The FDA Approved Several New Rheumatology Drugs in 2017

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SAN DIEGO—In a session at the 2017 ACR/ARHP Annual Meeting, Kam Nola, PharmD, MS, professor in the College of Pharmacy and vice chair in the Department of Pharmacy Practice at Lipscomb University in Nashville, Tenn., updated participants on new medications and new indications for rheumatology treatments and safety labeling changes approved by the U.S. Food and Drug Administration (FDA) over the past year. “One theme is incorporation of more new data from trials into labeling,” she said.

An important new development is approval of the first oral solution of methotrexate for patients with polyarticular juvenile idiopathic arthritis, she said. In May, the first FDA-approved therapy specifically for giant cell arteritis (GCA) was announced. “This is great news for GCA patients,” Dr. Nola said.

In an expansion of labeling, tocilizumab was approved as an intravenous dose for cancer patients receiving chimeric antigen receptor (CAR) T cell therapy and experiencing severe or life-threatening cytokine release syndrome.

Brodalumab, an interleukin (IL) 17 inhibitor, was approved in February in a prefilled, single-dose, subcutaneous syringe for moderate to severe plaque psoriasis. It is contraindicated for Crohn’s disease, and it comes with a significant warning for adverse events, such as suicidal ideation. Dispensing requires the provider’s enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program mandated by the FDA to ensure that patients, care­givers and providers are aware of the risks. Patients get a wallet card with information about risk.

“Have a conversation with your patients. Make sure they know that if they have [suicidal] thoughts, they need to talk to someone as soon as possible,” Dr. Nola said.

Other FDA approvals significant for rheumatology include:

• Abaloparatide, a human parathyroid hormone-related peptide analog was approved in April for post-menopausal women with osteoporosis and a high risk for fracture;
• Sarilumab, a new IL-6 receptor antagonist for patients with moderate to severe rheumatoid arthritis who have not responded well to one or more disease-modifying anti-rheumatic drugs (DMARDs), was approved in May. It can be prescribed as monotherapy or in combination with methotrexate or other conventional DMARDs;
• Guselkumab, an IL-23 blocker for severe plaque psoriasis, was approved in July, with a few warnings and precautions, mostly around infections. “Remember, infections are something we can’t overlook,” Dr. Nola said;
• Belimumab in a new self-injectable form for lupus patients was approved in July; and
• A fixed-dose combination of lesinurad and allopurinal was approved for the treatment of hyperuricemia in patients with gout who have not reached serum uric acid treatment targets on allopurinol alone. Considerations include how to set doses for the combination product for patients who are already receiving allopurinol.

In the world of biosimilars, a number of products have been approved by the FDA, and a number of others are in the pipeline. “The hot questions at this conference have been: ‘Are you using them yet? What are you doing with them?’” Dr. Nola observed. She expects news of more approvals in the near future for biosimilars for oncology and rheumatology drugs, such as filgrastim, bevacizumab, trastuzumab and rituximab, among others.