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 the marketing of Vimovo (AstraZeneca), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) naproxen and the proton pump inhibitor (PPI) esomeprazole, for symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk for NSAID-associated ulcers.

Golimumab (Simponi - Centocor), a fully humanized anti-tumor necrosis factor (TNF)-a antibody, has been approved by the FDA for the treatment of: (1) moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate; (2) active psoriatic arthritis (PsA) alone or in combination with methotrexate; and (3) active ankylosing spondylitis (AS).

Meloxicam, a nonsteroidal anti-inflammatory drug (NSAID) with some cyclooxygenase-2 (COX-2) selectivity in vitro, has been approved by the FDA for treatment of osteoarthritis.