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With the arrival of subsequent entry biologics (SEBs), prescribers, payers and patients will have some difficult decisions ahead. One of the most important decisions that we will have to make is whether we should switch stable patients from an innovator molecule to a more cost-effective SEB. There are many patients in Europe, Asia and South America who have been forced to switch from Remicade to Celltrion's infliximab. Unfortunately, although many of us have heard our colleagues speak of positive experiences, there is little published data. We are all anxiously awaiting results from Norway’s NOR-SWITCH Study, which is formally evaluating this question.
At ACR today, Douglas Wolf and colleagues in the United States presented data on stable patients with rheumatoid arthritis on TNFi therapy who discontinued or switched to another therapy for non-medical reasons (unrelated to clinical efficacy, safety or tolerability) and compared these patients to control patients who did not stop or switch their medication. The majority of those who stopped/switched did so for economic reasons including increased co-pay, switching of insurance, job loss, or other. They captured data on 83 matched pairs, 70% of whom were switchers and 30% discontinuers, and followed them for 12 months. Adalimumab and etanercept were the most frequently used medications, 64% were on background DMARD therapy, and 15-20% were on concurrent steroid therapy. Interestingly, those who switched TNFi therapy had significantly more flares, and lower rates of disease control at 12 months compared to those who did not switch. Furthermore, switchers had higher rates of health care utilization, including emergency room visits, outpatient visits and inpatient stays compared to those who did not switch.
One of the main limitations for using these data to decide whether to switch stable patients to an SEB is that in this study, patients were switched from a TNFi to a DIFFERENT TNFi and not to an SEB, which is supposed to be SIMILAR to the innovator product. Regardless, it supports some of the worries that many of us share when it comes to switching patients who are stable. Until we have good data that efficacy and safety do not change with switching stable patients to an SEB, I will continue to advocate to leave stable patients alone.
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About the Author
Dr. Shahin Jamal
Dr. Jamal is a Clinical Associate Professor at the University of British Columbia and an active staff physician at Vancouver Coastal Health. Her interests include diagnosis and prognosis of early inflammatory arthritis, and timely assessment and access to care for patients with rheumatoid arthritis.
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