New guidelines for moderate to severe Crohn disease help streamline more advanced therapy options, such as biologics and JAK inhibitors.
In this episode, TRC Healthcare Assistant Editor and Clinical Pharmacist Gina Corley, PharmD, walks through the latest guideline updates for moderate to severe Crohn disease. She breaks down advanced therapy options such as biologics and JAK inhibitors, discusses how factors like prior biologic exposure shape treatment decisions, and where immunomodulators and steroids fit in.
This is an excerpt from our March 2026 Pharmacy Essential Updates continuing education webinar series.
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TRC Healthcare offers CE credit for this podcast for pharmacist subscribers at our platinum level or higher and pharmacy technician subscribers. Log in to your Pharmacist’s Letter or Pharmacy Technician’s Letter account and look for the title of this podcast in the list of available CE courses. None of the speakers have anything to disclose.
Clinical Resources from Pharmacist’s Letter, Pharmacy Technician’s Letter, and Prescriber Insights:
- Article: Prioritize Advanced Therapies in Crohn Disease
- Chart: Biologics and JAK Inhibitors for Moderate to Severe Crohn Disease
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Transcript:
This transcript is automatically generated.
00:00:05 Narrator
Welcome to Clinical Capsules from TRC Healthcare, your trusted source for practical, evidence-based updates.
00:00:13 Narrator
On this episode, Assistant Editor and Clinical Pharmacist Gina Corley walks us through advanced therapies used to help manage Crohn disease.
00:00:21 Narrator
She discusses biologics and JAK inhibitors, outlines their place in therapy, and also highlights the role of immunomodulators and steroids in an excerpt from our popular Pharmacy Essential Updates webinar series.
00:00:34 Narrator
This podcast offers Continuing Education credit for pharmacists and pharmacy technicians. Please log in to your Pharmacist’s Letter or Pharmacy Technician’s Letter account and look for the title of this podcast in the list of available CE courses.
00:00:47 Narrator
None of the speakers have anything to disclose.
00:00:50 Narrator
Catch new episodes of Clinical Capsules every 2nd and 4th Tuesday—bringing concise, actionable insights from TRC experts straight to your ears.
00:00:59 Narrator
Let’s dive in.
00:01:07 Gina Corley
So now we’re going to dive into some of the advanced therapies that are used to treat Crohn disease.
00:01:13 Gina Corley
And just like our article says, you’ll see more upfront use of advanced therapies in moderate to severe Crohn disease due to updated guidelines.
00:01:24 Gina Corley
But what do we mean by advanced therapies?
00:01:27 Gina Corley
What types of drugs are these?
00:01:29 Gina Corley
We’ll go into all that in just a bit.
00:01:32 Gina Corley
But first, let’s remind ourselves what Crohn disease is.
00:01:38 Gina Corley
So Crohn disease is a type of inflammatory bowel disease that can cause things like stomach upset, severe diarrhea, bloody stools, fatigue, and weight loss.
00:01:51 Gina Corley
And while Crohn disease can affect different areas of the digestive system, it most commonly affects the area that’s towards the end of the small intestine and the beginning of the large intestine.
00:02:03 Gina Corley
Inflammation from Crohn disease can also spread into deeper layers of the bowel.
00:02:08 Gina Corley
And as you can imagine, this can be very painful and debilitating.
00:02:15 Gina Corley
And the way we treat Crohn disease has evolved over the years.
00:02:20 Gina Corley
In the past, we used what was known as a step-up approach.
00:02:24 Gina Corley
Patients would start with oral corticosteroids such as prednisone to induce remission.
00:02:31 Gina Corley
Then they would usually transition to an immunomodulator, such as azathioprine or methotrexate for maintenance therapy.
00:02:41 Gina Corley
And these immunomodulators would work to help enhance the body’s immune response against Crohn disease.
00:02:50 Gina Corley
Now, if this wasn’t enough, patients could transition to injectable biologics, which are more advanced therapies to help manage their symptoms better.
00:03:01 Gina Corley
Two of the most common biologics are infliximab and adalimumab, and we’ll go into the details of these a little more later.
00:03:11 Gina Corley
Now let’s fast forward a bit.
00:03:14 Gina Corley
More recent guidelines recommend starting biologics sooner rather than doing a step-up approach.
00:03:21 Gina Corley
Keep in mind, immunomodulators such as azathioprine or methotrexate could still be added onto biologics, which helps to reduce the risk of forming anti-drug antibodies, and therefore increases the chance that the patient will respond to the biologic.
00:03:39 Gina Corley
And then the most recent set of guidelines created a really streamlined approach and recommended using advanced therapies up front.
00:03:49 Gina Corley
And of course, we just touched on what advanced therapies were, but let’s dig a little deeper.
00:03:55 Gina Corley
So like we said, the most common advanced therapies used in Crohn disease are biologics.
00:03:59 Gina Corley
So let’s talk about what a biologic actually is.
00:04:04 Gina Corley
Biologics are medications that come from living organisms.
00:04:08 Gina Corley
Scientists will take proteins or genetic materials from living cells and reproduce, clone, or mutate them somehow to get the desired drug that they need.
00:04:19 Gina Corley
This is why biologics are often used to treat difficult diseases such as autoimmune diseases that drugs made in a more traditional way cannot treat.
00:04:30 Gina Corley
And as you can imagine, making drugs this way can get a little pricey, which is why many biologics cost tens of thousands of dollars, often require prior authorizations, and are usually dispensed from specialty pharmacies.
00:04:46 Gina Corley
Now you’ll notice that all the biologics I mentioned for Crohn disease all end in MAB.
00:04:52 Gina Corley
And this is because they are a specific class of biologics called monoclonal antibodies.
00:04:59 Gina Corley
Monoclonal antibodies are made-up of many copies of a single antibody, which is a protective protein made by your immune system.
00:05:08 Gina Corley
This allows these drugs to target and destroy certain disease cells in the body.
00:05:15 Gina Corley
So let’s get into some of the different monoclonal antibodies used to treat Crohn disease.
00:05:21 Gina Corley
In a patient who has never taken a biologic before, guidelines say to start with a high efficacy med.
00:05:28 Gina Corley
So for example, patients typically start with infliximab or adalimumab.
00:05:33 Gina Corley
But for patients who have tried and failed biologics, guidelines suggest that a high or intermediate efficacy med can be used.
00:05:42 Gina Corley
So that means if a patient tries infliximab and doesn’t respond, we can switch them to a high or intermediate efficacy med, usually in a different class.
00:05:53 Gina Corley
So while most of the drugs end in MAB, there’s one that does not.
00:05:58 Gina Corley
And this is upadacitinib.
00:06:01 Gina Corley
This med is a Janus kinase or a JAK inhibitor.
00:06:05 Gina Corley
So it is not a monoclonal antibody, nor is it a biologic.
00:06:10 Gina Corley
But it’s still considered an advanced therapy for Crohn disease.
00:06:14 Gina Corley
So now let’s take a deeper look into all of these meds and their classes.
00:06:21 Gina Corley
All right, starting off with the TNF-alpha inhibitors.
00:06:26 Gina Corley
These meds include infliximab or Remicade, adalimumab or Humira, and certolizumab or Cimzia.
00:06:36 Gina Corley
Infliximab and adalimumab are usually first line for Crohn disease.
00:06:41 Gina Corley
Both are considered high-efficacy meds.
00:06:44 Gina Corley
And like I previously mentioned, you may see one of these meds combined with an immunomodulator, such as azathioprine, to help improve patient response.
00:06:53 Gina Corley
And then sometimes, patients will also start on a steroid to help manage Crohn disease symptoms while they wait for biologics to kick in.
00:07:03 Gina Corley
Conversely, certolizumab is a lower efficacy med, so we aren’t likely to see this one used as often.
00:07:12 Gina Corley
And then I wanted to touch on the dosing for adalimumab and infliximab since these are common meds for Crohn disease.
00:07:20 Gina Corley
Adalimumab is given subcutaneously, either as a single 160 milligram dose on day one or in two divided 80 milligram doses on days one and two.
00:07:32 Gina Corley
After that, patients will get 80 milligrams on week two and then 40 milligrams every other week after that.
00:07:40 Gina Corley
The first injection must be given by a healthcare provider.
00:07:43 Gina Corley
But after that, patients are able to inject themselves if they feel comfortable.
00:07:50 Gina Corley
And then on the other hand, patients who get infliximab must start with IV therapy.
00:07:56 Gina Corley
So they’ll get a 5 mg per kg induction dose at weeks 0, 2, and 6.
00:08:01 Gina Corley
And then for maintenance dosing, they can either do 5 to 10 mg per kg IV every eight weeks or 120 milligrams subcutaneously every two weeks.
00:08:12 Gina Corley
The IV infusion must be administered by a healthcare provider in a clinic, but patients opting for the subcutaneous injection can administer the dose themselves.
00:08:25 Gina Corley
Next, we’ll talk about the non-selective anti-interleukin med.
00:08:28 Gina Corley
Ustekinumab or Stelara.
00:08:32 Gina Corley
This med is considered higher efficacy in biologic naive patients, but is an intermediate efficacy if patients have prior biologic exposure.
00:08:41 Gina Corley
It’s older than the more selective anti-interleukin meds that we’ll talk about next, so its effects tend to be more moderate.
00:08:50 Gina Corley
We usually consider this med for patients who don’t respond to TNF-alpha inhibitors.
00:08:55 Gina Corley
And similarly to the TNF-alpha inhibitors, it can also be used with or without immunomodulators.
00:09:04 Gina Corley
Induction dosing for ustekinumab is weight-based and given IV.
00:09:09 Gina Corley
Patients 55 kilograms or under will get 260 milligrams IV.
00:09:14 Gina Corley
And then patients 56 to 85 kilograms will get 390 milligrams IV.
00:09:20 Gina Corley
And lastly, patients over 85 kilograms will get 520 milligrams IV.
00:09:26 Gina Corley
Then maintenance dosing is the same, 90 milligrams every eight weeks for all patients, but this time it’s given subcutaneously.
00:09:36 Gina Corley
Moving right along, we have the selective interleukin-23 antagonists.
00:09:41 Gina Corley
Guselkumab or Tremfya, mirikizumab or Omvoh, and risankizumab or Skyrizi.
00:09:48 Gina Corley
All three of these meds are newer and considered higher efficacy in biologic-naive patients.
00:09:55 Gina Corley
Guselkumab and risankizumab are also high efficacy if patients failed prior biologics, but mirikizumab’s efficacy is more intermediate.
00:10:06 Gina Corley
And then like the other meds, these can either be given IV or subcutaneously, depending on the drug.
00:10:13 Gina Corley
So for example, guselkumab can be given IV or subcutaneously for maintenance dosing, but mirikizumab and risankizumab are both given IV.
00:10:23 Gina Corley
And then even though all maintenance doses are given subcutaneously, dosing regimens can vary.
00:10:33 Gina Corley
So for example, risankizumab can be dosed at 180 milligrams or 360 milligrams, depending on disease severity.
00:10:44 Gina Corley
Next, we have vedolizumab or Entyvio, which is an anti-integrin med.
00:10:49 Gina Corley
This one is high efficacy in biologic naive patients.
00:10:54 Gina Corley
But if patients fail biologics, we likely won’t see it used, since it’s considered low efficacy in this instance.
00:11:02 Gina Corley
And then for dosing, patients take a 300 milligram IV induction dose at weeks 0, 2, and 6, and then have a couple different options for maintenance doses depending on their disease state.
00:11:15 Gina Corley
Lastly, we have upadacitinib or Rinvoq.
00:11:19 Gina Corley
Like I mentioned before, this is the only advanced therapy med that is not a biologic or monoclonal antibody.
00:11:26 Gina Corley
Instead, it is a Janus kinase or a JAK inhibitor and is the first oral med that is indicated for moderate to severe Crohn disease.
00:11:35 Gina Corley
It’s reserved for patients who have failed prior biologic therapy and therefore should not be initiated first line.
00:11:44 Gina Corley
It also should not be combined with biologics or immunomodulators because it can have added immunosuppressant effects and make patients more susceptible to severe infections or cancers as well as thrombosis or blood clots and cardiovascular events.
00:12:04 Gina Corley
All right, so now let’s cover some risks and side effects we want to watch out for with all biologics.
00:12:10 Gina Corley
Biologics can suppress the immune system, and this can make patients more susceptible to infections like we just mentioned with upadacitinib.
00:12:20 Gina Corley
To help reduce this risk, we want to make sure most vaccines are up to date.
00:12:25 Gina Corley
However, we want to avoid live vaccines in these patients since this can lead to a vaccine-induced infection or illness.
00:12:34 Gina Corley
And then along those same lines, patients on biologics are also at increased risk of developing complications from surgery, such as delayed wound healing or post-op infections, along with certain cancers such as lymphoma or non-melanoma skin cancer.
00:12:50 Gina Corley
And then since these are injectables, patients may also have infusion-related reactions, such as redness, swelling, or injection site pain, and may need to premedicate with antihistamines such as diphenhydramine or steroids like hydrocortisone.
00:13:08 Gina Corley
And then lastly, I just wanted to touch on a few practice pearls to go over if a patient drops off a prescription for an advanced therapy med.
00:13:17 Gina Corley
Like I mentioned, these meds can have very complicated dosing regimens, so we want to be extra careful when putting prescriptions into the computer system.
00:13:27 Gina Corley
Make sure to double check the dose, route, and frequency, since these things can all vary with the different therapies.
00:13:35 Gina Corley
Keep in mind, you’ll likely be transferring these prescriptions to specialty pharmacies, but we still want to update patient profiles to include these meds.
00:13:43 Gina Corley
So the pharmacist can screen for drug interactions or ask about vaccines.
00:13:49 Gina Corley
And then if you do happen to stock any of these meds in your pharmacy, make sure you check the storage requirements.
00:13:55 Gina Corley
Most of the injectable biologics will be kept in the fridge, but keep oral upadacitinib stored at room temperature.
00:14:04 Gina Corley
All right, so I know that was a lot of information we went over today, and these meds are not always easy to keep straight.
00:14:11 Gina Corley
But we have this really nice chart on our website, Biologics and JAK Inhibitors for Moderate to Severe Crohn Disease, that breaks down each class of meds.
00:14:21 Gina Corley
It gives info on dosing, side effects, and place in therapy, along with things to watch out for when patients are on these advanced therapies.
00:14:32 Narrator
Thanks for listening—we hope today’s episode gave you practical insights you can use right away.
00:14:37 Narrator
Now that you’ve listened, pharmacists and pharmacy technicians can receive CE credit. Just log into your Pharmacist’s Letter or Pharmacy Technician’s Letter account and look for the title of this podcast in the list of available CE courses.
00:14:49 Narrator
We’ve linked the resources we mentioned—and more on today’s topic—right in the show notes. Those links will take you straight to our websites, where you’ll find even more concise, evidence-based charts, articles, and tools.
00:15:01 Narrator
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00:15:19 Narrator
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00:15:34 Narrator
Thanks for listening… stay sharp, stay current—and join us next time on Clinical Capsules!
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