DUPIXENT basics
Per the indication, DUPIXENT is for adult patients with prurigo nodularis (PN).1
Itch reduction (as measured by the proportion of patients with a ≥4-point improvement in WI-NRS) was the primary endpoint in two 24-week randomized, double-blind, placebo-controlled, multicenter, parallel-group studies (PRIME and PRIME2). In the PRIME trial, a nominal difference was observed at Week 4 (19% with DUPIXENT vs 4% with placebo), with significant improvement at Week 24.1-3
- In PRIME, the proportion of DUPIXENT patients who achieved ≥4-point improvement in WI-NRS was ≈3 times more than placebo at Week 24 (60% with DUPIXENT vs 18% with placebo; P<0.001; primary endpoint)1,2
Definitive conclusions cannot be made for results earlier than at 24 weeks in PRIME. Data were not multiplicity controlled.
PRIME2
- 37% of DUPIXENT patients achieved a meaningful itch response at Week 12 vs 22% with placebo; P=0.022 (primary endpoint). At Week 24, 58% of DUPIXENT patients achieved significant itch relief vs 20% with placebo; P<0.001 (secondary endpoint)1,2
IN A POOLED ANALYSIS OF PRIME AND PRIME2,
Itch improvement observed after first dose (as measured at Week 2)3,4
- 7.9% of DUPIXENT patients had ≥4-point improvement in WI-NRS at Week 2 vs 1.9% with placebo
- 59% of DUPIXENT patients had ≥4-point improvement in WI-NRS at Week 24 vs 19% with placebo
Definitive conclusions cannot be made for these results as the data were not multiplicity controlled and P values were nominal.
DUPIXENT clinical trials
DUPIXENT has demonstrated results in two 24-week randomized, double-blind, placebo-controlled, multicenter, parallel-group studies. A total of 311 adults in PRIME and PRIME2 (24 weeks each) with severe pruritus (WI-NRS ≥7 on a scale of 0 to 10) and ≥20 nodular lesions, whose disease was not adequately controlled with topical prescription therapies or when those therapies were not advisable, were randomized to DUPIXENT or placebo.1,2
In these studies, subjects received either subcutaneous DUPIXENT 600 mg (two 300 mg injections) on Day 1, followed by 300 mg once every other week (Q2W) for 24 weeks, or matching placebo. Mean age was 49.5 years, the median weight was 71 kg, 65% of subjects were female, 57% were White, 6% were Black, and 34% were Asian. At baseline, the mean WI-NRS was 8.5, 66% of subjects had 20 to 100 nodules (moderate), and 34% had greater than 100 nodules (severe). Approximately 60% of participants were on background TCS/TCI therapy. Fifty-seven percent did not have a history of atopy (defined as having a medical history of atopic dermatitis, allergic rhinitis/rhinoconjunctivitis, asthma, or food allergy).1,2
The WI-NRS consists of a single item, rated on a scale from 0 (“no itch”) to 10 (“worst imaginable itch”). Subjects were asked to rate the intensity of their worst pruritus (itch) over the past 24 hours using this scale. The IGA PN-S is a scale that measures the approximate number of nodules using a 5-point scale from 0 (clear) to 4 (severe).1
The primary efficacy endpoint was the proportion of subjects with improvement (reduction) in WI-NRS by ≥4 points. Key secondary endpoints included the proportion of subjects with IGA PN-S 0 or 1 (the equivalent of 0 to 5 nodules) and the proportion of subjects who achieved a response in both WI-NRS and IGA PN-S per the criteria above.1,2
- ≈3x as many patients in PRIME had significantly reduced itch at Week 24 (60% with DUPIXENT vs 18% with placebo; P<0.001), as measured by the WI-NRS1,2
- 37% of DUPIXENT patients in PRIME2 achieved a meaningful response at Week 12 vs 22% with placebo; P=0.022 (primary endpoint). At Week 24, 58% of DUPIXENT patients in PRIME2 achieved significant itch relief vs 20% with placebo; P<0.001 (secondary endpoint)
- ≈2.5x as many patients in PRIME achieved clear or almost-clear skin at Week 24 (48% with DUPIXENT vs 18% with placebo; P<0.001), as measured by the IGA PN-S1,2
- 45% of DUPIXENT patients in PRIME2 achieved significant nodule clearance (IGA PN-S 0 or 1) at Week 24 vs 16% with placebo; P<0.001 (secondary endpoint)1,2
The most common adverse reactions in adult patients with prurigo nodularis (≥2%, pooled safety data across PRIME and PRIME2) are nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.
Discontinuation due to adverse events: 0% with DUPIXENT vs 3% with placebo. Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment.1
DUPIXENT safety profile
The most common adverse reactions in adult patients with prurigo nodularis (≥2%, pooled safety data across PRIME and PRIME2) are nasopharyngitis (5% for DUPIXENT vs 2% for placebo); conjunctivitis (4% for DUPIXENT vs 1% for placebo); herpes infection (3% for DUPIXENT vs 0% for placebo); dizziness (3% for DUPIXENT vs 1% for placebo); myalgia (3% for DUPIXENT vs 1% for placebo); and diarrhea (3% for DUPIXENT vs 1% for placebo).
No patients treated with DUPIXENT (0%) discontinued treatment due to adverse events vs 3% with placebo. Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic infection resolves in a patient who does not respond to anti-helminth treatment.1
Other attributes/considerations
Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT. Avoid use of live vaccines during treatment with DUPIXENT. It is unknown if administration of live vaccines during DUPIXENT treatment will impact the safety or effectiveness of these vaccines. Limited data are available regarding coadministration of DUPIXENT with nonlive vaccines.1
DUPIXENT is not an immunosuppressant.1
DUPIXENT does not have a boxed warning. In the DUPIXENT pivotal PN clinical trials, the most common adverse reactions in adult patients with prurigo nodularis (≥2%, pooled safety data across PRIME and PRIME2) were nasopharyngitis (5% for DUPIXENT vs 2% for placebo); conjunctivitis (4% for DUPIXENT vs 1% for placebo); herpes infection (3% for DUPIXENT vs 0% for placebo); dizziness (3% for DUPIXENT vs 1% for placebo); myalgia (3% for DUPIXENT vs 1% for placebo); and diarrhea (3% for DUPIXENT vs 1% for placebo). No patients treated with DUPIXENT (0%) discontinued treatment due to adverse events vs 3% with placebo. Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment.1
Note: Select Important Safety Information: 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. Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.
DUPIXENT does not have any known drug-to-drug interactions. DUPIXENT is not metabolized through the liver or excreted through the kidneys.1
In the DUPIXENT pivotal clinical trials, the most common adverse reactions in adult patients with prurigo nodularis (≥2%, pooled safety data across PRIME and PRIME2) were nasopharyngitis (5% for DUPIXENT vs 2% for placebo); conjunctivitis (4% for DUPIXENT vs 1% for placebo); herpes infection (3% for DUPIXENT vs 0% for placebo); dizziness (3% for DUPIXENT vs 1% for placebo); myalgia (3% for DUPIXENT vs 1% for placebo); and diarrhea (3% for DUPIXENT vs 1% for placebo). Discontinuation due to adverse events: 0% with DUPIXENT vs 3% with placebo. Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment.1
Please see Prescribing Information related to use with live and nonlive vaccines.
No. Tuberculosis testing is not required with DUPIXENT according to the Prescribing Information.1
Using DUPIXENT
Prurigo nodularis is a chronic disease, and you may consider treating with DUPIXENT based on your clinical judgment. Individual patient responses may vary.5
Access and support
The amount your patients pay for DUPIXENT will largely depend on whether they have insurance, the type of insurance they have, whether their insurance provider considers the medication to be preferred or not preferred, and whether they’ve met their deductible.
A great place to start is with DUPIXENT MyWay®, a patient support program that provides guidance with the insurance approval process as well as patient-centric education.
The DUPIXENT MyWay® Interim Access Program assists eligible, commercially insured patients who previously started DUPIXENT and are experiencing a specific, short-term lapse in therapy. It temporarily provides eligible patients DUPIXENT at no cost, subject to program terms and conditions. You or your patients can contact DUPIXENT MyWay at 1-844-DUPIXEN(T)
(1-844-387-4936) to learn more.
You can use this guide to find out about the prior authorization request and appeal process for your patients appropriate for DUPIXENT.
NAVIGATING PRIORAUTHORIZATIONS
AND
APPEALS FOR DUPIXENT
IGA PN-S, Investigator’s Global Assessment PN-Stage; Q2W, once every 2 weeks; TCI, topical calcineurin inhibitors; TCS, topical corticosteroids; WI-NRS, Worst Itch numerical rating scale.
Itch improvement and nodule clearance, with a demonstrated safety profile
for treatment for adults with
prurigo nodularis.