Bimzelx (bimekizumab) is an interleukin-17A and 17F inhibitor used to treat moderate to severe plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and axial spondyloarthritis. As with any medication that affects the immune system, there are significant precautions that patients and healthcare providers must be aware of before and during treatment. These precautions are vital for minimizing risks and ensuring patient safety.
Infections and Immunity
Because Bimzelx works by suppressing the immune system, it increases a patient's risk of developing infections. These can range from common upper respiratory tract infections to serious or even life-threatening conditions.
Screening for Infections and TB
Before initiating treatment, a healthcare provider will screen the patient for any clinically important active infections. They must also test for latent or active tuberculosis (TB).
- Active Infection: Treatment with Bimzelx should not begin if the patient has an active infection that is not resolved.
- Chronic or Recurrent Infection: For patients with a history of chronic or recurring infections, the healthcare provider must weigh the benefits against the risks before prescribing Bimzelx.
- Tuberculosis: Patients with a history of latent TB must be treated before starting Bimzelx. Those with active TB cannot use the medication. All patients should be closely monitored for signs of TB during and after treatment.
Vaccinations
Due to the immunosuppressive nature of Bimzelx, certain vaccinations are restricted.
- Live Vaccines: Patients should not receive live vaccines, such as those for measles, mumps, and rubella (MMR), while on Bimzelx.
- Non-Live Vaccines: Non-live vaccines, such as most influenza and COVID-19 vaccines, can generally be administered, but it is best to complete all age-appropriate immunizations before starting therapy.
Suicidal Thoughts and Behavior
There have been reports of suicidal ideation and behavior in some patients treated with Bimzelx, although a definitive causal link has not been established. This warning emphasizes the importance of monitoring for mental health changes.
What to Monitor For
Patients, caregivers, and family members should be vigilant for the following signs:
- New or worsening depression or anxiety
- Thoughts of suicide or dying
- Unusual changes in mood or behavior
- Acting on dangerous impulses
When to Seek Help
If a patient experiences any of these symptoms, they should seek immediate medical attention. Healthcare providers will need to re-evaluate the potential risks and benefits of continuing Bimzelx. The National Suicide and Crisis Lifeline can also be reached by calling or texting 988.
Liver Biochemical Abnormalities
Treatment with Bimzelx can cause elevated liver enzymes, and liver function should be monitored. Patients with acute liver disease or cirrhosis may be at increased risk for severe hepatic injury and should generally avoid Bimzelx.
Monitoring and Discontinuation
- Testing: Liver enzymes, alkaline phosphatase, and bilirubin should be tested at baseline and periodically throughout treatment.
- Interruption: If significant increases in liver enzymes occur, Bimzelx may be interrupted until drug-induced liver injury is ruled out.
- Discontinuation: Bimzelx should be permanently discontinued if a causal link to combined elevations of transaminases and bilirubin is confirmed.
Inflammatory Bowel Disease (IBD)
Cases of new or worsening inflammatory bowel disease, including Crohn's disease and ulcerative colitis, have been reported in patients treated with IL-17 inhibitors like Bimzelx.
IBD Precautions
- Active IBD: Avoid using Bimzelx in patients with active IBD.
- Monitoring: All patients should be monitored for signs and symptoms of IBD, such as abdominal pain, diarrhea, and bloody stools.
- Discontinuation: Treatment should be discontinued if a new onset or worsening of IBD symptoms occurs.
Comparison of Bimzelx Precautions with a Biologic Targeting TNF-Alpha
| Precaution | Bimzelx (IL-17A/F inhibitor) | Adalimumab (e.g., Humira, TNF-alpha inhibitor) |
|---|---|---|
| Increased Infection Risk | Yes, due to immunosuppression; includes serious infections. | Yes, also increases risk of serious infections. |
| Tuberculosis Screening | Required before and during treatment; latent TB must be treated. | Required before treatment, with monitoring for active TB. |
| Live Vaccines | Must be avoided during treatment. | Must be avoided during treatment. |
| Suicidal Thoughts/Behavior | Monitoring required; history of severe depression warrants caution. | Not a stated precaution in the same manner, but mental health should always be monitored. |
| Inflammatory Bowel Disease | Reported cases of new/worsening IBD; avoid in active IBD. | Can trigger or worsen IBD in some patients. |
| Liver Enzyme Elevation | Periodically test liver enzymes; avoid in acute liver disease. | Possible, requiring monitoring, but less prominent as a precaution in the cited data. |
Conclusion
Bimzelx is a targeted biologic therapy that can be highly effective for treating certain inflammatory conditions, but it is not without risk. The most significant precautions involve the increased risk of infections, including serious infections and tuberculosis, and the need for mental health monitoring due to reports of suicidal ideation and behavior. Additionally, patients should be vigilant for signs of liver problems and inflammatory bowel disease. It is crucial for patients to have a thorough health evaluation and vaccination update before starting treatment. As with any potent medication, a strong, ongoing dialogue between the patient and their healthcare provider is essential to ensure a safe and effective treatment experience.
For more detailed information, consult the official Bimzelx Prescribing Information provided by the manufacturer.
