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How Are Progressive ILD and PH‑ILD Treated? · UF Health MedEd Cast

• 0:03
  Melanie Cole, MS (Host): Welcome to UF Health MedEd Cast with
• 0:05
  UF Health Shands Hospital.
• 0:07
  I'm Melanie Cole.
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  And today, we're offering updates on diagnosis and treatment of
• 0:11
  interstitial lung disease and PH-ILD.
• 0:15
  Joining me is Dr.
• 0:17
  Jared Freitas.
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  He's an Assistant Professor in the Division of Pulmonary, Critical Care,
• 0:22
  and Sleep Medicine at the University of Florida College of Medicine.
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  Dr.
• 0:26
  Freitas, thank you so much for joining us today.
• 0:29
  So, what are some of the most significant updates or advancements
• 0:33
  in our understanding as we think of interstitial lung disease and pulmonary
• 0:38
  hypertension interstitial lung disease?
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  Since you've begun practicing medicine, Dr.
• 0:43
  Freitas, what do we know now that we didn't know, say, 10 or even 15 years ago?
• 0:49
  Dr. Jared Freitas:
• 0:49
  First off, thank you so much for having me on.
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  This is a pleasure, I'm glad that I can come on and talk to everyone about
• 0:57
  things that I'm pretty passionate about.
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  So, to begin, because you asked a very excellent question, but
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  that takes some unpacking.
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  I think it's always helpful whenever we're talking about
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  what's new to talk about what the paradigm has been up to this point.
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  The field of, like, interstitial lung disease has progressed significantly
• 1:18
  since I've even been in medicine.
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  For the longest time, we didn't really have any treatments
• 1:23
  for interstitial lung disease.
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  It's specifically for IPF, which many people think of as the poster
• 1:29
  child for interstitial lung diseases.
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  And that changed in 2014 when the FDA approved two anti-fibrotic medicines
• 1:39
  called nintedanib, which is the brand name Ofev or pirfenidone,
• 1:44
  which is the brand name, Esbriet.
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  There were some landmark trials at the time that showed that both of these
• 1:51
  medicines working on different molecules and kind of a general fibrotic pathway
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  were able to slow down the creation of scar tissue or fibrosis in the lung.
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  And that was a huge kind of paradigm shift or game-changer at that time,
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  and that was all the way back in 2014.
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  Currently, over the last decade or decade and a half, there's been a
• 2:13
  large push in the field to identify new molecules to both treat IPF as well
• 2:21
  as other interstitial lung diseases.
• 2:23
  Because, believe it or not, there are more diseases under the
• 2:26
  umbrella term ILD other than IPF.
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  One of them, which was just approved, is called narendomilast, and the
• 2:34
  brand name for that is Jascayd.
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  We can kind of talk about the details of that trial and what's different.
• 2:40
  Melanie Cole, MS: Well, I would like to hear about that.
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  And before we do, for other providers, what are some of the early warning signs
• 2:47
  of ILD and PH-ILD that patients and general practitioners should not ignore?
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  How can they be picked up sooner in primary care?
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  Because, Dr.
• 2:55
  Freitas, that is often who sees these patients first.
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  Dr. Jared Freitas:
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  One of my colleagues is actually working on a project about trying to
• 3:04
  get better awareness in primary care.
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  So, that we can get earlier referrals, if there's any sort of worry
• 3:11
  about interstitial lung disease.
• 3:12
  But the issue with ILD is that the symptoms can be
• 3:15
  non-specific, especially at first.
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  But it's usually longstanding shortness of breath decreased exercise
• 3:21
  intolerance, or patients are not able to do as much as they were before.
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  Sometimes, a dry cough that's been ongoing or a hacking cough
• 3:29
  that just doesn't seem to go away.
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  And a constellation of those symptoms would prompt a provider
• 3:35
  to usually get a chest X-ray first.
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  Sometimes, interstitial abnormalities can be picked up on that, but a
• 3:42
  high-resolution CT scan is the test of choice that would show abnormalities.
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  Usually, we may be the ones that are ordering that test.
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  But especially, a provider orders one and finds abnormalities, then that
• 3:57
  should certainly prompt a referral.
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  But definitely, not just ignoring those symptoms or ascribing them
• 4:04
  to age or obesity is important.
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  Because a lot of times, we get patients who should have been referred sooner.
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  And unfortunately, most of the time, there's already been
• 4:13
  damage that can't be reversed.
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  And so, we're just working very hard to stave off any further damage.
• 4:19
  Melanie Cole, MS: Well, along those lines then, Doctor, tell us about some
• 4:23
  of the updates in diagnosis today.
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  You mentioned testing.
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  And compared to five or 10 years ago, is there any diagnostic equipment,
• 4:32
  radiologic intervention, things that excite you right now that have changed?
• 4:37
  Dr. Jared Freitas:
• 4:37
  Yeah.
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  I think the field in general is moving farther and farther away
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  from more invasive modalities and trying to just diagnose patients
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  with labs and radiography alone.
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  So for instance, like in the most recent update to the IPF guidelines, in 2022,
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  the ATS released updates that talked about both progressive pulmonary fibrosis
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  and IPF, and the consensus was to move away from surgical lung biopsy.
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  And if someone is going to pursue a biopsy, if the institution has
• 5:14
  providers who are proficient in crowd biopsy, that is less invasive,
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  and it doesn't involve a surgery.
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  It can be done same day as an outpatient procedure in the bronchoscopy suite.
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  It can get biopsies that can be almost equivalent to surgical lung biopsies
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  without the need for an inpatient stay.
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  And then, also, just greater reliance on high-resolution CT scans.
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  And if a pattern is what's called UIP or probable UIP without any other signs
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  or symptoms that suggest an alternative diagnosis, that person likely has IPF,
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  and that precludes patients from getting biopsies that they don't necessarily need.
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  And then, I think, ongoing research is happening in terms of incorporating
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  xenon MRIs into diagnosing patients with interstitial lung disease.
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  That is an area of ongoing research, and it hasn't been
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  adopted or approved of by the kind of governing societies as a whole.
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  But I think in the next five to 10 years, that's something that's an active area
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  of research that could become a more widely adopted diagnostic modality,
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  when either diagnosing patients with interstitial lung disease or looking
• 6:24
  for progression, because that's a big thing that we take care of.
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  Once we diagnose someone, we're constantly seeing them in close
• 6:33
  follow-up and patients may be having worsening symptoms, but their CT scans
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  or pulmonary function tests may not be sensitive enough to pick that up.
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  So, that could be something in the future that is more widely used to
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  help us actually pick up disease progression so we can make changes
• 6:49
  in their management before we start seeing some of that evidence of
• 6:53
  new scar on CT scan, for instance.
• 6:56
  Melanie Cole, MS: That's so interesting, and what an exciting time in your field.
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  And Dr.
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  Freitas, as we think of all of the exciting technologies and interventions,
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  for example, when we think of digital monitoring, home spirometry, or even
• 7:10
  telemedicine, which has come onto the scene, what of these have been
• 7:15
  shown to improve outcomes or quality of life in ILD and PH-ILD patients?
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  Are there any non-drug interventions that really excite you right now?
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  Dr. Jared Freitas:
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  For me, what comes to mind is trying to get better access
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  to people for pulmonary rehab.
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  I think that in and of itself is it can really improve someone's quality of life.
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  I think that's a big area that, as a community, we need to work
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  on because a lot of improving quality of life, I'm trying to say.
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  A lot of our patients, despite the medications that we have that
• 7:48
  can help alter the course of the disease, a lot of times they don't
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  necessarily improve symptoms.
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  And I find that's one of the biggest ways people actually can feel better is through
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  exercise therapy or pulmonary rehab.
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  And a lot of the research and a lot of excitement is around
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  new medication and drug therapy.
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  But something as simple as trying to get people better access to
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  pulmonary rehab programs, I think, is key because it keeps people
• 8:15
  engaged and keeps people functional.
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  A good way of doing that is a lot of telemedicine-based rehab programs.
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  I think that is definitely a modality, especially as our population is aging
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  not a lot of these programs that you can go to in person, and it can
• 8:32
  be difficult for people to travel.
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  So definitely, leveraging people's access to their smartphone or laptop
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  and helping them try to exercise at home is pretty important.
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  Melanie Cole, MS: Well, as an exercise physiologist myself, I
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  couldn't agree more with you there.
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  Dr. Jared Freitas:
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  There you go.
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  That's good.
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  Melanie Cole, MS: But when we think of the challenges of adherence, right?
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  And getting people to actually engage in these modalities from your clinical
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  experience, when we think of those challenging aspects of managing care,
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  what strategy or models besides things like telemedicine and pulmonary rehab,
• 9:09
  such as multidisciplinary clinics, have you found most effective?
• 9:13
  Dr. Jared Freitas:
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  Therein lies the benefit a larger tertiary or quaternary center
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  specifically like an ILD clinic, that you can get coordination of care with
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  other specialties more easily and we can help treat patients who have
• 9:28
  systemic diseases of which interstitial lung disease is only a part of.
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  Here at UF, we have very good collaboration between us in the
• 9:36
  ILD clinic, our rheumatology colleagues, radiology, pathology,
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  and gastroenterology and dermatology.
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  Because a lot of our patients, for instance, with regards to
• 9:46
  sarcoid, we have a neurosarcoid specialist and cardiac sarcoid.
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  Sarcoid sometimes can be treated as it's like its own special disease.
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  But my point is that a lot of patients are not affected just in the lungs.
• 9:58
  For instance, patients with systemic sclerosis, they can have terrible
• 10:02
  esophageal dysmotility, pulmonary hypertension, interstitial lung disease,
• 10:06
  terrible skin lesions, Raynaud's.
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  So, they may need a whole host of doctors and what's nice about being a center
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  that takes care of those patients is that we have personal relationships
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  with those doctors who also manage them.
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  And so, we can reach out to them on behalf of that patient, discuss their case,
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  try to make management decisions, that are going to affect multiple systems.
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  And so, I think that can help with comprehensive care.
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  That's why sometimes can be helpful for patients to seek out specialty care
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  at a larger center that has all these specialties, because that can kind of
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  group their care so that they don't have to keep seeing subspecialists who are at
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  different institutions, which can create a lot of issues for those people with
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  different people seeing different things.
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  So, I think in ILD especially, it's definitely a team sport.
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  It's very difficult to just be a solo practitioner.
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  Because a lot of times, the diagnosis is not clear nor the management.
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  And so, we need everyone's help to patients get their best outcome.
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  Melanie Cole, MS: So along those lines, and it is a comprehensive approach with
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  that multidisciplinary care that you were discussing, speak a little bit about
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  current guidelines and how balancing the use of steroids, immunosuppressive drugs
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  versus the anti-fibrotic therapies that you mentioned in different ILD subtypes.
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  And as you say, it's not a solo practice.
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  And so, there's going to be theories opinions on these.
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  But when we think of connective tissue-related ILD or hypersensitivity
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  pneumonitis, what do you think about the guidelines?
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  How do they suggest balancing the use of these meds?
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  Dr. Jared Freitas:
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  That's a big part of why our clinic exists and why ILD specialists are there because
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  it's not necessarily straightforward.
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  And so when we talk about ILD, there's roughly, if you think
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  of it as a pie chart, there's five or six main categories.
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  I think historically people thought that IPF caused the majority
• 11:59
  of interstitial lung disease.
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  But IPF is represents maybe fifth to a quarter of patients who have ILD.
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  And the other pieces of the pie are made up of sarcoidosis, connective
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  tissue disease, ILD, hypersensitivity pneumonitis, and sort of a grab
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  bag of smoking-related interstitial lung diseases, what we call
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  pneumoconioses, drug-related ILDs, and some of the more rare diagnoses.
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  And so, our job is twofold.
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  When someone comes to us, they may already come to us with a diagnosis.
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  And it's our job to confirm that was the correct one, and then see if they
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  have had disease progression, how best we can modify or improve that treatment.
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  Or they may come to us as an undifferentiated patient, and
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  we need to make that diagnosis and then initiate treatment.
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  And so, what the guidelines suggest is we need a very comprehensive
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  evaluation, which includes taking a good history and physical.
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  If they've had previous biopsies, obtaining them.
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  So, we can review the slides and have our pathologists review that with us.
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  Making sure we have a high-resolution CT scan and acquiring previous CT
• 13:03
  scans to look at disease progression.
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  Looking at their pulmonary function tests.
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  If we feel that their presentation could be related to a connective tissue disease.
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  We get a wide variety of autoimmune serologies, that could help point
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  us in one direction or another for a connective tissue disease ILD.
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  And then, once we have all this data, we meet together as a multidisciplinary
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  group and present the patients.
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  And we have input from our pulmonologists, radiologists, pathologists, and needed
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  a rheumatologist, and we make a decision as to what we think the diagnosis is
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  and then what our treatment plan is.
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  It doesn't have a special name.
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  It's just a multidisciplinary discussion, but that's recommended
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  on the guidelines, and there's data out there that suggests we make
• 13:50
  more accurate diagnoses and patient outcomes are better when that happens.
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  Once that takes place, if we determine the patient has a connective tissue
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  disease-related ILD, that would benefit from immunosuppression, we will go
• 14:04
  ahead and start patients on that.
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  However, if we think it's related to smoking-related interstitial lung
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  disease or IPF, immunosuppression wouldn't necessarily help those patients.
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  And specifically in IPF, it could hurt those patients.
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  And then, I know on this podcast before, we've talked about patients
• 14:23
  with short telomere syndrome.
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  There's lots of data coming out recently that suggests if your
• 14:28
  patient does have telomere biology disease, immunosuppression could
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  actually worsen that patient.
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  So, that question of whether or not to start someone on an immunosuppression
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  versus just removing like an antigen that's in their environment or
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  starting them on an anti-fibrotic.
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  It's a question that we face every day, and it is helpful to be seeing
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  a pulmonologist that specializes in interstitial lung diseases because
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  they can have the expertise to help make that nuanced decision.
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  That's kind of a brief overview of the whole process of what we do.
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  But we don't make those decisions lightly because the medicines aren't
• 15:05
  easy and can have significant amount of side effects and we need to
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  monitor their labs quite frequently.
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  And so, we need to be careful in which patients we actually start them on.
• 15:16
  Melanie Cole, MS: You've given us a lot to think about, and it's
• 15:18
  really important information.
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  And so, when should lung transplant be considered for ILD or PH-ILD patients?
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  What are realistic expectations, Dr.
• 15:28
  Freitas?
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  And how early should general practitioners start that conversation or referrals?
• 15:33
  You've mentioned early referral for better outcome.
• 15:37
  How early should these conversations take place for referrals to transplant centers?
• 15:43
  Dr. Jared Freitas:
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  We have some data to inform us or at least guidelines to inform us on that,
• 15:47
  both from the transplant societies and from ATS that, you know, any patient
• 15:52
  that has been diagnosed with IPF should be referred given the nature of the
• 15:56
  disease that most of the time and progressive and patients will get worse.
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  And so, it's important to establish care with that patient, while they're
• 16:05
  still very sick, so that the transplant team can do a comprehensive evaluation
• 16:11
  evaluating all of their organ systems and then also their social background
• 16:15
  to make sure that they can appropriately manage a transplanted organ.
• 16:20
  So, IPF is one of those things.
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  And then, the other thing is it's someone, who with chronic respiratory failure, like
• 16:27
  interstitial lung disease that is starting on oxygen or is already, is on oxygen at
• 16:33
  rest, that's definitely a time to refer.
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  So if you see someone with interstitial lung disease, who is getting worse,
• 16:40
  that's also a good time to refer.
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  Because at the end of the day, it's better for your patient to be
• 16:47
  seeing a transplant pulmonologist and them telling your patient
• 16:51
  that, "Thanks for coming to see us.
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  You're a little too early.
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  I'm going to send you back to your pulmonologist whoever
• 16:58
  is managing your care."
• 17:00
  And then, the opposite of that where it's like, "Well, I wish you
• 17:03
  would've sent this patient sooner."
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  So, I think, there are specific diagnoses like IPF.
• 17:07
  And then, if you have someone who's starting on oxygen or is just rapidly
• 17:11
  getting worse, those are all good times to send your patient to transplant.
• 17:16
  But hopefully, if you're seeing an ILD specialist, we're working with that
• 17:20
  patient to prevent that progression so they don't have to get there.
• 17:23
  And that's where this new drug, nirendomilast, is entering the
• 17:27
  fray, which I'd love to talk about.
• 17:29
  Melanie Cole, MS: Well, so then why don't you?
• 17:31
  Because we're going to get ready to wrap up here, and so I'd
• 17:34
  like you to speak about the most promising areas of current research.
• 17:37
  And really, how those new drug classes, as you're about to tell us, biomarkers,
• 17:41
  genetics, regenerative therapies, how close are these to everyday clinical use?
• 17:46
  And take us from bench to bedside.
• 17:48
  Dr. Jared Freitas:
• 17:48
  The newest drug that we have, so it's been over 10 years since
• 17:53
  there's been a new therapy for IPF, and that's nirandromolast.
• 17:58
  It's a PDE4B inhibitor, and it works on both anti-fibrotic
• 18:04
  and inflammatory pathways.
• 18:06
  And it was thought initially to be able to kind of in preclinical data
• 18:11
  that was able to halt lung scarring.
• 18:14
  The trial itself did not show that.
• 18:16
  However, it did show that over 52 weeks.
• 18:19
  So, a whole year that they studied it, it slowed down progression of fibrotic
• 18:24
  lung disease by a significant amount similar to the previous drugs that
• 18:29
  have been improved, Ofev and Esbriet.
• 18:32
  It offers a new therapy that works in a different way that we can offer patients.
• 18:38
  And the cool thing about the way they did this trial was they allowed enrollment of
• 18:42
  patients already on background therapy.
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  And it showed regardless of whether you were on background therapy, which
• 18:48
  would be either Ofev or you weren't, the result was significant across the board.
• 18:53
  So, it slowed down lung scarring.
• 18:55
  That's important because it offers another therapy for patients who are already on a
• 19:01
  medication but are continuing to progress.
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  And upfront, it may offer just a third option that we can place patients on.
• 19:10
  Or if they don't tolerate one of the medicines, we have this third medicine.
• 19:14
  So, I think it's a huge win for the community.
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  But it's also a reminder that we can't stop here because we still have yet to
• 19:22
  find a medication that can halt fibrosis.
• 19:26
  Another thing I'll say is that the great thing was that they
• 19:28
  did kind of parallel trials.
• 19:30
  So, they enrolled and studied the medication both in patients with just
• 19:34
  IPF as well as patients with progressive pulmonary fibrosis from a whole
• 19:39
  host of interstitial lung diseases.
• 19:42
  They found a similar effect in both groups.
• 19:44
  So, the medication is also approved for progressive pulmonary fibrosis.
• 19:49
  That's a huge deal.
• 19:50
  So, we can use it because previously the only drug we could use for patients with
• 19:54
  progressive pulmonary fibrosis was Ofev.
• 19:57
  And so, that gives us another option.
• 20:00
  And then, with regards to pulmonary hypertension in the setting of
• 20:03
  interstitial lung disease, we had FDA approval for inhaled
• 20:08
  treprostinil, which is the brand name Tyvaso a couple years ago.
• 20:13
  That was also a huge improvement for the community.
• 20:16
  Because prior to that, there had been a lot of negative trials for
• 20:20
  oral PH medicines that were either minimally effective or not effective
• 20:25
  or actually made patients worse.
• 20:27
  And so, this was the first medication that we could actually offer and
• 20:29
  prescribe to patients that could help improve their exercise capacity
• 20:33
  and six-minute walk distance.
• 20:35
  And so, the interesting thing about that, which was in the increased trial, was
• 20:39
  that one of the secondary outcomes that they looked at was their progression on
• 20:44
  their PFTs of their pulmonary fibrosis.
• 20:47
  And for a portion of those patients, they saw that their PFTs either
• 20:53
  stabilized or slightly got better.
• 20:55
  And so, that was very hypothesis generating.
• 20:57
  So, it spurred a whole new group of clinical trials called the TETON
• 21:01
  trials and that looked at—so they proved that inhaled treprostinil
• 21:06
  can help patients with PH-ILD, but can it help their ILD in general?
• 21:11
  Because there's some lab work and preclinical data that shows
• 21:15
  that treprostinil can work in fibrotic pathways, and could
• 21:18
  actually help in that scenario.
• 21:20
  And so, they did three different trial groups.
• 21:23
  They looked at IPF, PPF and in different parts of the world.
• 21:29
  And so, they recently published results from one of those groups looking at
• 21:33
  IPF and showed that it achieved its primary endpoint, that there is in fact a
• 21:38
  significant difference for patients using inhaled therapy, that they had almost 100
• 21:44
  milliliter reduction in FVC progression on their PFTs over the course of the year.
• 21:51
  That's exciting.
• 21:51
  So, that's almost a year's time, we have two new therapies.
• 21:55
  When the previous 10, we hadn't.
• 21:58
  Building on that, I think moving forward, we're going to be using a combination
• 22:04
  of both, inhaled and oral anti-fibrotic medications, as well as if the disease
• 22:10
  process warrants it, immunosuppression.
• 22:13
  And it's going to be a multidisciplinary care with multiple doctors if
• 22:16
  you have a systemic illness.
• 22:18
  And then, a third big thing that's happened is the emergence
• 22:21
  of awareness of telomere biology disorders and testing for telomere
• 22:25
  length to help inform our practice.
• 22:28
  And so, I think that also is going to be you mentioned looking at genetics and
• 22:32
  whatnot, a thing that may start becoming more commonplace in the next five to 10
• 22:36
  years as laboratories keep testing for it.
• 22:38
  And we have more data that tells us that's something that we need to do.
• 22:42
  And so for the future, I think, what's going to be interesting is how we use
• 22:47
  more of this preclinical data or lab data.
• 22:50
  And then, seeing if we can use AI or even like machine learning to help us
• 22:56
  interpret that data to comment both on new drug therapies and then also helping
• 23:01
  us interpret radiology and picking up changes in CT scans that a human eye
• 23:06
  can't detect or something like that.
• 23:07
  So, I think I'm very hopeful and excited for the field, because there's
• 23:12
  been a lot of rapid progression in new testing modalities and
• 23:17
  treatments in the last 10 to 15 years.
• 23:19
  And I think that there's going to be more good things to come.
• 23:22
  Melanie Cole, MS: Thank you so much, Dr.
• 23:23
  Freitas, for joining us today and sharing your incredible expertise, and I hope
• 23:27
  you'll join us again as we learn more.
• 23:30
  So, come on and give us more updates.
• 23:32
  And thank you so much again for joining us.
• 23:34
  To learn more about this and other healthcare topics at UF
• 23:37
  Health Shands Hospital, please visit innovation.ufhealth.org.
• 23:41
  And to listen to more podcasts from our experts, please
• 23:44
  visit ufhealth.org/medmatters.
• 23:47
  That concludes today's episode of UF Health MedEd Cast with
• 23:50
  UF Health Shands Hospital.
• 23:52
  I'm Melanie Cole.