FRI0110 RITUXIMAB BIOSIMILAR NON-MEDICAL SWITCH – DOES IT WORK?
Authors: Muhammad Khurram Nisar
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Since the introduction of anti-TNF biosimilars in routine clinical practice, there has been a drive to implement the switch program for all biosimilars at the point of availability. Rituximab biosimilar was granted marketing authorisation by the EMA in February 2017. Our Trust was one of the first centres to embrace a CQUIN which required adoption of biosimilar within three months for new patients and one year for switchers. This could help deliver significant savings to the NHS whilst achieving similar clinical outcomes. <h3>Objectives</h3> We report our early experience of introducing rituximab biosimilar in people with RA. <h3>Methods</h3> A list of all patients prescribed rituximab was extracted through our database. A 'switch' letter was drafted and sent to all patients including Truxima information sheet. Patients were given the opportunity to contact nurse helpline for information or if disease control worsened/adverse effects developed. We reviewed all relevant records and collected data on any adverse events and disease outcome on either side of the switch. Patients were reviewed as originally planned by their respective clinicians. <h3>Results</h3> 44 patients with RA on 2 g dose six-monthly were identified established on rituximab. Four had stopped treatment prior to switching. All 40 agreed to switch to Truxima that was completed by February 2018. Mean age of switchers was 58.6 (range 26-80 years). Eight were men and remaining 32 (80%) were women. Fourteen (35%) were Asian, one Afro-Caribbean and the rest (62%) were White Caucasian. DAS28 scores were available for all participants. Prior to the switch median DAS28 was 3.0 (range 0.6-5.1). Following the switch it was 2.95 (range 1.5-5.7). Amongst these, eight (20%) reported adverse effects. Four had serum sickness reaction within the first week of the second dose with loss of efficacy. One required admission to ED (&lt;24 hrs) for further management. All decided against further biosimilar and three were swapped back to the originator with no further concerns. In one case the clinician decided to change the class of drug to a TNF inhibitor. Three patients had mild intolerance and agreed to continue Truxima with no further issues. One patient developed miliary tuberculosis and was taken off biologic therapy. Adverse events related to Rituximab biosimilar switch <h3>Conclusion</h3> Our experience of switching rituximab patients is certainly not as smooth as it was for infliximab and etanercept. All were happy to switch after receiving a letter and having the opportunity to contact if necessary. Substantial annual cost savings of nearly £140,000 were achieved once the switch process completed. At group level there were no major differences in disease outcomes. However, 10% had severe serum sickness reaction with loss of efficacy and loss of confidence in the drug. One patient developed military TB despite having one previous originator cycle with no issues. We support the routine switching from originator to biosimilar rituximab however close monitoring is required certainly in the first few weeks of dose administration. <h3> Disclosure of Interests: </h3> Muhammad Khurram Nisar Grant/research support from: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Novartis, Celgene, Mallinckrodt, UCB and Lilly, Consultant for: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Novartis, Celgene, Mallinckrodt, UCB and Lilly, Speakers bureau: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Novartis, Celgene, Mallinckrodt, UCB and Lilly