What are the indications for Cimzia (certolizumab pegol)?

Indications for Cimzia (Certolizumab Pegol)

Cimzia (certolizumab pegol) is FDA-approved for seven specific indications: Crohn's disease, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and moderate-to-severe plaque psoriasis. 1

FDA-Approved Indications

• Crohn's Disease: Reducing signs and symptoms and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1

• Rheumatoid Arthritis: Treatment of adults with moderately to severely active rheumatoid arthritis 1, 2

• Polyarticular Juvenile Idiopathic Arthritis (pJIA): Treatment of active pJIA in patients 2 years of age and older 1

• Psoriatic Arthritis: Treatment of adult patients with active psoriatic arthritis 1, 3

• Ankylosing Spondylitis: Treatment of adults with active ankylosing spondylitis 1, 4

• Non-radiographic Axial Spondyloarthritis: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation 1, 4

• Plaque Psoriasis: Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy 1, 5

Dosing Recommendations

Crohn's Disease

• 400 mg initially and at Weeks 2 and 4
• If response occurs, follow with 400 mg every four weeks 1

Rheumatoid Arthritis

• 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week
• For maintenance dosing, 400 mg every 4 weeks can be considered 1, 2

Polyarticular Juvenile Idiopathic Arthritis

• Weight-based dosing:
  • 10 kg to <20 kg: 100 mg initially and at Weeks 2 and 4, followed by 50 mg every other week
  • 20 kg to <40 kg: 200 mg initially and at Weeks 2 and 4, followed by 100 mg every other week
  • ≥40 kg: 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week 1

Psoriatic Arthritis

• 400 mg initially and at weeks 2 and 4, followed by 200 mg every other week
• For maintenance dosing, 400 mg every 4 weeks can be considered 1, 6

Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis

• 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4
• Followed by 200 mg every other week or 400 mg every 4 weeks 1, 6

Plaque Psoriasis

• 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week
• For patients weighing ≤90 kg: Consider 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week 1, 6

Clinical Considerations

Unique Properties of Certolizumab Pegol

• Certolizumab pegol is a humanized antigen-binding fragment (Fab') of a monoclonal antibody that has been conjugated with polyethylene glycol 6, 7
• The absence of the Fc region prevents complement fixation and antibody-mediated cytotoxicity 6
• It does not interact with the neonatal Fc gamma receptor, which minimizes transfer across the placenta, making it potentially safer for use during pregnancy compared to other TNF inhibitors 6, 5

Use in Inflammatory Bowel Disease-Associated Spondyloarthritis

• Certolizumab pegol is an effective option for axial spondyloarthritis in patients with Crohn's disease 6
• Unlike etanercept (which is ineffective for Crohn's disease), certolizumab pegol effectively treats both axial spondyloarthritis and Crohn's disease 6

Considerations for Psoriasis Treatment

• For moderate-to-severe plaque psoriasis, the approved dosing is 400 mg every other week 6
• For patients weighing ≤90 kg (198 pounds), an alternative dosing regimen may be considered: 400 mg initially and at weeks 2 and 4, followed by 200 mg every other week 6

Important Safety Considerations

• Serious Infections: Increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, and invasive fungal infections 1
• Tuberculosis Screening: Perform test for latent TB; if positive, start treatment for TB prior to starting Cimzia 1
• Malignancy Risk: Lymphoma and other malignancies have been reported in patients treated with TNF blockers 1
• Heart Failure: Monitor patients for new onset or worsening congestive heart failure 1
• Hypersensitivity Reactions: Discontinue Cimzia and institute appropriate therapy if anaphylaxis or other serious hypersensitivity reactions occur 1

Special Populations

• Pregnancy: Minimal transfer across the placenta due to the absence of an Fc region, making it potentially safer than other TNF inhibitors during pregnancy 6, 5
• Weight Considerations: For plaque psoriasis, weight-based dosing is recommended, with different regimens for patients weighing ≤90 kg 6
• Biologic-Experienced Patients: May be considered in patients who have failed other biologic therapies, though comparative data is limited 3