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Risankizumab - Uses, Mechanism of Action, Precautions, and Side Effects

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Risankizumab is used in adults who qualify for systemic therapy or phototherapy and have moderate to severe plaque psoriasis.

Written by

Dr. Shikha

Medically reviewed by

Dr. Sandhya Narayanan Kutty

Published At December 2, 2022
Reviewed AtFebruary 7, 2023

Overview:

Risankizumab is a medication used to treat plaque psoriasis, a skin condition that results in red, scaly patches. Psoriasis refers to a chronic inflammatory condition of the skin most frequently characterized by elevated, red plaques covered with silver scales. Psoriasis has several kinds, although plaque psoriasis is the most common. This illness primarily affects adults; its prevalence ranges from 0.91 to 8.5 percent.

The incidence of psoriasis is highest in two age groups: 30 to 39 years old and 60 to 69. Psoriasis can substantially impact the quality of life, cause humiliation, and have adverse social repercussions depending on the disease's severity. Adults who need systemic treatment for diseases of moderate to severe severity utilize Risankizumab (treatment with medicines given orally or by injection). Individuals with psoriatic arthritis, which results in psoriasis and joint inflammation, can also be treated with Risankizumab.

When treatment with one or more drugs known as disease-modifying anti-rheumatic drugs (DMARDs) has not performed well enough or has unacceptably negative side effects, Risankizumab is administered alone or in combination with another drug, Methotrexate. Disease-modifying anti-rheumatic drugs are drugs such as Methotrexate that prevent the progression of the disease.

Risankizumab is a humanized monoclonal antibody that targets interleukin 23A and is marketed under the trade name Skyrizi. A partnership between Boehringer Ingelheim, a German pharmaceutical company, and AbbVie, an American publicly traded bio pharmaceutical company.

Risankizumab has received approval for the treatment of moderate to severe plaque psoriasis in individuals who are postulants for systemic therapy in the European Union, the United States, and Canada, as well as moderate to severe Crohn's disease in the United States. It has been given the go-ahead in Japan to treat people with plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis who have not responded well to traditional treatments.

How Does Risankizumab Work?

Risankizumab, the active ingredient, is a monoclonal antibody, a protein intended to bind to interleukin-23 (IL-23) and inhibit its action. Inflammation, which is associated with arthritis and the development of plaque psoriasis, is brought on by IL-23. Risankizumab lessens inflammation and other signs and symptoms of plaque psoriasis and psoriatic arthritis by inhibiting the function of IL-23.

Indications:

A prescription drug called Risankizumab is used to cure adults with:

  • Moderate to serious plaque psoriasis, which may improve from receiving injections, tablets, or ultraviolet or UV light therapy (phototherapy).

  • Psoriatic arthritis, which is active (PsA).

  • Crohn's disease, which is mild to severe.

Dosage:

Risankizumab is only available with a prescription and should only be used under the guidance of a medical professional skilled in identifying and managing psoriatic arthritis or plaque psoriasis.

Pre-filled pens and syringes for Risankizumab are available. It is injected beneath the skin in a psoriasis-free area, typically on the thigh or belly. The dose that is advised is 150 mg. The first two 150 mg doses are administered four weeks apart and then every 12 weeks after that.

Each pre-filled syringe has 0.83 mL, which contains 75 mg of Risankizumab-rzaa, 0.88 mg of disodium succinate hexahydrate, 0.17 mg of polysorbate 20, 34 mg of sorbitol, and 0.049 mg of succinic acid, along with Water for Injection, USP.

If the condition does not improve beyond 16 weeks, the doctor might opt to cease the treatment. If the doctor deems it acceptable, patients may administer Risankizumab by themselves after receiving training.

Warnings and Precautions:

Evaluation Before Treatment for Tuberculosis

Before beginning Risankizumab medication, patients should be tested for tuberculosis (TB) infection.None of the participants with latent tuberculosis who were concurrently treated with Risankizumab and the proper tuberculosis prophylaxis throughout the Phase 3 psoriasis clinical investigations acquired active tuberculosis throughout the mean follow-up weeks on Risankizumab.

In patients with a medical history of latent or active tuberculosis who cannot be assured of receiving an adequate course of treatment, consider anti-tuberculosis medication before starting Risankizumab. During and after Risankizumab treatment, an eye should be kept out for any indications or symptoms of active tuberculosis in the patient. Risankizumab should not be given to people who have active tuberculosis.

Infections

Infection risk may rise with the use of Risankizumab. In clinical studies, infections developed in 22.1 % of the Risankizumab medication group after 16 weeks of treatment, compared to 14.7 % of the placebo group. Infections of the upper respiratory tract and tinea were more prevalent in the Risankizumab group than in the group on placebo. Patients with any clinically significant current infection should wait to start treatment with Risankizumab until the infection clears up or is sufficiently treated.

Before providing Risankizumab to patients who have a chronic infection or a history of repeated infections, the advantages and disadvantages should be weighed. People should be instructed to seek medical attention if any signs or symptoms of an infection of clinical importance appear. Suppose a patient gets such an illness or stops responding to the usual medication. In that case, a careful eye should be kept on them, and one should wait to give them Risankizumab until the infection is under control.

Vaccinations

Consider completing all age-appropriate vaccines in accordance with current immunization recommendations before beginning therapy with Risankizumab. Live vaccinations should not be administered to people receiving Risankizumab. There is no data available on the reaction to living or inactive vaccines.

Adverse Reactions:

After receiving Risankizumab via intravenous infusion, a Crohn's disease patient experienced a rash, altered liver blood tests, and required hospitalization. Before, during, and up to 12 weeks into treatment, if issues are found, Risankizumab medication may be stopped. Any following symptoms, including an unexplained rash, nausea, vomiting, stomach pain, yellowing of the skin and eyes (jaundice), lethargy, lack of appetite, and dark urine, should be reported to the doctor immediately.

For those treated for Crohn's disease with Risankizumab, upper respiratory infections, injection site responses, fever, headaches, stomach (abdominal) discomfort, back pain, joint pain, and low red blood cells (anemia) are the most frequent side effects.

Patients taking Risankizumab for plaque psoriasis and psoriatic arthritis most frequently have upper respiratory infections, Infections with tinea, fatigue, fungal skin infections, headaches, and injection site reactions.

Under one percent of serious infections were caused by an unfavorable medication reaction, such as:

For Patients:

What Is Plaque Psoriasis?

Skin conditions like psoriasis often affect the scalp, trunk, knees, and elbows. It produces a rash that has scaly, itchy patches. The most commonly observed kind of psoriasis, plaque psoriasis, causes scale-covered, dry, raised skin areas, which could be few or many. Usually, the knees, scalp, and lower back will exhibit them. The hue of the patches varies depending on the skin tone. The affected area may temporarily change color on dark or black skin as it heals (post-inflammatory hyperpigmentation).

What Are the Symptoms Seen in Plaque Psoriasis?

Psoriasis plaques are raised, scaly, inflammatory regions of skin that can be uncomfortable and itchy. Plaques often appear as elevated, red areas on Caucasian skin that are covered in a silvery-white accumulation of dead skin cells or scale. The plaques on the skin of color may seem thicker, darker, and more purple, gray, or darker brown in hue. Plaques can be seen anywhere on the body, although they are usually found on the scalp, elbows, knees, and chest. Plaques often form evenly on the body and affect the same body sections on both the left and right sides. Plaque psoriasis frequently coexists with nail psoriasis, which can show up as pitting, discoloration, or separation of the nail from the nail bed.

What Causes Plaque Psoriasis?

Plaque psoriasis is an immune system problem. Overreacting by the immune system causes inflammation and uncontrollably quick cell proliferation in the developing skin. Typically, new skin cells form around every 28 to 30 days. However, fresh skin cells are brought to the skin's surface every three to four days in those with plaque psoriasis. Plaques form when a concentration of fresh cells overwhelms the older cells. Plaque psoriasis runs in families, suggesting that a hereditary component may be present. It might be passed down to kids from their parents.

How Is Plaque Psoriasis Diagnosed?

The doctor will search for typical plaque psoriasis symptoms as they evaluate the affected parts of the patient's body. Along with the symptoms, the family history and whether one has recently started or stopped using any products or medications right before the flare-up will be assessed. The healthcare professional may administer several tests to rule out other disorders, such as eczema or dermatitis, that might be the source of the plaques. A differential diagnosis is made using this set of tests.

The tests could consist of the following:

  • Allergy test.

  • Biopsy.

  • Blood tests to look for rash reasons other than plaque psoriasis.

How to Treat Plaque Psoriasis?

Curing psoriasis is difficult. The rash will probably improve for a while before flaring up once more. Less frequent and less severe flare-ups are the aim of treatment. Options for treatment include:

Topical Medications: If an individual has a few plaques, their doctor will likely start by using a lotion applied directly on the skin. They lessen inflammation or stop the development of new skin cells. Some examples are anthralin, corticosteroids, vitamin A, and vitamin D. Attempt over-the-counter topical medications. For the treatment of psoriasis, coal tar and salicylic acid are permitted. After taking a shower or bath, a topical emollient should be applied to keep the skin moisturized.

Systemic Drugs: If plaque psoriasis is severe, patients could need medications that are effective across their bodies. They reduce the growth of skin cells or the hyperreactivity of the immune system. However, they may have detrimental side effects, such as the increased risk of skin cancer, violent thoughts, liver issues, or depression. Systemic medications, including Acitretin, Cyclosporine, and Methotrexate, are taken orally or injected by the doctor.

Light Therapy: The doctor might use UV light to treat the rash if it is more severe or pervasive. This is accomplished at their office or with a unique box that patients can keep at home. Going outside in the sunlight may also provide relief, but this can increase their chance of developing skin cancer. Consider limiting the time one spends outside and wearing clothing or sunscreen in areas without plaques.

Biologic Medications: The immune system is also the target of another type of systemic medication. Biologic medications used to treat plaque psoriasis are administered intravenously or as an injection into an arm vein. They influence certain immune cells or prevent some proteins from provoking inflammation. However, these medications may make it more difficult for the patient to fight infection.

What Should a Patient Inform Their Doctor About Before Starting Risankizumab?

Patients should inform their healthcare practitioner of all of their medical problems before using Risankizumab, particularly if they:

  • Possess an infection that would not go away or keeps returning.

  • Either they or a close friend or family member has tuberculosis.

  • Have just had or are slated to have a vaccination (vaccine). The chance of contracting an infection after receiving live vaccines may rise if patients use medications that affect the immune system. Live vaccinations should not be administered before, during, or shortly after Risankizumab treatment.

  • Either currently or soon are expecting or intend to get pregnant.

  • Either currently breastfeed or want to do so.

  • All the medications one uses, including prescription and over-the-counter medications, vitamins, and herbal supplements, should be disclosed to the healthcare professional.

If an individual suspects they may have an infection or are exhibiting symptoms of an illness, such as:

  • Chills, sweats, or fever.

  • Cough.

  • Blood in the mucus (phlegm).

  • Breathing difficulties.

  • Muscular aches.

  • Vomiting or diarrhea.

  • Loss of weight.

  • Burning sensation while urinating or needing to urinate more frequently than usual.

If an individual is allergic to Risankizumab or any of its chemicals, do not use it.

More About the Drug:

Storage, Supply, and Handling of the Drug:

The injection form of the medication Risankizumab-rzaa is sterile, free of preservatives, colorless to slightly yellow, transparent, and somewhat opalescent. A fixed 29 gauge one-and-a-half-inch needle with a needle guard is included with each one-milliliter glass syringe of the product. The drug is stored at two °C to 8°C (36°F to 46°F) in a refrigerator, but it should not be frozen. The drug should not be shaken. The packaging is not created with natural rubber latex. The pre-filled syringes should be kept in a box to protect against light.

Before Administering the Drug:

Before administering injections, one should get instructions on how to inject the drug. If a patient requires assistance, they should contact their healthcare provider.

  • Patients should be reminded on their calendars on when to take the drug.

  • Give the carton 15 to 30 minutes to warm up at room temperature and out of direct sunshine.

  • While waiting for Risankizumab to warm up, the syringe should not be removed from the carton.

  • Risankizumab should not be warmed in any other manner (such as in a microwave or hot water).

Safety Instructions to Abide by Before Using the Drug:

  • The liquid may contain minute white or transparent particles and should seem clear to slightly yellow. Do not use the drug if the liquid is hazy or contains flakes or other big particles.

  • The drug should not be used if the expiration date is printed on the box and the pre-filled syringe has passed.

  • Do not use the drug if the needle has been spilled or broken.

  • If the injection tray seal is damaged or missing, the drug should not be used, and the drug should be returned to the pharmacy.

  • The drug should be kept in the refrigerator between 36 and 46 degrees Fahrenheit (two and eight degrees Celsius).

  • Until it is ready to use, the drug should be stored in the original box to protect it from light.

  • If the liquid has been frozen, it should not be used.

  • Keep Risankizumab and all other medications away from children.

How Is the Drug Administered?

  • After gathering the injection supplies, place the items on a clear, flat area.

  • Clean, then dry hands.

  • For the first injection, begin with a single pre-filled syringe.

  • Choose one of the three injectable areas: The front of the right or left thigh or the belly; should extend at least two inches past the navel.

  • Before each injection, use the alcohol swab to gently wipe the injection site in a circular motion.

  • After cleaning the injection site, avoid touching or blowing on it.

  • Before injecting, allow the skin to dry out.

  • Strictly avoid injecting through clothing.

  • Avoid injecting into psoriasis-affected areas or into the skin that is tender, bruised, red, hard, scarred, or bears stretch marks.

  • Always hold the pre-filled syringe with the covered needle downward.

  • Verify the prefilled syringe's liquid content.

  • The liquid should seem clear to slightly yellow and may contain minute white or transparent particles. It is usual to see one or more bubbles in the window.

  • If the liquid is unclear or contains flakes or other big particles, discard the pre-filled syringe and do not use it.

  • Take off the needle cap.

  • Use just one hand to hold the syringe.

  • Carefully pull the needle cover off with the other hand. A liquid drop may be visible at the needle's tip. Dispose of the needle cover.

  • Avoid using fingers to touch the needle or letting any needle contact.

  • Hold the prefilled syringe's body between the thumb and index finger. With the other hand, gently pinch the cleaned skin and securely grip it. The needle should be inserted into the skin at a 45-degree angle utilizing a swift, brief motion. Keep the angle consistent.

  • Once the entire amount of fluid has been injected, and the syringe is empty, slowly push the plunger rod all the way in, holding the syringe at the same angle and removing the needle from the skin.

  • Release the plunger rod and let the pre-filled syringe rise until the needle guard completely encloses the entire needle. The pre-filled syringe needle guard will not turn on until the entire liquid has been injected.

  • Do not rub the injection site; apply pressure with a cotton ball or gauze pad for ten seconds. One could be bleeding a little. This is commonplace.

For Doctors:

Chemical Taxonomy:

chemical-taxonomy-risankizumab

Pharmacodynamics:

Although Risankizumab has not been the subject of any formal studies examining pharmacodynamic properties, this medication is anticipated to reduce psoriasis symptoms by targeting interleukin 23 (IL-23) and preventing the start of the inflammatory cascade that is believed to be responsible for psoriasis.

Mechanism of Action:

Inflammatory skin signs, including redness, discomfort, and plaques, are frequently brought on by producing pro-inflammatory cytokines and chemokines. Human interleukin 23 (IL-23) cytokine 2's p19 subunit is highly affinely bound by Risankizumab. A monoclonal immunoglobulin G1 (IgG1) antibody; Risankizumab-rzaa, preferentially binds to the human interleukin 23 (IL-23) cytokine's p19 component, prevents it from interacting with the IL-23 receptor. The human body produces IL-23, a cytokine that has a role in immunological and inflammatory processes, particularly in peripheral tissues. Risankizumab-rzaa prevents the release of cytokines and chemokines that cause inflammation.

IL-23 influences the polarized type 1 T cell-mediated inflammatory response. The blood of psoriasis patients and the skin affected by the condition contain extremely high levels of type-1 T lymphocytes. Type-1 T cells boost the expression of several inflammatory genes that trigger inflammatory cascades by enhancing interferon (IFN)-gamma action. The etiology of plaque psoriasis has been linked to variants of the genes encoding the IL-23 p19 subunit and the IL-23 receptor, making IL-23 an attractive target for Risankizumab therapy.

Pharmacokinetics:

Plasma concentrations of Risankizumab-rzaa rose proportionately in participants with plaque psoriasis and healthy volunteers following subcutaneous injection. Following subcutaneous treatment of Risankizumab-rzaa at every four weeks intervals till three weeks, steady-state concentrations were reached by week 16. The calculated steady-state peak (Cmax) and trough (Ctrough) concentrations at the 150 mg dose were roughly 12 mcg/mL and 2 mcg/mL, respectively.

Absorption:

After a dose is administered by subcutaneous injection, Risankizumab is thought to have an approximate 89% absolute bioavailability. Peak concentration (Cmax) was attained following the start of Risankizumab medication within 3 to 14 days in a clinical investigation. Using a predictive pharmacokinetic model, it was discovered that the estimated Risankizumab trough plasma concentrations (Ctrough) in individuals with psoriasis were 1.72 at week 16 of treatment and 1.36 at week 52 of treatment.

Metabolism:

Risankizumab-rzaa's metabolic route has not been identified. Risankizumab-rzaa is a humanized IgG1 monoclonal antibody anticipated to break down into amino acids, and tiny peptides through catabolic mechanisms, much like natural IgG does.

Distribution:

In participants with plaque psoriasis, the estimated steady-state volume of distribution was 11.2 L or 34 %; however, this value may change with increased body weight.

Elimination:

In participants with plaque psoriasis, the estimated systemic clearance was 0.31 L/day or 24%, and the terminal elimination half-life was roughly 28 days.

Studies on Drug Interactions:

Substrates for cytochrome P450

When used concurrently with Risankizumab-rzaa 150 mg administered subcutaneously at weeks 0, 4, 8, and 12, subjects with plaque psoriasis did not experience any clinically significant changes in exposure to Omeprazole (CYP2C19 substrate), Warfarin (CYP2C9 substrate), Metoprolol (CYP2D6 substrate), Midazolam (CYP3A) substrate, or caffeine (CYP1A2 substrate).

Effect of Body Weight:

As body weight rises, Risankizumab-clearance and volume of distribution increase, and its plasma concentrations fall; nonetheless, based on body weight, no dose change is advised.

Specific Population:

Based on age, if it is 18 years or older, there were no clinically relevant changes in the pharmacokinetics of Risankizumab-rzaa. Risankizumab-pharmacokinetics have not been specifically studied to see how renal or hepatic impairment affects them.

Nonclinical Toxicology- Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies on Risankizumab's carcinogenicity and mutagenicity have not been done. Male cynomolgus monkeys that were sexually mature and given Risankizumab-rzaa subcutaneously once a week for 26 weeks at a dose that was 20 times higher than the clinical exposure showed no effects on male reproductive indices.

Clinical Trial Experience:

Because adverse drug reaction rates in clinical trials of one medicine cannot be directly compared to rates in clinical trials of another treatment and may not accurately represent rates seen in practice, clinical trials are done under a wide range of situations.

Risankizumab was administered to 2234 patients participating in clinical research studies for plaque psoriasis. Risankizumab was administered to 1208 psoriasis patients for at least a year. To assess the safety of Risankizumab for up to 16 weeks, statistics from placebo- and active-controlled research were combined.

The adverse medication responses during the 16-week controlled phase of pooled clinical studies were at a rate of at least 1% and a greater rate in the Risankizumab group compared to the placebo group. Folliculitis and urticaria were adverse medication responses that occurred. An upper respiratory tract infection was also seen.

Infections occurred in 22 % of the Risankizumab group over the first 16 weeks as opposed to 14 % of the placebo group; however, Risankizumab use was not halted. The Risankizumab and the placebo groups saw rates of severe infections of less than 0.4 %. The Risankizumab group experienced serious cellulitis, osteomyelitis, sepsis, and herpes zoster infections.

The frequencies of the adverse events were comparable to those seen during the first 16 weeks of treatment, and no new adverse reactions were found through week 52. Pneumonia was one of the major diseases that caused this period's research cancellations.

Immunogenicity:

Similar to all therapeutic proteins, immunogenicity is an evident possibility. The specificity and sensitivity of the assay play a key role in detecting antibody production. Additionally, several factors, such as the assay's technique, sample handling, the timing of sample collection, concurrent drugs, and underlying diseases, may impact the recorded incidence of antibody (including neutralizing antibody) positive in an assay. Due to these factors, comparing the prevalence of antibodies in the trials listed below with those in other studies or products, such as other Risankizumab products, may be inaccurate.

Around 24 % of the participants receiving the drug at the suggested dose by week 52 had antibodies to Risankizumab-rzaa. About 57 % of the subjects who generated antibodies to Risankizumab-rzaa had antibodies that were categorized as neutralizing. In almost one percent of the patients who received Risankizumab, higher antibody titers were linked to lower Risankizumab-rzaa concentrations and a worsened clinical response.

Interaction With Other Drugs:

When treating patients with Risankizumab, avoid administering live vaccines.

Overdose:

In the event of an overdose, keep an eye out for any adverse reaction signs or symptoms in the patient and start symptomatic treatment immediately.

Usage of Risankizumab in a Specific Population:

Usage in Pediatric Patients:

It has not yet been determined whether Risankizumab is safe and effective for use in pediatric patients younger than 18 years of age.

Usage in Lactating Patients:

There is no information on Risankizumab-presence in human milk, its effects on nursing infants, or its impact on milk production. Human milk is known to include maternal IgG. Along with the mother's clinical requirement for the drug and any potential negative effects from it or the underlying maternal disease on the breastfed newborn, it is important to weigh the developmental and health benefits of breastfeeding.

Usage in Geriatric Patients:

243 of the 2234 plaque psoriasis patients exposed to Risankizumab were 65 or older, and 24 were 75 or older. There were no changes in exposure, safety, or effectiveness of Risankizumab-rzaa between younger and older individuals who received the drug. However, the sample size of the older participants was insufficient to assess whether their responses differed from those of younger participants.

Usage in Pregnant Individuals:

The limited information currently available on Risankizumab during pregnancy is insufficient to assess the potential risk of significant birth abnormalities, miscarriage, or other undesirable maternal or fetal outcomes. Since IgG is known to pass through the placental barrier, Risankizumab might get passed from the mother to the growing fetus.

Pregnant cynomolgus monkeys received subcutaneous doses of five and 50 mg/kg of Risankizumab-rzaa once per week during the period of organogenesis up until parturition as part of an expanded pre- and post-natal developmental toxicity research. Increased fetal or infant loss was observed in pregnant monkeys. In infant monkeys from birth to 6 months of age, no Risankizumab-rzaa-related effects on functional or immunological development were seen. It is unclear what these findings mean clinically for people.

Every pregnancy has a background risk of birth deformity, miscarriage, or other unfavorable consequences. For the indicated group of individuals, it is uncertain what can be the background risk is for serious birth abnormalities and miscarriages. The estimated background risks of significant birth abnormalities and miscarriage in clinically recognized pregnancies in the general population are two to four percent and 15 to 20 percent, respectively.

Frequently Asked Questions

1.

Risankizumab Belongs to Which Class of Drugs?

Risankizumab belongs to a class of medications called monoclonal antibodies and is used in treating moderate to severe plaque psoriasis in adult patients. In patients with psoriatic arthritis, it can be administered alone or in combination with nonbiologic disease-modifying anti-rheumatic drugs (DMARDs). It is also an effective drug to treat moderate to severe Crohn’s disease.

2.

What Is Crohn’s Disease?

A type of inflammatory bowel disease (IBD), which causes inflammation of the tissues of the digestive tract, is referred to as Crohn’s disease. It results in severe diarrhea, fatigue, abdominal pain, and weight loss. It is a chronic or long-term condition that certain dietary modifications and medications can manage.

3.

What Is the Mechanism of Action of Risankizumab?

Human interleukin 23 (IL-23), a cytokine’s p19 component, is responsible for immunological and inflammatory responses in the body. Risankizumab is a monoclonal immunoglobulin G1 (IgG1) antibody that binds to IL-23, and inhibits the release of chemokines and cytokines, thus preventing inflammation.

4.

How Is Crohn’s Disease Managed?

The main aim of the treatment for Crohn’s disease is to reduce the inflammation that triggers the disease's symptoms and improve the prognosis by preventing complications. Medications such as corticosteroids, oral aminosalicylates, antibiotics, immunosuppressants such as Azathioprine, Methotrexate, or biologics such as Risankizumab, Infliximab, Ustekinumab, etc. can help manage Crohn’s disease. 

5.

What Is the Duration of Action of Risankizumab?

After initiating treatment with Risankizumab, patients with psoriasis or psoriatic arthritis may show improvement in around four weeks, and the symptoms may reduce over 16 weeks. Risankizumab treatment in Crohn’s disease has a good clinical response within four weeks and in some patients by about 12 weeks of treatment. 

6.

What Is the Half-Life of the Drug Risankizumab?

Risankizumab is an IG1 monoclonal antibody, which is directed against interleukin-23. In patients with plaque psoriasis, the systemic clearance was 0.31 L/day (liters per day), or approximately 24 percent, with a half-life of 28 days. In patients with Crohn’s disease, the systemic clearance was 0.30 L/day (34 percent), with a half-life of 21 days.

7.

What Is the Duration of Treatment of Risankizumab?

The duration of treatment of Risankizumab depends on the disease;
- For patients with plaque psoriasis and psoriatic arthritis, 150 mg is administered subcutaneously at 0,4 and 12 weeks thereafter. It can be used alone or combined with DMARDs.
- For patients with Crohn’s disease, 600 mg intravenous infusion for at least one hour at weeks 0,4,8 and thereafter; a maintenance dose of 360 mg subcutaneously at week 12 and every eight weeks.

8.

What Are the Side Effects of Risankizumab?

Side effects of Risankizumab include;
- Nausea and vomiting
- Stomach discomfort
- Back and joint pain
- Anemia
- Fever
- Headache
- Upper respiratory tract infections
- Reactions at the site of injection.

9.

For Which Age Group Is Risankizumab Recommended?

Risankizumab is indicated for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn’s disease in adult patients, and the safety and efficacy of the drug in patients below 18 years of age have not been established.

10.

Is Risankizumab Injection Painful?

Risankizumab injection may be painful for most patients, and some side effects include redness, irritation, itching, warmth, swelling, bruising, etc., at the administration site. A doctor must be contacted immediately if any other side effects are observed.

11.

When Was Risankizumab Approved?

Risankizumab received approval for treating plaque psoriasis and psoriatic arthritis from the United States Food and Drug Administration (USFDA) on 23 April 2019 and the European Medicines Agency (EMA) on 26 April 2019. The FDA approved it for Crohn’s disease in June 2022.

12.

Is Risankizumab an Expensive Drug?

Risankizumab is a biological drug (a drug made from living cells), and they do not have genetic alternatives. These medications are difficult to manufacture as they require extensive research and testing methods to ensure safety and effectiveness and may be expensive depending on the brand.
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Dr. Sandhya Narayanan Kutty
Dr. Sandhya Narayanan Kutty

Venereology

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