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

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 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.^1,2 

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]).¹ This data analysis for the primary endpoint did not meet statistical significance.

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 included¹: 

• 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

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

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

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

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.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 BP 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

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.¹ 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.

DUPIXENT is not an immunosuppressant and avoids broad immunosuppression.¹

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. DUPIXENT is not an immunosuppressant. DUPIXENT is a human monoclonal antibody that inhibits the signaling of IL-4 and IL-13, two of the type 2 cytokines that contribute to type 2 inflammation in bullous pemphigoid.¹

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

DUPIXENT can be administered by patients and/or caregivers at home after proper training on preparation and administration prior to use.¹

DUPIXENT does not have a boxed warning. In the DUPIXENT pivotal clinical trial, the most common adverse reactions (incidence ≥2%) in patients with bullous pemphigoid are arthralgia, conjunctivitis, vision blurred, herpes viral infections, and keratitis.¹

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

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

No. Tuberculosis testing is not required with DUPIXENT according to the Prescribing Information.¹

DUPIXENT is not a steroid.¹

DUPIXENT is a biologic that inhibits the signaling of IL-4 and IL-13, two of the key drivers of type 2 inflammation contributing to asthma, atopic dermatitis, bullous pemphigoid, chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis, and prurigo nodularis.¹

The mechanism of dupilumab action has not been definitively established.

The recommended dosage of DUPIXENT for adult patients with bullous pemphigoid is an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given Q2W.¹

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

Individual patient responses may vary. Bullous pemphigoid is a chronic disease, and you may consider treating continuously with DUPIXENT based on your clinical judgment.

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.