Bimzelx (bimekizumab) is a targeted biologic medication approved to treat several autoimmune conditions, including moderate-to-severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa. It works by selectively blocking two inflammatory cytokines, interleukin-17A (IL-17A) and interleukin-17F (IL-17F), to reduce inflammation. While effective for many, this mechanism of action also affects the immune system, making it unsuitable for certain individuals. Patient safety requires a thorough evaluation of existing health conditions and risks before and during treatment.
Contraindications and absolute restrictions
Certain conditions pose an immediate and serious risk, and Bimzelx should not be used in these circumstances.
Active and significant infections
Bimzelx suppresses parts of the immune system, increasing the risk of developing infections, including serious ones. For this reason, treatment should not be started in patients with any clinically important, active infection until it is fully resolved or adequately treated.
Untreated active tuberculosis (TB)
Before initiating Bimzelx, all patients must be screened for tuberculosis (TB) infection. Use of Bimzelx is to be avoided in those with an active TB infection. Patients with latent (inactive) TB must be treated for it before starting Bimzelx. Those with a history of latent or active TB where adequate treatment cannot be confirmed should also be considered for anti-TB therapy prior to starting.
Prior allergic reaction to Bimzelx
Individuals who have experienced a previous hypersensitivity reaction to bimekizumab or any of its inactive ingredients should not take Bimzelx due to the risk of a severe allergic reaction.
Important warnings and precautions
Even without a direct contraindication, certain health issues warrant extreme caution and close medical supervision before and during Bimzelx treatment.
Mental health conditions
In clinical trials, a higher rate of suicidal ideation and behavior was reported in some patients treated with Bimzelx. Prescribers are advised to weigh the risks and benefits carefully, especially in patients with a history of severe depression or suicidal thoughts. Patients and caregivers must be vigilant for new or worsening depression, anxiety, or suicidal thoughts and seek medical attention immediately if they occur.
Inflammatory bowel disease (IBD)
Cases of inflammatory bowel disease, including new onset or flare-ups of Crohn's disease or ulcerative colitis, have been reported in patients treated with IL-17 inhibitors. Bimzelx should be avoided in patients with active IBD. All patients should be monitored for signs and symptoms of IBD, such as persistent diarrhea, abdominal pain, or weight loss, and treatment should be discontinued if these symptoms arise.
Liver problems
Elevated liver enzymes were observed in some patients during clinical trials, and patients with existing liver disease, such as cirrhosis or acute liver disease, may be at increased risk of severe liver injury. Your healthcare provider should conduct baseline and periodic liver function tests.
Chronic or recurrent infections
Patients with a history of chronic or recurring infections should be carefully evaluated by their doctor before starting Bimzelx. The risks and benefits of potential treatment must be considered, as the medication could increase the frequency or severity of these infections.
Vaccinations and Bimzelx
Avoiding live vaccines
Because Bimzelx affects the immune system, the administration of live vaccines during treatment is not recommended. Live vaccines contain a weakened version of a virus or bacterium that can potentially cause infection in an immunocompromised individual. Before starting Bimzelx, patients should ensure all age-appropriate vaccinations are completed according to current guidelines. Examples of live vaccines to avoid include measles, mumps, rubella (MMR), chickenpox, and the nasal flu vaccine.
Inactivated vaccines
Inactivated (non-live) vaccines, such as most seasonal flu shots and COVID-19 vaccines, may be safely administered while on Bimzelx, but patients should always consult their healthcare provider first.
Considerations for pregnancy, breastfeeding, and pediatric patients
Pregnancy
There is insufficient data on the use of Bimzelx in pregnant women to assess the risk of birth defects or miscarriage. While animal studies did not show adverse effects at high doses, the medication may cross the placenta, potentially affecting the infant's immune system. Women who are pregnant or planning to become pregnant should discuss this with their doctor. A pregnancy registry exists to monitor outcomes for women exposed to Bimzelx during pregnancy.
Breastfeeding
It is not known whether Bimzelx passes into breast milk or its effect on the breastfed infant. A doctor should be consulted to weigh the benefits and risks before breastfeeding while on this medication.
Pediatrics
The safety and effectiveness of Bimzelx have not been established in pediatric patients.
Comparison of patient factors affecting Bimzelx eligibility
| Patient Factor | Medical History Evaluation | Bimzelx Consideration |
|---|---|---|
| Active Infection | Is there a clinically significant active infection? | Should not take; delay treatment until the infection is resolved. |
| Tuberculosis (TB) | Screen for active and latent TB before starting. | Should not take if active TB is present. Treat latent TB first. |
| Mental Health | History of severe depression or suicidal ideation? | Use with caution; monitor for mood changes or worsening depression. |
| Inflammatory Bowel Disease (IBD) | History or signs of Crohn's or ulcerative colitis? | Avoid use if active IBD is present. Monitor for symptoms. |
| Liver Health | Pre-existing acute liver disease or cirrhosis? | Avoid use. Monitor liver enzymes at baseline and periodically. |
| Live Vaccines | Need for specific live immunizations? | Avoid live vaccines during treatment. Complete vaccinations beforehand. |
| Pregnancy | Pregnant or planning to become pregnant? | Consult doctor. Consider enrolling in the pregnancy registry due to unknown risks. |
| Pediatric Use | Child or adolescent? | Safety and efficacy not established in this population. |
Conclusion
Deciding to begin treatment with Bimzelx is a serious medical decision that requires a comprehensive evaluation of a patient's overall health and medical history. Individuals with active infections, untreated tuberculosis, active inflammatory bowel disease, and severe liver disease are typically advised against taking the medication. Furthermore, caution is warranted for those with a history of severe depression or suicidal thoughts. Patients must also complete any required live vaccines before starting Bimzelx and avoid them throughout treatment. Open and honest communication with a healthcare provider is essential to determine if the potential benefits of Bimzelx outweigh the associated risks, ensuring the safest possible outcome. Always refer to the official prescribing information for the most complete guidance. You can find detailed information on the drug and its administration in the FDA-approved Bimzelx prescribing information.
