The FDA has approved a 0.15% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of mild to moderate atopic dermatitis (AD) in patients ≥6 years old. Roflumilast is the second PDE4 inhibitor to be approved in the US for treatment of AD; crisaborole (Eucrisa), which can be used in patients ≥3 months old, was the first. Roflumilast is available as Zoryve in a 0.3% cream for treatment of plaque psoriasis and a 0.3% foam for treatment of seborrheic dermatitis. It is also available in an oral formulation (Daliresp) for treatment of chronic obstructive pulmonary disease.

The FDA has approved a 0.3% foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of seborrheic dermatitis in patients ≥9 years old. Roflumilast is the first PDE4 inhibitor to be approved in the US for this indication. It is also available in a 0.3% cream formulation (Zoryve) for treatment of plaque psoriasis and in an oral formulation (Daliresp, and generics) for treatment of chronic obstructive pulmonary disease. A 0.15% cream formulation for treatment of atopic dermatitis in patients ≥6 years old will be reviewed by the FDA in July.

The FDA has approved Verkazia (Santen), a 0.1% ophthalmic emulsion formulation of the calcineurin inhibitor cyclosporine, for treatment of vernal keratoconjunctivitis (VKC). Verkazia is the first product to be approved in the US for this indication.

The FDA has approved a 1.5% topical cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) for short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients ≥12 years old whose disease has not been adequately controlled with other topical prescription drugs. Ruxolitinib is the first JAK inhibitor to be approved for topical use and the first to be approved in the US for treatment of AD. An oral formulation of ruxolitinib (Jakafi) is approved for treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.

Atopic dermatitis (AD; also known as eczema) is frequently associated with other atopic disorders such as allergic rhinitis, asthma, and food allergy. It commonly presents in infancy and early childhood and has a relapsing course, often improving by adolescence, but sometimes persisting into (or first appearing in) adulthood or even old age.

Mild to moderate psoriasis can be treated with topical drugs or with phototherapy. Patients with moderate to severe disease generally require systemic therapy.

Allergic rhinitis can be classified as seasonal, perennial, or episodic. It is often associated with allergic conjunctivitis, rhinosinusitis, and asthma.

H₁-ANTIHISTAMINES — Oral – Oral second-generation H₁-antihistamines are the preferred first-line treatment for relief of the itching, sneezing, and rhinorrhea that characterize mild-to-moderate allergic rhinitis. They are less effective for nasal congestion.

The FDA has approved dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously-injected fully human monoclonal antibody, for treatment of adults with moderate to severe atopic dermatitis (eczema) that has not responded to topical therapies. It can be used with or without topical corticosteroids.

The FDA has approved crisaborole 2% ointment (Eucrisa – Pfizer) for topical treatment of mild to moderate atopic dermatitis in patients ≥2 years old. It is the first phosphodiesterase type-4 (PDE4) inhibitor to be approved in the US for this indication.

Drugs for glaucoma, age-related macular degeneration, bacterial conjunctivitis, and dry eyes are reviewed here. Drugs for the treatment of allergic conjunctivitis will be reviewed in a future issue of Treatment Guidelines on Drugs for Allergic Disorders.

Drugs for glaucoma, age-related macular degeneration, bacterial conjunctivitis, and dry eyes are reviewed here. Ophthalmic drugs can have local and systemic adverse effects. In addition, for some elderly patients, the complexity of self-administering numerous ophthalmic drugs may be the limiting factor in their ability to care for themselves. Drugs for the treatment of allergic conjunctivitis will be reviewed in a future issue of Treatment Guidelines on Drugs for Allergic Disorders.

Allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria, anaphylaxis and asthma (reviewed in Treatment Guidelines 2005; 3:33 and not included here), are prevalent worldwide, especially in industrialized countries. Pharmacologic treatment of these disorders continues to improve in efficacy and safety. In addition to using drugs to prevent and control the symptoms of their allergic diseases, patients should also be instructed to avoid, if possible, specific allergens and/or environmental conditions that trigger or worsen their symptoms.

The FDA issued a public health advisory on March 10, 2005 warning about a risk of cancer with topical formulations of tacrolimus (Protopic) and pimecrolimus (Elidel) used to treat eczema in adults and children more than 2 years old. Elidel has been heavily promoted to the general public on television. The warning was based on reports of dose-related cancer in animals and 29 reports of cancer (including 8 skin malignancies and 12 lymphomas) in adults and children treated with these immunosuppressive drugs. Cause and effect have not been established. When Protopic was first marketed, The Medical Letter warned that the possibility of an increased risk of skin malignancies and lymphoma should be kept in mind (Med Lett Drugs Ther 2001; 43:33).

Allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria and anaphylaxis, along with asthma (reviewed in Treatment Guidelines 2002; 1:7 and not included here), have increased in prevalence during the past 30 years and are now epidemic worldwide, especially in industrialized countries. Many safe and effective drugs are currently available for prevention and relief of symptoms in these disorders, but pharmacological treatment alone may not be sufficient. Patients should also be instructed to avoid specific allergens or environmental conditions that trigger their symptoms. Allergen-specific immunotherapy, parenteral administration of gradually increasing doses of the allergen ("allergy shots"), has been effective in allergic rhinitis, allergic conjunctivitis and allergic asthma, and also in prevention of anaphylaxis triggered by stings from bees, yellow jackets, hornets and wasps. It has not been effective in food allergy, atopic dermatitis or urticaria.

Pimecrolimus 1% cream (pim e kroe' limus; SDZ ASM 981; Elidel - Novartis) has been approved by the FDA for short-term and intermittent long-term treatment of mild to moderate atopic dermatitis in non-immunocompromised patients at least 2 years old.

Tacrolimus ointment (Protopic) has been approved by the FDA in 0.03% and 0.1% formulations for treatment of atopic dermatitis. Tacrolimus is used systemically (Prograf) to prevent rejection of organ transplants.