Frunevetmab, a felinized anti-nerve growth factor monoclonal antibody, for the treatment of pain from osteoarthritis in cats.

BACKGROUND: Frunevetmab, a felinized antinerve growth factor monoclonal antibody, effectively decreases osteoarthritis (OA) pain in cats. OBJECTIVE: To evaluate the efficacy of frunevetmab given at monthly intervals in a randomized, placebo-controlled, parallel-group, double-blind superiority study. ANIMALS: Two hundred seventy-five client-owned cats with naturally-occurring OA pain and associated mobility impairment and disability. METHODS: Randomized, placebo-controlled, parallel-group, double-blind, superiority study. Following screening, cats received frunevetmab (nominal dose of 1.0 mg/kg, SC [effective dose range of 1.0-2.8 mg/kg]) or placebo on days 0, 28, and 56. Outcome measures were owner questionnaires and veterinary physical and orthopedic evaluations at days 28, 56, and 84. Success/failure rates (and numbers needed treat, NNT) and change in scores (and standardized effect size, ES) were analyzed. RESULTS: Frunevetmab (182) and placebo (93) treated cats were enrolled and received at least 1 treatment. Significant improvement with frunevetmab over placebo occurred at days 28 and 56 for the client specific outcome measures (CSOM) questionnaire (success rates and total scores [NNT of 9 and ES of 0.3 at day 56]); at days 28 and 56 for owner-assessed global treatment response; and at days 56 and 84 for veterinarian-assessed joint pain (ES of 0.18 at day 56). Adverse events did not differ between groups, except skin disorders which collectively occurred significantly more frequently in frunevetmab treated (32/182 cats) vs placebo (8/93 cats). CONCLUSIONS AND CLINICAL IMPORTANCE: Frunevetmab has the potential to address a critical gap in the treatment of pain because of osteoarthritis in cats.

A blinded, randomized, placebo-controlled trial of the efficacy and safety of the Janus kinase inhibitor oclacitinib (Apoquel®) in client-owned dogs with atopic dermatitis.

BACKGROUND: Pruritus is the hallmark clinical sign of atopic dermatitis (AD) in dogs. Preliminary study results suggest that oclacitinib, a selective Janus kinase inhibitor, could reduce pruritus and associated inflammatory skin lesions in dogs with AD. HYPOTHESIS/OBJECTIVES: The objective was to evaluate efficacy and safety of oclacitinib (Apoquel®) for the control of AD in a randomized, double-blind, placebo-controlled trial. ANIMALS: Clinicians at 18 specialty clinics enrolled client-owned dogs (n = 299) with a history of chronic AD. METHODS: Dogs were randomized to receive either oclacitinib (0.4-0.6 mg/kg twice daily for 14 days and then once daily for up to 112 days) or an excipient-matched placebo. Owners assessed visual analog scale (VAS) scores of pruritus on days 0, 1, 2, 7, 14, 28, 56, 84 and 112. Clinicians assessed Canine AD Extent and Severity Index (CADESI-02) scores on days 0, 14, 28, 56, 84 and 112. RESULTS: On days 1, 2, 7, 14 and 28, oclacitinib-treated dogs had a 29.5, 42.3, 61.5, 66.7 and 47.4% reduction from baseline in owner-assessed pruritus scores, respectively, compared with a 6.5, 9.1, 6.5, 3.9 and 10.4% reduction in placebo-treated dogs. On days 14 and 28, dermatologists recorded a 48.4% reduction in CADESI-02 scores in oclacitinib-treated dogs compared with a 1.7% reduction and a 3.6% increase in placebo-treated dogs. After day 28, >86% of all placebo-treated dogs had moved to an open-label study, making between-group comparisons biased. Differences were significant at all time points assessed (P < 0.0001). CONCLUSIONS AND CLINICAL IMPORTANCE: Oclacitinib provided rapid, effective and safe control of AD, with substantial improvement in VAS and CADESI-02 scores.