A recent, randomized controlled trial comparing the Celltrion biosimilar to infliximab demonstrated equivalent efficacy, comparable adverse events and a comparable development of anti-drug antibodies, but was only continued for 30 weeks.6 A similar 24-week study comparing an etanercept biosimilar to reference etanercept also demonstrated comparable efficacy, immunogenicity and safety.7
“Neither study addresses the question of immunogenicity in patients who switch from the reference drug, which could occur without the prescribing physician’s knowledge in the case of interchangeables,” Dr. Goodman points out. The protections and requirements for physician and patient notification for interchangeables vary by state.
Be Wary of Increased Heart Attack Risk with NSAIDs
Rheumatologists should be aware that the FDA strengthened its warning regarding the effects of NSAIDs on the cardiovascular system in July 2015.8 In particular, after the first few weeks of therapy they carry an increased risk of heart attack. The risk is also increased with higher doses of NSAIDs, as well as for individuals without underlying cardiac disease—although the risk is greatest in those with underlying cardiac disease. The FDA recommends that patients and practitioners be on alert for heart-related side effects.
‘Approval of biosimilars will add complexity to rheumatology practice when RA drugs are approved in the United States.’ —Dr. Susan M. Goodman
“For patients with preexisting cardiac disease and those who smoke, risk–benefit discussions should reflect the heightened awareness of the cardiovascular risk of NSAIDs,” Dr. Goodman says. “For many patients, the benefits [with] regard to maintained function and quality of life outweigh the risk, and decisions can be made on an individual basis when adequate relief of symptoms is not achieved by acetaminophen alone.”
Conclusion
When treating a patient newly diagnosed with RA, look first to organizations’ standard protocols. Then, evaluate the individual patient, discussing their specific needs and goals. Follow-up evaluations are necessary to determine optimum treatment.
Karen Appold is a medical writer in Pennsylvania.
Beyond Drugs: Easing RA Symptoms with Exercise, Diet
In addition to medications, joint therapies, exercises and tailored diets can benefit certain patients with rheumatoid arthritis (RA). John Indalecio, OTR/L, CHT, MS, occupational therapist and staff hand therapist at the Hospital for Special Surgery (HSS) in New York, recommends several strategies for relieving joint pain, including joint protection, energy conservation and adaptive techniques and tools to ensure maximal functional independence.
“Because of the systemic nature of the disease and consequential destruction of the synovium and soft tissue, it’s important to protect joints from stress, such as challenging or pushing through pain,” Mr. Indalecio says.