Certolizumab

Cimzia® Certolizumab pegol CMZ (UCB-Pharma AG)

Monoclonal, PEGylated anti-TNFα Fab fragment without an Fc domain (=no or minimal placental transfer or transfer via breast milk)

Moderate to severe plaque psoriasis, for patients 18 years of age and older. First-line treatment for women aged 18–45. Approved for use during pregnancy and while breastfeeding. Psoriatic arthritis in adults

Yes (Infliximab: if previous treatment with a TNF inhibitor has failed)

Severe plaque psoriasis with a refractory response to treatment with cyclosporine, MTX, acitretin, UVB, or PUVA, or in cases where there is a contraindication to or intolerance of such therapies. In cases of active psoriatic arthritis where prior DMARD therapy has been inadequate.

Pre-filled syringe, pre-filled pen.

Differential blood count, liver enzymes, creatinine, CRP, urinalysis, screening for HBV, HCV, HIV, and TB (optional: including chest X-ray).

Differential blood count, liver enzymes, and CRP.

After 3 months, then every 6 months.

400 mg (200 mg each) in weeks 0, 2, and 4, then 200 mg every 2 weeks. If there is no response, increase to 400 mg every 2 weeks if necessary.

If there is no therapeutic response after 16 weeks, treatment should be discontinued.

Week 16: 76.7% (at 200 mg every 2 weeks, pooled CIMPASI-1 & CIMPASI-2) and 82.0% (at 400 mg every 2 weeks); Week 48: 70.7% (200 mg) and 83.6% (at 400 mg)

Week 16: 45.9% (200 mg) and 52.2% (400 mg),

Week 48: 50% (200 mg) and 61.6% (400 mg)

Avoid live vaccines (European Guidelines recommendation: no injection for at least 4 weeks after live vaccination and until at least 21 weeks after the last dose).

Cimzia® 12,612 (14,714)

No data available regarding resuming therapy after an interruption; decide on a case-by-case basis whether to interrupt therapy in the event of an infection. For elective surgery, consider a preoperative interruption lasting 35 half-lives, especially in patients with diabetes (note that T₁/₂ = 14 days).

PASI, BSA, and DLQI at 12 and 16 weeks

Antibody formation against certolizumab in 8.3% (400 mg every 2 weeks) and 19.2% (200 mg every 2 weeks)

Antibody positivity is associated with reduced plasma concentrations and, in some patients, reduced efficacy. Cases of lupus-like syndrome have been reported (discontinue therapy).

Absolute contraindications: Active TB, severe infections (e.g., sepsis, abscess, opportunistic infections), moderate to severe heart failure (NYHA class III/IV)

Relative contraindications: Latent TB, concurrent diagnoses of systemic lupus erythematosus and multiple sclerosis, PUVA therapy >200 treatments, malignant tumors, and lymphoproliferative disorders

Reactivation is possible in chronic HBV infection (potentially fatal); discontinue if hepatitis B develops

Combination with anakinra and abatacept is not recommended (due to an increased risk of infection without any increase in efficacy in studies with other TNF-α inhibitors; no specific data available for Cimzia®)

TB prophylaxis with isoniazid, rifampicin, or isoniazid + rifampicin for at least 1 month before starting treatment.