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Dr. Kristin Kirby-Shaw: How to use Solensia (frunevetmab) for Feline Osteoarthritis Pain Management
360 Plays11 months ago
From subtle tail twitches to silent yowls, cats have mastered the art of hiding their discomfort, leaving us humans scratching our heads feeling somewhat purr-plexed when it comes to decoding the mysteries of recognizing and managing pain in this stoic species. In this episode, we are going to sink our claws into feline osteoarthritis pain management by discussing the newest drug to hit the market designed to diminish feline osteoarthritic pain: Solensia. Solensia (frunevetmab) is a monthly injection administered at a veterinary clinic that can help control pain from osteoarthritis in cats. Our guide to understand this new and revolutionary medication is Dr. Kristin Kirby-Shaw, a board-certified veterinary surgeon and animal rehabilitation specialist who currently serves as a Pain and Osteoarthritis Specialist at Zoetis. Together with host Dr. Bonnie Gatson, they will discuss tools that can help veterinarians and pet owners recognize osteoarthritis pain in cats, summarize how Solensia provides pain control in this population of cats, and review important clinical trial and safety information to ensure we are using this innovative drug efficaciously to its full potential in our feline companions. Listen now to learn how Solensia helps our cats feel-ine good!
We want to inform our listeners about important safety information regarding Solensia (frunevetmab). Solensia is for use in cats only. Women who are pregnant, trying to conceive, or breastfeeding should take extreme care to avoid self-injection. Hypersensitivity reactions, including anaphylaxis, could occur with self-injection. Solensia should not be used in breastfeeding cats, or in pregnant or lactating queens. Solensia should not be used in cats with a known hypersensitivity to frunevetmab. The most common adverse events reported in a clinical study were vomiting and injection site pain. Review important safety information and prescribing information on the Zoetis website.
Resources mentioned in today’s episode:
Screening tool for osteoarthritis pain in cats.
If a patient experiences an adverse event associated with use of Solenia, or if inappropriate human exposure occurs, please contact product support at Zoetis at 1-888-963-8471.
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All opinions stated by the host and their guests are theirs alone and do not represent the thoughts or opinions of any corporation, university, or other business or governmental entity.
The NAVAS Podcast is published monthly on or near the 15th of the month.
Special thanks to Chris Webster for editing, producer Maria Bridges, and Saul Jimenez for IT support in making this podcast a reality.
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Transcript
Introduction to Navas Podcast
00:00:06
Speaker
Hello to all those gas pastors out there and welcome to another episode of the Navas Podcast, where we delve into the realm of veterinary anesthesia and pain management. I am your host,
New Development for Feline Osteoarthritis
00:00:17
Speaker
Dr. Bonnie Gatson, and today we're embarking on a journey to explore a remarkable development that promises to transform the lives of cats suffering from osteoarthritis.
00:00:28
Speaker
Osteoarthritis, a common ailment among older cats, can often go unnoticed, leaving our furry family members silently grappling with discomfort. And although the veterinary profession has made significant progress in the recognition, diagnosis, and treatment of arthritis, there are still significant gaps in sustainable long-term treatment for our furry feline friends
00:00:54
Speaker
as many of these long-term treatments are cumbersome, expensive, or may have unwanted side effects in an aging population.
Introducing Salencia: A Solution for Cats
00:01:03
Speaker
But if you're not, four, a new medication has just hit the market that arrives as a beacon of hope. Picture this.
00:01:11
Speaker
A world where our feline friends can frolic and pounce with the same agility and joy they once had. It's a world made possible by Salencia, a revolutionary pain medication tailored specifically for our whispered companions suffering from this debilitating condition.
Dr. Kristin Kirby Shaw's Insights on Pain Management
00:01:30
Speaker
In this episode, we speak with Dr. Kristin Kirby Shaw, a small animal surgeon and rehabilitation specialist whose career has focused on bridging the gap between these two disciplines with specific emphasis on treatment of arthritis. She is a world-renowned expert in canine and feline osteoarthritis and currently works with Zoetis, a manufacturer of salencia as a specialist in pain management and osteoarthritis.
00:01:58
Speaker
With Dr. Kirby Shaw's guidance, we'll take you behind the scenes, shedding light on the science, dedication, and compassion that brought Cilencia from the lab to the hands of veterinary professionals. We'll unravel the mysteries behind its unique mechanism of action, exploring how it tackles pain at the root, all while ensuring minimal side effects and maximal, per-inducing relief.
00:02:23
Speaker
So, tune in, dear gas-passers, as we unwrap the story of Salencia that's set to redefine the golden years for our feline friends. Get ready to be inspired to confidently diagnose and treat arthritic cats as we explore this incredible leap forward in feline osteoarthritis care right here on the Nav-Ass Podcast.
00:02:49
Speaker
All right, thank you so much for coming on the NavAss podcast today. Why don't you go ahead and tell me a little bit about yourself? Sure. Well, thank you so much for having me. First of all, my name is Kristin Kirkby Shaw. I am a small animal surgeon and rehabilitation specialist. I did basically all of my training at the University of Florida. So we're obligated to say go Gators when we say that.
00:03:10
Speaker
Go Gators. Exactly. So I lived in Gainesville, trained there and practiced at the university for a couple years after my residency. Then moved to Seattle. I was in a specialty hospital out in Seattle for about nine years doing both surgery and rehabilitation.
00:03:27
Speaker
My passion has been around chronic pain management, especially osteoarthritis pain management, that sort of intersection between surgery and rehab.
Understanding Osteoarthritis in Cats
00:03:37
Speaker
And about two and a half years ago, early 2021, I left practice and joined Zoetis. And so I do work full-time as an employee of Zoetis and I'm the pain and arthritis specialist for Zoetis. My job now, my role is around education around osteoarthritis, chronic pain management in dogs and cats.
00:03:56
Speaker
Can you tell me a little bit more about your role in the rollout of salencia? Yeah. So my role as again, the quote unquote pain and arthritis specialist is to provide education around salencia. You know, specifically we talk a lot about
00:04:12
Speaker
how salencia works and that's what we're going to talk about here today, but also how we recognize pain in cats and the greater impact that pain has on not only the cats, but also the human-animal bond. So my role has been to travel around the entire country working with local zoetis teams and veterinarians around the education of salencia primarily.
00:04:37
Speaker
I do also get to interact a little bit with the researchers, the amazing researchers that brought Salencia to us, though I haven't been directly involved in any of the actual research that was done. So I'm going to go ahead and jump on recognizing painting cats and treating painting cats, which is definitely a field that has been gaining a lot of interest
00:04:59
Speaker
in the past decade or so. And salensate was a drug that was developed for the treatment and management of osteoarthritic pain. So I kind of want to start with that. And just talking about degenerative joint disease in cats, what do we know about the portion of the feline population that has osteoarthritis?
00:05:20
Speaker
Yeah, I definitely want to answer that. I want to clarify the actual indication of salencia for the control of osteoarthritis pain in cats. And so this is important because the prevalence of osteoarthritis is quite high in cats. If we look at just radiographic changes in cats with OA,
00:05:42
Speaker
90% of cats over the age of 12 have radiographic evidence of OA. 60% of cats over the age of 6 have radiographic OA or degenerative joint disease. But what's important to recognize is that radiographs, well, first of all, they lag behind what's going on pathologically in the joint. So essentially by the time a cat becomes a teenager, they all have arthritis.
00:06:04
Speaker
But we also know there's a huge disconnect between what we see radiographically and what's actually clinically relevant. This is the case for humans, cats, dogs. We say we don't walk on our x-rays. So the number, the statistic to keep in mind is that 40% of cats across all age ranges have clinically relevant osteoarthritis pain. So again, 40% of cats have clinically relevant osteoarthritis pain.
00:06:29
Speaker
That's an astonishing number. And also, I think you made some really great points about the fact that we might see radiographic signs of pain, but not necessarily that translates to clinical pain. Exactly. Yeah. What is the physiologic process that occurs to create the pain that's associated, at least the clinical pain that's associated with osteoarthritis?
00:06:49
Speaker
So osteoarthritis is a cycle of tissue degeneration, so wearing away of articular cartilage. There's also a proliferative response, so we see those osteophytes that form. And then there is a low-grade inflammation that is a result of some of the release of inflammatory and degradative products within the joint.
00:07:09
Speaker
Those inflammatory mediators, those various different cytokines, they bind to nerve endings and sensitize the nerves, so those peripheral nerves. And through that peripheral sensitization, there's also subsequent changes.
00:07:25
Speaker
including central sensitization and all of the changes that come with that central sensitization we get hyperalgesia, allodynia, spontaneous nerve firing. So ultimately we have these physical changes happening in the joint that release mediators that sensitize the nervous system and create a maladaptive pain state.
00:07:45
Speaker
For our listeners, do you mind defining some of those things that you just mentioned? So things like allodynia, maladaptive pain, just in case our listeners are not familiar with those terms. Absolutely. So I'll start with peripheral sensitization. That is when an inflammatory mediator such as PGE or NGF, which is the target of salencia, one of these mediators binds to a peripheral nerve and sensitizes it. It makes that nerve more easily send a pain signal.
00:08:13
Speaker
Central sensitization is now where the nervous system starts to physically change, generally in response to repeated pain stimuli. And this is a component of that maladaptive pain. And if we distinguish maladaptive pain from adaptive pain, adaptive pain is where we talk about no-susceptive pain, physiologic pain, or even our acute inflammatory pain.
00:08:37
Speaker
Those types of adaptive pain states are protective. They act as a warning signal. They say, don't do that thing you're about to do, danger. Maladaptive pain is a pathologic disease state. It is no longer serving any protective or physiologic role.
00:08:53
Speaker
Osteoarthritis is the most common cause of maladaptive pain. And some of the components of maladaptive pain or hallmarks are hyperalgesia that I mentioned. And hyperalgesia means that the threshold for pain is lowered. It doesn't take quite as much stimuli to have that nociceptive signal transmitted to feel that pain.
00:09:15
Speaker
Allodynia means that a non-anoxious stimuli is now perceived as painful. What that looks like in our cat patients is you go to pet them, to brush them, to touch them up or pick them up and everything hurts. It feels like fire. And so they pull away and they don't want to engage with you because just everything hurts.
00:09:36
Speaker
Yeah, I want to expand a bit on clinical signs, at least in cats that are associated with pain. And this is just a tidbit of a personal story. Recently, I was at a clinic and I was working on a cat that was owned by a technician. The cat was there because the owner perceived that the animal had been eating less and kind of slowing down. And they thought that the reason for that was that the cat had some dental disease, which it did have some dental disease.
00:10:05
Speaker
But just upon doing a quick physical exam, it was very obvious to me that this cat had pretty severe hip dysplasia or at least pain coming from the hips. And this is a veterinary technician and she was quite shocked to even hear that her cat maybe had some osteoarthritis. It was an older cat as well. So I want to jump in a little bit and talk about what are some signs or some clinical signs that you might see in a cat that is experiencing
00:10:33
Speaker
any kind of chronic pain, but maybe we should focus more on degenerative joint disease and clinical signs you would see with that.
00:10:40
Speaker
Absolutely. So your story there is spot on for, I think all of us in the profession and then certainly even worse, cat owners that aren't in the veterinary profession. We just haven't known what the right signs of pain are in cats. Cats are their masters at hiding their pain. That is literally their survival instinct is to not show pain. So in the wild, they are mid-level predators. If they become injured or
00:11:05
Speaker
sick or in pain, they then become potential prey. So they are literally going to do everything they can to hide that pain. So if we have cat owners that think that their cat's going to show obvious things like crying out or even changes in facial expression that we see with acute pain, we're not expecting those with chronic pain. Instead, what we do know now, and there's actually some really good research that's shown that cats show chronic pain through changes in their behavior at home.
00:11:34
Speaker
And there are actually six specific changes in mobility that have been validated and are very, very highly predictive and accurate at indicating this cat has chronic pain. And those six behaviors are changes in how they jump up, how they jump down, go upstairs, go downstairs, run and play.
00:11:54
Speaker
And I want to clarify, though, that it's not that the cats stop jumping or that they stop playing or they stop going up and down stairs. They change how they move. They change their body mechanics to compensate for that area of pain. Additionally, there's other changes such as decreased appetite or changes in litter box habits. If it requires going up or downstairs to get to the litter box, they may not use it.
00:12:18
Speaker
We also know that cats that have especially pelvic limb pain, they might urinate or potentially defecate over the side of the litter box or they may hide more. They don't want to engage with the family because again, everything kind of hurts. So it's those changes in behavior that we need to ask about when we're talking to our clients about these changes they might see at home.
00:12:40
Speaker
There have been some recent pain scales that have come out that have helped to define the amount of pain that an animal is experiencing. And our listeners may or may not have heard of things like the feline grimace scale that have come out in the last few years. And I want to know if you're familiar with any
00:13:03
Speaker
research or development of pain scales that helped to qualify the degree of pain that cats are experiencing specifically either with chronic pain or with osteoarthritic pain.
00:13:16
Speaker
Yeah, absolutely. So I'll make the first clarification that the feline grimace scale is a phenomenal tool, but it is only validated for that acute pain. On the chronic pain side, the feline musculoskeletal pain index or FMPI is probably the best one out there. It is still being worked on and still being refined, but that's probably the best pain scale to track response to treatment.
00:13:40
Speaker
Although we'll also use things like the client specific outcome measure and that's we call it the CSOM. This is where a cat owner is asked to identify three behaviors specific to their cat that their cat is having difficulty with and they assign it a score generally from zero to four or zero to five. And the CSOM is something that is often used and it was actually used in the studies for Salencia.
00:14:05
Speaker
But the tool that I actually think is most beneficial is a checklist that has been developed out of the research that was done using the FMPI and this research was conducted at North Carolina State University. There's a checklist that asks cat owners about those six changes in mobility.
00:14:24
Speaker
and then some other questions around their behavior and personality. This checklist is meant to act as a screening tool. It's ideally used to screen every single cat. And if we say, all right, let's just say every cat over the age of six, regardless of why they're coming in, the cat owner should be asked to fill out this screening tool.
00:14:44
Speaker
If the cat owner checks off yes to any one of the questions, it is highly, highly accurate predicting that cats can have OA pain. So that checklist is available at catoachecklist.com and that's free to use.
00:14:59
Speaker
Oh, that's amazing. That's actually a checklist I hadn't heard of before. So I'm definitely going to go check that out and we'll make sure that we have a link to that website in our description on the podcast episode.
Treatment Evolution: From NSAIDs to Salencia
00:15:12
Speaker
So before Salencia was released, what was the gold standard of treating osteoarthritic pain in cats?
00:15:20
Speaker
In my opinion, the gold standard was NSAIDs. Even though NSAIDs aren't approved for long-term use in the United States, we know that they are approved in many other countries around the world, and we know that they can be effective. So whether it's Miloxacam or Robinoxim,
00:15:36
Speaker
There is some research to show that they can be effective. However, in the United States, it's off-label to use as beyond the perioperative period or beyond the acute period, Veloxacambine 1 injection or Abundant Coxabine 3 doses over 3 days. So there's efficacy for them, but a few downsides. One is of course, we do worry about potential impacts on renal disease.
00:16:00
Speaker
And it also requires giving this cat an oral medication once a day, which can be a barrier to some cat owners.
00:16:08
Speaker
Okay. So I think we've done a pretty good job of talking at least a little bit about osteoarthritic pain in cats. How does it form in cats and what are signs that cats might have that if they're suffering from degenerative joint disease. So let's jump into salencia now. So what is this drug and how does salencia work to combat pain associated with osteoarthritis in cats?
00:16:32
Speaker
Salencia is a monoclonal antibody that targets something called nerve growth factor or NGF. It's gonna take a little bit of explanation because it's a completely new type of medication with a completely new target. So it works unlike anything else that we have in veterinary medicine today.
00:16:53
Speaker
So I'll start with NGF, the target of salencia. NGF or nerve growth factor is in fact a growth factor. So in utero and in postnatal development, it is required. It's crucial for normal growth and development of the nervous system. But once that nervous system is fully developed, that role of NGF kind of shifts. And it's been found that there are elevated levels of NGF in chronic pain states, including osteoarthritis.
00:17:19
Speaker
And that NGF becomes a very, very potent pain mediator. In fact, it's as potent, if not probably more potent than prostaglandin E. So it works similarly in terms of sensitizing the nerve ending, causing that peripheral sensitization. But elevated NGF also causes central sensitization,
00:17:41
Speaker
Neurogenic inflammation amplifies traditional inflammation by increasing the release of other inflammatory mediators. It actually also has a positive feedback on cells that release more and more and more NGF, causing more central sensitization, more amplification of traditional inflammation. And then last but not least, it causes in-growth of new nerve endings into a joint. So more nerve endings mean more opportunities to send a pain signal.
00:18:08
Speaker
That is all about why NGF is a very opportune target to reduce chronic pain. Now, salencia is a monoclonal antibody. Monoclonal antibodies, you may be familiar with cytopoint, which is another monoclonal antibody in veterinary medicine right now. Few reasons that we like monoclonal antibodies and by we, I mean veterinary medicine and human medicine is going in the direction of monoclonal antibodies or MABs for short.
00:18:37
Speaker
These maps are designed to be targeted to one thing and one thing only. So Salencia binds to NGF and NGF only. It doesn't have any off-target effects. So that's going to contribute to its safety profile.
00:18:51
Speaker
Monoclonal antibodies are also really, really, really big proteins. They get broken down to smaller proteins and amino acids. This does not require cytochrome P450 or any metabolism through the liver or kidneys. So in terms of drug interactions, there's not any known drug interactions. They are also really long lasting. So we can give an injection of salencia once a month.
00:19:12
Speaker
and have weak starvation of effect. So we know from what you just described that salencia, its mechanism of action is to stop or at least combat the pain that is associated or the clinical pain that's associated with osteoarthritis in cats. Do we know if salencia actually stops development of osteoarthritis in cats?
00:19:34
Speaker
Salencia is not labeled as a disease modifying osteoarthritic drug. That's sort of the holy grail of arthritis management. So it really is meant to control the pain of OA. And if we think about why osteoarthritis matters, of course we care about that wearing away of cartilage and we care about the changes that happen in the joint. And ideally we would be changing that progression, but
00:19:59
Speaker
From a clinical standpoint, we mostly care about that pain. And so combating the pain is crucially important. If we think again about that mechanism of action, how it's reducing neurogenic inflammation, it is reducing the release of inflammatory mediators, it's reducing
00:20:15
Speaker
in growth of new nerve endings, it does play a role in changing that progression, especially of the pain state. But no, at this point in time, we don't have any evidence to show that salencia changes the disease of osteoarthritis itself. Can you just let our listeners know exactly how salencia is labeled and how it should be used?
Clinical Trials and Effectiveness of Salencia
00:20:38
Speaker
So salensia is labeled for the control of OA pain in cats, which that means that's the only disease state that it's been studied in. And it's labeled to be given once a month as a subcutaneous injection. And that injection should be given by a veterinarian or a veterinary technician in the vet hospital.
00:20:56
Speaker
So let's talk about the efficacy of salencia and some of the clinical trials that came out with this particular drug. Can you describe the results of any clinical trials that occurred during the approval process for salencia? And do we know how the analgesic response to salencia compares to off-label use of like chronic NSAIDs in cats?
00:21:20
Speaker
What is called the pivotal clinical trial, this is kind of the big final clinical trial that's done for the approval of salencia, was done in cats with naturally occurring osteoarthritis. So these are client owned cats and they had to have OA evidence based on radiographs as well as veterinary palpation and pain and at least two joints.
00:21:41
Speaker
And then they are enrolled in the studies. These studies were conducted across the US, Baldi centers, general practices. And the cats are randomized to receive either salencia or placebo. And they are administered once a month as a subcutaneous injection. And that was performed over a three month period. So cats received three injections.
00:22:02
Speaker
The primary outcome measure that was used was that client-specific outcome measure. Again, that's where the cat owners are asked what specific behaviors are their cats demonstrating that are indicative of pain, and then that is tracked over time. And so this CSOM, it is a validated outcome measure for chronic pain in cats. The veterinarians were also doing their examination.
00:22:25
Speaker
So the results were that at every single time point that was looked at, the salencia cats outperformed the placebo cats in every single outcome measure that it was looked at. And this is the first time that there's been any chronic pain treatment that has shown this type of results.
00:22:45
Speaker
However, what was not unexpected or was expected in these trials is that there was a very high placebo effect. In fact, it was over 60% at some time points, and that's not unexpected. Again, we know that the placebo effect is very, very real. So there was not necessary statistical significance at each time point, but there was clinically relevant improvement at every single time point.
00:23:10
Speaker
And what we are seeing now, now that Celenci has been available for almost a year now, the changes and the outcomes that cat owners are seeing in their cats, they are seeing things that they forgot their cats had been doing in the past. And so when I think about those outcome measures, those client-specific outcome measures, I wonder if the actual things that should have been looked at were things that cat owners had completely forgotten that their cats were doing. And those are some of the early things that are coming back.
00:23:39
Speaker
So in terms of efficacy, the efficacy is quite robust. Are 100% of cats going to respond to 100% of time? No, certainly not. But the vast majority of cats certainly will. Now, one thing to point out is that the mechanism of action of salencia is that it's not going to be acutely effective, meaning it's not going to work on the matter of hours or potentially even days. It's going to take
00:24:05
Speaker
a couple of weeks to really start showing its effect. And we know that from a pharmacokinetic standpoint, it takes two injections to reach steady state. So when getting a cat started on salencia, we want to set clients up for realistic expectations and always set them up for those two injections before we decide, is it working or is it not? So let's say a cat has had several injections of salencia, maybe over the course of like four or five months.
00:24:33
Speaker
And something happens, like an owner decides to skip a month or something like that. How long lasting after an injection do you see clinical improvements in a cat? Do we have any data on that? The data only looked at injection every four weeks, so every 28 days or so.
00:24:55
Speaker
So we don't have data to say that you can space it out to five weeks or six weeks. I think the reality is that there will be some individual variation. There may be some cats that can get closer to that five or six weeks, and there may be some cats that really do need that injection every four weeks. I think this is something that we are going to learn over time, and it may be a sense of giving six injections once a month for six months, and then maybe we'll see that we can space it out
00:25:23
Speaker
But that's definitely not my recommendation at this point in time. I strongly recommend that we try and stick as close as possible as that once a month injection. Because we know it's not changing the course of OA, it is intended to be a lifelong treatment.
Guidelines and Safety for Salencia Use
00:25:38
Speaker
But of course, there's going to be art of medicine. There's going to be individual variation. And so there might be some cats that can go a little bit longer or potentially need it closer to that really on that four-week mark.
00:25:50
Speaker
Would the dosing or the dose range be any different for obese cats? Would you recommend dosing on lean body weight for overweight cats?
00:25:58
Speaker
The recommendation for dosing is based on actual body weight. So that's how Salencia was studied, was based on actual body weight, not lean body weight. I think we talk about lean body weight with NSAIDs and some other drugs where we're more concerned about that safety profile. In this case, it is actual body weight. And if you are on that cusp of the cat really does need two vials, but you'd really like to give it one, it's a great opportunity to have a strong weight loss conversation with that
00:26:25
Speaker
So salencia is recommended for a subcutaneous injection. Is there a specific part of the body that you should be administering that subq injection into? Or at least in the studies, was it indiscriminate? Does it not matter exactly where you inject the drug into? There are no recommendations for where you give the subq injection. So anywhere that works for that cat or that you feel comfortable in your practice, the majority of cats in the trial were injected between the scapula.
00:26:55
Speaker
And that's where I've treated the cats that I've been involved with personally. For cats that are on salencia, is it possible to combine salencia treatment with other types of treatments such as use of NSAIDs or adequate injections, maybe nutraceuticals that people want to try? Do we know if salencia
00:27:16
Speaker
can be mixed with these other types of treatments that are available for osteoarthritis. In the clinical trials, cats could not be on nonsteroidals because that would potentially confound the outcome. So we don't have any studies looking at concurrent use of NSAIDs with salencia.
00:27:34
Speaker
From the standpoint of nutraceuticals, yes, there's no problem with having them on nutraceuticals. Likewise with Atiquan. In the studies that they had been on Atiquan for an extended period of time, there was no change there. And there's no expected interaction with Salencia and Atiquan or oral joint supplements.
00:27:54
Speaker
What I'll say, especially around the oral joint supplements, is there's pretty minimal evidence to support their efficacy or their need. And so oral joint supplements, especially in cats, are not something that I'm typically recommending from a cost-saving standpoint and from needing to give a cat an oral medication. But if it's still something that you want to do, then there's no problem using it with salencia.
00:28:15
Speaker
Attoquan, I am a pretty big advocate for Attoquan and I would continue to use Attoquan with salencia. If you're going to do that, they can be injected on the same day. We just recommend giving it at different locations on the body. Now, when it comes to non-steroidals, again, there's no research looking at concurrent use, but what I would do personally is knowing that salencia may take a couple of weeks to take effect, I may consider using a few days
00:28:46
Speaker
potentially a couple weeks of a nonsteroidal, especially if that cat's already been on it and we know that they can tolerate it as we're easing into the salencia. But what's interesting is we know from the European experience, so Europe and the UK has had salencia for over two years now, and many of those cats were on NSAIDs before going on to salencia. 90% of cats don't need any other concurrent medication once they've started on salencia.
00:29:14
Speaker
So potentially salencia could be used as a single treatment for osteoarthritis. But from what I'm understanding from your answer is that.
00:29:22
Speaker
it needs to be taken on an individual cat basis. Absolutely. That's exactly right. So what about safety studies? I'm assuming, of course, that safety studies would need to have been conducted for the approval process. So can you summarize the results of these safety studies and describe any common side effects that are seen, either in the safety studies or in the clinical trials?
00:29:47
Speaker
There are quite a few safety studies that are conducted before any FDA drug is put into a client-owned animal. And so the biggest safety study that's usually conducted is called the target animal safety study. And this is usually done at doses up to five times the clinical dose. And so with salencia, it was five times the dose
00:30:10
Speaker
given once a month for six months. And this is really trying to challenge that medication. In this case, the Prunavetmab, the active ingredient in salencia. And these are in laboratory cats. And ultimately, the safety investigators are looking at everything from blood work, they're looking, they do necropsies at the end, they look at
00:30:31
Speaker
physical exam changes there. And I think most of us are probably most concerned about kidneys and cats. And what we can say is that even at five times the dose there was no impact.
00:30:42
Speaker
of selencia really on changes in the kidneys. In fact, there was really no impact of selencia on anything other than potentially the skin. And I'll come back and address the skin after talking about what was found with selencia in client owned cats. And so in those clinical trials that looked at efficacy,
00:31:01
Speaker
side effects or adverse events were also looked at. And an adverse event is basically anything that's abnormal that the client or the veterinarian reports or thinks is abnormal, whether or not they think it's actually related to the drug or the placebo.
00:31:18
Speaker
So in the clinical trials, the top two adverse events that were reported with salencia were pain with injection and vomiting. And so for context there, the pain with injection, that was really just that some cats reacted to the injection like they were getting poked by a needle. It wasn't a dramatic response. It wasn't a predictable stinging response.
00:31:41
Speaker
And some cats react, some cats don't. And it's just at the time of getting an injection. It's not a lingering effect. Now vomiting, cats in these studies ranged in age up to 22. The average age was 13. Half of them actually had stage one or two iris kidney disease.
00:31:57
Speaker
And they were followed for three months. So we can all imagine that vomiting is pretty common over a three-month period in cats, especially cats that are a little bit older. So 13% of the salensia-treated cats and 10% of the placebo-treated cats did vomit at some point in time in there. Whether or not that's truly related to salensia, really not clear, but probably not.
00:32:20
Speaker
The side effect that really does seem to be related to saliency in this was seen in the target animal safety studies and in the clinical trials, though it wasn't really attributed to saliency in the clinical trials, is that some cats will develop alopecia, dermatitis, peritis that tends to be localized to the head and neck.
00:32:42
Speaker
It's usually mild, usually can be treated with whatever topical or oral antibiotics or anti-inflammatories you would otherwise use. And it's more often seen in cats that already have an underlying skin disorder. So they have an allergic dermatitis.
00:32:57
Speaker
So if you see that that is something that is tracking, it's so uncommon that I don't have all the answers yet. First of all, I can't tell you why it happens frustratingly. We don't know why I can't tell you whether it's more likely to happen after the first injection or the sixth injection or the 10th injection.
00:33:15
Speaker
Those are still things that we're trying to understand as we collect more data. So if this is something that you see, please call it into Zoetis and you can talk to your Zoetis representative, your local sales rep, and they can help get you that phone number or email to call. I should actually add one more thing to the safety information.
00:33:34
Speaker
And this wasn't a result of any actual trials that were done, but understanding the role of NGF in growth and development of the nervous system. Salencia is contraindicated in cats that are breeding pregnant or lactating. So that is really the true contraindication as any cat that is breeding pregnant or lactating, salencia is not indicated for.
00:33:56
Speaker
Now to expand on that just a little bit further, the age recommendation, the label is for using cats over seven months of age, but we recommend being a little bit more conservative and using cats over a year of age. The last point that I'll make here is also that there's a warning on the label that says to avoid self injection if you're a woman who is
00:34:20
Speaker
pregnant, trying to conceive, or is breastfeeding because of that role of NGF. And now self-injection means actually administering a full dose of salencia, not just a needle prick. And no, there were not studies done giving salencia to humans to see what would happen, but there were studies done in non-human primates that show that anti-NGF monochrome antibodies can affect a developing fetus.
00:34:43
Speaker
So would you recommend that if there is a practitioner in or a veterinary professional handling salencia that people who are like pregnant or lactating should avoid handling the drug or it shouldn't be okay if they just take normal precautions?
00:34:59
Speaker
I mean, to me, it's taking normal precautions. Again, thinking about it does not just a needle prick, it's injecting yourself with an entire mill or two of something, which I think is incredibly unlikely. But one of the reasons that we discuss it is that we strongly discourage sending it home with clients because the liability that a practitioner could face if something did go wrong. But it is up to the individual
00:35:27
Speaker
who is pregnant, who is breastfeeding, to make the right choice for what is most comfortable for them. So appropriate handling and safety is always important, but it's not something that needs to be used in a hood or you don't need to use gloves or anything like that. Just don't give yourself the injection.
00:35:46
Speaker
So if a cat has an adverse effect of a salencia injection, let's say they started vomiting or they started getting extremely poetic or itchy, can salencia be reversed or do we just kind of have to wait it out for a few weeks or until the drug dissipates from the body?
00:36:05
Speaker
Salencia can't be reversed, so there's no anti-salencia antidote. We do need to wait for it to be cleared from the body, which is going to take a few weeks there, depending on how soon an adverse event does happen after the injection. So these cats that have experienced some of these skin disorders, it does mean that you treat it symptomatically.
00:36:27
Speaker
And many cats that have experienced these skin issues are showing dramatic improvement with salencia and are continued on salencia. And so that again is an individual decision of weighing the risk reward. So it doesn't necessarily mean that you have to stop the salencia if it's a mild case that you can control. But the short answer is no, there's no way that we can reverse salencia. Do you know what the approximate cost per single injection is at this time?
00:36:55
Speaker
What I can say is the vials cost $40 to the veterinarian for an independently owned practice. Now what I can't comment on are corporate practices that may have different pricing structures, but the most common cost of a single vial is $40. Now what
00:37:13
Speaker
the individual practice then decides to do in terms of markup or charging. That is, again, practice dependent. The recommendation from the zoeticide is to charge an injection fee, not necessarily doubling the price, but it is meant to be cost-effective to be able to use once a month long-term. Can a practitioner use salencia for another species besides a cat, like for example, for dogs?
00:37:41
Speaker
No, so very important question and very important point to clarify. Salencia, the monoclonal antibody, that frunavent mag monoclonal antibody is speciated, meaning it was engineered and designed to look just like a cat protein. So we cannot interchange species. You cannot give salencia to a dog or a rabbit or a hamster because that other species will react to that antibody as a foreign antibody. The beauty of speciating that antibody means that the cat
00:38:10
Speaker
is not expected to react to it as a foreign antibody. If a veterinarian is interested in carrying salencia in their clinic and offering it to their patients, who should they contact?
Integrating Salencia into Veterinary Practice
00:38:22
Speaker
Veterinarian should contact their local Zoetis sales representative, so they do need to order it directly through Zoetis. It is something that needs to be kept refrigerated, so it's sterile, preservative free, but just reach out to your local Zoetis rep and they will get you hooked up.
00:38:37
Speaker
How should Salency be stored? So is it a multi-dose vial? Do you have to keep it in the fridge? Salency comes in a single dose vial and it does need to be kept in the refrigerator. So it's sterile, preservative free, single use, single puncture. There's a dosing chart where the vast majority of cats are going to receive one single vial, but there are some cats over about 15 and a half pounds that will receive two vials, but it's not a multi-dose vial.
00:39:03
Speaker
So in general, we've talked about salencia as being potentially a single treatment for managing osteoarthritic pain in cats. We've talked about using multiple therapies, including salencia, but in general, how would you advise veterinarians to incorporate salencia into their current treatment plan for cats with osteoarthritis?
00:39:32
Speaker
I think actually what it starts with is understanding that, first of all, we're just not diagnosing osteoarthritis enough in cats. So the plan is really to start with screening more cats, understanding that 40% of cats out there are suffering from OA pain. So once you find the cats and you make that recommendation, then I would get them started on salencia. And again, setting the client up for realistic expectations, we want to set them up for success with two injections. And I would personally have
00:40:02
Speaker
the injections be technician driven. So coming back in to see the technician for that follow-up injection. And one of the things that we really know helps with compliance is forward booking appointments. So making sure that before the client leaves, they've scheduled out their subsequent injection. So I would always schedule that second and potentially even third injection after the first one. And then if things are going well and it's working, continue to book them out indefinitely.
00:40:30
Speaker
Now, the other way that I think that Salencia can be quite helpful is for those cats that you're not quite sure is it pain or is it not pain. We now have this very effective analgesic pain reliever that can sometimes be used as a diagnostic tool itself just to see response to treatment. And I think there will be a lot of veterinarians and cat owners that will be amazed to see that once you treat the pain,
00:40:55
Speaker
some behaviors that may not have been chalked up to pain might actually be resolved or improved.
00:41:02
Speaker
Yeah, I'm really excited that we now have this new and innovative drug to help us in our management of a condition that a lot of cats do experience, especially in their older age. So I just want to thank you so much for taking the time to chat with me about this drug and to help educate veterinary professionals out there about this really fantastic new option that we have to manage pain in cats. So thank you so much. Well, thank you so much for having me.
00:41:29
Speaker
If people want to learn more about this drug, where can they go to get more information? There are basically two websites that you can visit. The all-encompassing everything Salencia website is salenciavetteam.com. If you want to look just specifically at the Salencia label, so everything that
00:41:51
Speaker
We've talked about from mechanism of action, safety, efficacy data. That's at selenciapi.com. So selenciapi as in productinsert.com. And we will make sure that links for those websites will be in the description for the podcast episode.
00:42:11
Speaker
We would like to make our listeners aware of some important safety information regarding salencia. Salencia is for use in cats only. Women who are pregnant, trying to conceive or breastfeeding should take extreme care to avoid self-injection. Hypersensitivity reactions, including anaphylaxis, could potentially occur with self-injection.
00:42:30
Speaker
Salencia should not be used in breeding cats or in pregnant or lactating queens. Salencia should not be administered to cats with known hypersensitivity to Fruinivitmab. The most common adverse events reported in clinical studies were vomiting and injection site pain. To see the full prescribing information for salencia, please visit www.salenciapi.com.
00:42:56
Speaker
If you like what you heard today, I encourage you to check out NavAss and consider becoming a member. As a member of the North American Veterinary Anesthesia Society, you get tons of benefits, including access to CE events, focusing on anesthesia and pain management, blog posts, fireside chats with boarded anesthesiologists, as well as specialty technicians, and just so much more. Visit www.mynavass or N-A-V-A-S.
00:43:23
Speaker
to advance your anesthesia journey today. If you've been listening and enjoying this podcast, I would sincerely appreciate it. If you could give us a like or subscribe to our podcast, write a review, or simply just tell a friend about this podcast. If you have any questions about this week's episode or the NavAss podcast in general, or if you want to suggest topics you would like for us to discuss in future episodes, please reach out to us at education at mynavass.org.
00:43:52
Speaker
We would love to hear from all of you. Also, a huge thank you to our sponsor, Decra, without whom this podcast would not be possible. Visit their website, www.decra-us.com to learn more about their line of veterinary anesthesia products. This podcast was produced and edited by Chris Webster of Chris Webster Productions.
00:44:13
Speaker
I want to thank our guests, Dr. Kristin Kirby Shaw, for this insightful discussion on osteoarthritis management in cats and for introducing us to Slensia as a viable treatment option for cats with this condition. And a huge thank you to all the gas pastors out there who choose to spend their time with me today on the NavVis podcast.
00:44:33
Speaker
Becoming a skilled anesthetist is a lifelong journey of learning and self-discovery, so I hope you consider listening in the future. Until next time, I'm your host, Dr. Bonnie Gatson, and thank you for listening. I hope you consider tuning in next month for another episode of the NavAss Podcast.