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JAK Inhibitors: Non-Responders and Safety Considerations


Drs James Q. Del Rosso and Neal Bhatia explain how to manage patients who fail therapy and provide safety considerations when treating those patients.

James Q. Del Rosso, DO: One of the questions I think, Neal, that is talked about in patients that are non-responders or partial responders, let’s say to something like dupilumab [Dupixent], and now you have to throw tralokinumab [Adtralza] into the mix. We have patients that are treated with these drugs that may not be considered responders based on the end points in the study, but they’re doing very well. They’re much happier than they were, and they’re pleased with their results. They may still be having problems and you may want to consider trying to step up and doing even better. There is data with upadacitinib [Rinvoq] when you take that group of patients that you can actually improve their results when they’re switched to upadacitinib. There was a study recently on that. But, in the conversation with the patient, getting them to think about, “Yeah, do you want to make this change, but now you’re going to be getting a laboratory test and having some safety considerations that you haven’t really had to think about before.” The patient involved with that discussion and the clinician offering that is going to be really an important part of this dialogue, I think.

Neal Bhatia, MD: Yeah, that goes without saying. I think even more so it comes back to our expectations. A lot of these patients were enrolled in trials at their worst, and I would be 1 of the first to say given the speed of onset of JAK [Janus kinase] inhibitors, why not put them on JAK inhibitors to get the fire put out for a couple months, and if we’re worried about safety signals long term, maybe make the switch over to biologics in that third or fourth month and maintain them that way. And, if they break through on that, put them back on the JAK inhibitors and go back and forth. Again, it’s not a recipe that is going to get studied, but it’s usually in the common sense of the mechanism, the approach, as well as the safety signals that allow that change. But, as you said, there are going to be patients who don’t want to take those every day. There are going to be patients who don’t want any kind of shots, and there are those who eventually maybe we’re going to have to wean them down and maintain on topicals. It’s just a matter of using that good clinical judgment as well as knowing which surface area we are treating that will allow that. There are a lot of opportunities at least that we didn’t have before.

James Q. Del Rosso, DO: Absolutely. And it’s like with many drugs that come to market, the product monographs, the package inserts, and the Physicians’ Desk Reference—if you remember that book that we used to have sent to us every year—is not a therapeutic compendium, and it doesn’t state that it’s the book you go to for how to treat patients. It just talks about the studies that were done that brought the drugs to market that the FDA [Food and Drug Administration] has mandated. That’s what the companies have to follow. We figure out how we utilize the treatments, and we teach each other how we do that. I think it was all well said, right?

Neal Bhatia, MD: We have these conversations a lot about “OK, the drug’s out on the market; alright, thanks for playing, take your package insert” and “Let’s see how we actually treat patients.” Definitely ways to do both within reason, within safety, but also again learning from the colleagues. Take isotretinoin, for example. We were doing blood every month, but now we do blood every 4 [months] because we learned. We’re going to learn from these drugs, and we’re going to learn from our colleagues as well as those who actually do a bit more of the trials to figure out what we’re going to do best for these patients.

James Q. Del Rosso, DO: And we have to remember that package inserts are not automatically updated. There are package inserts that have data and information in there that has nothing to do with the standard of care anymore. That’s the bottom line.

I’m going to wrap it up at this point and thank Dr Bhatia for participating. He always brings a lot of insights. We talk to each other a lot about this behind the scenes, and we work a lot on these areas in clinical research and in treating patients. Hopefully, we brought you something that will be meaningful to you in understanding this class of drugs and how to use them. Thanks a lot.

Transcript edited for clarity.

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