Ladies and gentlemen, thank you for standing by, and welcome to the Canixxra Announces the FDA Approval of Arteclis for Recurrent Pericarditis conference call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Mr.
Mark Ragosa, Chief Financial Officer. Sir, you may begin.
Thank you, Valerie. Good evening, everyone, and thank you for joining Kinixa's call to discuss the FDA approval of Arclis for recurrent pericarditis. A press release announcing the approval as well as the presentation for today's call can be found on our website under the Investors and Media section. As for the agenda, our CEO, Sanjay Patel, will start with an introduction. John Paolini, Kamiq's Chief Medical Officer, will follow with a review of the ARPULUS label and the statistically significant data from RAPSODY, our pivotal Phase III trial in recurrent pericarditis.
Ross Mote, the Arplus General Manager, will detail our commercial operations and strategy. And finally, Sandro will turn for closing remarks before we start the Q and A session. Before getting started, please note that we'll be making forward looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements. A review of these statements and risk factors are found on this slide as well as under the heading of Risk Factors in our SEC filings. And with that, I'll turn the call over to Sanj.
Thank you, Mark. Good afternoon, everyone, and thank you for joining us on this very exciting call. I'm thrilled to be here today to discuss the FDA approval of Arcolyst, previously known as ronaset, for the treatment of recurrent pericarditis and reduction in risk of recurrence. This is a massive milestone for patients with recurrent painful and debilitating auto inflammatory disease. We believe the approval of ARCHALIST represents a transformational therapeutic advancement in the treatment of patients with recurrent pericarditis.
Less than 6 years ago, we set out to build a company to help patients suffering from devastating diseases. And only 3.5 years ago, we in licensed ARCHALIST, which is also approved in CAPS and DIRA from Regeneron to develop it for the potential treatment of recurrent pericarditis. Throughout this time, we've been exceedingly focused on improving the outcomes for patients. And this approval is a testament to our exceptional team, whose hard work and unwavering devotion to patients achieve our first commercial launch. I'd like to take this opportunity to reiterate our sincere appreciation to the recurrent pancreatitis community, which includes the patients, nurses, physicians and caregivers who participated in the clinical trials and that have played a critical role in getting us here today.
While today is certainly an S. Commercial and medical affairs teams and helping to ensure that patients who may benefit from Alcarist have access to it as quickly as possible. I'll come back later at the end of the presentation to share with you the rest of the exciting pipeline and the number of near term milestones that we have coming up. Ross Moats, the Arcolyst General Manager will discuss our tactical operational plans as well as the strategic commercial approach and the organization that we already have in place. But before that, I'll now turn the call over to John Paolini, our Chief Medical Officer, who will walk you through the Arcolysis label and the data that supported it.
John?
Thank you, Sanj, and good evening, everyone. The approval of Arcolis for recurrent pericarditis could be a potentially transformational therapeutic advance in the management of patients with recurrent pericarditis. We start as always with the patients and it is important to remember that recurrent pericarditis is a painful and debilitating auto inflammatory disease. Recurrent pericarditis typically presents with chest pain, often associated with changes in electrical conduction and sometimes build up a fluid around the heart called pericardial effusion. Recurrent pericarditis episodes are painful and debilitating, lead to frequent emergency department visits and hospitalizations and sometimes there are life threatening complications.
For these patients, this chronic disease is highly disruptive to quality of life. Until today, there has not been any FDA approved therapies. These patients are typically treated with NSAIDs, colchicine and even corticosteroids often for years. But we have to realize that the treatment itself then adds to the morbidity of the disease. Putting it all together from the patient perspective, beyond the severity of the disease and the side effects of the medication, the unpredictability of these recurrences forces changes in lifestyle in an effort often futile to avoid precipitating the next event.
This can all result in significant anxiety and depression. Patients and physicians often resort to opioids to manage the pain. The main areas of unmet need that the patients have identified are resolution of acute pericarditis episodes, reducing the risk of subsequent episodes while on treatment, steroid sparing disease control and finally improvement in their quality of life. Kinixa wanted to do better for these patients. So the identification of the IL-one alpha and IL-one beta as key mediators of the disease created the opportunity to develop a targeted immunomodulation approach.
Arcolist is an engineered IL-one soluble decoy receptor invented by Regeneron, which traps both IL-one alpha and IL-one beta. With a decade of clinical experience as an approved product in the U. S. For caps, while ARCHALYST appeared to us to be ideally suited for the bench to bedside approach to treat patients suffering from this devastating disease. ARCHALIS was initially approved in 2,008 for the treatment of cryopyrin associated periodic syndromes or CAPS, including familial cold auto inflammatory syndrome, FCAS and knucklewell syndrome in adults and children 12 years and older.
And subsequently in 2020, for the maintenance of remission of the deficiency of interleukin-one receptor antagonist or DIRA in adults and pediatric patients weighing at least 10 kilograms. ARCHALIST has now been approved for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. The data that has been incorporated by the FDA into the label underscore the strength of the data from the Phase 3 study RAPSODY, which was designed to inform both the treatment of recurrent pericarditis and the reduction of risk of recurrence. The results of this study were recently published in the New England Journal of Medicine in November of 2020. RAPSODY was a global pivotal Phase III clinical trial of Arcolis in recurrent pericarditis, which utilized a randomized withdrawal design.
While enrolling a broad representative recurrent pericarditis patient population, we focused the study on those suffering with the highest level of unmet need, Patients with idiopathic and post cardiac injury pericarditis who were acutely symptomatic, breaking through standard therapies such as NSAIDs, colchicine and corticosteroids in any combination. We will now review these data, which are designed to inform those 4 data areas of unmet need and help clinicians and patients understand the data supporting how Arcolyst be used. Data from the run-in period showed rapid resolution of acute pericarditis episodes with rapid and sustained reductions in both reported pain and inflammation as early as after the first dose. The median time to treatment response was 5 days with a 97% treatment response rate. Turning to tapering and discontinuation of standard of care treatments, time to ARPALIST monotherapy was 7.9 weeks, 2 weeks earlier than the protocol specified maximum of 10 weeks.
Approximately half of the patients in the study had been receiving corticosteroids at baseline and these patients tapered off and transitioned to Arcolyst monotherapy also within 8 weeks. None of the patients treated with corticosteroids at baseline and randomized to Arcolyst monotherapy experienced a recurrence while on therapy. The study met its primary efficacy endpoint time to first adjudicated pericarditis recurrence in the randomized withdrawal period. This Kaplan Meier curve shows Arcolysis recipients in purple and placebo patients in gray. Median time to first recurrence in the placebo arm was 8.6 weeks after randomization, consistent with the expected washout pharmacokinetics of weekly Arcolis at steady state.
Almost half of those went on to suffer a recurrence event in the placebo arm did so within the 1st month after randomization, underscoring the tenacity of recurrent pericarditis. Median time to first recurrence in the Arcolysis arm could not be calculated calculated. There were only 2 events in the Arcolyst arm and these occurred after brief temporary study drug interruptions of 1 to 3 weekly doses. The hazard ratio of 0.04 means that patients randomized to Arcolist experienced a 96% reduction in risk for a recurrent pericarditis event with a highly statistically significant p value of less than 0 point 0,001. Finally, bailout Arcolyst when given to patients who experienced an on study pericarditis recurrence resulted in resolution of the acute episode.
These data demonstrate that in this study of patients with recurrent pericarditis remaining on continues ARCHALIST therapy resulted in continued clinical response and a reduction in the risk of recurring events. While on therapy, patient symptoms remained reduced and clinical response was maintained as evidenced by the major secondary efficacy endpoints in the randomized withdrawal period, which were also highly statistically significant. From the patient perspective, 92% of trial days through week 16 were reported by patients treated with Arcolis as being pain free or at most experiencing minimal pain versus 40% of trial days for those on placebo with a p value of less than 0.0001. The warnings and precautions for Arcolis remain the same as those for CAPS and DIRA indications and the most common adverse reactions in the recurrent pericarditis clinical studies occurring in greater than or equal to 10% of patients included injection site reactions, upper respiratory tract infections, myalgias and arthralgias. We believe that Arcolist could represent a significant advance in the treatment paradigm of recurrent pericarditis in clinical practice.
The mean duration of recurrent pericarditis from real world evidence is approximately 2 years from the first episode. RAPSODY patients had 2.4 years of disease duration prior to trial entry. The data point to recurrence of inflammation and symptom breakthrough after premature cessation or interruption of treatment in patients with continued auto inflammation. The median duration of ARCHELUS treatment in RAPSODY was 9 months up to 14 months to the point when the event driven portion of the trial concluded. At that time, 74 out of 75 eligible patients rolled into the long term extension, potentially indicating satisfaction with treatment and ongoing patient outcomes.
In general, the duration of treatment will likely be individualized to each patient depending on the baseline characteristics and potentially supplemented with imaging data while on treatment to elucidate the severity and duration of the underlying auto inflammation and IL-one production. One other important concept from Rhapsody is steroid sparing. Nearly half of the patients entering the trial had previously been receiving corticosteroids and these patients while on Arcolyst monotherapy had outcomes similar to
the total
population. In addition, the data also support potentially obviating the need to initiate steroids in patients who are failing ANZYZY or COLCHISY. Ultimately, these data support a potential paradigm shift in the therapeutic strategy from broad immunosuppression to targeted immunomodulation for the management of patients with this devastating disease. I'll now turn the call over to Ross Mote, the Arcolis General Manager to detail our commercialization strategy. Thank you.
Thanks very much, John. We're clearly very excited to have the approval of our first commercial product. Not only does Arclis become the 1st and only approved drug in recurrent pericarditis that has the potential to become the standard of care. Recurrent pericarditis represents the 3rd indication for ARCHALIST following on from CAPS and DERA and further supports the utility of interleukin-one alpha and beta blockade. As a reminder, Kynixa now controls the full sales and distribution for all three indications in the U.
S. Importantly, whilst our promotional efforts will be focused on recurrent pericarditis, we remain fully committed to serving patients who are and will be treated with Arcolis across all of the indications. Turning to Slide 18, I'll take a moment to outline our field team. I'm happy to announce that we have fully hired our cardiology specialist sales team of 27 clinical sales specialists that are on board, trained and will be ready to roll over the coming days. This team have on average 16 years commercial experience with robust knowledge of virtual selling and drug launches, 2 thirds of whom have extensive cardiovascular experience and the remaining have backgrounds in biologics or rare diseases.
For several months, we've also had our payer team in the field conducting early payer engagement as well as our patient access leads who will support healthcare providers and patients during the initiation and journey with Arcolis. Our medical science liaison team have been in the field for more than 2 years and continue to disseminate our compelling clinical data from is on the 14,000 patients on their 2nd recurrence who have the highest unmet need, the refractory, multiple relapsing, poorly controlled and steroid dependent patients. These patients have failed on current systemic non targeted treatments and require a solution that directly addresses interleukin-one alpha and beta, the underlying drivers of pericardial inflammation. This allows for a very clear call to action for health care providers. Slide 20 highlights our targeted strategy.
Through market research and claims analysis, we believe that around 70% of our target patient population is concentrated at around 800 practice settings. During the early launch phase, our sales team will target the top 10 to 15 highest potential accounts per territory, which will cover around 45% of all the recurrent pericarditis patients nationally. This focus will help to enable rapid uptake within the target population and ensure the high touch support during the prescribing and initiation period. Just a quick word on launch preparations in this COVID-nineteen environment. Since the start of the pandemic, we pivoted very quickly to using online tools and we have been conducting all of our disease awareness activities virtually.
Physicians are now quite used to virtual sales calls and our team are experienced in this environment and most have existing relationships with cardiology teams. Some areas of the country have returned to in person engagement. So where we can, we will utilize that and also continue with digital technologies through effective and compliant virtual engagements. Turning to Slide 22. I'd like to highlight some of our key activities.
We've been conducting disease education for some time, including through heartofinformation.com, which is designed for healthcare professionals and watchespericarditis.com, designed for patients. The community has been extremely responsive. We've had over 700 medical organizations visits and now we have more than 1,000 patients and caregivers registered with Kinixa, demonstrating strong engagement with the physician and patient community. Additionally, earlier this year, we launched a series of webcasts for patients suffering from recurrent pericarditis. Now that we have approval, we will continue to boost these further to boost the awareness of ARCLIF and the importance of IL-one alpha and beta inhibition.
The appointments set up with the top target accounts over the coming days and our MSL team will continue to support disseminating the data and the final PI. We continue to have been very active with patient organizations, the Pericarditis Alliance, Myocarditis Foundation and the Auto Inflammatory Alliance all continue to provide excellent patient to patient support for this community. With the payers, we continue to be pleased with the receptivity of the data and the understanding of the disease. To remind you, the price of ARCHALYST is $20,000 per month and has been established since 2,008 with very broad commercial coverage for caps. In recurrent pericarditis, we received breakthrough therapy designation, orphan drug designation and are now the 1st and only approved therapy.
The pricing is consistent with other specialty biologics and we aim to secure broad access with minimal payer restrictions for our target population. We expect the majority of payers would establish favorable coverage policy within 6 months and almost all payers to have updated coverage policy within a year. In the meantime, given the current coverage in CAHPS and DIERA, we anticipate that Arcolyst will be approved by some payers via an exceptional review very typical for line extensions until full coverage is in place. We have invested in our patient support program. This service will support both patients and physicians on their journey with Arclis.
This service provides personalized one to one support for every Arclis patient through every step of the treatment journey. The Kinixa patient access lead will serve as the primary point of contact for health care providers and patients to support them with determining insurance coverage and benefit verification, assist them with the prior authorization and any appeals where required, providing injection training during the patient's initiation and identifying any financial assistance for eligible patients. Patient affordability is one of the core principles of this program. The service will offer a suite of programs to eligible patients to ensure that patient gains access to treatment. Our patient services team are fully staffed and ready to guide physicians and patients.
And before I hand back to Sanj, I'd like to say that having led many launches, I'm very encouraged by the early interest from target physicians, the engagement from patients suffering from the current pericarditis and the number of payer meetings that the teams have been completing. As this is a flaring disease, this launch is going to be a steady and progressive build. This early launch period is about getting the commercial wheels in motion and setting the stage for ARCHULIST's success for revenue to be built in the coming quarters. We're very excited by the opportunity ahead and look forward to supporting patients on ARCULIST. Sanj, over to you.
Thanks, Ross. Slide 26 is a reminder of the profit share arrangement with Regeneron. With the approval of Arcolyst in recurrent perioditis, we will book and evenly split profits on sales of Arcolyst for all the approved indications in the U. S. That includes CAPS and DERA after deducting certain commercialization expenses subject to specified limits.
We will pay Regeneron 50% of this adjusted gross profit, which will be reflected as a separate line item within the operating expenses. So before we take questions, I want to reiterate our excitement of this launch. We are extremely focused on building the maximum value across our entire portfolio. And the fact that we have multiple programs gives us a tremendous amount of optionality to allocate capital relative to the opportunity for the benefit of patients and shareholders. I'll give you an overview of the rest of our product candidates.
We're evaluating mabozolimab in giant cell arthritis and severe COVID-nineteen pneumonia and hyper inflammation. We have vixolilimab in prurigo nodularis. And last, but by no means least, we're also conducting a clinical trial for our anti CD40 program, KPL404. Each of our product candidates have the potential to be best in class therapies and they're all supported by validated mechanisms. Additionally, the initial indication for each one of our product candidates offers potentially attractive commercial prospects as indicated by their current addressable populations.
In terms of the commercial rights for our programs, we maintain worldwide rights for the 3 product candidates I just mentioned. We continue to be energized by our progress across our entire pipeline. And we have near term data coming up in MAVI and our anti CD40 program in the first half of this year. And we believe we're well positioned to execute throughout this year and beyond. And importantly, we are very well capitalized.
So with that, we want to thank you all for joining us on this call today. And operator, I'll turn it back to you to open it up for questions. Thank
you. Thank you. Our first question comes from Paul Choi of Goldman Sachs. Your line is open.
Hi, good evening and congratulations to you, Sanj and team on the the really quick march from in licensing to approval here. A few questions from us, please. Just looking at the label, it's pretty expansive and on the safety side, it's not there's nothing really new. So I think in the trial, you had a median of like 3 prior events and I think Rob spoke to targeting patients with 2 prior events. But I
was just
curious since the label is not specific to the number of events, just how you think about potentially targeting the first recurrence population? Are they just harder to identify? And just how you think about targeting that incremental group of patients?
John, why don't I hand it over to you to take that?
Happy to and good evening, Paul. Nice to speak with you. Thanks for the question. So your question really deals with the question of treatment of patients maybe even as early as their first recurrence of pericarditis. In our view scientifically, the biology is the same.
Once these patients have been identified as having had recurrent disease, they tend to present very similarly with pain, with elevated markers, specifically C reactive protein as well as other pericarditis manifestations. And so biologically, it would make sense that with interleukin-one being the primary mediator of their disease that targeted immunomodulation with Argalyst that would be in a position to interrupt that disease. And the label as written is supportive of the treatment of patients who have recurrent pericarditis and does not specify a particular number of recurrences that are required.
Okay. Thanks for that. And then maybe as a follow-up, can you maybe provide any updates with regards to the extension portion and just where duration of therapy or duration of treatment is shaking out and just sort of your best sense as to what it might look like on the label because a fair amount of patients were continuing on to the extension portion. So just that I think provides a potentially meaningful driver to your revenue outlook. So any update there would be great.
So maybe what I could do is I can talk about the long term extension and some of the elements of design and then I can turn it over to Ross to handle the issues of the transition, if you will, from the long term extension into commercialization. So with regard to your question about the long term extension, yes, when the randomized withdrawal portion of the study closed, 74 out of 75 of the eligible patients transitioned to open label Archivist. And so with that transition, they were eligible to receive up to 2 years of additional therapy. If you look in the American Journal where we have the study design published, you'll see there that after 18 months of continuous treatment from their most recent pericarditis episode, acute pericarditis episode, they are eligible for an evaluation potentially with cardiac imaging to either continue therapy for the full 2 years or to interrupt study drug to stop study drug under observation with the option to resume treatment if the pericarditis recurs. So that's how the trial is designed.
At this point, there are patients at various stages of their follow-up therapy. So we don't have any additional information at this time about the rollout of the data. But I think more importantly from the patient perspective, I'll turn it over to Ross to talk about the transition in the U. S.
Yes. Thank you very much, John. Thanks for that question, Paul. So RAPSODY, as you know, is a global study. We had 74 out of 75 patients roll into the long term extension portion of the study.
And as you may remember, around half of those patients are enrolled in the U. S. So these patients are now able to convert to commercial supply without treatment interruption. If indeed the treatment physician determines continued treatment is warranted for those patients. Ex U.
S, patients will remain in the extension for up to 2 years of treatment.
Okay. Thank you for that. And maybe just one more quick one to Sanj, just on the EU or rest of world strategy ex MENA, just any updated thoughts there on the regulatory path and potential timing?
Yes. Thanks, Paul. So obviously, our current efforts are now focused on the commercialization of Arcolyst in the U. S. But in parallel, we are absolutely exploring opportunities for other regions, including EU and Japan, Asia, potentially South America.
But at the moment, we're focused on the U. S. And we are in parallel doing that work. So hopefully more to come.
Okay, great. Thank you and congratulations again.
Thanks, Paul.
Thank you. Our next question comes from Geoff Meacham of Bank of America. Your line is open.
Good afternoon, everyone. This Jason on for Jeff. Congratulations on the approval. Just a few from us. In terms of thinking about uptake, where do you see kind of the greatest potentials for bottlenecks?
And given how much you've invested already into the launch strategy, how meaningful do you think these are going to be? I'm just thinking in terms of kind of the payer willingness, what does that look like?
Yes. Hi, Jason. Very happy to take that question. Thank you very much for the question. So yes, we're really excited by making it to markets and being able to reach patients now in recurrent pericarditis.
We've put a lot of pre work in the pre launch environments around disease education, really sharing a lot of awareness and education around the disease. And now we're at the time of launch. We know that there will be some bottlenecks there in terms of the patient throughput. We know recurrent pericarditis is a flare in disease. But we spent a lot of time really working with the community.
We have a pool of patients, as I said during my main presentation, that are registered with Kinixa now. And we think the patients will really mobilize towards their physicians now that we have a broad label in place. The points that you mentioned around payer reimbursements, it would take some time to get the payer coverage in place and for the law to really have policies fully finalized. However, we have a Kinixa OneConnect service that's now going to be up and running, really supporting the physicians through the prescribing and gaining the coverage for patients through the exceptional review process where that's possible for the patients. So as I said, I think we'll be a slow and steady build because of some of those reasons as well as others.
But we're confident in the data that we have and the engagement that we've had with payers, patients and physicians to this time point to get patients prescribed and initiated on ARPIST. Perfect.
Thank you. That's very helpful. And then can you comment on maybe the potential of moving upstream, so perhaps in more of an acute setting or kind of an initial bout of pericarditis, what's the potential of using Arcolist in that sort of treatment setting, maybe the patient has higher risk of recurrence, but maybe isn't
quite there yet? Yes. Thanks, Jason. Maybe I'll take that as well and hand over to John, if you have anything to add additionally afterwards. But ultimately, we're really pleased with the broad label that we just got from the FDA.
That certainly supports our target population, which is the 14,000 patients that experience multiple recurrences. We think they are the patients that are most in need and really where we want to start. In time, quite possibly, physicians may expand the utilization. One example may be in the group of patients that have just one recurrence, but high risk factor categories, such as cardiac tamponade with significant effusion or constriction. But that may happen over time.
At launch, our focus is really going to be on those 14,000 where we have very solid compelling data behind and there's a clear call to action from physicians to treat those
patients. Thank
you. Appreciate the insights.
Thank you. Our next question comes from David Negraffson of Wedbush. Your line is open.
Hey, thanks and congrats. I have one question, maybe it's related to a couple of the earlier questions. But in your discussions with payers, understanding if this is probably going to be in patients with a second or third recurrence, have you had any discussions on or with those payers on whether there might be a time limit or speaking to an earlier question about trip duration, time limits of therapy like when or in discussions with doctors, is there a duration where a doctor feels the patient is likely to have a long term relapse? Or is there any thoughts around that? Just thinking about when is a patient considered essentially a responder and unlikely to relapse and that has any bearing on duration of therapy in the clinic now that you're going to be commercialized?
Thanks Or in discussion of those payers. Thanks.
Thanks very much, David. I'm happy to make a start on that question. Again, I'll just can add if they have additional insights to provide. But yes, I mean, as I say, certainly, we're going to be focused on a core group of patients and we'll wait and see what the payer reaction will be after we get out and message post launch now, but be really happy with how responsive they've been in the lead up until this time. In terms of treatments, we're really focused on those with 2 or more recurrences.
There are other treatments that are used earlier on in the disease course, which are non targeted and systemic, such as NSAIDs and colchicine and often corticosteroids as well. We think that NSAIDs and colchicine will really kind of keep us the mainstay for that first acute pericarditis episode and likely on the first recurrence very often as well. With corticosteroids, however, they are linked to disease recurrence and longer disease course. They're linked with substantial safety and toxicities of concern. So really having an ability to wean patients off corticosteroids or to act as a steroid sparing agent, I think, has a strong place and then both payers and patients and physicians will want to avoid
that approach. Right. And then maybe for me just to add in the Rhapsody data. So in terms of the evidence base, specifically with ARPELIST, the treatment experience in RAPSODY was a median of 9 months of treatment and up to 14 months of treatment at the time that the event driven portion of the trial was concluded. And at that point, that was when the patients transitioned over into the long term extension for open label rilanicept.
So I think that adds a little bit of additional information about the experience with rilonecept and the management of disease, especially when thinking about the fact that the reduction in risk that was associated with that treatment was a 96% reduction in risk. And while patients were on that continued therapy, the 92% of trial days were associated with non or minimal pericarditis pain.
I guess maybe is there when you've discussed these findings with doctors, is there an agreement that this should be really a longer term treatment? Or like I said, is there more of a perception that I would treat a patient for a year or so and feel that they're unlikely to relapse in the future. Is that unknown at this point? I'm just curious if that's evolved with doctors as you build lately? Thanks.
John, do you want to go?
Yes. So, what we know from some of the registry data is that we know two things. One is that many of these patients, certainly the ones that are on steroids are often in treatment often for years. And so that gives you a sense of the duration of the disease in general terms. We also know from some of the different registry data that if there's interruption of treatment or premature termination of treatment that that's associated with worse outcomes and recurrence of disease.
And that was shown in some of the European registries. And actually you even see it in Rhapsody where you see that the 2 patients for the only recurrences that took place in the ArcoS arm, for example, there were only 2 of them. And those occurred in the setting of temporary study drug interruption of 1 to 3 doses. So I think what that tells you is that as long as auto inflammation is present, that then continued treatment results in continued treatment response. And so I mean that's I think the educational piece that we'll work on with physicians to make them aware of the data.
I'm showing no further questions at this time. I'd like to turn the call back over to Sanj Patel for any closing remarks.
Thank you very much, operator. I appreciate everyone's time today. Obviously, we're very, very excited. It's been a great result for us. I just want to reiterate once more that we're obviously very pleased with the approval.
We're pleased with the review that the agency, the FDA did. I want to remind everybody that Arclis is indicated for the treatment of recurrent preheumatoid arthritis and reduction in risk of recurrence. So with that, I want to thank everybody for joining today, and I'm sure we'll be in touch soon. Thank you very much. Bye bye.
Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all for participating and have a great day. You may all disconnect.