BIMEKIZUMAB-BKZX INJ,SOLN
Clinical Criteria Summary
Document 679
Indication & Patient Population
- Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Treatment Line & Sequence Requirements
- Proposed as a 5th–6th-line systemic therapy for moderate to severe PPsO.
- Indicated after methotrexate, phototherapy (if available and feasible), a TNF inhibitor (TNFI), and less-costly IL-17A inhibitors (IL-17Ais) and IL-23 inhibitors (IL-23is).
Pretreatment Evaluations & Monitoring
- Evaluate for tuberculosis infection.
- Assess liver enzymes, alkaline phosphatase, and bilirubin.
- Update all age-appropriate vaccinations as per current guidelines prior to initiation.
Dosing & Administration Criteria
- 320 mg subcutaneously at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.
- For patients weighing ≥ 120 kg, consider 320 mg every 4 weeks after Week 16.
Clinical Considerations & Place in Therapy
- May be preferred over ustekinumab 90 mg due to greater efficacy and lower cost; however, it is higher in cost than ustekinumab 45 mg.
- For severe PPsO (defined as affecting >10% body surface area, impairing work or biopsychosocial function, affecting hands/feet/nails/scalp/face/genital area, or causing intractable pruritus/pain/bleeding), an IL-17A antagonist (preferably ixekizumab) rather than a TNFI can be considered on a case-by-case basis.
- An IL-17A/F antagonist (e.g., bimekizumab-bkzx) or IL-23 antagonist (e.g., risankizumab) may be considered for severe PPsO as an alternative to a TNFI (e.g., infliximab/biosimilar) if an IL-17A antagonist is medically inadvisable.
Safety & Precautions Influencing Use
- Boxed warnings: None.
- Contraindications: None.
- Other warnings affecting clinical decision-making: Suicidal ideation and behavior, infections, tuberculosis, liver biochemical abnormalities, inflammatory bowel disease, immunizations.
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Exclusion Criteria
- History of severe or untreated depression, suicidal ideation/behavior, or risk factors for suicide (e.g., depression, bipolar disorder) – relative contraindication when potential risks outweigh benefits
- Uncontrolled active infection, including undrained abscess and fungal infection; therapy may be started/restarted only once the infection is controlled
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive status without antiviral prophylaxis; initiation permitted only after starting prophylaxis
- Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients are eligible)
- Concomitant live or live-attenuated vaccines, or administration of any inactivated/live/attenuated vaccines less than 4 weeks prior to initiation
- Concomitant treatment with natalizumab or other drugs with contraindicated drug interactions (e.g., Bacillus Calmette-Guerin [BCG] vaccine) unless risk-benefits favor use
- Acute liver disease or cirrhosis
- Diagnosis of inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
Inclusion Criteria
- Definite or provisional diagnosis of active ankylosing spondylitis or radiographic axial spondyloarthritis
- Prescription and monitoring by a VA/VA Community Care rheumatologist or locally-designated expert
- All age-appropriate vaccinations offered prior to initiating therapy
- Completed tuberculosis (TB) testing using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed hepatitis B screening (HBsAg, total antibody-to-hepatitis-B-core-antigen [anti-HBc], and anti-HBs)
- Current or past completion of hepatitis C screening; initiation permitted while awaiting test results
- Documented pre-treatment liver enzymes, alkaline phosphatase, and bilirubin levels
- Tumor necrosis factor inhibitor (TNFi) is medically inadvisable, not tolerated, or inadequate (defined as no or partial response after 3 months) or loss of initial response
- Intolerance or inadequate response (no or partial response after 3 months) to both ixekizumab and secukinumab
Additional/Conditional Inclusion Criteria
- HBsAg-negative but anti-HBc-positive patients: Consultation with a GI/liver or infectious diseases expert required to advise on antiviral prophylaxis versus preemptive monitoring for HBV reactivation
- Patients of childbearing potential: Counseling provided regarding treatment risks vs. benefits and requirement for effective contraception during therapy
- Pregnant patients or those planning pregnancy: Counseling provided regarding treatment risks vs. benefits
- Lactating patients or those planning to breastfeed: Counseling provided regarding treatment risks vs. benefits
Treatment Sequencing & Initiation Requirements
- Ixekizumab is the preferred interleukin-17A inhibitor for new starts
- First-line therapy: TNFi
- Second-line after TNFi failure: IL-17Ai (ixekizumab preferred before secukinumab, which is preferred before bimekizumab-bkzx) or Janus kinase inhibitor (tofacitinib or upadacitinib)
- Criteria apply only to new starts; stable patients on bimekizumab-bkzx should not be switched to a criteria-required prior drug for nonmedical reasons
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Exclusion Criteria
- History of depression or suicidal ideation/behavior/risk factors for suicide (relative contraindication when risks outweigh benefits)
- Uncontrolled active infection, including undrained abscess (may start/restart once controlled)
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting prophylaxis)
- Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
- Concomitant live or live-attenuated vaccines or administration of inactivated/live/live-attenuated vaccines less than 2 weeks before initiation
- Acute liver disease or cirrhosis
- Active inflammatory bowel disease
Inclusion Criteria
- Moderate to severe hidradenitis suppurativa (HS)
- Prescribed and monitored by a VA/VA Community Care dermatologist or locally-designated expert
- Offered all age-appropriate vaccinations prior to initiating therapy
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed hepatitis B screening (HBsAg, total antibody-to-hepatitis-B-core-antigen [anti-HBc], and anti-HBs)
- Current or past completion of hepatitis C screening (may initiate while waiting for results)
- Documented results of pre-treatment liver enzymes, alkaline phosphatase, and bilirubin
- Adalimumab/biosimilar (preferred) or infliximab/biosimilar (alternative) is medically inadvisable, not tolerated, or not adequate (NO/partial response after 3 months) or lost initial response
- Had intolerance or inadequate response (NO/partial response after 3 months) to secukinumab
Additional Inclusion Criteria
- If HBsAg-negative but anti-HBc-positive: Consultation with gastroenterologist/hepatologist or infectious diseases expert for advice on antiviral prophylaxis vs. preemptive monitoring for HBV reactivation
- Patients of childbearing potential: Counseling provided on risks vs benefits and use of effective contraception during therapy
- Pregnant or plan to become pregnant: Counseling provided on risks vs benefits
- Lactating/providing breastmilk/planning to do so: Counseling provided on risks vs benefits
Clinical Monitoring & Management
- Antiviral prophylaxis for HBV should use agents with a high genetic barrier to resistance (e.g., entecavir or tenofovir)
- Vaccinations should be updated prior to initiation; recombinant zoster vaccine should be completed/initiated by end of first year, preferably when dosage is low, disease is stable, or immune response can be expected
- Non-live and live vaccines should be administered 2 or more weeks before initiating interleukin immunosuppressives
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Exclusion Criteria
- History of severe or untreated depression, suicidal ideation/behavior, or risk factors for suicide (relative contraindication when risks outweigh benefits)
- Uncontrolled active infection (including undrained abscess and fungal infection); therapy may be started/restarted once controlled
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive without antiviral prophylaxis; initiation permitted after starting prophylaxis
- Untreated HIV infection (treated, well-controlled, asymptomatic patients are eligible)
- Concomitant live or live-attenuated vaccines, or administration of inactivated/live/attenuated vaccines within 4 weeks prior to initiation
- Concomitant treatment with natalizumab or other drugs with contraindicated interactions (unless risk-benefit favors use)
- Acute liver disease or cirrhosis
- Diagnosis of inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
Inclusion Criteria
- Definite or provisional diagnosis of active nonradiographic axial spondyloarthritis made by a VA/VA Community Care rheumatologist
- Prescribed and monitored by a VA/VA Community Care rheumatologist or locally-designated expert
- Offered all age-appropriate vaccinations prior to initiating therapy
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed hepatitis B screening (HBsAg, total anti-HBc, and anti-HBs)
- Current or past completion of hepatitis C screening (initiation permitted while awaiting results)
- Documented pre-treatment liver enzymes, alkaline phosphatase, and bilirubin
- Tumor necrosis factor inhibitor (TNFi) is medically inadvisable, not tolerated, or inadequate (no/partial response after 3 months) or loss of initial response
- Intolerance or inadequate response (no/partial response after 3 months) to ixekizumab and secukinumab
- Ixekizumab is the preferred interleukin-17A inhibitor for new starts
Additional Inclusion Criteria / Special Populations
- Patients of childbearing potential: Counseling on treatment risks vs benefits and use of effective contraception during therapy
- Pregnant patients or those planning pregnancy: Counseling on treatment risks vs benefits
- Lactating patients or those planning to breastfeed: Counseling on treatment risks vs benefits
- HBsAg-negative but anti-HBc-positive patients (if practitioner deems consult indicated): GI/liver or ID expert e-consult for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation
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Diagnosis & Clinical Presentation
- Inflammatory articular disease (joint, spine, and/or entheseal) with a definite or provisional diagnosis of psoriatic arthritis
Screening & Laboratory Requirements
- Completed tuberculosis test using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed hepatitis B screening (HBsAg, total antibody-to-hepatitis-B-core-antigen [anti-HBc], and antibody to hepatitis B surface antigen [anti-HBs])
- Current or past completion of hepatitis C screening (initiation permitted while awaiting results)
- Documented pre-treatment liver enzymes, alkaline phosphatase, and bilirubin
Contraindications & Exclusions
- Diagnosis of inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
- History of severe or untreated depression, suicidal ideation/behavior, or risk factors for suicide (relative contraindication when risks outweigh benefits)
- Uncontrolled active infection (including undrained abscess and fungal infection); therapy may be started/restarted once controlled
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive without antiviral prophylaxis; initiation permitted after starting prophylaxis
- Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients are eligible)
- Concomitant live or live-attenuated vaccines, or administration of such vaccines less than 4 weeks prior to initiation
- Concomitant treatment with natalizumab or other drugs with contraindicated interactions (e.g., BCG vaccine) unless risk-benefits favor use
- Acute liver disease or cirrhosis
Treatment History & Sequencing
- Tumor necrosis factor inhibitor (TNFi) must be medically inadvisable, not tolerated, or inadequate (NO or partial response after 3 months) or lost initial response
- Must have intolerance or inadequate response (NO or partial response after 3 months) to ixekizumab and secukinumab
- Ixekizumab is the preferred interleukin-17A inhibitor for new starts
- First-line therapy: TNFi (adalimumab/biosimilar, certolizumab, etanercept, or infliximab/biosimilar)
- First-line exception: IL-17Ai (ixekizumab preferred) may be used first-line instead of a TNFi for severe concomitant psoriasis
- Second-line after TNFi: IL-17Ai (ixekizumab preferred before secukinumab, which is preferred before bimekizumab-bkzx) or JAKi (tofacitinib or upadacitinib); apremilast if no joint erosions or axial disease
- Third-line after TNFi and IL-17Ai: IL-23i (guselkumab or risankizumab-rzaa) or IL-12/23i (ustekinumab)
Counseling & Patient Management
- Prescribed and monitored by a VA/VA Community Care rheumatologist, dermatologist, or locally-designated expert
- Offered all age-appropriate vaccinations prior to initiating therapy
- Patients of childbearing potential: Counseling on risks vs benefits and use of effective contraception during therapy
- Pregnant patients or those planning pregnancy: Counseling on risks vs benefits
- Lactating patients/providing breastmilk or planning to do so: Counseling on risks vs benefits
- HBsAg-negative but anti-HBc-positive patients: GI/liver or infectious diseases expert consultation required for advice on antiviral prophylaxis vs preemptive monitoring