Most rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients can switch from infliximab (Remicade) to biosimilar CT-P13 without losing safety or effectiveness. That’s the main takeaway from research published recently in Arthritis & Rheumatology.
The research centers on a distinction between what researchers call “subjective” and “objective” health complaints. Rather than undermining what patients are feeling, which is very real, a “subjective” complaint relates to symptoms that only the patient can perceive, such as headaches and nausea.
“They are not necessarily related to a particular drug, but they can be triggered when negative expectations of a drug steer experiences of symptoms and create side effects where none should occur,” says Lieke Tweehuysen, of the rheumatology department at the Dutch hospital Sint Maartenskliniek (St. Martin’s Clinic) and lead study author.
Those side effects are referred to as “nocebo,” which led a quarter of the patients in the study to discontinue CT-P13 over a six month period. “It was mainly due to subjective health complaints,” Tweehuysen says.
Physicians should be cautious lest their words or gestures unintentionally trigger the nocebo effect, warns Tweehuysen.
“A good physician-patient relationship is essential, and includes finding a balance between communicating important clinical information and ensuring that unnecessary negative instructions are minimized,” she says.
Many countries require physicians to tell patients about the option to switch to biosimilars — see a roundup here of such laws in U.S. states — so the only way to reduce the nocebo effect, Tweehuysen says, is to optimize the way that transition is conveyed to patients.
“Providing ‘soft skills’ training for physicians about education in communication techniques is useful,” she says. That training may often center on helping doctors slow down, listen, and ask questions of patients.
[Learn more about rheumatoid arthritis medications.]
In this study, 192 of 222 patients taking infliximab agreed to switch to CT-P13. After six months, Tweehuysen and colleagues found that 24 percent discontinued the CT-P13. Thirty seven restarted infliximab; seven tried a different biologic; and three stayed biologic free.
Tweehuysen expected that patients would discontinue CT-P13 at the same long-term rate that they did for infliximab.
“During the six months follow-up period, I was surprised by the gradual increase of patients who discontinued CT-P13,” she says. “I was familiar with the existence of the placebo effect, but I did not know that nonspecific effects of a treatment could also be harmful instead of beneficial.”
The term “nocebo” was introduced in 1961, but it’s only started receiving wider research attention of late, according to Tweehuysen. “Future research should focus on identifying ways to downplay the nocebo effect and thereby improving treatment outcomes,” she says.