The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.

The FDA has approved deucravacitinib (Sotyktu – BMS), an oral tyrosine kinase 2 (TYK2) inhibitor, for once-daily treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is the first selective TYK2 inhibitor to be approved in the US for any indication.

The FDA has approved a 0.3% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of plaque psoriasis in patients ≥12 years old. Roflumilast is the first topical PDE4 inhibitor to be approved by the FDA for this indication; crisaborole (Eucrisa), another topical PDE4 inhibitor, is approved for treatment of atopic dermatitis. Oral roflumilast (Daliresp) is approved for treatment of chronic obstructive pulmonary disease.

The injectable interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) has been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults. Risankizumab was approved earlier for treatment of plaque psoriasis and psoriatic arthritis.

The FDA has approved Vtama (Dermavant), a 1% cream formulation of the aryl hydrocarbon receptor (AhR) agonist tapinarof, for treatment of adults with plaque psoriasis. It is the first AhR agonist to be approved by the FDA.

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

View the Expanded Table: Some Drugs for Psoriasis

The FDA has approved the interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) for treatment of moderate to severe plaque psoriasis in adults. Risankizumab is the third IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) and tildrakizumab (Ilumya) were approved earlier.

Tildrakizumab-asmn (Ilumya – Sun), an interleukin (IL)-23 antagonist, has been approved by the FDA for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab is the second selective IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) was the first.

The FDA has approved the interleukin (IL)-23 blocker guselkumab (Tremfya – Janssen) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Guselkumab is the first selective IL-23 blocker to become available in the US.

The FDA has approved brodalumab (Siliq – Valeant), an injectable human interleukin (IL)-17A receptor antagonist, for treatment of adults with moderate to severe plaque psoriasis who have failed to respond to other systemic therapies. Brodalumab is the third IL-17A antagonist to be approved in the US for this indication; secukinumab (Cosentyx) and ixekizumab (Taltz) were approved earlier.

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.

View the Comparison Table: Some Topical Corticosteroids

The FDA has approved infliximab-dyyb (Inflectra – Pfizer; marketed as Remsima in some countries), as a biosimilar of the TNF inhibitor infliximab (Remicade). Infliximab-dyyb was approved in the European Union (EU) in 2013 and in Canada in 2014. It is the second biosimilar to be approved by the FDA. Filgastrim-sndz (Zarxio), a recombinant human granulocyte colony-stimulating factor, was the first.

The FDA has approved the subcutaneous IL-17A antagonist secukinumab (Cosentyx - Novartis), which was first approved in 2015 for treatment of plaque psoriasis, for treatment of psoriatic arthritis and ankylosing spondylitis in adults.1 Secukinumab is one of the most effective drugs available for treatment of plaque psoriasis.2

FDA approval of secukinumab for treatment of psoriatic arthritis was based on two randomized, double-blind trials with a primary endpoint of at least a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 24 weeks. In both trials, ACR20 response rates were significantly higher in patients receiving secukinumab than in those receiving placebo.3,4 Secukinumab was effective in both TNF inhibitor-naive and TNF inhibitor-experienced patients.

Approval of secukinumab for ankylosing spondylitis was based on two double-blind trials in which the primary endpoint was the percentage of patients who achieved at least a 20% improvement in Assessment of Spondyloarthritis International Society response criteria (ASA20) at 16 weeks. In both trials, ASA20 response rates were significantly higher in patients receiving secukinumab than in those receiving placebo.5

The most common adverse effects of secukinumab in clinical trials were nasopharyngitis, diarrhea, and upper respiratory infection. In general, infections occurred at a higher rate in secukinumab-treated patients than in those who received placebo. Patients should be screened for tuberculosis before starting therapy. Exacerbations of Crohn's disease were reported during clinical trials in patients taking secukinumab. Urticaria and anaphylaxis have occurred.

The recommended dosage of secukinumab for patients with psoriatic arthritis (without concomitant moderate to severe plaque psoriasis) or ankylosing spondylitis is 150 mg injected subcutaneously at weeks 0, 1, 2, 3, and 4, then every 4 weeks. The drug can also be given every 4 weeks without the weekly loading doses. The dose can be increased to 300 mg in patients who continue to have active psoriatic arthritis. The cost for one 150 mg/mL single-use pen is $1954.10.6

1. Secukinumab (Cosentyx) for psoriasis. Med Lett Drugs Ther 2015; 57:45.
2. Drugs for psoriasis. Med Lett Drugs Ther 2015; 57:81.
3. IB McInnes et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015; 386:1137.
4. PJ Mease et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med 2015; 373:1329.
5. D Baeten et al. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med 2015; 373:2534.
6. Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. May 5, 2016. Reprinted with permission by First Databank, Inc. All rights reserved. ©2016. www.fdbhealth.com/policies/drug-pricing-policy.

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The FDA has approved ixekizumab (Taltz – Lilly), an injectable humanized interleukin (IL)-17A antagonist, for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ixekizumab is the second IL-17A antagonist to be approved for this indication in the US; secukinumab (Cosentyx – Novartis) was the first.

The FDA has approved Enstilar (Leo), an aerosol foam formulation of the synthetic vitamin D₃ analog calcipotriene and the high-potency corticosteroid betamethasone dipropionate, for topical treatment of plaque psoriasis in adults. Topical ointment and suspension formulations of the same combination have been available for many years.

Mild to moderate psoriasis is generally treated with topical corticosteroids. Vitamin D analogs and tazarotene are topical alternatives that can be used in combination with topical corticosteroids. Phototherapy and systemic therapy, including biologic agents, are recommended for patients with moderate to severe disease.

Psoriatic arthritis is a chronic inflammatory arthropathy that develops in up to 40% of patients with psoriasis. Several guidelines for treatment of psoriatic arthritis have been published.

Secukinumab (Cosentyx – Novartis), an injectable human interleukin (IL)-17A antagonist, has been approved by the FDA for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. It is the first IL-17 inhibitor to be approved for any indication in the US.

The FDA has approved a new injectable formulation of methotrexate (Otrexup – Antares) for use in rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, and for severe psoriasis in adults. On its web site (www.otrexup.com), the manufacturer states: "Otrexup is the first subcutaneous (SC) methotrexate (MTX) for self-administration delivered once weekly by auto-injector." Methotrexate has been available as a once-weekly injection (IM or SC) for these indications for many years,1 but not specifically for self-administration and not in a single-dose auto-injector. Methotrexate is generally given orally, but injectable formulations may be helpful for patients who have adverse gastrointestinal effects from the oral formulation or lose benefit over time because of poor absorption.

Otrexup auto-injectors are available in strengths of 10, 15, 20, and 25 mg of methotrexate per 0.4 mL. The usual dosage of methotrexate for patients with rheumatoid arthritis ranges from 7.5 to 25 mg once weekly. Otrexup should be administered SC in the abdomen or thigh. Four 25-mg auto-injectors cost $548.00, compared to $5.00 for a single 4-mL vial of generic methotrexate containing 25 mg/mL.2 Nevertheless, some patients with rheumatoid arthritis who find it difficult to draw up methotrexate solution from a vial and inject it with a syringe may prefer Otrexup.

1. Drugs for rheumatoid arthritis. Treat Guidel Med Lett 2012; 10:37.

2. Approximate wholesale acquisition cost (WAC). Source: Analy$ource® Monthly (Selected from FDB MedKnowledge™) March 5, 2014. Reprinted with permission by FDB, Inc. All rights reserved. ©2014. www.fdbhealth.com/policies/drug-pricing-policy. Actual retail prices may be higher.

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Certolizumab pegol (Cimzia – UCB), a tumor necrosis factor (TNF) inhibitor previously approved for treatment of Crohn's disease and rheumatoid arthritis, and ustekinumab (Stelara – Janssen), a human interleukin-12 and -23 antagonist previously approved for treatment of moderate-to-severe plaque psoriasis, have now been approved by the FDA for treatment of active psoriatic arthritis.

The pathogenesis of acne is multifactorial: follicular hyperkeratinization, bacteria, sebum production, androgens, and inflammation all play a role. The gram-positive microaerophilic bacteria Propionibacterium acnes promote development of acne lesions by secreting chemotactic factors that attract leukocytes to the follicle, causing inflammation.

The FDA has approved calcitriol ointment (Vectical - Galderma), a vitamin D analog, for topical treatment of mild-to-moderate plaque psoriasis in adults ≥18 years old. Ointments are generally considered more potent than creams or solutions.

Some tumor necrosis factor (TNF) inhibitors are being promoted on the internet directly to the public for use in psoriasis (www.yahoo.com).

The pathogenesis of acne is multifactorial: follicular hyperkeratinization, bacteria, sebum production, androgens and inflammation all play a role. The gram-positive microaerophilic bacteria Propionibacterium acnes promote development of acne lesions by secreting chemotactic factors that attract leukocytes to the follicle, causing inflammation.

Taclonex ointment (Warner Chilcott/LEO Pharma), a combination of the vitamin D3 analog calcipotriene 0.005% (Dovonex) and the high-potency corticosteroid betamethasone dipropionate 0.064%, was recently approved by the FDA for treatment of psoriasis vulgaris in patients ≥ 18 years old.

The FDA has approved a new spray formulation of the super-high-potency corticosteroid clobetasol propionate 0.05% (Clobex - Galderma) for treatment of moderate to severe plaque psoriasis in adults. Clobetasol propionate is also available as a cream, ointment, gel, solution, foam, lotion and shampoo.

The pathogenesis of acne is multifactorial: follicular hyperkeratinization, Propionibacterium acnes bacteria, sebum production, androgens and inflammation have all been implicated. P. acnes, a gram-positive microaerophilic bacterium, plays an important role in the development of acne lesions by secreting chemotactic factors that attract leukocytes to the follicle, causing inflammation.

Efalizumab (Raptiva - Genentech/XOMA), a humanized monoclonal antibody that inhibits T-cell activation, has been approved by the FDA for treatment of adults with moderate to severe chronic plaque psoriasis.

Alefacept (a le' fa sept; Amevive - Biogen) has been approved by the FDA for parenteral treatment of adults with moderate to severe chronic plaque psoriasis.

Calcipotriene ointment 0.005% (calcipotriol; Dovonex - Westwood Squibb), a synthetic vitamin D 3 analog previously available in Europe and Canada, has now been approved by the US Food and Drug Administration (FDA) for treatment of moderate plaque psoriasis, the most common form of the disease.

Since the last Medical Letter review of generic drugs (Volume 28, page 1, 1986), the prediction that generic drugs newly approved in the USA under more relaxed federal regulations will probably be as reliable as brand-name drugs has generally been accurate. Few well-documented generic product failures have been reported. Recently, however, the equivalence of generic topical corticosteroids has been questioned.