Real-World Experience With SQ Monoclonal Antibodies
INSIGHTS FROM: AJAI CHARI, MD, MOUNT SINAI HEALTH SYSTEM; DANIEL VERINA, NP, MOUNT SINAI HEALTH SYSTEM
Tuesday, June 30, 2020
Ajai Chari, MD: Danny, maybe you can walk us through what it’s like to give subQ [subcutaneous] DARA [daratumumab] in clinic.
Daniel Verina, NP: Absolutely. The premeds, or the premedication, and testing would be identical to what we would do for a patient who was actually going to receive the intravenous [IV] version of the daratumumab, except the administration of the drug is different. You’re going to give it subQ like Dr Chari said earlier. It’s better in the belly because there’s a lot more subQ tissue in there, and it’s given over 3 to 5 minutes. It’s a very small needle; it’s about a 5/8-inch needle, so patients don’t experience much discomfort. Even though it sounds like a lot of volume, 15 cc, because we all learned in school that we’re only allowed to give 2 cc at the maximum, but you can literally give them 15 cc. They tolerate it extremely well. Usually the first 4 doses are 5 minutes, and if they tolerate it well, it’s given over 3 minutes. I think it adds an extra convenience for our population, instead of staying 7 hours or a minimum of 4 hours.
Ajai Chari, MD: Yes. I think to emphasize, maybe Danny, you can talk about the nursing implications in terms of the staffing of a nurse to first dose monoclonal antibody for IV versus subQ, and how that impacts the staffing.
Daniel Verina, NP: Absolutely. It allows staff to be freer. Instead of a 1:1 for your stay, for your first 4 to 7 hours of intravenous fluids, you’re with them maybe an hour the most. So now the increase in chair time in your institution, in the clinical trials the patients were monitored for 4 hours, and if it does become commercially available, the monitoring will be a little bit different on patients. But again, your chair time is no more than maybe 1 to 3 hours maximum instead of 7 hours maximum. And the nurses then can move from one patient to the next.
Ajai Chari, MD: Danny, I still remember when daratumumab was first coming on, we had that expanded access program, we started 50 patients on IV daratumumab in the span of 2 months. So talk about chair time in the infusion center, each patient is getting blocked not only for that long first day, but multiple hours every week after that. It really put a big damper on the infusion turnover time.
Daniel Verina, NP: Even other institutions, they were starting them inpatient, actually. Many institutions were starting their first doses inpatient to see if they were tolerating the drug and then moved them to outpatient. So you’re exposing a patient to an inpatient environment, or taking up an inpatient bed, just for a monoclonal antibody, and then again coming out to the infusion center, blocking at least 5 hours of a chair.
Ajai Chari, MD: I think another interesting question that folks who have not given daratumumab subQ, can you talk about what the injection site looks like, especially, let’s say, in comparison to bortezomib and what that looks like, the day of, the day after? What does it look like in somebody who’s gotten daratumumab subQ?
Daniel Verina, NP: Interestingly enough, there is some slight swelling. It’s a little bit different than bortezomib, where sometimes patients would get a redness or an irritation of the skin. You still would get some types of irritation. Some people do get a red blotchy kind of discoloration at the infusion site, but it’s very fleeting. It usually lasts about a day and it dissipates over that, but again a minimal amount of effects to the skin or discomfort to the patient themselves.
Ajai Chari, MD: I’ve shown up to a bedside after a patient got daratumumab subQ, and I can’t even find where the nurse injected. And I’m like, where did it go? It’s really hard to see. I think it’s really well tolerated. I think these are the sum of what we covered between COLUMBA, PLEIADES, and your bedside experience description. I always say that when we compare daratumumab IV and subQ, actually when you compare any medical treatments, we think about risk, benefit, and convenience, right? So risk here, we see lower rates of infusion-related reactions, significantly, as low as 4% in DRd [daratumumab, lenalidomide, dexamethasone] in PLEIADES and 9% in the other arms in COLUMBA, so less than 10% infusion-related reactions versus as high as 40% to 50% for IV.
Efficacy seems to be comparable, both by the response rates that we’ve seen in COLUMBA as well as PLEIADES, but also that important pharmacokinetic parameter called C trough was comparable. And of course the convenience is really unbeatable. I always say that when I’ve been consenting patients to daratumumab subcutaneous clinical trials, the discussion goes like this. “We have a drug that’s basically as efficacious, better risk profile, and is more convenient.” Very few patients have had any issues. I think it’s the easiest study to get patients consented on because who wants to spend more time in the infusion center? Danny, what do you think?
Daniel Verina, NP: I think it’s a great idea. Even though our patient population is the more mature adult, the average age is 69, they’re still working, or even if they’re not working they still have other extracurricular activities. They’re active, they’re seeing their grandkids. And to spend time in an infusion center for 7 hours, compared with, “I’m going to come in for my shot, I’m going to spend an hour or 2 in the infusion center, and I can still go back to work, I can still go on a trip, I can still enjoy my life.” I think when you look at patient satisfaction and convenience, that outweighs having the intravenous therapy.
Ajai Chari, MD: Yes, I always say what’s the point of having your myeloma be in remission but you’re chained to the infusion center all the time.
Daniel Verina, NP: True.
Ajai Chari, MD: It’s a great liberation from the infusion center.