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Rhapsido (Remibrutinib) Safety in Chronic Urticaria · The Science of Skin

• 0:00
  SPEAKER_01: This episode is sponsored by Novartis with content independently created by the Science of Skin Podcast.
• 0:14
  SPEAKER_02: Hello and welcome to the Science of Skin Podcast.
• 0:18
  SPEAKER_02: My name is Dr.
• 0:18
  SPEAKER_02: Ted Lane.
• 0:19
  SPEAKER_02: I'm a board-certified dermatologist practicing in Austin, Texas, and I'm your host for today.
• 0:24
  SPEAKER_02: But I'm really excited about our guest who is a friend of the show.
• 0:29
  SPEAKER_02: This is Dr.
• 0:30
  SPEAKER_02: Jason Hawks.
• 0:31
  SPEAKER_02: He is the principal investigator, the co-owner.
• 0:35
  SPEAKER_02: And there's one other thing, Jason.
• 0:36
  SPEAKER_02: I lost it in the chat for Oregon Medical Research Center.
• 0:40
  SPEAKER_02: Is that right?
• 0:41
  SPEAKER_00: Yep, Chief Scientific Officer.
• 0:43
  SPEAKER_02: Chief Scientific Officer for Oregon Medical Research Center.
• 0:47
  SPEAKER_02: So uh amazing.
• 0:49
  SPEAKER_02: So so Jason, thank you so much for being here.
• 0:51
  SPEAKER_02: Jason also sees patients.
• 0:53
  SPEAKER_02: So he's not just a researcher, he's also a clinical dermatologist.
• 0:57
  SPEAKER_02: He gosh, Jason, I could go on and on.
• 0:59
  SPEAKER_02: You consult for companies, you speak worldwide, you you you educate, it's you do it all.
• 1:06
  SPEAKER_02: That's what we do, right?
• 1:08
  SPEAKER_02: When you're Jason Hawks, you do.
• 1:10
  SPEAKER_02: All right.
• 1:10
  SPEAKER_02: So, Jason, listen, this is a sponsored episode, and we're talking about Rhapsodo, which is Remy Brutinib, which relatively recently got its approval for chronic spontaneous urticaria.
• 1:22
  SPEAKER_02: Now, because this is a one in a series of podcasts on Remy Brutenib, each one of our podcasts is going to focus on different attributes of the drug.
• 1:31
  SPEAKER_02: So if you'd like to learn more about efficacy or how the drug works, there that is available in other episodes in this series.
• 1:41
  SPEAKER_02: But today, Jason, we're going to focus on the safety of Remy Brutenib and kind of how you talk to your set your patients about the safety and certainly how you educate your peers on the safety as well.
• 1:54
  SPEAKER_02: You know, as a BTK inhibitor, um, we have to remember that BTK, that enzyme is present in many cells, not just the mast cell, right?
• 2:04
  SPEAKER_00: Yeah, and I I think for a lot of other specialties, they've had some experience with the uh first generation BTK inhibitors.
• 2:13
  SPEAKER_00: So, you know, they may be a little um biased in terms of their view of that class.
• 2:18
  SPEAKER_00: I I think for the most part, in dermatology and probably allergy to some degree, we really don't have a lot of experience with the first generation BTK.
• 2:27
  SPEAKER_00: So I think Remy Brutnib really is kind of that first experience, that introduction in that class.
• 2:33
  SPEAKER_00: And what I find is that a lot of our colleagues, we're talking about this as a brand new class of medications, even though it does have some history.
• 2:41
  SPEAKER_02: Yeah.
• 2:41
  SPEAKER_02: So it's bit, gosh, it has a long history in medicine, doesn't it?
• 2:45
  SPEAKER_02: I mean, certainly it's been used as a cancer drug as well, uh, and and many other uses.
• 2:51
  SPEAKER_02: So um we know from from this long history a lot about as a class, the safety, but if we focus on this covalently bound BTK inhibitor, uh I guess we should first start talking about the bleeding events, because when you look at the incidence of AEs and the pool data from the phase three program, the number one AE that's listed at 9% is bleeding events.
• 3:15
  SPEAKER_02: And and maybe, Jason, if you don't mind, if you could just kind of go into a little bit more detail, because I think if you if you really understand what that topic or or that name it kind of subsumes, uh it makes a it makes a big difference.
• 3:29
  SPEAKER_00: Yeah, this kind of goes back to what we talked about earlier on one of the other podcasts about just kind of how do we approach clinical trial safety information.
• 3:39
  SPEAKER_00: So I like to go back to the basics of you want to know what something does normally before you think about what it does before you inhibit it or activate it, for example.
• 3:50
  SPEAKER_00: So when you think about the cells that Remy brutinib would affect, it's gonna be cells that already have some reliance on BTK signaling.
• 4:00
  SPEAKER_00: So it's intracellular pathway, obviously, immune cells, mast cells is gonna be one of those main cells.
• 4:06
  SPEAKER_00: B cells come into the conversation with urticaria, but interestingly, also platelets.
• 4:11
  SPEAKER_00: And I think that makes it really central to the conversation around its effect on platelets.
• 4:18
  SPEAKER_00: So when we start to look at how this drug works for urticaria, it makes sense in that it's preventing these mast cells from degranulating and really driving the immune response.
• 4:29
  SPEAKER_00: But then we start to see a little bit of collateral damage.
• 4:32
  SPEAKER_00: It does have an impact on the platelets, probably impacts platelet function.
• 4:39
  SPEAKER_00: And so we're not going to see that in the PT, PTT, and INR.
• 4:43
  SPEAKER_00: But interestingly, with this medication, very few patients in the remix one and two trials had an impact on their bleeding time.
• 4:51
  SPEAKER_00: And so the impact of Remy brut nib on platelets, its effect is probably, you know, if we quantitate that effect, it's probably less than a baby aspirin.
• 5:03
  SPEAKER_00: So, how does that really play out in clinical practice?
• 5:07
  SPEAKER_00: For most of us, it doesn't really matter.
• 5:09
  SPEAKER_00: Small surgery, simple excision.
• 5:12
  SPEAKER_00: Most of these patients on baby aspirin usually don't stop, even high dose aspirin.
• 5:17
  SPEAKER_00: So these bleeding events are capturing really a bias, I think, from the first generation.
• 5:23
  SPEAKER_00: And most of these events weren't bleeding events, they were peticii and bruising.
• 5:29
  SPEAKER_02: Yeah, and you know what I misspoke actually, because the number one adverse event that occurred in the in the pivotal trials was nasopharyngitis, which as you and I can can attest to is pretty much every clinical trial program has the number one adverse event is nasopharyngitis, most likely not drug related.
• 5:46
  SPEAKER_02: And then as we go down, we see bleeding events at 9% and then headache at 7%.
• 5:52
  SPEAKER_02: So so you okay, so thank you so much for for kind of going over that.
• 5:55
  SPEAKER_02: And when we talk about you know all these bleeding events, first of all, they were all mucocutaneous related.
• 6:01
  SPEAKER_02: There were no severe uh events, none of these events were related as were were rated as severe by the investigator.
• 6:10
  SPEAKER_02: Uh, and I guess the they were all therefore moderate, mild or moderate.
• 6:15
  SPEAKER_02: And it looks like patekiae was the most common at about 3.8%.
• 6:21
  SPEAKER_02: Uh and all of these resolved uh with a median duration of 24 days.
• 6:27
  SPEAKER_02: And again, Jason, it sounds like most of them occurred within the first three months of treatment as well.
• 6:31
  SPEAKER_02: So if you're a prescriber out there and you're counseling your patients, if these patechia do occur, which again is a very low incidence, but most likely will occur early on in the treatment and uh and then most likely not recur, correct?
• 6:48
  SPEAKER_00: Yeah, it's been interesting to compare the clinical trial data to what we see in real clinical practice.
• 6:54
  SPEAKER_00: So, you know, one interesting comparison, we have, you know, quite a few patients actually on this therapy, but we also have the head-to-head, the dupilimab versus remibrutnib trial, the reclaim trial.
• 7:07
  SPEAKER_00: And what's interesting is that people that once they start on Remy brut nib, you see the bruising actually pretty early.
• 7:15
  SPEAKER_00: And patients will tell you, I just kind of get these small bruises, don't remember really hitting my skin anywhere.
• 7:21
  SPEAKER_00: They're not major, they're not really worrisome to a lot of patients.
• 7:26
  SPEAKER_00: They kind of come randomly.
• 7:28
  SPEAKER_00: Occasionally we'll see patechiae.
• 7:30
  SPEAKER_00: The patechiae, interestingly, uh what we've found is that they occur in areas where patients scratch.
• 7:36
  SPEAKER_00: So I have a really great picture of a girl that would she would scratch her neck and she has these nice four linear uh patechial changes on her neck.
• 7:46
  SPEAKER_00: And so I think it's really kind of having a minimal impact on platelets.
• 7:50
  SPEAKER_00: It's usually areas of trauma where we're not getting that you know coagulation quickly, or the pitechiae, we know there's that that breakage in the skin that's not being repaired.
• 8:00
  SPEAKER_00: But for the most part, what's interesting is patients aren't really that worried about it.
• 8:04
  SPEAKER_00: And remember in the clinical trials, there there was uh a major tooth extraction, I think an appendectomy as well that occurred on medication, and there were no major um sequelia complications.
• 8:16
  SPEAKER_00: So, you know, it it's really I I think the label, and in my opinion, is a little over-exaggerated in terms of making clinicians think they're gonna have major bleeding events.
• 8:27
  SPEAKER_00: I think the real issue is going to be those patients who are on you know anticoagulant therapy or high dose anti-platelet therapy for other conditions.
• 8:37
  SPEAKER_00: But remember, most of our article patients, they're pretty young and healthy.
• 8:41
  SPEAKER_00: A lot of these patients, it's you know, twice as common in female, very common between 20s and 40s, let's say.
• 8:47
  SPEAKER_00: And most of these patients are otherwise pretty healthy, maybe have a couple other autoimmune conditions like thyroid issues, but for the most part, we don't really see a lot of the issues that we'd worry about, say in a you know VA patient population where it's primarily older.
• 9:01
  SPEAKER_02: Yeah, I complet I completely agree.
• 9:03
  SPEAKER_02: I think the median age was in the mid-40s of the trials of the of the pivotal trials, again, predominantly female, which mirrors the incidence of disease itself.
• 9:13
  SPEAKER_02: So absolutely, we we tended to have a very healthy population.
• 9:17
  SPEAKER_02: And I think w one of the things to consider with the with the bleeding issue is it's in the warnings and precautions on the label.
• 9:24
  SPEAKER_02: So just to make sure everyone understands, because you know that we have some patients who open up that product insert, package insert, and they read the entire label.
• 9:32
  SPEAKER_02: And under warnings and precautions, it says risk of bleeding in a curve in you know, mucocutaneous-related bleeding in 9%.
• 9:39
  SPEAKER_02: And then it gives the uh recommendation to interrupt treatment with rap with rhapsodo for three to seven days pre- and post-surgery or invasive procedures.
• 9:49
  SPEAKER_02: It also says use of anti-thrombotic agents concomitantly with rhapsido may further increase the risk of bleeding, and therefore consider the benefits and risks of anti-thrombotic agents when using rhapsodo.
• 10:00
  SPEAKER_02: And of course, you'll want to monitor for signs and symptoms of bleeding as well.
• 10:04
  SPEAKER_02: So it's it's on there, it's it's under warnings and precautions.
• 10:07
  SPEAKER_02: I could see how that could be read as somewhat inflammatory and make people a little bit nervous.
• 10:13
  SPEAKER_02: But luckily, based on our you know, experience in the wild now, we see that okay, you know, you may see some patiki, as you said, in areas of trauma, they tend to resolve, tend to occur early on.
• 10:24
  SPEAKER_02: About 80% of patients just had one episode.
• 10:28
  SPEAKER_02: No patient had three or more, really, or more than three, I should say, excuse me.
• 10:32
  SPEAKER_02: So uh it it really, if it occurs, it's early, and you and you can make sure the patients understand not to be concerned if it does happen.
• 10:40
  SPEAKER_02: But like you said, and my experience as well, if it does happen, patients really haven't been concerned that much anyway.
• 10:45
  SPEAKER_02: So, so it's it's totally, totally fine.
• 10:48
  SPEAKER_02: Um, of note, um uh so aspirin uh up to doses of 100 milligrams daily or plavox or clopidogrill up to 75 milligrams daily were allowed in the clinical trials.
• 11:00
  SPEAKER_02: So just to know that we do have this data with patients who are on kind of baby aspirin or plavox.
• 11:06
  SPEAKER_02: So I think that's important to remember as well.
• 11:10
  SPEAKER_02: Um, Jason, anything else that you would like to say about these bleeding events just to wrap up?
• 11:14
  SPEAKER_00: Yeah, one other yeah, one other clinically important characteristic of the medication is that it's a very fast-acting medication.
• 11:22
  SPEAKER_00: So this plays into the bleeding events here as well.
• 11:25
  SPEAKER_00: So the onset's usually pretty fast, I think, for those patients who are gonna see some of the petican bruising.
• 11:32
  SPEAKER_00: It usually happens within sometimes the first few days, uh, certainly within the first couple of weeks for the most for my experience with most of those patients.
• 11:41
  SPEAKER_00: And one of the aspects of speed is important because when it's fast onset, it's also it's off fast, right?
• 11:49
  SPEAKER_00: So if patients do have to have surgery, stopping this medication, you know, has a big impact um on its effect.
• 11:59
  SPEAKER_00: Excuse me.
• 12:00
  SPEAKER_00: So for those patients who have to stop the medication, it's out of the system, you know, very quickly.
• 12:06
  SPEAKER_00: We're talking about a one to two hour half-life uh for the most part.
• 12:10
  SPEAKER_00: And that helps for planning.
• 12:12
  SPEAKER_00: It's much harder when we think about some of the biologics, for example, that have these prolonged half-life.
• 12:19
  SPEAKER_00: So there's an advantage, this medication, it can be quickly started, it can be quickly taken off in terms of its effect.
• 12:25
  SPEAKER_00: I think that's also a little bit of the weakness of this particular medication because it does have such a fast onset of action.
• 12:32
  SPEAKER_00: But if people miss a pill or they skip a day, uh again, you're taking it twice a day, morning and night.
• 12:39
  SPEAKER_00: We've had a lot of patients say, oh, if I, you know, if I forget my evening dose, I definitely have breakthrough activity.
• 12:45
  SPEAKER_00: So this is one important component of this medication where having good compliance and adherence with treatment, otherwise they may have inadequate disease control.
• 12:54
  SPEAKER_02: Okay.
• 12:55
  SPEAKER_02: Thank you for that.
• 12:56
  SPEAKER_02: That's all great uh information for us to consider.
• 12:59
  SPEAKER_01: This episode is sponsored by Novartis with content independently created by the Science of Skin Podcast.
• 13:05
  SPEAKER_02: As we move forward in in the um considerate safety considerations with Rhapsodot, vaccinations on label again, non-live vaccines are are okay, but live and live attenuated vaccines should be avoided, is is what's on label.
• 13:20
  SPEAKER_02: In terms of liver functions, yeah, there's no baseline labs required to start Rhapsodo.
• 13:26
  SPEAKER_02: And and I certainly don't check labs while patients are on it.
• 13:29
  SPEAKER_02: I don't know, Jason, do you do you vary from the label recommendation or do you do you do you check labs at all?
• 13:36
  SPEAKER_00: Yeah, so I think one of the confusing aspects of the label is um basically it talks about hepatic impairment, but it's really talking about child Pew class scoring, which by the way does not include LFTs.
• 13:50
  SPEAKER_00: And that's really important.
• 13:51
  SPEAKER_00: These are patients with ascites or liver cirrhosis, so these are patients that have low albumin, right?
• 13:58
  SPEAKER_00: We start to see some of those changes affecting the you know INR, for example.
• 14:02
  SPEAKER_00: So you don't want to read this label as saying if you have you know small fatty liver changes that you can't be on this medication.
• 14:11
  SPEAKER_00: These are uh really a score, a very specific scoring system looking at your risk of cirrhosis and ascites.
• 14:17
  SPEAKER_00: And so I think having that conversation, uh again, most of these patients are otherwise pretty healthy.
• 14:23
  SPEAKER_00: And interestingly, in the trial, there weren't any patients who met that scoring criteria in the trial.
• 14:29
  SPEAKER_00: So it's again, it's that disconnect from what actually occurred in the trial and probably some of the spillover from the first generation VTK uh medications.
• 14:40
  SPEAKER_00: So I, you know, here just it's important for clinicians to not read that and think about the typical liver changes that we see in patients because that's not what it's talking about.
• 14:49
  SPEAKER_00: But no requirement for testing for that reason because we're not going to be routinely checking coagulation labs, bleeding time, et cetera.
• 14:58
  SPEAKER_02: Yeah, I think um we we just need to differentiate the drug-induced liver injury that that you can see on some labels, and we can perhaps be concerned about with certain medications versus don't use in child pew B or C, which those patients have much bigger fish to fry than their hives, right?
• 15:16
  SPEAKER_02: That like you said, they're jaundice, many have ascites, especially with child Pew C.
• 15:20
  SPEAKER_02: So they probably won't be the ones coming into the office anyway with hives.
• 15:23
  SPEAKER_02: But um, you know, a good a good history like we should do with any patient when we're starting a new medication is is important to understand their their liver history.
• 15:33
  SPEAKER_02: But gosh, the the vast, vast majority of patients that walk into a dermatology office will not have that kind of moderate to severe liver impairment.
• 15:41
  SPEAKER_02: And and just to kind of tie a bow on this, uh in terms of elevations and ALT and AST, the the incidence on remibrutinum was exactly the same as placebo during the 24-week double blind period.
• 15:53
  SPEAKER_02: So we we really didn't see much effect, if any, on on the on transaminasis.
• 15:58
  SPEAKER_02: So you know, I I I don't think there's much to see there, but but certainly good to know about it and and you can kind of check that with a good history of a patient.
• 16:08
  SPEAKER_02: Um I guess the last thing to really talk about is a CYP3A4 drug interactions, Jason.
• 16:13
  SPEAKER_02: That's it sounds like Rhapsodo is metabolized by CYP3A4.
• 16:20
  SPEAKER_00: Yeah, so I uh really what you're looking at is the effect of other medications on Remy Brutinib or Remy Brutinib's effect on other medications that are gonna be going through that uh enzyme pathway.
• 16:32
  SPEAKER_00: So you do have to pay attention to the direction, especially as you're making a calculated decision, right?
• 16:38
  SPEAKER_00: So we are often going to use medications, even when there's maybe some mild interactions, we make that clinical decision making uh there at real in the real time uh with patients.
• 16:49
  SPEAKER_00: So you have to know which direction and which medication, right?
• 16:53
  SPEAKER_00: If you're dealing with a medication that has a very uh narrow therapeutic index, let's say some of the anti-convulsants, then you you have to approach that very carefully.
• 17:03
  SPEAKER_00: But we know that there are other medications that may be temporary or there may be mild interactions.
• 17:08
  SPEAKER_00: I think the clinicians have to just be aware of that list.
• 17:10
  SPEAKER_00: It's a horrible list of medications to try to remember.
• 17:13
  SPEAKER_00: I know that you deal with this in the trials, Ted.
• 17:15
  SPEAKER_00: It's like this is just one you just look up.
• 17:18
  SPEAKER_00: We have a list actually in the clinic where just list the very common medications.
• 17:23
  SPEAKER_00: This is always changing, but it's just good to run across that list.
• 17:27
  SPEAKER_00: I do think it's probably one of the most practical components of where you may run into a problem or or find that maybe another therapy is more ideal.
• 17:36
  SPEAKER_00: Uh we had a patient, for example, who would have been a great candidate, but was on uh an anti-convulsant, actually for trigeminal neuralgia, uh, really couldn't be on this medication.
• 17:46
  SPEAKER_00: So it does come up in our urticaria patients uh due to those other conditions.
• 17:51
  SPEAKER_00: So just run that list, double check it.
• 17:53
  SPEAKER_00: Again, for the most part, these patients are generally pretty healthy, but you're gonna see this every once in a while.
• 17:58
  SPEAKER_00: So it needs to be on your radar.
• 18:00
  SPEAKER_02: You know, because we're really focused on safety here, I just want to finish up with the adverse event profile.
• 18:06
  SPEAKER_02: Um, you know, bleeding at 9%, headache at 7%, placebo had 6%, nausea 3%, placebo had 2%, abdominal pain 3% versus 2% in placebo.
• 18:15
  SPEAKER_02: So again, gosh guys, this seems like an incredibly safe medication, especially now that we understand the bleeding and perhaps related to BTK's role in platelet aggregation.
• 18:27
  SPEAKER_02: Um, and certainly from the 600 plus patients who were on the active medication or Remi Brutinib in the phase three trials, we we only had one patient discontinue because of PTKI and all the cases were mild to moderate.
• 18:40
  SPEAKER_02: So I I feel very confident using this drug without re without needing to check any coag labs like you discussed, they wouldn't be helpful anyway, because we're like talking about platelet aggregation here.
• 18:52
  SPEAKER_02: Um so I I hope this gives people listening a little bit more confidence and understanding of the adverse event profile uh as well as the additional considerations that are on label, just so that again, maybe not not so important, but important to to at least have in the back of your mind as you're prescribing the drug and and kind of considering the patient type.
• 19:16
  SPEAKER_02: Um Jason, I think because you know you're such a great educator, I think it would be great just to talk about patient selection and counseling prior to starting this.
• 19:26
  SPEAKER_02: It's is do you have any patients for whom you may not consider this drug?
• 19:33
  SPEAKER_00: You know, we talked about the drug-drug interactions.
• 19:36
  SPEAKER_00: I I think that's probably the main thing.
• 19:39
  SPEAKER_00: Um the practical pearls for just everyday clinicians who, you know, maybe aren't in trials or maybe haven't had experience.
• 19:48
  SPEAKER_00: Really the only thing I think you I think you can get away with talking about just minor um patekiae or bruising for the most part.
• 19:57
  SPEAKER_00: I I really don't think the list of things you rattled off are there are things we see in virtually all the trials, right?
• 20:03
  SPEAKER_00: Uh nasal pharyngitis, headache.
• 20:06
  SPEAKER_00: I mean, these are just the everyday complaints people have.
• 20:08
  SPEAKER_00: So I really think the pateki and bruising is real.
• 20:12
  SPEAKER_00: It's very minor.
• 20:14
  SPEAKER_00: Most patients don't care.
• 20:15
  SPEAKER_00: They're able to sleep, they're not itching.
• 20:18
  SPEAKER_00: It's kind of interesting to them, and they are like, you know, pay attention to it.
• 20:22
  SPEAKER_00: I had a patient at the gym who, you know, dropped the dumbbell and she got a big bruise.
• 20:27
  SPEAKER_00: And again, that was just sort of an FYI.
• 20:29
  SPEAKER_00: She kind of knew what to anticipate.
• 20:31
  SPEAKER_00: So I think that's the conversation about the medication selection.
• 20:35
  SPEAKER_00: This can be used right after antihistamines, after high dose.
• 20:39
  SPEAKER_00: That's in the international guidelines.
• 20:41
  SPEAKER_00: You've got three options with homolysimab, dupliumab, and remibrut nib.
• 20:45
  SPEAKER_00: Uh, for patients who really want to take a pill, who feel like they're doing a good job at taking pills.
• 20:50
  SPEAKER_00: We had a lot of patients that were already taking blood pressure medication or cholesterol medication, for example.
• 20:57
  SPEAKER_00: Uh, they didn't mind incorporating, you know, the morning and the evening dose.
• 21:01
  SPEAKER_00: And also remember, these patients with herticaria have come from a world of a ton of pills.
• 21:06
  SPEAKER_02: Yeah, right?
• 21:06
  SPEAKER_00: They're taking a bunch of antihistamines and sometimes H2 blockers, right?
• 21:11
  SPEAKER_00: They they they they're used to a lot of pills.
• 21:14
  SPEAKER_00: So sometimes the twice-a-day dosing with Remy Brutin is actually a simplification of what they've been doing for many months or years.
• 21:22
  SPEAKER_00: So I think the pill patient is good right after antihistamines.
• 21:26
  SPEAKER_00: It works for wheels, it works if you have wheels and angiodema.
• 21:30
  SPEAKER_00: It worked in patients that had not responded well to omolysumab or had had a secondary failure with omolysumab.
• 21:38
  SPEAKER_00: It works in patients with low or high IgE.
• 21:43
  SPEAKER_00: So this really gives it versatility in terms of the endotypes that we know about with urticaria.
• 21:49
  SPEAKER_00: Um, and I think for the patient who walks in, that's really severe, right?
• 21:54
  SPEAKER_00: These patients that come in, they've got angioedema, their eyes are swollen, their you know, UC.
• 22:00
  SPEAKER_00: Score is very low or their UAS 7 score, activity score is very high with hives niching.
• 22:06
  SPEAKER_00: For those patients that would come in and say, give me prednisone, right?
• 22:10
  SPEAKER_00: Like I need something now, this is a good option because there are patients that in you know a day, a couple of days can have a pretty dramatic response.
• 22:18
  SPEAKER_00: So, you know, this really has kind of the Swiss Army knife of treatments for urticaria, and there's very few downsides overall.
• 22:28
  SPEAKER_02: I had a patient the other day, um, a 28-year-old female who I'd been treating for acne, and then she comes into the office and she had this huge swollen lip.
• 22:37
  SPEAKER_02: And I was like, What?
• 22:39
  SPEAKER_02: What's going on?
• 22:40
  SPEAKER_02: And she said, Oh, yeah, for the last couple of months or four months maybe, I've been having, you know, swelling on my face.
• 22:47
  SPEAKER_02: I'm like, you can tell me these things, you know.
• 22:50
  SPEAKER_02: Right.
• 22:51
  SPEAKER_02: She's like, Yeah, it's completely embarrassing.
• 22:53
  SPEAKER_02: I'm not, you know, I don't go out in public.
• 22:55
  SPEAKER_02: I mean, you're fixing my acne, but this is now happening.
• 22:58
  SPEAKER_02: And so then we started talking about Remy because it was a great use case for Remy.
• 23:03
  SPEAKER_02: In addition, she was having hives as well, but the angioedema was really driving her crazy, uh, as you can imagine.
• 23:09
  SPEAKER_02: So um I I was super grateful to have this drug available uh to treat this young woman and and many other patients.
• 23:17
  SPEAKER_02: So um, you know, as a final comment, I would just say that the there's no box warning for this drug.
• 23:22
  SPEAKER_02: You know, it does work inside the cell, but differentiate this from the Jack inhibitors that we're using for other inflammatory skin diseases, there there is no box warning for Remy Brutnib.
• 23:32
  SPEAKER_02: And I think that we have, you know, comprehensively covered some of the the um safety issues and questions that you may encounter, but you know, not not not to downplay them, but I just make want to make sure, and and Jason, you did a great job.
• 23:46
  SPEAKER_02: I want to make sure everybody understands, yes, it's a low incidence, it's it's low intensity as well, and low bother for the patients, for the much for the majority of patients.
• 23:55
  SPEAKER_02: So it really that that's great.
• 23:56
  SPEAKER_02: Nothing's perfect.
• 23:57
  SPEAKER_02: Every drug has its a little bit of drawbacks, and and Remy is is can't can't escape that.
• 24:02
  SPEAKER_02: But um, I think for CSU, it's uh it's such a great addition to our inventarium.
• 24:08
  SPEAKER_02: So uh Jason, thank you so much once again.
• 24:11
  SPEAKER_02: You have been incredible.
• 24:12
  SPEAKER_02: Uh we're you know, what's it been a maybe a month or two since we've had you on?
• 24:16
  SPEAKER_02: I'm sure we'll we'll reach out again.
• 24:18
  SPEAKER_02: Um I hope you're having a great summer.
• 24:20
  SPEAKER_02: Everything going well?
• 24:21
  SPEAKER_00: Everything's going well.
• 24:22
  SPEAKER_00: Always happy to get on and talk about urticaria.
• 24:25
  SPEAKER_00: It's just it's amazing how fast this particular area in dermatology has been evolving.
• 24:31
  SPEAKER_00: So, you know, the trial just keep coming and the new medications, and we're figuring out the pathogenesis.
• 24:37
  SPEAKER_00: So uh this is this has been fun.
• 24:38
  SPEAKER_00: So I'm happy to have been here.
• 24:40
  SPEAKER_02: All these medications have different targets, like they're not all in the same class.
• 24:44
  SPEAKER_02: It's amazing.
• 24:45
  SPEAKER_02: Yep.
• 24:46
  SPEAKER_02: Yeah.
• 24:46
  SPEAKER_02: Um, well, listen, guys, thank you so much for for listening to the Science the Skin podcast.
• 24:50
  SPEAKER_02: If you like the episode, please give us a five-star rating, subscribe, and tell all your friends.
• 24:55
  SPEAKER_02: That's how we've really grown this podcast is through word of mouth.
• 24:58
  SPEAKER_02: And we have great guests like Dr.
• 25:00
  SPEAKER_02: Jason Hawkes from Oregon, and uh they're able to educate us on the latest and greatest in all facets of dermatology.
• 25:06
  SPEAKER_02: So if you have any questions or ideas for future episodes, please shoot us an email at inquiry at science of skinsummit.com.
• 25:13
  SPEAKER_02: That's inquiry at science of skinsummit.com.
• 25:16
  SPEAKER_02: Otherwise, thank you so much for listening.
• 25:18
  SPEAKER_02: For Dr.
• 25:18
  SPEAKER_02: Jason Hawks, I'm Ted Lane.
• 25:20
  SPEAKER_02: Thanks again.
• 25:31
  SPEAKER_01: This episode is sponsored by Navartis, with content independently created by the Science of Skin Podcast.