Dive deeper into DUPIXENT and explore helpful resources

PATIENT PROFILE VIDEO: PRIOR SINO-NASAL SURGERY
Dr David Yen explains a patient's treatment journey with DUPIXENT

DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRS with NP).

IMPORTANT SAFETY INFORMATION

Contraindication: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

Please watch the entire video to hear additional Important Safety Information.

Dr David Yen:

By way of introduction, my name is Dr David Yen. I am a board-certified otolaryngologist in Pennsylvania, and I have been in practice for 21 years.

Here I present a hypothetical patient with chronic rhinosinusitis with nasal polyposis, Danielle, who came to see me with bothersome and persistent symptoms. This individual has been a patient in my practice for some time. Danielle is a 51-year-old female who suffers from loss of sense of smell and nasal congestion, which leaves her frustrated and impacts her quality of life.

Danielle has had CRS with NP for 12 years now, confirmed by nasal endoscopy. She did not respond to medical management. She has had 1 prior surgery. I performed functional endoscopic sinus surgery or so-called full house or complete FESS, where I opened the maxillary sinuses, ethmoid sinuses, sphenoid sinuses, and frontal sinuses as well.

Despite ongoing medical management with saline irrigation and intranasal corticosteroids, and despite prior surgery that, as I said, I had done myself, Danielle is unfortunately continuing to suffer from slow but steady recurrence of bothersome symptoms. We treated her with 2 courses of oral corticosteroids over the previous year, in addition to the medications that I previously described.

Danielle complains of moderate nasal congestion with a score of 2 on a 3-point scale, with 0 being none, 1 being mild, 2 being moderate, and 3 being severe.

Her combined nasal polyp score, or NPS, on endoscopy is a 6. On exam, she has nasal polyps medial to middle turbinates evident on both sides, correlating to a score of 3 in each nasal cavity.

She continues to complain of severe loss of sense of smell. I administered the University of Pennsylvania Smell Identification Test, or UPSIT, and she scored 15 out of 40, consistent with anosmia.

Danielle enjoys spending time with her family, including gardening with her two daughters. This has been difficult for her to enjoy because when bending over, her congestion gets worse and she does not appreciate some of the joys of spending time outside in the garden, without her sense of smell. In addition, she also enjoys coffee, or at least she used to.

In the United States, Type 2 inflammation underlies disease pathophysiology in about 80 percent of patients with CRS with NP. And this Type 2 inflammation contributes to the symptoms of disease, including nasal congestion and obstruction, as well as loss of the sense of smell. Type 2 inflammation can manifest as allergies and/or eosinophilic inflammation in the nasal cavity.

Danielle does not want another surgery and I can understand that, as the previous surgery was not as successful as she or I had wished, and despite performing a complete surgery, the polyps have recurred.

It's quite gratifying to be able to discuss with patients the option of adding DUPIXENT. I brought this up with Danielle as an option to consider.

DUPIXENT inhibits the interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, contributors to systemic and localized Type 2 inflammation, by binding to the IL-4 receptor alpha subunit shared by the IL-4 and IL-13 receptor complexes. DUPIXENT inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. The Type I receptors are found predominantly on circulating immune cells, and signal in response to IL-4, while the Type II receptors are predominantly found on structural cells such as fibroblasts and epithelial cells, and signal in response to primarily IL-13 but also IL-4.

DUPIXENT was studied in the largest clinical development program for CRS with NP to date. The clinical development program included 2 phase 3 studies, SINUS-24 and SINUS-52. In SINUS-24, 276 patients were randomized 1:1 to receive DUPIXENT 300 mg or placebo every other week for 24 weeks. In SINUS-52, 448 patients were randomized 1:1:1 to receive either DUPIXENT 300 mg every other week for 52 weeks; DUPIXENT 300 mg every other week until week 24 followed by 300 mg DUPIXENT every 4 weeks until week 52; or placebo every other week for 52 weeks. In both trials, patients were enrolled despite prior surgery or systemic corticosteroid use, and all patients received background standard-of-care treatment with intranasal corticosteroids during the treatment period. Rescue with systemic corticosteroids or surgery was allowed at the investigator’s discretion.

Coprimary endpoints were change from baseline to week 24 in bilateral endoscopic nasal polyps score, or NPS, and change from baseline to week 24 in nasal congestion and obstruction score, or NC score.

Key secondary endpoints include change from baseline to week 24 in daily loss of smell score, Lund-Mackay CT score, Sino Nasal Outcomes Test, or SNOT-22 score, and the University of Pennsylvania Smell Identification Test, or UPSIT. Additional key secondary endpoints include change from baseline to week 52 in NPS, NC score, and SNOT-22 score.

All primary and key secondary endpoints were met with statistical significance.

Improvement in sense of smell was measured by UPSIT. In SINUS-52, 67% of the total improvement demonstrated with DUPIXENT in addition to background intranasal corticosteroids was seen at Week 2, after the first dose. Over the 52-week treatment period, the UPSIT score improved 71% with DUPIXENT, compared with a 6% worsening in sense of smell in patients treated with placebo and intranasal corticosteroids. This analysis was not multiplicity controlled, and results are descriptive only.

At week 52 in SINUS-52, there was a 54 percent improvement in nasal congestion and obstruction with DUPIXENT on top of intranasal corticosteroids, which correlates with a −1.35 change from a mean baseline score of 2.48, vs a 16 percent improvement with placebo on top of intranasal corticosteroids, which correlates with a negative 0.37 change from the mean baseline score of 2.38.

At Week 52 in SINUS-52, there was a 2.24 improvement in NPS with DUPIXENT 300 mg every other week on top of intranasal corticosteroids, from a baseline NPS of 6.07, vs a 0.15 worsening with placebo on top of intranasal corticosteroids, from a baseline NPS of 5.96.

The most common adverse reactions (incidence greater than or equal to 1 percent) in patients with chronic rhinosinusitis with nasal polyposis are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

Danielle came in for a follow-up visit 1 month after starting DUPIXENT, and said that she already noticed an improvement in her sense of smell seen at 2 weeks, after the first dose.

Danielle can now enjoy coffee and fine dining which she was not able to do for some time due to her loss of sense of smell.

After 1 year, Danielle experienced reduced nasal congestion and obstruction along with a reduction in nasal polyp size. Her results were consistent with those demonstrated in the DUPIXENT clinical trials.

The reduced nasal congestion and obstruction has positively impacted Danielle and she is able to manage her symptoms with DUPIXENT on top of her other maintenance therapy.

DUPIXENT can be administered in office or self-administered at home every 2 weeks if appropriate for the patient.

After prescribing DUPIXENT, my staff and I use DUPIXENT MyWay. The DUPIXENT MyWay program helps enable prescribed patients access to DUPIXENT. Patient resources are available on the website, DUPIXENTHCP.com. There you can find information on the DUPIXENT MyWay program including coverage support, patient access support, and nursing support.

I’m looking forward to your clinical experience with appropriate patients on DUPIXENT.

PATIENT PROFILE VIDEO: CRSwNP AND ASTHMA
Dr Nina Ramirez discusses a CRSwNP patient with history of asthma

DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRS with NP).

IMPORTANT SAFETY INFORMATION

Contraindication: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

Please watch the entire video to hear additional Important Safety Information.

Dr Ramirez:

Hello, my name is Dr Nina Ramirez, and I am a board-certified allergist. Today, I’m here to present a hypothetical patient, Jasmine, a 37-year-old female with chronic rhinosinusitis with nasal polyposis with nasal obstruction symptoms and comorbid asthma, which has left her frustrated and unable to enjoy time with her family.

For a little bit of background, Jasmine has had chronic rhinosinusitis with nasal polyposis for 8 years, confirmed by an ENT upon endoscopy. She has not had prior sino-nasal surgery. In the past year, she’s had 2 systemic corticosteroid bursts in addition to maintenance intranasal steroids, to address her symptoms. She’s had coexisting mild to moderate asthma, which is being treated with inhaled corticosteroids and short-acting beta-agonists. Delineation of her clinical characteristics includes the following:

Jasmine has a nasal congestion score of 2, which is associated with moderate symptoms, on a scale of 0 to 3, 0 meaning no symptoms and 3 meaning severe symptoms.

SNOT-22 is an instrument that we use to assess symptoms and symptom impacts, including quality of life measures, in patients with CRS with NP. The Sino-Nasal Outcomes Test, SNOT-22, includes 22 items assessing symptoms and symptom impact. Each item is scored from 0, no problem, to 5, problem as bad as it can be. Jasmine has a score of 46 on a scale of 0 to 110.

Jasmine reports reduced productivity due to symptoms. I’m concerned about her upper airway obstruction. She also experiences sinus pressure. This patient enjoys spending a lot of time with her school-aged kids and large extended family, but her disease keeps her from doing some activities that she loves.

Chronic rhinosinusitis with nasal polyposis can be a result of persistent systemic Type 2 inflammation that has local manifestations.

Localized Type 2 inflammation contributes to symptoms of disease, including congestion and obstruction and loss of the sense of smell.

Patients with coexisting atopic or Type 2 inflammatory diseases can have persistent systemic Type 2 inflammation that also contributes to their disease symptoms and severity. Patients with CRS with NP can frequently have coexisting asthma. These patients are more likely to need more than one surgery and more intensive therapies such as oral corticosteroid bursts and higher doses of maintenance inhaled corticosteroids to control their asthma. Systemic corticosteroid use is associated with adverse effects, and note that this patient has already had 2 corticosteroid bursts this past year alone.

Like many patients, Jasmine does not want surgery. And after discussing the available options with her, I recommended DUPIXENT.

DUPIXENT inhibits the interleukin-4, or IL-4, and interleukin-13, or IL-13, signaling, contributors to systemic and localized Type 2 inflammation, by binding to the IL-4 receptor alpha subunit shared by the IL-4 and IL-13 receptor complexes. DUPIXENT inhibits interleukin-4 signaling via the type I receptor and both IL-4 and IL-13 signaling through the type II receptor. The type I receptors are found predominantly on circulating immune cells, and signal in response to IL-4, while the type II receptors are found predominantly on structural cells such as fibroblasts and epithelial cells, and signal in response to primarily IL-13 but also IL-4.

There is no need for biomarker testing according to the DUPIXENT Prescribing Information.

DUPIXENT was studied in the largest clinical development program for CRS with NP to date. The clinical development program included 2 phase 3 studies, SINUS-24 and SINUS-52. In SINUS-24, 276 patients were randomized 1:1 to receive DUPIXENT 300 mg or placebo every other week for 24 weeks. In SINUS-52, 448 patients were randomized 1:1:1 to receive either DUPIXENT 300 mg every other week for 52 weeks; DUPIXENT 300 mg every other week until Week 24 followed by 300 mg DUPIXENT every 4 weeks until Week 52; or placebo every other week for 52 weeks. In both trials, patients were enrolled despite prior surgery or systemic corticosteroid use, and all patients required background standard-of-care treatment with intranasal corticosteroids during the treatment period. Rescue with systemic corticosteroids or surgery was allowed at the investigator’s discretion.

Coprimary endpoints were change from baseline to week 24 in bilateral endoscopic nasal polyps score, or NPS, and change from baseline to week 24 in nasal congestion and obstruction score, or NC score.

Key secondary endpoints included change from baseline to Week 24 in daily loss of smell score, Lund-Mackay CT score, Sino-Nasal Outcomes Test, or SNOT-22, score, and the University of Pennsylvania Smell Identification Test, or UPSIT. Additional key secondary endpoints include change from baseline to Week 52 in NPS, NC, and SNOT-22 score.

All primary and key secondary endpoints were met with statistical significance.

DUPIXENT demonstrated a rapid and sustained improvement in nasal congestion and obstruction, as measured by the nasal congestion score. At week 4, patients on DUPIXENT 300 mg every other week and intranasal corticosteroids experienced a 0.52 score improvement versus a 0.16 score improvement with placebo and intranasal corticosteroids. At week 52 in SINUS-52, there was a 54 percent improvement in nasal congestion and obstruction with DUPIXENT and intranasal corticosteroids, which correlates with a 1.35 score improvement from a mean baseline of 2.48, vs a 16 percent improvement with placebo and intranasal corticosteroids, which correlates with a 0.37 score improvement from the mean baseline score of 2.38.

An improvement as measured by SNOT-22, was observed as early as week 4 and sustained through week 52. 39 percent of the total improvement demonstrated in patients who received DUPIXENT 300 mg every other week was observed at week 4. After 1 year, at week 52, patients treated with DUPIXENT demonstrated a 59 percent improvement from baseline, compared with a 17 percent improvement observed with placebo. Changes in the mean baseline SNOT-22 scores in patients treated with DUPIXENT exceeded the mean minimal clinically important difference of 8.9.

The most common adverse reactions with an incidence of greater than or equal to 1 percent in patients with chronic rhinosinusitis with nasal polyposis are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

I followed-up with Jasmine 1 month after initiation of DUPIXENT. She had experienced a rapid improvement in nasal congestion and obstruction. She was excited to be able to enjoy entertaining her family again and had experienced improved quality of life, as measured by SNOT-22.

I had Jasmine come back for another follow-up 1 year after starting DUPIXENT. I witnessed sustained improvements in symptom burden. Her improvement in congestion and obstruction was sustained, and she experienced an improvement in quality of life, as measured by SNOT-22.

DUPIXENT can be administered in office or self-administered at home every 2 weeks if appropriate for the patient.

After prescribing DUPIXENT, my staff and I use DUPIXENT MyWay. The DUPIXENT MyWay program helps enable prescribed patients access to DUPIXENT. Patient resources are available on the DUPIXENT website, DUPIXENTHCP.com. There you can find information on the DUPIXENT MyWay including coverage support, patient access support, and nursing support.

I’m looking forward to hearing about your experiences with appropriate patients on DUPIXENT.

PATIENT PROFILE VIDEO: CRSwNP AND NSAID-ERD
Dr Yen and Dr Ramirez co-manage a CRSwNP patient with comorbid NSAID-ERD

DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRS with NP).

IMPORTANT SAFETY INFORMATION

Contradication: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

Please watch the entire video to hear additional Important Safety Information

Dr Ramirez:

Hello, my name is Dr Nina Ramirez, and I am a board-certified allergist. Today, I am here to present a hypothetical patient, Charlie, a 45-year-old male who presents with chronic rhinosinusitis with nasal polyposis and coexisting nonsteroidal anti-inflammatory drug exacerbated respiratory disease, otherwise known as NSAID-ERD.

Charlie was diagnosed with CRS with NP at the age of 21 and has since had several sinus surgeries. He developed asthma in his mid-30s, at about the age of 35. He has had 2 oral corticosteroid bursts in the previous year in addition to maintenance intranasal corticosteroids for his CRS with NP, and medium-dose combination inhaled corticosteroids and a long-acting bronchodilator for his asthma. NSAID-ERD was confirmed by an aspirin challenge.

He owns an organic farm, but his disease really gets in the way and keeps him from being able to keep up with the demands that are needed to maintain the farm.

After my initial assessment, I suspected that his nasal polyps have recurred as part of his CRS with NP disease, and I wanted him to see my ENT colleague, Dr Yen, for confirmation.

Dr Yen:

My name is Dr David Yen. I'm a board-certified otolaryngologist. In general, I spend quite a bit of my time taking care of patients with sino-nasal complaints, particularly those with chronic rhinosinusitis with nasal polyposis. I often co-manage patients with Dr Ramirez and other allergists because, simply put, I cannot always adequately treat a systemic inflammatory process with surgery alone, or by focusing on the nose or sinuses alone. So, I'm quite grateful to have the management expertise input from my colleagues. In this particular case, Charlie suffers from NSAID-ERD in addition to his CRS with NP, and in otolaryngology practice, these can be some of the more challenging patients to manage.

Charlie complains of moderate nasal congestion with a score of 2 on a 3-point scale, with 0 being no symptoms, 1 being mild symptoms, 2 being moderate symptoms, 3 being severe symptoms.

His combined nasal polyp score, or NPS, on endoscopy is a 6. On exam, he has nasal polyps medial to middle turbinates evident on both sides, correlating to a score of 3 in each nasal cavity.

Charlie’s computed tomography, or CT, evaluation reveals a Lund-Mackay or LMK score of 18.

Charlie’s nasal polyps are evident on anterior rhinoscopy.

NSAID-ERD can be a disease driven by Type 2 inflammation. I discussed with Charlie the possibility for additional surgery, but he is not particularly eager to proceed. Of note, the patient also decided against aspirin desensitization.

I wanted to touch base with Dr Ramirez and see what she thought about treatment with a biologic.

Dr Ramirez:

DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis.

DUPIXENT inhibits the interleukin-4, or IL-4, and interleukin-13, or IL-13, signaling, contributors to systemic and localized Type 2 inflammation, by binding to the IL-4 receptor alpha subunit shared by the IL-4 and IL-13 receptor complexes. DUPIXENT inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. The Type I receptors are found predominately on circulating immune cells, and signal in response to IL-4, while the Type II receptors are predominately found on structural cells such as fibroblasts and epithelial cells, and signal in response to primarily IL-13 but also IL-4.

Additionally, there is no need for biomarker testing according to the DUPIXENT Prescribing Information.

I spoke with Dr Yen about why I believe that based on DUPIXENT’s unique mechanism of action as well as the SINUS-24 and SINUS-52 clinical trials, DUPIXENT would be an appropriate choice for Charlie.

Dr Yen:

DUPIXENT was studied in the largest clinical development program for CRS with NP to date. The clinical development program included 2 phase 3 studies, SINUS-24 and SINUS-52. In SINUS-24, 276 patients were randomized 1:1 to receive DUPIXENT 300 mg or placebo every other week for 24 weeks. In SINUS-52, 448 patients were randomized 1:1:1 to receive either DUPIXENT 300 mg every other week for 52 weeks; DUPIXENT 300 mg every other week until Week 24 followed by 300 mg DUPIXENT every 4 weeks until Week 52; or placebo every other week for 52 weeks. In both trials, patients were enrolled despite prior surgery or systemic corticosteroid use, and all patients received background standard-of-care treatment with intranasal corticosteroids during the treatment period. Rescue with systemic corticosteroids or surgery was allowed at the investigator’s discretion.

Coprimary endpoints were change from baseline to week 24 in bilateral endoscopic nasal polyps score, or NPS, and change from baseline to week 24 in nasal congestion and obstruction score, or NC score.

Key secondary endpoints included change from baseline to Week 24 in daily loss of smell score, Lund-Mackay CT score, Sino-Nasal Outcomes Test, or SNOT-22, score, and the University of Pennsylvania Smell Identification Test, or UPSIT. Additional key secondary endpoints include change from baseline to Week 52 in NPS, NC score, and SNOT-22 score.

All primary and key secondary endpoints were met with statistical significance.

The most common adverse reactions, with an incidence greater than or equal to 1% in patients with chronic rhinosinusitis with nasal polyposis are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

Dr Ramirez:

27% of patients enrolled in SINUS-52 presented with NSAID-ERD.

This subgroup of patients with NSAID-ERD demonstrated improvement in key measures of disease severity, including nasal congestion and obstruction, nasal polyp size, and LMK-CT score.

In this subgroup of patients, there was a 56% improvement in nasal congestion and obstruction demonstrated at Week 52 with DUPIXENT in addition to background intranasal corticosteroids, while an 8% improvement was observed in patients treated with placebo on top of intranasal corticosteroids. There was a 2.54 improvement in NPS at Week 52 in patients treated with DUPIXENT vs a 0.03 worsening in the placebo group. Additionally, there was a 37% improvement in the LMK score at Week 52 in patients treated with DUPIXENT vs a 2% improvement in the placebo group.

Dr Yen:

Charlie came in for a follow-up visit 1 year after starting DUPIXENT.

I observed a significant improvement in nasal congestion and obstruction.

Upon CT scan of Charlie’s sinuses, I was pleased to see that he had reduction in opacification across each sinus as well.

Dr Ramirez and I were also curious as to what his nasal polyps looked like upon endoscopic examination. Charlie showed significant improvement in polyp burden.

Dr Yen:

After Dr Ramirez and I have decided to prescribe DUPIXENT, my staff and I use DUPIXENT MyWay. The DUPIXENT MyWay program helps enable prescribed patients access to DUPIXENT. Patient resources are available on the website, DUPIXENTHCP.com. There you can find information on the DUPIXENT MyWay program including coverage support, patient access support, and nursing support.

Dr Ramirez:

DUPIXENT can be administered in office or self-administered at home every 2 weeks if appropriate for the patient.

Living on a farm makes it more challenging for him to come into the office every other week for his injection. So, it's great that this therapy can be self-administered by a patient at home, if appropriate.

Dr Yen:

We are looking forward to hearing about your experience with appropriate patients on DUPIXENT.