World Arthritis Day: Patients Benefit From Clinical Advances, Face Practical Challenges

The Center for Biosimilars Staff

On this World Arthritis Day, patients with inflammatory diseases have increasing treatment options as biosimilars gain regulatory approval and become more widely available for use. New clinical data also help support the efficacy and safety of these therapies.

On this World Arthritis Day, patients with inflammatory diseases have increasing treatment options as biosimilars gain regulatory approval and become more widely available for use. New clinical data also help support the efficacy and safety of these therapies.

Biologic treatments are known to be effective in the treatment of inflammatory diseases, including rheumatoid arthritis (RA), and new data add to the body of evidence showing that biosimilar etanercept has comparable efficacy to the originator drug. A recent study of Samsung Bioepis’ SB4 (which is approved in the Republic of Korea, the European Union, Australia, and Canada) observed no difference in radiographic progression of RA in patients receiving SB4 and patients receiving the originator etanercept, at 52 weeks of treatment.

While clinical efficacy of a biologic therapy is critical, adherence to the treatment regimen is also important for good outcomes. A recent study found that enrollment in patient support programs was associated with greater adherence to adalimumab (Humira) therapy, as well as with reduced healthcare costs. These programs assist patients, including those with RA, psoriatic arthritis (PA), ankylosing spondylitis (AS), with drug costs, in addition to providing injection training and nursing support. The study found that patients enrolled in these programs had a 14% higher rate of treatment adherence than control patients who did not utilize these programs.

Unfortunately, despite treatment adherence, some patients do not achieve an adequate response. A recent paper recommends switching patients with PA who are non-responders to a different biologic therapy. The paper’s authors investigated 13 studies in which patients with PA were switched after failing to respond or no longer responding to a biologic, and found that switching to a different drug could be both safe and effective, especially when switching to a biologic with a different method of action.

Newer drugs, including IL-6 inhibitors like tocilizumab (Acterma), also present patients with good therapeutic options; a new study comparing the clinical effectiveness of anti—tumor necrosis factor (TNF) agents such as etanercept, adalimumab, certolizumab pegol, infliximab, and golimumab found that tocilizumab outperformed anti-TNF agents in both effectiveness and drug survival. However, excitement about IL-6 inhibitors has been tempered by concerns about safety in at least 1 case: the FDA recently issued a complete response letter to Janssen Biotech for the company’s proposed IL-6 inhibitor, sirukumab. The drug was associated with a number of patient deaths during its clinical program.

Despite advances in drug development and approval, patients continue to face challenges in navigating access to the most appropriate treatments for their arthritis; many health plans use “step therapy,” (sometimes called “fail-first therapy”) a policy that requires doctors to prescribe older, less expensive drugs first in an effort to save on costs. Only after a patient has failed to respond to such therapies can a physician prescribe a newer, more expensive drug, such as a biologic or a biosimilar. In diseases like RA, delays in access to better treatment can lead to pain, loss of function, and higher healthcare costs.

While step therapy may force patients to receive a number of drugs before they reach higher-cost treatments like biologics, physicians are concerned that other payer policies could also have an impact on what drugs they prescribe their patients. Because formulary decisions can restrict which treatment a provider can prescribe, some clinicians are voicing concerns that patients may have to switch treatments among non-interchangeable biologics and biosimilars.

In a recent Peer Exchange panel discussion by The Center for Biosimilars®, Marcus Snow, MD, of the University of Nebraska Medical Center, raised questions about multiple switches among products, saying, “Does your body react to that long term? Do you lose efficacy? Does it increase your immunogenicity, which basically means that you have more drug-to-drug antibodies because you switched from product A to product B and maybe then to product C then back to product B, depending on how the winds blow with the formulary? That’s something that, as rheumatologists, we are very concerned about. And it’s something that we are trying to help regulate with the FDA.”