“The NOR-SWITCH trial demonstrated that switching from Remicade (infliximab) to CT-P13 was not inferior to continued treatment with the originator product, which supports that switching from the originator to CT-P13 could happen for non-medical reasons,” he said.
Dr. Kvien said data are still needed in the cases of multiple switches, which, in the real world, can sometimes be necessary.
“We are discussing now and seeking funding for a multiple switch study in Norway,” he said. “We now have access to four different infliximab molecules in Norway with rather similar prices after the last national tender. Thus, it should be feasible to do a controlled study with multiple switches between four infliximab molecules compared to stable treatment with CT-P13, which is now the standard infliximab drug in Norway. We think this study will answer some important questions regarding multiple switching, as well as switching from a biosimilar back to the originator drug. We are planning one separate study for rheumatoid arthritis and one for Crohn’s disease.”
Transition Tips
Tracy French, a clinical nurse specialist in rheumatology at University Hospitals Bristol in the United Kingdom, offered lessons from her center on how to go about transitioning patients to biosimilars.
When the transition began for switches from infliximab, etanercept (Enbrel) and rituximab (Rituxan) to their biosimilars, clinicians discussed a possible change at their next review, rather than simply switching all patients at once. Ms. French said the face-to-face conversations helped, and that patients were told they were being asked to change, not required. They were told the request was being made to save money, and that they could switch back to the originator if they had flares or side effects.
Some of the 155 total patients refused to switch at first—including 22 of the 105 etanercept patients. But in the end, all but four patients made the switch, Ms. French said. She noted that seven of the 18 patients who had switched to the infliximab biosimilar had to switch back to the originator because of loss of efficacy, and she didn’t know the reason for this high number. Four of 103 patients who had switched from etanercept to a biosimilar had to switch back to etanercept due to loss of efficacy. None of the 32 rituximab switchers had to go back for loss of efficacy.
She emphasized consistency in the conversations with patients, so they are all told the same thing, as well as having a plan for how to manage patients who decline to switch, and clarifying how to manage those patients who perceive they’ve flared.
