Safety Profile of Biologics When Treating Asthma

Transcript:

Stanley Goldstein, MD: As I think Shahzad mentioned, that the primary outcome of all the biologics studies, are looking at reduction in exacerbation. Giselle, you also just mentioned how biologics help reduce oral corticosteroids in our patients, and there are specific biologics that have been investigated in that. What do you think about lung function? Does that play a role in biologics and looking at that as far as improvement in lung function?

Giselle Mosnaim, MD, MS:Yes. The dupilumab has some very nice data on improving lung function, and as Dr. Mustafa was saying before, being able to have objective measures; if you’re able to show this is lung function before starting the medication, and then the start of the medication and then do lung function (test) and show an improvement, that’s very impactful for the patient to see those numbers, so when they’re feeling better and they also see those objective numbers. I think for clinicians as well, when we see those objective numbers, that is very reinforcing. Unfortunately, right now, we’re not able to do the spirometry because of coronavirus, and that’s very challenging. But that is a very important outcome to measure.

Stanley Goldstein, MD: One of the reasons I think that many physicians, including specialists, I’m talking about pulmonologists and allergists, sometimes may not treat with a biologic or will not have a conversation with a patient regarding a biologic, is because they are concerned about adverse effects, they’re concerned about the safety profile of the biologics. What could we tell our colleagues or our patients about safety of these products?

Giselle Mosnaim, MD, MS: I can talk a little bit about that. With the omalizumab, at the beginning there was some concern about increased risk of malignancies. Larger studies have shown that there is no increased rate of malignancy with omalizumab. That was an original concern and it is no longer a concern. With omalizumab, there is a very small, but real risk of anaphylaxis. That is why we give the first 4 injections either in the allergist immunologist office or the infusion center, and we have patients wait for 2 hours after the first several doses, and then we decrease it down to 30 minutes and then the patients can self-administer at home. Most of the anaphylaxis, most of the adverse reactions happen in the first few doses, so that’s how we do that with the omalizumab.

In terms of the anti-IL-5s, we have not had significant issues at least in our practice in terms of anaphylaxis, so those are self-administered at home. We teach them how to do the first dose and then they can be administered at home. Then in terms of the dupilumab, there have been some concerns over ocular symptoms, and if that is the case, then we would stop the medication. In general, that has not been a major safety concern for our patients. If they have a little bit of ocular symptoms, they are overall, in general, very pleased with the improvement in their asthma, improvement in their atopic dermatitis, and they want to continue on the therapy. That’s been the experience that we’ve had.

Shahzad Mustafa, MD: I think a small point, Stan, with dupilumab and the ocular side effects, and I think the literature would say we see that more in the atopic dermatitis space than in the asthma indication. I think that’s interesting, where the side effect is almost dependent on the condition that you’re treating, we see that a little bit. One small point that I think specialists appreciate, but I still get this question from primary care referral base, is any 5 of the biologics that are FDA approved for asthma, they are not considered to be immunosuppressive. I think that’s an important point. I think we sometimes think of injectables and monoclonal antibodies and biologics as immunosuppressive because we’ve used so many anti-TNF agents and things like that. These 5 medications are really not felt to be immunosuppressive, and I think that’s an important point that still comes up a lot, that the literature certainly supports, but there still remains this misconception. I think that’s an important point.

At the end of the day, so many asthmatics are getting so many courses of systemic steroids, so they’re on them all the time. The risk-benefit profile, the safety of these biologics compared to frequent courses of oral steroids. It’s a very beneficial safety profile. Certainly they’re not benign, there are important considerations, but these are safe and effective medications when used in the right way.

Stanley Goldstein, MD: Thank you, Shahzad, for those important points, and thank you, Giselle, for adding in.

Transcript Edited for Clarity