Bimzelx (Bimekizumab)
Dual IL-17A and IL-17F inhibitor for inflammatory conditions
Bimzelx (bimekizumab) is a first-in-class biologic medicine that simultaneously blocks two key inflammatory proteins – interleukin-17A (IL-17A) and interleukin-17F (IL-17F). It is approved for the treatment of moderate-to-severe plaque psoriasis, active psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa in adults. Administered as a subcutaneous injection, Bimzelx has demonstrated high rates of complete skin clearance and significant improvement in joint symptoms in clinical trials.
Quick Facts
Key Takeaways
- Bimzelx is the first and only biologic approved to simultaneously block both IL-17A and IL-17F, providing broader suppression of the IL-17 inflammatory pathway than single-target inhibitors.
- In clinical trials for plaque psoriasis, up to 60% of patients achieved PASI 100 (complete skin clearance) by week 16, with responses maintained long-term.
- Bimzelx is approved for four indications: plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis), and hidradenitis suppurativa.
- The most notable safety concern is an increased risk of oral candidiasis (thrush), which occurs in approximately 3-7% of patients and is generally mild and manageable.
- The medicine is self-administered at home using a pre-filled pen after initial training, with dosing frequency varying by indication from every 2 weeks to every 8 weeks.
What Is Bimzelx and What Is It Used For?
Bimzelx contains the active substance bimekizumab, a humanized monoclonal antibody produced using recombinant DNA technology. It belongs to a group of medicines called interleukin inhibitors (IL-inhibitors). Unlike older IL-17 inhibitors that only target IL-17A, bimekizumab was specifically designed to neutralize both IL-17A and IL-17F simultaneously. This dual mechanism of action provides a more comprehensive blockade of the IL-17 pathway, which plays a central role in the inflammatory processes underlying several chronic immune-mediated diseases.
The IL-17 family of cytokines includes several members, but IL-17A and IL-17F are the most closely related and share overlapping biological functions. Both cytokines are produced primarily by T-helper 17 (Th17) cells and contribute to the recruitment of neutrophils, stimulation of keratinocyte proliferation, and promotion of tissue inflammation. In conditions such as psoriasis, the concentrations of both IL-17A and IL-17F are significantly elevated in affected skin, joints, and other tissues. By blocking both cytokines, bimekizumab aims to achieve deeper and faster suppression of inflammation compared to agents that inhibit IL-17A alone.
Plaque Psoriasis
Bimzelx is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Plaque psoriasis is a chronic autoimmune skin condition characterized by raised, red, scaly patches (plaques) that can appear anywhere on the body but most commonly affect the scalp, elbows, knees, and lower back. These plaques are caused by the accelerated growth of skin cells driven by immune system dysfunction, and they often cause significant itching, pain, and psychological distress.
In the pivotal phase 3 clinical trials (BE VIVID, BE READY, and BE SURE), bimekizumab demonstrated remarkably high rates of skin clearance. In the BE READY trial, approximately 68% of patients achieved PASI 90 (at least 90% improvement in the Psoriasis Area and Severity Index) and about 59% achieved PASI 100 (complete skin clearance) at week 16. These response rates were significantly higher than those observed with placebo and were also superior to the active comparators adalimumab and secukinumab in head-to-head studies. The rapid onset of action, with many patients seeing meaningful improvement within the first 4 weeks, is a notable advantage of this treatment.
Psoriatic Arthritis
Bimzelx is approved for the treatment of active psoriatic arthritis in adults who have had an inadequate response to, or who are intolerant of, one or more disease-modifying antirheumatic drugs (DMARDs). Psoriatic arthritis is a chronic inflammatory condition that causes pain, swelling, and stiffness in the joints and is often accompanied by skin psoriasis. Over time, unchecked inflammation can lead to permanent joint damage and disability.
In the BE OPTIMAL and BE COMPLETE clinical trials, bimekizumab demonstrated significant improvements in joint symptoms, physical function, and skin disease compared with placebo. At week 16, approximately 44% of biologic-naive patients (BE OPTIMAL) and 43% of patients who had previously failed TNF inhibitors (BE COMPLETE) achieved ACR50 responses, indicating at least 50% improvement in their joint symptoms. Bimzelx can be used alone or in combination with methotrexate, and it also helps to slow the progression of structural joint damage, reduce nail psoriasis, and decrease fatigue.
Axial Spondyloarthritis
Bimzelx is indicated for the treatment of active axial spondyloarthritis in adults, including both non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (radiographic axial spondyloarthritis or r-axSpA). Axial spondyloarthritis is a chronic inflammatory condition that primarily affects the spine and sacroiliac joints, causing persistent back pain, stiffness, and reduced mobility. In ankylosing spondylitis, structural changes can be seen on X-rays, whereas in non-radiographic axial spondyloarthritis, significant inflammation is present without visible radiographic damage.
Clinical trial data (BE MOBILE 1 and BE MOBILE 2) demonstrated that bimekizumab significantly reduced the signs and symptoms of axial spondyloarthritis compared to placebo. Patients treated with bimekizumab experienced meaningful reductions in back pain, morning stiffness, and fatigue, with improvements maintained through at least 52 weeks of treatment. The ASAS40 response rate (a composite measure of disease activity improvement) was achieved by approximately 45-47% of bimekizumab-treated patients at week 16, compared to around 22% of placebo-treated patients.
Hidradenitis Suppurativa
Bimzelx is approved for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adults who have had an inadequate response to conventional systemic therapy. Hidradenitis suppurativa, also known as acne inversa, is a chronic, painful inflammatory skin condition characterized by recurrent nodules (lumps), abscesses (boils), and draining tunnels (sinus tracts) that typically develop in skin folds such as the underarms, groin, buttocks, and under the breasts. The condition can lead to significant scarring and severely impacts quality of life.
In the BE HEARD I and BE HEARD II phase 3 clinical trials, bimekizumab showed statistically significant reductions in inflammatory lesion counts compared with placebo. At week 16, approximately 48% of patients in the optimized dosing group achieved HiSCR50 (at least 50% reduction in total abscess and inflammatory nodule count), compared with approximately 29% of placebo-treated patients. Bimzelx reduces the number and severity of painful nodules, abscesses, and draining lesions, and helps to decrease the pain associated with this debilitating condition.
What Should You Know Before Taking Bimzelx?
Contraindications
Bimzelx must not be used if you are allergic (hypersensitive) to bimekizumab or any of the other ingredients in the medicine, including glycine, sodium acetate trihydrate, glacial acetic acid, polysorbat 80, and water for injections. It must also not be used if you have a clinically important active infection that your doctor considers significant, such as active tuberculosis (TB). Before starting Bimzelx, your doctor will assess whether you have any active infections and may perform tests to check for latent tuberculosis.
Stop using Bimzelx and seek immediate medical attention if you experience blood in your stool, stomach cramps, pain, diarrhea, or unexplained weight loss. These may be signs of new or worsening inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Warnings and Precautions
Before starting Bimzelx, it is essential to discuss your complete medical history with your healthcare provider. Several conditions require special consideration and close monitoring during treatment. Your doctor needs to evaluate the potential benefits against the risks in your individual situation.
Talk to your doctor, pharmacist, or nurse before using Bimzelx if any of the following apply to you:
- Active or recurrent infections: Bimzelx can increase your susceptibility to infections because it affects the immune system. If you have a current infection or tend to get infections frequently, your doctor will monitor you closely. Treatment may need to be paused during serious infections.
- Tuberculosis (TB): If you have ever had tuberculosis or have been exposed to someone with active TB, your doctor will test you before starting treatment. Latent TB may need to be treated before Bimzelx can be initiated.
- Inflammatory bowel disease: Cases of new or worsening Crohn's disease and ulcerative colitis have been reported in patients taking IL-17 inhibitors, including bimekizumab. If you have a history of inflammatory bowel disease, your doctor will carefully weigh the risks and benefits and monitor you for symptoms.
- Vaccinations: You should not receive live vaccines while taking Bimzelx. Live vaccines include measles, mumps, rubella (MMR), oral polio, yellow fever, and BCG. Inactivated vaccines (such as influenza and COVID-19 mRNA vaccines) can generally be given during treatment, though the immune response may be slightly reduced.
- Allergic reactions: In rare cases, Bimzelx may cause serious allergic reactions. Seek immediate medical attention if you experience difficulty breathing or swallowing, low blood pressure causing dizziness, swelling of the face, lips, tongue or throat, or severe skin itching with a rash.
Children and Adolescents
Bimzelx should not be given to children and adolescents under 18 years of age. The safety and efficacy of this medicine have not been established in this age group. Clinical trials in pediatric populations are ongoing, and approval for younger patients may follow in the future if study results are favorable.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your healthcare provider before using Bimzelx. The use of Bimzelx should be avoided during pregnancy because the effects of this medicine on the unborn child are not known. As a large protein (monoclonal antibody), bimekizumab is expected to cross the placental barrier, particularly during the second and third trimesters, which means the baby could be exposed to the medicine.
Women of childbearing potential should use effective contraception during treatment and for at least 17 weeks after the last dose of Bimzelx. This washout period is based on the elimination half-life of the medicine and ensures that bimekizumab has been substantially cleared from the body before conception.
If you are breastfeeding or plan to breastfeed, discuss this with your doctor before using Bimzelx. It is not known whether bimekizumab passes into breast milk. Like other monoclonal antibodies, it may be present in breast milk, particularly during the first few days after birth. You and your doctor should decide together whether you should breastfeed or use Bimzelx, taking into account the benefit of breastfeeding for the child and the benefit of therapy for you.
Driving and Using Machines
Bimzelx is not expected to affect your ability to drive or use machines. No studies on this topic have been performed, but based on the pharmacological properties of the medicine and the clinical trial experience, no impairment is anticipated.
Bimzelx contains 0.4 mg polysorbate 80 per 1 mL of solution, which may cause allergic reactions in some individuals. Inform your doctor if you have any known allergies to polysorbate. The medicine also contains less than 1 mmol (23 mg) sodium per dose, meaning it is essentially sodium-free.
How Does Bimzelx Interact with Other Drugs?
Because bimekizumab is a monoclonal antibody, it is broken down by general protein degradation pathways rather than by the cytochrome P450 (CYP450) enzyme system in the liver. This means that traditional drug-drug interactions mediated by enzyme inhibition or induction are not expected. However, there are some important considerations regarding concomitant medications and therapies.
During chronic inflammation, certain cytokines (including IL-17) can alter the expression and activity of CYP450 enzymes. When inflammation is reduced by effective biologic therapy, the levels of CYP450 enzymes may return to normal, which could theoretically affect the metabolism of concomitant medications that are CYP450 substrates. This effect is particularly relevant for drugs with a narrow therapeutic index, where small changes in blood levels could have clinically significant consequences.
| Interacting Agent | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Live vaccines (MMR, BCG, yellow fever, oral polio) | Pharmacodynamic | Risk of vaccine-related infection due to immunosuppression | Contraindicated during treatment; complete live vaccinations before starting Bimzelx |
| Narrow therapeutic index CYP450 substrates (warfarin, theophylline, cyclosporine) | Indirect (via cytokine modulation of CYP450) | Potential change in drug levels when inflammation is controlled | Consider therapeutic drug monitoring when starting or stopping Bimzelx |
| Other immunosuppressants (methotrexate, azathioprine) | Additive immunosuppression | Increased risk of infection | Methotrexate is approved for combination use; other agents require careful risk-benefit assessment |
| Inactivated vaccines (influenza, COVID-19 mRNA, pneumococcal) | Reduced immune response | Slightly reduced antibody production possible | Can be given during treatment; ensure vaccinations are up to date before starting |
| Other biologic therapies (TNF inhibitors, other IL-17 inhibitors) | Additive immunosuppression | Significantly increased infection risk; no clinical benefit established | Do not use in combination with other biologic immunosuppressants |
Always tell your doctor or pharmacist about all medicines you are using, have recently used, or might use. This includes prescription medicines, over-the-counter drugs, herbal products, and dietary supplements. Although formal drug interaction studies with Bimzelx are limited, comprehensive reporting of all medications helps your healthcare team to monitor for any unexpected interactions and ensure your safety.
What Is the Correct Dosage of Bimzelx?
Always use Bimzelx exactly as your doctor or pharmacist has instructed. The dosage, frequency, and duration of treatment depend on the specific condition being treated. Do not change your dose or stop using Bimzelx without first consulting your healthcare provider, as discontinuation may lead to a return of symptoms.
Dosage by Indication
Plaque Psoriasis
The recommended dose is 320 mg (given as two pre-filled pens of 160 mg each) administered as subcutaneous injections:
- Weeks 0, 4, 8, 12, and 16: 320 mg every 4 weeks
- From week 16 onwards: 320 mg every 8 weeks (maintenance)
- Patients weighing over 120 kg: Your doctor may decide to continue dosing every 4 weeks from week 16
Psoriatic Arthritis
The recommended dose is 160 mg (given as one pre-filled pen) administered as a subcutaneous injection every 4 weeks. For patients with concurrent moderate-to-severe plaque psoriasis, the dosing regimen follows the plaque psoriasis schedule (320 mg). After week 16, your doctor may adjust the dose to 160 mg every 4 weeks based on your joint symptoms.
Axial Spondyloarthritis
The recommended dose is 160 mg (given as one pre-filled pen) administered as a subcutaneous injection every 4 weeks. This applies to both non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis).
Hidradenitis Suppurativa
The recommended dose is 320 mg (given as two pre-filled pens of 160 mg each) administered as subcutaneous injections:
- Weeks 0 through 16: 320 mg every 2 weeks
- From week 16 onwards: 320 mg every 4 weeks (maintenance)
| Indication | Induction Dose | Induction Period | Maintenance Dose |
|---|---|---|---|
| Plaque Psoriasis | 320 mg every 4 weeks | Weeks 0–16 | 320 mg every 8 weeks |
| Psoriatic Arthritis | 160 mg every 4 weeks | Continuous | 160 mg every 4 weeks |
| Axial Spondyloarthritis | 160 mg every 4 weeks | Continuous | 160 mg every 4 weeks |
| Hidradenitis Suppurativa | 320 mg every 2 weeks | Weeks 0–16 | 320 mg every 4 weeks |
How to Administer
Bimzelx is given as a subcutaneous injection (under the skin). After your healthcare provider has trained you or your caregiver on the correct injection technique, you can self-inject at home. Choose an injection site on your abdomen (at least 5 cm from the navel), thigh, or the back of the upper arm (caregiver only). Rotate injection sites to avoid irritation, and never inject into skin that is tender, red, scaly, hard, bruised, or scarred.
Before injecting, allow the pre-filled pen to reach room temperature by leaving it out of the refrigerator for 30 to 45 minutes. Do not use heat to warm the pen, and do not shake it. Remove the cap only when you are ready to inject. Press the pen firmly against the skin at a 90-degree angle and wait for the first click, then hold in place until the second click (approximately 15 seconds), which signals that the injection is complete. The yellow indicator in the inspection window confirms the full dose has been delivered.
Missed Dose
If you forget to inject a dose of Bimzelx, contact your doctor as soon as possible. Your doctor will advise you on when to take the missed dose and will help you establish a new dosing schedule if needed. It is important to maintain a consistent injection schedule for optimal treatment outcomes.
Overdose
If you have used more Bimzelx than prescribed or injected your dose too early, inform your doctor. In clinical trials, doses up to 640 mg have been administered without dose-limiting toxicity. However, exceeding the recommended dose may increase the risk of side effects, particularly infections. There is no specific antidote for bimekizumab overdose; treatment would be supportive and symptom-based.
Do not stop using Bimzelx without talking to your doctor first. If you discontinue treatment, your symptoms may return. Your doctor will help you decide the best course of action based on your individual situation and disease activity.
What Are the Side Effects of Bimzelx?
Like all medicines, Bimzelx can cause side effects, although not everybody gets them. Most reported side effects are mild to moderate in severity and do not require discontinuation of treatment. However, some side effects can be serious and require prompt medical attention. Understanding the potential risks helps you and your doctor make informed decisions about treatment and recognize problems early.
Contact your doctor or seek emergency medical care immediately if you experience signs of a serious infection (fever, flu-like symptoms, night sweats, persistent cough, warm/red/painful skin, or a painful skin rash with blisters) or signs of a serious allergic reaction (difficulty breathing or swallowing, low blood pressure causing dizziness, swelling of face/lips/tongue/throat, severe itching with rash). Your doctor will determine whether you can continue treatment.
Very Common
- Upper respiratory tract infections (sore throat, nasal congestion, common cold symptoms)
Common
- Oral thrush (oral candidiasis) – white or yellow patches, red or sore mouth, pain when swallowing
- Skin fungal infections, including athlete's foot (tinea pedis)
- Ear infections
- Cold sores (herpes simplex infections)
- Gastroenteritis (stomach flu)
- Folliculitis (inflamed hair follicles that may look like pimples)
- Headache
- Itchy, dry skin or eczema-like rash (dermatitis), sometimes with swollen and red skin
- Acne
- Injection site reactions (redness, pain, swelling, bruising)
- Fatigue
- Vulvovaginal yeast infections (vaginal thrush)
Uncommon
- Neutropenia (decreased white blood cell count)
- Mucocutaneous fungal infections (including esophageal candidiasis)
- Conjunctivitis (eye discharge with itching, redness, and swelling)
- Signs of inflammatory bowel disease (blood in stool, stomach cramps and pain, diarrhea, weight loss)
Rare
- Serious allergic reactions (anaphylaxis)
- Serious bacterial, viral, or opportunistic infections
Understanding the Candidiasis Risk
Oral candidiasis (thrush) is a well-recognized class effect of IL-17 inhibitors, and it occurs at somewhat higher rates with bimekizumab due to its dual inhibition of both IL-17A and IL-17F. Both cytokines play important roles in mucosal immune defense against Candida species. In clinical trials, oral candidiasis occurred in approximately 3-7% of bimekizumab-treated patients compared with less than 1% in placebo groups. The vast majority of cases were mild to moderate, responded well to standard antifungal treatment (such as topical nystatin or oral fluconazole), and did not require discontinuation of Bimzelx.
Risk factors for developing candidiasis during Bimzelx therapy include prior history of oral thrush, concurrent use of inhaled corticosteroids, diabetes mellitus, immunocompromised state, and denture use. If you develop symptoms of oral thrush, such as white patches in the mouth, redness, soreness, or difficulty swallowing, contact your doctor promptly. Early treatment is usually very effective, and most patients can continue their Bimzelx therapy.
Reporting Side Effects
It is important to report any suspected side effects after a medicine has been approved. This allows ongoing monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients can report suspected adverse reactions to their national pharmacovigilance authority, such as the EMA in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom.
How Should You Store Bimzelx?
Proper storage of Bimzelx is essential to maintain the effectiveness and safety of the medicine. Incorrect storage can degrade the active substance, potentially reducing its efficacy or causing adverse reactions. Follow these storage guidelines carefully:
- Keep out of the sight and reach of children at all times.
- Refrigerate at 2–8°C (36–46°F). This is the standard storage condition for the pre-filled pens.
- Do not freeze. If the solution has been frozen, even if subsequently thawed, do not use the pen.
- Keep in the original carton to protect the pre-filled pens from light.
- Room temperature storage: If necessary, Bimzelx can be kept at up to 25°C (77°F) for a maximum of 25 days in its outer carton, protected from direct light. Record the date removed from the refrigerator. Do not return the pens to the refrigerator after room temperature storage.
- Do not use after the expiry date printed on the label and carton (EXP). The expiry date refers to the last day of the stated month.
- Inspect before use: The solution should be clear to slightly opalescent and free from particles. The color may range from colorless to slightly brownish-yellow. Air bubbles in the liquid are normal. Do not use if the liquid is cloudy, discolored, or contains particles.
Dispose of used pre-filled pens in a sharps disposal container immediately after use. Do not throw them in household waste or recycling. Ask your pharmacist about proper disposal of medicines and sharps containers to help protect the environment.
What Does Bimzelx Contain?
Active Ingredient
The active substance is bimekizumab. Each single-use pre-filled pen contains 160 mg of bimekizumab in 1 mL of solution for injection. Bimekizumab is a humanized monoclonal IgG1 antibody produced in Chinese hamster ovary (CHO) cells using recombinant DNA technology.
Inactive Ingredients (Excipients)
The other ingredients that make up the formulation are:
- Glycine – an amino acid used as a stabilizer to protect the antibody protein
- Sodium acetate trihydrate – a buffering agent to maintain the correct pH of the solution
- Glacial acetic acid – a pH adjuster
- Polysorbate 80 – a surfactant that prevents protein aggregation (contains 0.4 mg per 1 mL; may cause allergic reactions in sensitive individuals)
- Water for injections – the solvent base
Appearance and Packaging
Bimzelx is a clear to slightly opalescent liquid that may vary in color from colorless to slightly brownish-yellow. It is supplied in a single-use pre-filled pen for subcutaneous injection. Bimzelx 160 mg solution for injection in a pre-filled pen is available in packs containing 1 or 2 pre-filled pens, and in multipacks of 3 cartons (each containing 1 pre-filled pen) or 2 cartons (each containing 2 pre-filled pens). Not all pack sizes may be marketed in every country.
UCB Pharma S.A., Allee de la Recherche 60, B-1070 Brussels, Belgium. Manufactured by UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Frequently Asked Questions About Bimzelx
Bimzelx (bimekizumab) is used to treat four inflammatory conditions in adults: moderate-to-severe plaque psoriasis, active psoriatic arthritis, axial spondyloarthritis (including both non-radiographic axial spondyloarthritis and ankylosing spondylitis), and moderate-to-severe hidradenitis suppurativa. It works by blocking both IL-17A and IL-17F, two proteins that drive inflammation in these conditions. For psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa, Bimzelx is typically used when other treatments have not worked well enough.
Bimzelx is the first biologic medicine to simultaneously block both IL-17A and IL-17F. Other IL-17 inhibitors (such as secukinumab and ixekizumab) target only IL-17A. Clinical research has shown that IL-17F also contributes significantly to inflammation, so blocking both cytokines may provide more comprehensive disease control. In head-to-head trials, bimekizumab achieved higher rates of complete skin clearance (PASI 100) compared with secukinumab and adalimumab, suggesting that dual inhibition of IL-17A and IL-17F provides a clinical advantage.
Bimzelx has a relatively rapid onset of action. In clinical trials for plaque psoriasis, many patients saw meaningful skin improvement within the first 4 weeks of treatment. Peak efficacy is typically reached by week 16, when up to 60% of patients may achieve complete skin clearance (PASI 100). For joint symptoms in psoriatic arthritis and axial spondyloarthritis, patients may start to notice improvements in pain and stiffness within the first few weeks, with full therapeutic benefit emerging over the first 12 to 16 weeks.
Yes, Bimzelx is designed for self-injection at home after you have received proper training from a healthcare professional. The medicine comes in a pre-filled pen that makes self-injection straightforward. You can inject into your abdomen or thigh, while a caregiver can also inject into the back of your upper arm. The pen features an audible click system: a first click indicates the injection has started, and a second click (about 15 seconds later) confirms the full dose has been delivered. Always follow the injection instructions provided by your doctor or included in the product packaging.
Oral thrush (candidiasis) is a known side effect of Bimzelx and other IL-17 inhibitors. If you notice white or yellowish patches in your mouth, redness, soreness, or pain when swallowing, contact your doctor. In most cases, oral thrush is mild and can be treated effectively with antifungal medicines such as nystatin mouth rinse or oral fluconazole. Treatment usually resolves the symptoms within a few days to weeks, and you typically do not need to stop Bimzelx. However, if the candidiasis is recurrent or severe, your doctor may adjust your treatment plan.
Store Bimzelx in the refrigerator at 2–8°C (36–46°F) in its original carton to protect from light. Never freeze the pens. If needed for travel or convenience, the pens can be stored at room temperature (up to 25°C / 77°F) for a maximum of 25 days in the outer carton, away from direct light. Write the date you removed them from the fridge on the carton. Once stored at room temperature, do not put them back in the refrigerator. Discard pens stored outside the fridge for more than 25 days.
References
- European Medicines Agency (EMA). Bimzelx (bimekizumab) – Summary of Product Characteristics. Last updated 2025. Available at: ema.europa.eu
- Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486. doi:10.1016/S0140-6736(21)00126-4
- Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130-141. doi:10.1056/NEJMoa2102388
- Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med. 2021;385(2):142-152. doi:10.1056/NEJMoa2102383
- Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-alpha inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023;401(10370):38-48. doi:10.1016/S0140-6736(22)02303-0
- van der Heijde D, Deodhar A, Gensler LS, et al. Bimekizumab in patients with active ankylosing spondylitis: results of a 48-week, randomised, double-blind, placebo-controlled, phase 3 trial (BE MOBILE 2). Ann Rheum Dis. 2023;82(4):515-526. doi:10.1136/ard-2022-223595
- Glatt S, Jemec GBE, Engmann J, et al. Bimekizumab in moderate-to-severe hidradenitis suppurativa: results from two randomised phase 3 trials (BE HEARD I and BE HEARD II). Lancet. 2024;403(10432):1104-1117.
- U.S. Food and Drug Administration. BIMZELX prescribing information. 2023. Available at: fda.gov
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list, 2023. Geneva: WHO; 2023.
- Armstrong AW, Puig L, Joshi A, et al. Comparison of biologics and oral treatments for plaque psoriasis: a meta-analysis. JAMA Dermatol. 2020;156(3):258-269. doi:10.1001/jamadermatol.2019.4029
Editorial Team
iMedic Medical Editorial Team – Specialists in Clinical Pharmacology, Dermatology, and Rheumatology with documented academic background and clinical experience.
iMedic Medical Review Board – Independent panel of medical experts reviewing all content according to international guidelines (WHO, EMA, FDA, AAD, EULAR). Evidence Level 1A based on systematic reviews and randomized controlled trials.
Methodology: All information on this page is based on the approved Summary of Product Characteristics (SmPC) from the European Medicines Agency, FDA prescribing information, published phase 3 clinical trial data in peer-reviewed journals (The Lancet, The New England Journal of Medicine, Annals of the Rheumatic Diseases), and international treatment guidelines from AAD, EULAR, and WHO. No commercial funding was received for the creation of this content.