A novel biologic for the treatment of moderate-to-severe psoriasis
Each vial contains 25 mg of itolizumab. Itolizumab is a humanized recombinant anti-CD-6 monoclonal antibody.
Each mL contains 5 mg of itolizumab for intravenous use.
Mechanism of Action:
Itolizumab is a humanized recombinant anti-CD6 mAb of immunoglobulin (Ig) G1 isotype that binds to domain 1 of CD6. The CD6 leukocyte differentiation antigen is a membrane glycoprotein mainly expressed on the surface of mature thymocytes, in most peripheral blood CD3+ T-cells and in a subtype of B-lymphocytes called B1a cells. In peripheral blood T‑cells, CD6 participates in cell activation as a co-stimulatory molecule. The ligand of CD6, Activated Leukocyte-Cell Adhesion Molecule (ALCAM) is widely distributed in normal tissues, including the thymus, spleen, lymph nodes and skin. Itolizumab immunomodulates human lymphocytes without interfering with the binding of CD6 to ALCAM.
Preclinical studies with T-cells showed that the antibody blocks intracellular Mitogen Activated Protein Kinase (MAPK) and Signal Transducer and Activator of Transcription-3 (STAT-3) signaling pathways, the secretion of pro‑inflammatory cytokines (including tumor necrosis factor-α, interferon-γ and interleukin-6) and T-cell proliferation, even when co-stimulated with ALCAM.
ALZUMAb™ is indicated for the treatment of patients with active moderate to severe chronic plaque psoriasis who are candidates for systemic therapy.
Posology and Method of Administration
- The recommended dose of ALZUMAb™ for the treatment of plaque psoriasis is 1.6 mg/kg given as IV infusion once every 2 weeks for 12 weeks, followed by 1.6 mg/kg every 4 weeks up to 24 weeks.
- Prior to initiating ALZUMAb™ and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection [see Special Warnings and Precautions for Use and Contraindications].
- ALZUMAb™ should not be administered to patients having history of severe allergy or known hypersensitivity reaction to any component of ALZUMAb™ or any murine proteins. Additionally, ALZUMAb™ is contraindicated in patients with any active serious infection [see Special Warnings and Precautions for Use].