abrocitinib

Abrocitinib, a selective inhibitor of JAK1, has recently received approval for the treatment of moderate-to-severe atopic dermatitis in adults. Numerous clinical trials have shown its effectiveness and safety in both children and adults, whether used as a standalone treatment or when compared to dupilumab.

The study included 837 participants, and the results showed that a higher percentage of individuals who took CIBINQO with topical steroids and daily moisturizer achieved clear or almost clear skin at 3 months. Specifically, 36% of those who took 100 mg of CIBINQO and 47% of those who took 200 mg of CIBINQO achieved clear or almost clear skin. In comparison, only 14% of the participants who took placebo with topical steroids and daily moisturizer achieved the same level of skin improvement.

39% of patients on the 100 mg dose, 46% of patients on the 200 mg dose, and 24% of patients on placebo achieved an Investigator Global Assessment response rate of 0 or 1. Additionally, 64% of patients on the 100 mg dose, 71% of patients on the 200 mg dose, and 41% of patients on placebo achieved a 75% improvement in their Eczema Area and Severity Index scores.

According to available data, it is recommended to administer oral 30 mg of upadacitinib once daily for moderate-to-severe AD patients, as it has shown better outcomes compared to oral 200 mg of abrocitinib once daily. In the event of treatment-emergent adverse events, an alternative dosage regimen of oral 15 mg of upadacitinib once daily may be considered.

Abrocitinib is prescribed for patients with moderate to severe atopic dermatitis (eczema) who have not responded well to other medications or whose condition is not well managed with other treatments, or for those who cannot tolerate these treatments.

Abrocitinib focuses on inhibiting JAK1 and functions by disrupting the activity of certain cellular pathways that contribute to the symptoms of atopic eczema.

Pfizer Inc. (NYSE: PFE) revealed today that the U.S. Food and Drug Administration (FDA) has given the green light to CIBINQO (abrocitinib), an oral JAK1 inhibitor taken once daily, for the management of refractory, moderate-to-severe atopic dermatitis (AD) in adults whose condition is not effectively controlled.

In 2023, a new eczema treatment called Cibinqo (abrocitinib) was approved for adolescents aged 12 and older. This oral JAK1 inhibitor was originally approved by the FDA in January 2022 for adults with refractory moderate to severe atopic dermatitis.

Steroid treatments are synthetic drugs that decrease skin inflammation by blocking the chemical responsible for inflammation, thereby alleviating eczema symptoms. On the other hand, JAK inhibitors target more specific pathways associated with atopic dermatitis.

Abrocitinib not only enhances clinical scores but also effectively alleviates the main symptom of atopic dermatitis, itching. However, further research is necessary to comprehensively evaluate the safety of abrocitinib and its potential applications in treating atopic dermatitis.

The FDA has approved Cibinqo, a brand name for the generic drug abrocitinib, in tablet form. It was first approved on January 14, 2022. The company responsible for manufacturing Cibinqo is Pfizer Inc. This medication is used for the treatment of Atopic Dermatitis.

Abrocitinib is prescribed for patients with moderate to severe atopic dermatitis (eczema) who have not responded well to other medications or whose condition is not well managed with other treatments, or for those who cannot tolerate these treatments.

Abrocitinib was approved by the US Food and Drug Administration (FDA) in January 2022 for the treatment of moderate-to-severe atopic dermatitis in adults.

CIBINQO is an eczema treatment that operates beneath the skin to combat moderate-to-severe symptoms. It belongs to a unique category of treatments known as JAK inhibitors, which work by interrupting a specific process that can trigger inflammation and itching.

CIBINQO (abrocitinib) is a once-daily pill that provides safety information.

The price for a supply of 2.28 milliliters of Dupixent subcutaneous solution (200 mg/1.14 mL) is approximately $3,788, but may vary depending on the pharmacy. These prices are for customers paying with cash and do not apply to those using insurance plans.

Cibinqo and Rinvoq have different FDA-approved uses. While Cibinqo has no other FDA-approved uses, Rinvoq has multiple approved uses, including the treatment of moderate to severe rheumatoid arthritis in adults and psoriatic arthritis in adults.

Caution: This medication carries a significant risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. Please refer to the full prescribing information for a complete boxed warning.

Caution: Severe infections, death, cancer, significant adverse cardiovascular events, and blood clotting.

Individuals aged 65 and above, individuals who have a history of long-term smoking, and individuals with atherosclerotic cardiovascular disease or other cardiovascular risk factors, the use of JAK inhibitor should be considered only when no other appropriate treatment options are accessible.

Symptoms include the common cold, nausea, headache, and herpes simplex, including cold sores. There is also an increased blood level of creatine phosphokinase, dizziness, urinary tract infection, and tiredness.

Patients with active infection, severe kidney disease, or severe liver disease are not recommended to use this product.

JAK inhibitors are generally regarded as safe, however, like any medication, they do carry potential side effects. In clinical trials, the most frequently observed side effects in patients using a JAK inhibitor for skin condition treatment were relatively mild and included the common cold and bronchitis.

When prescribing oral JAK inhibitors, dermatologists should take into account patients’ baseline risk factors for developing serious complications. The most frequent adverse events associated with these inhibitors are upper respiratory infections, nasopharyngitis, nausea, headache, and acne.

Pfizer (NYSE: PFE) has announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib (100mg and 200mg). Abrocitinib is an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, intended for the treatment of moderate to severe atopic dermatitis.

Abrocitinib belongs to a group of drugs known as Janus kinase (JAK) inhibitors. Its mechanism of action involves reducing the immune system’s activity.

However, there were significant differences in acne and headache between both the upadacitinib and abrocitinib groups. Additionally, the upadacitinib group had significantly higher risks of upper respiratory tract infection and nasopharyngitis, while the abrocitinib group had significantly higher risks of nausea (Table 3).

Pfizer’s oral Janus kinase (JAK) inhibitor, abrocitinib (Cibinqo), has been granted an expanded indication by the US Food and Drug Administration (FDA) to include adolescents aged 12 through 17 years for the treatment of atopic dermatitis (AD). Previously, abrocitinib was only approved for adults aged 18 and older and is taken once daily.

Abrocitinib is primarily eliminated through hepatic metabolism via cytochrome P450 (CYP), with CYP2C19 accounting for 53%, CYP2C9 for 30%, CYP3A4 for 11%, and CYP2B6 for 7% of the elimination process. A small percentage of 1.0-4.4% is eliminated unchanged in urine.

Based on the comparison with clinical trials of conventional AD treatments, it can be concluded that abrocitinib is a more effective option. This oral JAK 1 inhibitor has recently been approved by the FDA for patients who are 18 years old or older and have moderate-to-severe AD. It is recommended for use in cases where patients have not responded to systemic medications or when these medications are contraindicated.

CAUTION: CIBINQO MAY INCREASE RISK OF SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS. Patients who receive treatment with CIBINQO should be aware that they may be at a higher risk of developing severe infections that could result in hospitalization or death.

After reviewing several clinical trials, it was found that the 30 mg dose of Rinvoq may be more effective than the 15 mg dose of Rinvoq and all doses of Cibinqo. However, it was also associated with a higher likelihood of causing side effects.

According to analysts, AbbVie’s Rinvoq has surpassed Sanofi and Regeneron’s Dupixent in the treatment of eczema. However, safety concerns may restrict its usage. Dupixent has been a highly effective treatment for atopic dermatitis, but Rinvoq has managed to exceed its efficacy.

The initial recommended dose of CIBINQO is 100 mg per day. If this dose does not provide satisfactory results after 3 months, your doctor may increase the dose to 200 mg per day. If the 200 mg dose is still not effective, your doctor may recommend discontinuing the use of CIBINQO.

Abrocitinib and upadacitinib are medications suitable for individuals aged 12 and above who suffer from moderate to severe eczema and have not responded to other treatments. In cases where dupilumab is ineffective or causes adverse reactions, baricitinib may be suggested as an alternative medication.

Cibinqo (abrocitinib), Triamcinolone topical, Betamethasone topical are available in various dosage forms including oral tablet, mucous membrane paste, topical cream, topical lotion, topical ointment, topical spray, topical foam, topical gel, and topical lotion. These medications may also be available under different brand names.

Individuals aged 50 and above with at least one cardiovascular (CV) risk factor who are taking a JAK inhibitor are at a higher risk of experiencing major CV events, including heart attack, stroke, or death. This risk is particularly elevated for current or former smokers. It has been reported that some individuals taking CIBINQO have experienced major CV events.

Dupixent, similar to other costly medications such as Humira, Cosentyx, and Enbrel, is a biologic drug that is challenging to produce a generic version of due to its derivation from living cells. The typical cost for a one-month supply of Dupixent is $5,298 if purchased without insurance coverage. Fortunately, more than 80% of insurance plans do cover Dupixent, although certain limitations may apply.

Why is Dupixent priced so high? Dupixent is exclusively sold as a brand-name medication and falls under the category of biologic drugs, which are derived from living organisms. However, it is not offered as a biosimilar alternative.