Results found Librela to have fewer adverse events and provided equal efficacy for managing osteoarthritis
Zoetis shared the results from the first clinical trial comparing the NSAID meloxicam to Librela (bedinvetmab injection) for the management of canine osteoarthritis (OA) pain. The study, sponsored by Zoetis, was published in Frontiers in Veterinary Sciences and showed that the canine anti-nerve growth factor monoclonal antibody, showed equivalent pain relief to a NSAID. The data from the study was found to support guidelines that were previously published recommending both NSAIDs and Librela as a first line therapy for managing OA in canine patients.
"The results of this clinical trial provide veterinarians with the first data directly comparing the efficacy and safety of Librela to meloxicam. This new information is valuable for clinicians and pet owners when making treatment decisions for canine OA pain. My experience using Librela in the clinic for over 4 years aligns with the findings from this study," said John F. Innes, BVSc, PhD, DSAS(Orth), FRCVS, Royal College of Veterinary Surgeons. Specialist, Movement Referrals, in an organizational release.1
The study was a randomized, open-label, and multicentered clinical comparator study following an ethical review by the Zoetis VMRD Ethical Assessment Committee. Dogs were eligible to participate through clinics that were randomly assigned 1 of 2 treatment groups based on the order in which they presented to the clinic. Each site was to attempt to enroll at least 2 complete blocks, which is 4 animals.
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The patients in the study sample sizes were determined on the assumption that Librela would be superior to meloxicam when it came to efficacy, and the outcome measure was the Canine Orthopedic Index (COI). According to to the study, the sample size estimates using the COI required multiple assumptions first, published work indicated a standard deviation for COI in a population of dogs with OA to be “10” for the aggregate COI score and that treatment with the NSAID carprofen resulted in a mean decrease in COI score of 12.2
The study enrolled 101 dogs with 52 randomized to Librela and 49 dogs randomized to meloxicam. The release noted that due to the small sample size and the short duration of the study, the statistical difference in adverse events (AE) numbers between each group could not be evaluated.
The study results indicated that Librela performed as well as meloxicam for managing pain associated with OA starting at day 14, the first time measured. Each product showed efficacy improving over the 56-day period. Within the study itself, it was noted that more dogs completed the study in the Librela group, 44, compared to the meloxicam group, 33.2 The results also showed that while there was a positive trend observed in mean reduction in the COI scoring, for the Librela group, there was a non-significant difference in efficacy each of the products. However, Librela was associated with fewer AEs compared to meloxicam.
Throughout the study, the following AEs were recorded and reported through the pharmacovigilance system1:
“Zoetis is committed to generating post-approval data on new innovations, like Librela. We previously shared study results showing that Librela improves quality of life in dogs. Zoetis supports peer-reviewed clinical research, and we are excited to see the results of those studies, such as this first comparative trial, being shared with veterinarians,” expressed Richard Goldstein, DVM, DECVIM-CA, DACVIM (SAIM), global chief medical officer and head of medical affairs at Zoetis.1
References
Podcast CE: A Surgeon’s Perspective on Current Trends for the Management of Osteoarthritis, Part 1
May 17th 2024David L. Dycus, DVM, MS, CCRP, DACVS joins Adam Christman, DVM, MBA, to discuss a proactive approach to the diagnosis of osteoarthritis and the best tools for general practice.
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