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Efficacy and Safety of an Anti-nerve Growth Factor Antibody (Frunevetmab) for the Treatment of Degenerative Joint Disease-Associated Chronic Pain in Cats: A Multisite Pilot Field Study.

ABSTRACT: Background: Pain management for cats with degenerative joint disease (DJD) remains a critical unmet need. Recent work has shown promise for a feline-specific anti-nerve growth factor monoclonal antibody (frunevetmab) to deliver safe and effective pain management. Our objectives were to evaluate the efficacy and safety of frunevetmab administered twice using two administration routes (subcutaneous and intravenous) compared to placebo. Methods: This was a randomized placebo-controlled, double-masked study. After a week-long pain and activity baseline, 126 cats were randomized to receive injections of frunevetmab (IV then SC; n = 42 or SC then SC; n = 43) or placebo (IV then SC; n = 41) on Days 0 and 28. Owners completed questionnaires on Days 14, 28, 42, and 56. Accelerometry data were collected continuously throughout. Results: Owner questionnaire results showed significant improvement in frunevetmab-treated cats [compared to placebo; (p < 0.05)] at Days 42 and 56; no difference was found between routes of administration for frunevetmab. All groups had decreased objectively measured weekly activity from baseline; frunevetmab-treated cats had a mean decrease of 0.9%, while placebo-treated cats had a mean decrease of 9.3%. Treatments were generally well-tolerated. The majority of adverse events included dermatitis/alopecia related to activity-monitor collars; these occurred in a higher percentage of frunevetmab, compared to placebo, treated cats. Conclusions and Clinical Relevance: Treatment with frunevetmab provided improvements in owner ratings of mobility over treatment with placebo; these results were supported by objectively measured accelerometry. Frunevetmab has the potential to address a critical gap in the treatment of chronic pain in cats.

SUBMITTER: Gruen ME

PROVIDER: S-EPMC8195238 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesThe aim of this study was to develop an evidence-based, clinically expedient checklist to identify cats likely to have degenerative joint disease (DJD)-associated pain.MethodsData were compiled from previously conducted studies that employed a standardized subjective outcome measure consisting of a series of questions. These studies included a prevalence study (with DJD non-informed owners) and therapeutic trials (with DJD-informed owners). For each cat, and each question, response scores were converted to 'impaired' and 'unimpaired'. Cats were categorized as 'DJD pain' and 'non-DJD' based on orthopedic pain and radiographic DJD scores. These binary data were compared between cat phenotypes (non-DJD and DJD pain) for each question. Sensitivity and specificity of each question were calculated using the binary data; based on this, potential questions for the checklist were selected. Sensitivity and specificity across this group of questions were calculated, and questions sequentially removed to optimize length, sensitivity and specificity. Finally, the proposed checklist was applied to a novel data set to evaluate its ability to identify cats with DJD pain.ResultsIn total, 249 DJD pain cats and 53 non-DJD cats from five studies were included. Nine questions with adequate sensitivity and specificity were initially identified. Following sequential removal of questions, a checklist with six binary questions was proposed. Based on the data from the cohorts of DJD-informed and DJD non-informed owners, the sensitivity and specificity of the proposed checklist were approximately 99% and 100%, and 55% and 97%, respectively.Conclusions and relevanceThe proposed checklist represents a data-driven approach to construct a screening checklist for DJD pain in cats. This checklist provides a clinically expedient tool likely to increase veterinarians' ability to screen for DJD pain in cats. The identified behaviors comprising the checklist may further provide a foundation for increasing awareness of DJD pain among cat owners.

Project description:Introduction and objectivesAccelerometry is used as an objective measure of physical activity in humans and veterinary species. In cats, one important use of accelerometry is in the study of therapeutics designed to treat degenerative joint disease (DJD) associated pain, where it serves as the most widely applied objective outcome measure. These analyses have commonly used summary measures, calculating the mean activity per-minute over days and comparing between treatment periods. While this technique has been effective, information about the pattern of activity in cats is lost. In this study, functional data analysis was applied to activity data from client-owned cats with (n = 83) and without (n = 15) DJD. Functional data analysis retains information about the pattern of activity over the 24-hour day, providing insight into activity over time. We hypothesized that 1) cats without DJD would have higher activity counts and intensity of activity than cats with DJD; 2) that activity counts and intensity of activity in cats with DJD would be inversely correlated with total radiographic DJD burden and total orthopedic pain score; and 3) that activity counts and intensity would have a different pattern on weekends versus weekdays.Results and conclusionsResults showed marked inter-cat variability in activity. Cats exhibited a bimodal pattern of activity with a sharp peak in the morning and broader peak in the evening. Results further showed that this pattern was different on weekends than weekdays, with the morning peak being shifted to the right (later). Cats with DJD showed different patterns of activity from cats without DJD, though activity and intensity were not always lower; instead both the peaks and troughs of activity were less extreme than those of the cats without DJD. Functional data analysis provides insight into the pattern of activity in cats, and an alternative method for analyzing accelerometry data that incorporates fluctuations in activity across the day.

Project description:BACKGROUND:Degenerative disc disease (DDD) is a common cause of lower back pain with radicular symptoms and has a significant socioeconomic impact given the associated disability. Limited effective conservative therapeutic options result in many turning to surgical alternatives for management, which vary in the rate of success and also carry an increased risk of morbidity and mortality associated with the procedures. Several animal based studies and a few human pilot studies have demonstrated safety and suggest efficacy in the treatment of DDD with mesenchymal stem cells (MSCs). The use of bone marrow-derived MSCs for the treatment of DDD is promising and in the present study we report on the safety and efficacy findings from a registry based proof of concept study using a percutaneous intradiscal injection of cultured MSCs for the management of DDD with associated radicular symptoms. METHODS:Thirty-three patients with lower back pain and disc degeneration with a posterior disc bulge diagnosed on magnetic resonance imaging (MRI) met the inclusion criteria and were treated with culture-expanded, autologous, bone marrow-derived MSCs. Prospective registry data was obtained at multiple time intervals up to 6 years post-treatment. Collected outcomes included numeric pain score (NPS), a modified single assessment numeric evaluation (SANE) rating, functional rating index (FRI), measurement of the intervertebral disc posterior dimension, and adverse events. RESULTS:Three patients reported pain related to procedure that resolved. There were no serious adverse events (i.e. death, infection, or tumor) associated with the procedure. NPS change scores relative to baseline were significant at 3, 36, 48, 60, and 72 months post-treatment. The average modified SANE ratings showed a mean improvement of 60% at 3 years post-treatment. FRI post-treatment change score averages exceeded the minimal clinically important difference at all time points except 12 months. Twenty of the patients treated underwent post-treatment MRI and 85% had a reduction in disc bulge size, with an average reduction size of 23% post-treatment. CONCLUSIONS:Patients treated with autologous cultured MSCs for lower back pain with radicular symptoms in the setting of DDD reported minor adverse events and significant improvements in pain, function, and overall subjective improvement through 6 years of follow-up. NCT03011398. A Clinical Registry of Orthobiologics Procedures. https://clinicaltrials.gov/ct2/show/NCT03011398?term=orthobiologics&rank=1.

Dataset Information

Efficacy and Safety of an Anti-nerve Growth Factor Antibody (Frunevetmab) for the Treatment of Degenerative Joint Disease-Associated Chronic Pain in Cats: A Multisite Pilot Field Study.

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