P483 Patient-reported quality of life, anxiety, and depression associated with switching originator infliximab to biosimilar

Ritter, T.E.(1);Mehta, S.A.(2);Van Anglen, L.J.(2);

(1)GI Alliance, Research and Education, Southlake- TX, United States;(2)Healix Infusion Therapy, Clinical Research, Sugar Land- TX, United States;


Non-medical switching from biologics to biosimilars is becoming increasingly common. Previous studies have demonstrated efficacy and safety of switching originator to biosimilar infliximab in inflammatory bowel disease (IBD) patients. Limited data exist on patient-reported quality of life (QOL) and possible emotional duress associated with these switches. The purpose of this study was to describe the impact of non-medical switches to infliximab biosimilars on QOL, anxiety, and depression.


This was a retrospective review of all IBD patients switched from originator to infliximab biosimilar at a large multicenter gastroenterology private practise in Texas. Patients were asked to complete standardised questionnaires on a quarterly basis beginning 3/2021, concurrent with large US payor policy changes mandating non-medical biosimilar switches. The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) was used to assess disease-specific QOL. The Hospital Anxiety and Depression Scale (HADS) was used to determine anxiety and depression. All questionnaires through 10/2021 were collected and designated as “pre” or “post” based on the date of the patient’s non-medical switch to infliximab biosimilar. Wilcoxon rank sum test was used to compare scores. We also performed subset analyses on patients with both “pre” and “post” questionnaires with paired t-test.


From 3/2021 to 10/2021, a total of 81 questionnaires were submitted by 54 patients who underwent non-medical switches to an infliximab biosimilar. 30 questionnaires were submitted prior to (“pre”) and 51 questionnaires were submitted after (“post”) the non-medical switch. Median “pre” SIBDQ score was 58 (IQR 53-63). Median “pre” HADS-Anxiety and HADS-Depression score were 3.5 (IQR 1-6) and 1 (IQR 0-5), respectively. As shown in Figure 1, “post” scores were unchanged [SIBDQ 59 (IQR 54-63); HADS-Anxiety 3 (IQR 1-7); HADS-Depression 2 (IQR 1-4)]. Subset analyses included 14 patients who submitted both “pre” and “post” questionnaires. Similarly, no significant changes were observed [Figure 2]. 

Figure 2. Subset Analysis of Patients with Both


Non-medical switches to infliximab biosimilar did not affect QOL or mental health. To our knowledge, this is the first biosimilar switch study to incorporate anxiety and depression measures. These relationships should continue to be assessed.