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  • Early Dose Optimisation of ...
    Philip, George; Cornillie, Freddy; Adedokun, J Omoniyi; Melsheimer, Richard; Rutgeerts, Paul; Colombel, Jean-Frédéric; Marano, Colleen

    Journal of Crohn's and colitis, 09/2019, Letnik: 13, Številka: 10
    Journal Article

    In nonresponders to golimumab induction for ulcerative colitis, we assessed clinical response rates and golimumab serum concentrations when the 100-mg dose was used early in the course of maintenance. This post-hoc analysis of golimumab maintenance dosing in the PURSUIT-M study examined clinical outcomes and golimumab concentrations in early Week 6 responders and nonresponders to induction, including subgroups based on body weight. In nonresponders to golimumab induction assessed at Week 6, the 100-mg maintenance dose starting at Week 6 resulted in a meaningful proportion 28.1% of patients achieving a partial Mayo response at Week 14. After 1 year of maintenance, clinical outcome response, remission, mucosal healing, corticosteroid-free state rates in these "late" Week 14 responders were similar to those in early Week 6 responders. Golimumab concentrations in early nonresponders were approximately half those of early responders, suggesting that early nonresponders had more rapid golimumab clearance. Examined by body weight, the early nonresponders weighing <80 kg and receiving 100 mg had golimumab concentrations similar to the early responders weighing <80 kg or ≥80 kg and receiving 50 mg or 100 mg, respectively. Early use of the 100-mg maintenance dose leads to positive clinical outcomes in a meaningful proportion of patients who did not respond to golimumab at Week 6. Early nonresponders <80 kg who received the 100-mg maintenance dose achieved adequate golimumab concentrations and a clinically meaningful proportion of these patients had a late clinical response.PURSUIT-M protocol number C0524T18; ClinicalTrials.gov, NCT00488631; EudraCT, 2006-003399-37.