Background Tocilizumab (TCZ) is administered by IV infusions over 1 hour. Reduction of infusion time will optimize the utilization of hospital resources and be of benefit for patients. However, the treatment bears a risk of infusion reactions. Optimizing administration has been shown for other biological DMARDs [1,2].
Objectives The purpose of this study was to investigate whether an infusion time of TCZ IV in RA patients can be halved without impact on infusion reactions, overall safety concerning administration of TCZ and efficacy. Primary objective was incidence of infusion reactions defined as any reaction that occurred during infusion with TCZ, or in the following 24 hours. Additional safety, immunogenicity and clinical efficacy assessments were evaluated as secondary outcomes.
Methods This was a 24 week multi-center, open-label, randomized parallel group study to compare infusion reactions to TCZ IV 8 mg/kg every 4 week. Patients with moderate to severe RA, who had an inadequate clinical response to DMARDs and/or a TNF a-inhibitor were randomized to one of two arms: Control group: 1 hour infusion for 6 infusions. Fast infusion group: Infusion over 1 hour at the first infusion followed by infusion over 31 minutes (remaining five infusions).
Results 47 patients were included in the study. Incidences of infusion reactions were similar between the two groups, none of them leading to withdrawal. There was no difference in the incidence of AE's. Two serious AE's were reported, both in the control group (infective tenosynovitis and lymphoma cutis). Four patients withdrew due to adverse events, 2 from each arm. Efficacy at Week 24 was comparable between the two groups.
Conclusions Administration of TCZ in 31 minutes did not show any differences compared to the current recommended administration time (1 hour) regarding adverse events or infusion reactions. The safety profile of a faster infusion was consistent with the results of clinical studies where a 60 minutes administration was recommended and furthermore with results seen in similar fast infusion trials [3,4].
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Acknowledgements The study was sponsored by Roche a/s
Disclosure of Interest H. Lindegaard: None declared, P. Johansen: None declared, G. Gröndal: None declared, E. Jensen: None declared, L. Juul: None declared, A. Schlemmer: None declared, B. Agular Employee of: Roche A/S, I. Hansen: None declared