Indication
DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.
Hi. I’m Dr Jim Del Rosso, and this is the Beyond the Surface series.
Today on the green couch, it’s a pleasure to have with us Dr Ben Lockshin, who is a board-certified dermatologist practicing in Silver Spring, Maryland.
Jim, it’s nice to see you and it’s a pleasure to be here to talk about DUPIXENT in atopic dermatitis.
So, Ben, now let’s talk about the case, or I should actually say cases that you’re bringing to discuss with me today.
One is the son who has severe atopic dermatitis, the other is the father that has moderate atopic dermatitis. So let’s start with the son first.
Jim, I’d been following a family for a number of years where the son had severe atopic dermatitis since early childhood.
He had lost hope, plagued with itch, where the itch seemed to be just as disruptive as the skin changes.
The excoriations, the erythema, the redness he had, and the lichenification, the thickening of the skin that he was experiencing.
And what is it in the history that leads you to think about it’s time to step up to DUPIXENT therapy?
Prior to the initiation of DUPIXENT, the son was on various topical prescription therapies, including topical corticosteroids and calcineurin inhibitors. In addition, he was on numerous systemic immunosuppressive agents.
So all the conventional treatments, but it wasn’t adequate control.
When I brought it up, actually I was surprised, because the parents were more on board than the son. I really had to coach him through the idea of being on an injectable medication.
When I talk about the safety profile with patients, I really like to highlight the fact that this drug was studied in various different age groups.
So, what about the discussion that there’s no need for any baseline laboratory monitoring or testing?
There are a number of things that really resonate with the patients, and one of them is the lack of laboratory monitoring.
Not having any black box warnings is another thing that really resonates with patients, that this is not a steroid, it’s not an immunosuppressant.
The patients don’t know that, and many of them are apprehensive because they think that this is.
You initiated DUPIXENT therapy, and when did you see them back? And when did they start noticing, for example, an improvement in the itch?
I remember when he came back about 6 months later, and he said, “Why didn’t I do this earlier?” And he was just over-the-moon happy. And his mother, she was over the moon.
So not only did he have significant reduction of itch, but his skin looked significantly better, really going from an IGA of 4, which he had lived with an IGA of 4 almost consistently for years, down to virtual clearance.
You’re describing that the parents are watching their kid go through this. Can you capsulize the story of what happened with the father who had moderate-severity disease?
He was frustrated by the amount of creams that he had to apply, the number of treatments that he needed to cycle through. He got to see firsthand the efficacy of the product.
He came in, and just during a regular visit he said, “I never have a moment where I don’t have any atopic dermatitis, even though mine was not nearly as bad as my son’s. Would I be a candidate for DUPIXENT as well?”
And I said, “Actually, you’d be an excellent candidate.”
After initiating DUPIXENT, he stated that his itch was dramatically better. And during today’s visit he reported that his skin was clear.
Ben, thank you for these two excellent cases of atopic dermatitis, one an adolescent that obviously battled severe disease, and then the father, who got to observe the improvement in the son and was actually motivated to come to you and ask for the therapy and did very well with more moderate severity.
Treatment choices in severe patients are a lot easier to kind of navigate because, I think all, you know, indicators are pointing towards a systemic therapy like DUPIXENT.
But those moderate patients putting topical steroids on and going through the motions day by day and still having lingering disease, those are just as good of a candidate as the really bad patients.
So, Ben, I want to really thank you for everything you shared today. These were two great cases, different situations, so it brings to light what some of the different discussions are. So I really appreciate your time in sharing this with us. Thank you.
Well, Jim, thanks for inviting me. It’s a pleasure to be here.
INDICATION AND IMPORTANT SAFETY INFORMATION
Indication
DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.
Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines during treatment with DUPIXENT.
ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.
USE IN SPECIFIC POPULATIONS
- Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
- Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.
Please see accompanying full Prescribing Information.
