Cytopoint™

The first monoclonal antibody therapy licensed to help provide sustained control of the clinical signs associated with atopic dermatitis in dogs

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Description

Cytopoint™ aids in the reduction of clinical signs associated with atopic dermatitis in dogs.

Cytopoint™ is a ready-to-use, sterile liquid containing a caninized monoclonal antibody (mAb) against interleukin-31 (IL-31). IL-31 has been shown to induce pruritus in dogs in laboratory studies.

Cytopoint™ remains in circulation for several weeks. It exerts a therapeutic effect by binding to and neutralizing soluble IL-31, thus inhibiting pruritus and reducing skin lesions. Like other naturally-occurring antibodies and antibody-antigen complexes, elimination is via normal protein degradation pathways.

SAFETY: A field safety study has demonstrated that Cytopoint™ is well tolerated in dogs after subcutaneous injection. Adverse events occurred at a similar frequency between treated and placebo groups in a study of 245 canine patients presented to veterinary hospitals and diagnosed with atopic dermatitis. In this study, dogs were administered Cytopoint™ (1.0-3.3 mg/kg body weight) or placebo by the subcutaneous route on Days 0 and 28. Signs of patient discomfort on administration and adverse events occurred at a similar frequency between treatment groups. In addition, there was no clinically important difference in clinical pathology changes between groups following either dose. A wide variety of concomitant medications were safely used, including parasiticides, antibiotics, antifungals, corticosteroids, vaccines, immunotherapy, antihistamines and other antipruritics, such as oclacitinib and cyclosporine.

Cytopoint™ has also been demonstrated to be well-tolerated in dogs in a laboratory safety study in which 7 consecutive monthly subcutaneous injections were administered at doses of 3.3 mg/kg or 10 mg/kg body weight (12 dogs per group).
Effectiveness
Cytopoint™ has a demonstrated onset of efficacy within 1 day and maintains efficacy for at least 1 month following a single dose in the field study.

In a study of 211 canine patients presented to veterinary hospitals and diagnosed with atopic dermatitis, a single dose of Cytopoint™ (up to 2.0 mg/kg) or placebo was administered subcutaneously. The study confirmed a significant (P<0.05) increase in the frequency of treatment success compared to placebo for at least one month at a dose of 2.0 mg/kg. Treatment success measures were based on the owner assessment of pruritus (Visual Analog Scale; VAS) scores and veterinarian assessment of skin lesion scores (Canine Atopic Dermatitis Extent and Severity Index; CADESI-03).

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