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Randomization, blinding, and treatment allocation

LS Lara S. van der Schoot
JR Juul M. P. A. van den Reek
LG Lynda Grine
LS Lisa Schots
WK Wietske Kievit
JL Jo L. W. Lambert
EJ Elke M. G. J. de Jong
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The investigator will enroll participants. After including the participant and obtaining written informed consent, the investigator will enter participants in a web-based randomization program (Castor). Participants will be allocated to each group (DR or UC) by this web-based randomization program (Castor) that generates block randomization (variable block size of 6, 9, 12) with a random (2:1) allocation sequence and stratified by biologic. After randomization, the randomization group is visible for the investigator and the investigator will inform the participant. Patients will be randomized 2:1 to DR or continuation of the normal dose (UC). The ratio of 2:1 is chosen to be able to include more determinants in an analysis for successful DR. Due to the pragmatic character of this trial, and due to the nature of the intervention (injections), patients and investigators will not be blinded. Patients in the DR group will receive secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab, or tildrakizumab, and doses will be lowered according to the schedule as described below (Table ​(Table1).1). Patients in the control group will receive the normal, standard dose of secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab, or tildrakizumab without interval prolongation.

Dose reduction (DR) steps per biologic

Abbreviations: DR dose reduction, mg milligram

Copyright and License information: The Author(s) ©2021
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