancy only if the potential benefit outweighs the potential risk to the unborn baby.

Breastfeeding and Ustekinumab:

No information is available on the effects of Ustekinumab on breastfed infants, the presence of it in human milk, and the drug's effect on milk production. Animal studies in monkeys have shown the presence of Ustekinumab in breast milk. Though the animal studies are not completely reliable, consider the risks and benefits of taking Ustekinumab in the mother, the child's need for breast milk, etc., before prescribing Ustekinumab for breastfeeding mothers.

Ustekinumab in Pediatric Patients:

The safety and effectiveness of Ustekinumab have been established in pediatric patients 6 years to 17 years old with moderate to severe plaque psoriasis, whereas using Ustekinumab in patients younger than six years to treat psoriasis is not recommended. The use of Ustekinumab in treating pediatric patients with psoriatic arthritis, Crohn's disease, and ulcerative colitis have not been verified.

Ustekinumab in Geriatric Patients:

A study conducted to see the efficacy of Ustekinumab did not show any differences in safety or efficacy between older and younger patients. However, the study is still questionable as the number of patients aged 65 (340 older adults in 6709 patients under Ustekinumab therapy) who participated in the survey was insufficient to determine whether they respond differently from younger patients.

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Last reviewed at:
06 Jul 2022  -  20 min read

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