Frequently asked questions

DUPIXENT is indicated for the treatment of adult patients with bullous pemphigoid (BP).¹

DUPIXENT was evaluated in ADEPT, a pivotal phase 2/3 study that evaluated DUPIXENT as a treatment for adults with bullous pemphigoid. A total of 106 adults with bullous pemphigoid were randomized to DUPIXENT or placebo. All patients who received DUPIXENT were given 300 mg Q2W after a 600 mg loading dose. On Day 1, all participants also started a standard-of-care regimen of prednisone or prednisolone (0.5 or 0.75 mg/kg/day).^1-3 

Tapering of oral corticosteroid (OCS) dose was to begin no later than Week 6, provided that disease control (defined as no new lesions and existing lesions beginning to heal) was maintained for 2 weeks. Inclusion criteria included BPDAI activity score ≥24 (on a scale of 0 to 360) and weekly averaged Peak Pruritus NRS score ≥4 (on a scale of 0 to 10). At baseline, mean patient age was 71 years, mean Peak Pruritus NRS was 7.5, and disease severity was moderate (66% of patients) or severe (34% of patients), as measured by BPDAI activity score.^1-3​,a

The primary endpoint was the proportion of patients achieving sustained remission at Week 36 (18% of patients treated with DUPIXENT + OCS taper vs 6% with placebo + OCS taper; 95% CI: 12.2% [-0.8, 26.1]). This data analysis for the primary endpoint did not meet statistical significance.^1,2

The primary endpoint consisted of 3 components¹:

• Complete remission and off OCS by Week 16
• No rescue therapy from baseline to Week 36
• No disease relapse after completing OCS taper to Week 36

Secondary endpoints included^1,2: 

• Proportion of subjects with a ≥4-point improvement in Peak Pruritus NRS at Week 36 (38% with DUPIXENT + OCS taper vs 11% with placebo + OCS taper; 95% CI: 27.8% [11.6, 43.4])
  • Definitive conclusions cannot be made for these results. Data were not multiplicity controlled
• Median cumulative dose of OCS at Week 36 was 2.8 g in patients treated with DUPIXENT vs 4.1 g with placebo

^aModerate BP defined as ≥20 and ≤56 BPDAI activity score and severe BP defined as ≥57 BPDAI activity score.

The primary endpoint of sustained remission at Week 36 consisted of 3 components¹: 

• Complete remission and off OCS by Week 16
• No rescue therapy from baseline to Week 36
• No disease relapse after completing OCS taper to Week 36

Complete remission was defined as the absence of new lesions and epithelialization of old lesions. During OCS taper, participants were permitted to increase their OCS dose once (subsequent dose increases were considered rescue therapy).^1,2

Rescue therapy could include a second increase of OCS dose during the taper period, use of OCS after completion of the OCS taper/Week 16, or initiation of high-potency TCS, systemic nonsteroidal immunosuppressive medication, or immunomodulating biologic therapy.^1,2

Disease relapse was defined as appearance of ≥3 new lesions/month (blisters, eczematous lesions, or urticarial plaques) or ≥1 large (>10 cm in diameter) eczematous lesion or urticarial plaque that did not heal within 1 week.²

In the DUPIXENT pivotal clinical trials in bullous pemphigoid, itch was evaluated as a patient-reported measure using a 0- to 10-point numerical rating scale (NRS) assessing a patient’s worst itch over the previous 24 hours.⁴

To calculate Peak Pruritus NRS, patients are asked: “On a scale of 0 to 10, how would you rate your itch overall (on average) during the previous 24 hours?”

A reduction of ≥4 points from baseline is a clinically meaningful change.¹

The most common adverse reactions (incidence ≥2%) in patients with bullous pemphigoid are arthralgia, conjunctivitis, vision blurred, herpes viral infections, and keratitis.¹

A case of acute generalized exanthematous pustulosis (AGEP) was reported in 1 subject with bullous pemphigoid treated with DUPIXENT compared with 0 subjects in the placebo group.¹

Discontinuation due to adverse events: 4% with DUPIXENT vs 9% with placebo.²

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

See more information on DUPIXENT safety.

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 non-live vaccines.¹

DUPIXENT does not have a boxed warning.¹

Select Important Safety Information: Warnings and Precautions—Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. A case of AGEP was reported in an adult subject who participated in the bullous pemphigoid development program. 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 can be administered by patients and/or caregivers at home after proper training on preparation and administration prior to use.¹

The pre-filled pen and pre-filled syringe do not need reconstitution.¹

Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.

No. No initial lab testing or ongoing lab monitoring is required with DUPIXENT, according to the Prescribing Information.¹

No, DUPIXENT is not an immunosuppressant.¹

DUPIXENT offers at-home and in-office administration options. DUPIXENT is administered as a 300 mg subcutaneous injection every 2 weeks for adults with bullous pemphigoid.¹

DUPIXENT has one dosing regimen in adults with bullous pemphigoid, regardless of weight.¹

• 600 mg loading dose (2 × 300 mg SC injections), then 300 mg (1 SC injection) every 2 weeks

Use DUPIXENT in combination with a tapering course of oral corticosteroids. Once disease control has occurred, gradually taper corticosteroids, after which continue DUPIXENT as monotherapy. In case of relapse, corticosteroids may be added if medically advisable.¹

See more administration guidance.

You can direct them to patient-friendly education and support resources available at DUPIXENT.com, which help explain biologic therapy, set expectations, and support patients throughout treatment.

Key resources include:

• Educational content on how DUPIXENT works and how it differs from traditional systemic therapies
• Step-by-step supplemental injection training videos and instructions to support at-home administration
• Patient stories and testimonials from other patients taking DUPIXENT
• Treatment journey and FAQ sections that address common questions about safety, dosing, and cost
• The DUPIXENT MyWay^® program, which offers nurse support, financial assistance information, and ongoing patient guidance

≈96% of commercial patients (18+ years of age) nationally are covered for DUPIXENT^2,a

100% of Medicare BP patients (18+ years of age) nationally are covered for DUPIXENT²

^aMMIT Analysis, May 2026.

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 can help enable access to DUPIXENT and offers financial assistance to eligible patients, one-on-one nursing support, and more.

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.