Bimekizumab-bkzx Therapeutic Cheat Sheet

Bimekizumab (Bimzelx®) is a new injectable medication FDA approved for plaque psoriasis. It is the first and only FDA approved IL-17A and IL-17F inhibitor for this disease, but is also being used as an off-label option for other conditions including psoriatic arthritis and hidradenitis suppurativa. This Therapeutic Cheat Sheet will focus on the on and off label uses of bimekizumab.  

Bimekizumab-bkzx Therapeutic Cheat Sheet

Compiled by: Alexis E. Carrington, MD Reviewed by: Adam Friedman, MD

TRADE NAME

• • BIMZELX®

MECHANISM OF ACTION^1,2

• • Bimekizumab is an IgG1 antibody that inhibits proinflammatory cytokines IL-17A and IL-17F, both of which are key in the pathogenesis of plaque psoriasis. Evidence suggests inhibiting both of these cytokines is more effective at treating plaque psoriasis than inhibiting IL-17A alone.

FDA APPROVED FOR¹

• • Adults with moderate to severe plaque psoriasis

OFF-LABEL USES^3-7

• • Psoriatic arthritis
  • Lichen planus
  • Nail psoriasis
  • Axial spondyloarthritis
  • Hidradenitis suppurativa
  • Palmoplantar pustular psoriasis

DOSING¹

• • Loading dose: 320 mg (two 160 mg injections) subcutaneous injection at Weeks 0, 4, 8, 12, and 16
  • Maintenance dose: 160 mg injection every 8 weeks*

*For patients weighing ≥ 120 kg, consider a dose of 320 mg every 4 weeks after week 16.

SIDE EFFECTS¹

Most common side effects of bimekizumab include:

• • Upper respiratory infections (15%)
  • Oral candidiasis (9%)
  • Fungal infections (3%)
  • Pain at the injection site (3%)
  • Gastroenteritis (2%)
  • Herpes simplex infections (1%)
  • Fatigue (1%)
  • Acne (1%)

WARNINGS¹

• • May increase the risk of suicidal of ideation*
  • Increased risk infections, including tuberculosis (TB)
  • Elevated liver enzymes
  • Increased risk of irritable bowel disease (IBD)

*This warning came from a trial study where few study subjects without a history of suicidal ideation and treated with bimekizumab had a higher rate of suicidal ideation than those with placebo (1.3% vs. 0.6%). Overall, it has not been established that bimekizumab can cause suicidal ideation or behavior.

CONTRAINDICATIONS¹

• • Patients with known hypersensitivity to bimekizumab or any of the excipients in the formulation

PREGNANCY & BREASTFEEDING¹

• • There is insufficient data on the risk of birth defects or miscarriage in pregnant women
  • Bimekizumab may be transmitted from the mother to fetus
  • There is no data on the presence of bimekizumab in animal or human milk or on its effect on breastfeeding infants

MONITORING¹

Baseline:

• • Psychiatric history
  • Quantiferon gold for TB followed by a yearly TB test
  • Pregnancy test for female patients of child bearing potential
  • CBC
  • CMP to evaluate for liver enzymes
  • HBV and HCV studies
  • HIV

NSiD_Bimekizumab Therapeutic_Cheat Sheet

Conclusion

Bimekizumab is an effective new addition for treating plaque psoriasis in adults. More research and trials are coming down the pipeline on its effectiveness on other diseases. For this reason, it is important to be on the lookout for new publications studying these off-label treatments.

Further Reading

If you would like to learn more about bimekizumab, check out the following recently published articles:

Bimekizumab Self-Injection Devices: Two Multicenter, Randomized, Open-Label Studies on Self-Administration by Patients With Psoriasis.

Published in the Journal of Drugs in Dermatology.

Bagel J, Tatla D, Hellot S, Knapp B, Murphy C, Peterson L, Sebastian M.

Abstract

Background: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A.

Objectives: To assess patients’ ability to self-inject bimekizumab subcutaneously using a 1 mL safety syringe or auto-injector.

Methods: DV0002 and DV0006 were sub-studies of BE BRIGHT, a multicenter, phase 3 open-label extension study. Patients with moderate to severe plaque psoriasis received bimekizumab 320 mg (2×160 mg injections) every 4 or 8 weeks and were randomized 1:1 to the safety syringe or the auto-injector. The ability of patients to safely and effectively self-inject bimekizumab was assessed at 8 weeks (primary endpoint) and immediately after self-injection training at Baseline (secondary endpoint). Patient experience was evaluated using the pain visual analog scale (VAS; 0–100 mm; 100 being worst pain), and the Self-Injection Assessment Questionnaire (SIAQ; 0–10; 10 being most positive experience).

Results: All evaluable patients in DV0002 (n=125) and DV0006 (n=86) safely and effectively self-injected bimekizumab at Week 8. All evaluable patients in DV0002 who used the safety syringe (n=64) and 97.1% (n=66/68) who used the auto-injector, as well as all evaluable DV0006 patients (n=88) also self-injected bimekizumab safely and effectively at Baseline. Median VAS scores were low (range: 7.0–20.0), and median pre-injection and post-injection SIAQ scores were high (range: 5.8–10.0 and 7.1–10.0, respectively) across both devices, sub-studies, and timepoints.

Conclusions: Both devices provide a safe and effective option for patients to self-administer bimekizumab. Furthermore, patients reported a positive self-injection experience.

References

1. 1. BIMZELX® (Bimekizumab) [Package Insert]. Brussels, Belgium.: UCB Inc. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf
   2. Gordon KB, Foley P, Krueger JG, Pinter A, Reich K, Vender R, Vanvoorden V, Madden C, White K, Cioffi C, Blauvelt A. 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 Feb 6;397(10273):475-486. doi: 10.1016/S0140-6736(21)00126-4. Erratum in: Lancet. 2021 Mar 27;397(10280):1182. PMID: 33549192.
   3. Tanaka Y, Shaw S. Bimekizumab for the treatment of psoriatic arthritis. Expert Rev Clin Immunol. 2023 Nov 1. doi: 10.1080/1744666X.2023.2277266. Epub ahead of print. PMID: 37909894.
   4. ​​Deodhar A, Machado PM, Mørup M, Taieb V, Willems D, Orme M, Pritchett D, Gensler LS. Comparative efficacy and safety of bimekizumab in axial spondyloarthritis: a systematic literature review and network meta-analysis. Rheumatology (Oxford). 2023 Nov 8:kead598. doi: 10.1093/rheumatology/kead598. Epub ahead of print. PMID: 37947318.
   5. Hwang JK, Grover C, Iorizzo M, Lebwohl MG, Piraccini BM, Rigopoulos DG, Lipner SR. Nail Psoriasis & Nail Lichen Planus: Updates on Diagnosis & Management. J Am Acad Dermatol. 2023 Nov 23:S0190-9622(23)03224-3. doi: 10.1016/j.jaad.2023.11.024. Epub ahead of print. PMID: 38007038.
   6. Malvaso D, Calabrese L, Chiricozzi A, Antonelli F, Coscarella G, Rubegni P, Peris K. IL-17 Inhibition: A Valid Therapeutic Strategy in the Management of Hidradenitis Suppurativa. Pharmaceutics. 2023 Oct 11;15(10):2450. doi: 10.3390/pharmaceutics15102450. PMID: 37896210; PMCID: PMC10609891.
   7. Passeron T, Perrot JL, Jullien D, Goujon C, Ruer M, Boyé T, Villani AP, Quiles Tsimaratos N. Treatment of Severe Palmoplantar Pustular Psoriasis With Bimekizumab. JAMA Dermatol. 2023 Dec 6:e235051. doi: 10.1001/jamadermatol.2023.5051. Epub ahead of print. PMID: 38054800; PMCID: PMC10701662.

Did you enjoy this Therapeutic Cheat Sheet? You can find more here.