April 18, 2018
American College of Rheumatology White Paper on Biosimilars: The American College of Rheumatology (ACR) published a white paper that reviews the scientific, clinical, economic, and prescribing issues related to use of biosimilars. A "biosimilar" is a biologic product that is highly similar to an approved reference (or originator) biologic product and has no clinically meaningful differences in efficacy, adverse effects, or immunogenicity compared to the reference product. Based on the outcomes of rigorous regulatory requirements, the ACR white paper asserts that patients and healthcare providers should have confidence that an approved biosimilar should produce clinical outcomes comparable to those achieved with its reference product. The paper encourages healthcare providers to incorporate biosimilars into their practices where appropriate with the goal of continued delivery of high-quality health care at lower cost to individual patients.
CHAPTER SUMMARY FROM THE PHARMACOTHERAPY HANDBOOK
For the chapter in the Wells Handbook, please go to Chapter 4. Rheumatoid Arthritis.
Rheumatoid arthritis (RA) is a systemic disease characterized by symmetrical inflammation of joints, yet may involve other organ systems.
Control of inflammation is the key to slowing or preventing disease progression as well as managing symptoms.
Drug therapy should be only part of a comprehensive program for patient management, which would also include physical therapy, exercise, and rest. Assistive devices and orthopedic surgery may be necessary in some patients.
Patients should be treated to target of low disease activity or remission.
Traditional or conventional synthetic disease-modifying antirheumatic drugs (referred to as DMARDs) should be started as soon as possible after diagnosis of RA.
Nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids should be considered adjunctive therapy early in the course of treatment and as needed if symptoms are not adequately controlled with DMARDs or biologic DMARDs (referred to as biologics).
When DMARDs used alone are ineffective or not adequately effective, other monotherapies or combination therapy with two or more DMARDs or a DMARD plus biologic agent may be used to induce a response.
Patients require careful monitoring for toxicity and therapeutic benefit for the duration of treatment.
Rheumatoid arthritis (RA) is the most common systemic inflammatory disease characterized by symmetrical joint involvement. Extra-articular involvement, including rheumatoid nodules, vasculitis, eye inflammation, neurologic dysfunction, cardiopulmonary disease, lymphadenopathy, and splenomegaly, can be manifestations of the disease. Although the usual disease course is chronic, some patients will enter a remission spontaneously.
RA is estimated to have a prevalence of 1% and does not have any racial predilections. It can occur at any age, with increasing prevalence up to the seventh decade of life. The disease is three times more common in women. In people aged 15 to 45 years, women predominate by a ratio of 6:1; the sex ratio is approximately equal among patients in the first decade of life and in those older ...