BACKGROUND AND AIMS: Multiple adalimumab [ADA] biosimilars are now approved for use in inflammatory bowel disease [IBD]; however, effectiveness and safety data remain scarce. We aimed to investigate long-term outcomes of the ADA biosimilar SB5 in IBD patients following a switch from the ADA originator [SB5-switch cohort] or after start of SB5 [SB5-start cohort]. METHODS: We performed an observational cohort study in a tertiary IBD referral centre. All IBD patients treated with Humira underwent an elective switch to SB5. We identified all these patients in a biological prescription database that prospectively registered all ADA start and stop dates including brand names. Data on IBD phenotype, C-reactive protein [CRP], drug persistence, ADA drug and antibody levels, and faecal calprotectin were collected. RESULTS: In total, 481 patients were treated with SB5, 256 in the SB5-switch cohort (median follow-up: 13.7 months [IQR 8.6-15.2]) and 225 in the SB5-start cohort [median follow-up: 8.3 months [4.2-12.8]). Of the SB5-switch cohort, 70.8% remained on SB5 beyond 1 year; 90/256 discontinued SB5, mainly due to adverse events [46/90] or secondary loss of response [37/90]. In the SB5-start cohort, 81/225 discontinued SB5, resulting in SB5-drug persistence of 60.3% beyond 1 year. No differences in clinical remission [p = 0.53], CRP [p = 0.80], faecal calprotectin [p = 0.40] and ADA trough levels [p = 0.55] were found between baseline, week 26 and week 52 following switch. Injection site pain was the most frequently reported adverse event. CONCLUSION: Switching from ADA originator to SB5 appeared effective and safe in this study with over 12 months of follow-up.
BACKGROUND AND AIMS: Multiple adalimumab [ADA] biosimilars are now approved for use in inflammatory bowel disease [IBD]; however, effectiveness and safety data remain scarce. We aimed to investigate long-term outcomes of the ADA biosimilar SB5 in IBD patients following a switch from the ADA originator [SB5-switch cohort] or after start of SB5 [SB5-start cohort]. METHODS: We performed an observational cohort study in a tertiary IBD referral centre. All IBD patients treated with Humira underwent an elective switch to SB5. We identified all these patients in a biological prescription database that prospectively registered all ADA start and stop dates including brand names. Data on IBD phenotype, C-reactive protein [CRP], drug persistence, ADA drug and antibody levels, and faecal calprotectin were collected. RESULTS: In total, 481 patients were treated with SB5, 256 in the SB5-switch cohort (median follow-up: 13.7 months [IQR 8.6-15.2]) and 225 in the SB5-start cohort [median follow-up: 8.3 months [4.2-12.8]). Of the SB5-switch cohort, 70.8% remained on SB5 beyond 1 year; 90/256 discontinued SB5, mainly due to adverse events [46/90] or secondary loss of response [37/90]. In the SB5-start cohort, 81/225 discontinued SB5, resulting in SB5-drug persistence of 60.3% beyond 1 year. No differences in clinical remission [p = 0.53], CRP [p = 0.80], faecal calprotectin [p = 0.40] and ADA trough levels [p = 0.55] were found between baseline, week 26 and week 52 following switch. Injection site pain was the most frequently reported adverse event. CONCLUSION: Switching from ADA originator to SB5 appeared effective and safe in this study with over 12 months of follow-up.
Authors: Jean-Frédéric Colombel; William J Sandborn; Paul Rutgeerts; Robert Enns; Stephen B Hanauer; Remo Panaccione; Stefan Schreiber; Dan Byczkowski; Ju Li; Jeffrey D Kent; Paul F Pollack Journal: Gastroenterology Date: 2006-11-29 Impact factor: 22.682
Authors: A Blauvelt; J-P Lacour; J F Fowler; J M Weinberg; D Gospodinov; E Schuck; J Jauch-Lembach; A Balfour; C L Leonardi Journal: Br J Dermatol Date: 2018-07-15 Impact factor: 9.302
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Authors: Mirthe Emilie van der Valk; Marie-Josée J Mangen; Max Leenders; Gerard Dijkstra; Ad A van Bodegraven; Herma H Fidder; Dirk J de Jong; Marieke Pierik; C Janneke van der Woude; Mariëlle J L Romberg-Camps; Cees H M Clemens; Jeroen M Jansen; Nofel Mahmmod; Paul C van de Meeberg; Andrea E van der Meulen-de Jong; Cyriel Y Ponsioen; Clemens J M Bolwerk; J Reinoud Vermeijden; Peter D Siersema; Martijn G H van Oijen; Bas Oldenburg Journal: Gut Date: 2012-11-07 Impact factor: 23.059
Authors: Peter Nash; Johan Vanhoof; Stephen Hall; Udayasankar Arulmani; Rita Tarzynski-Potempa; Kristina Unnebrink; Andrew N Payne; Alfred Cividino Journal: Rheumatol Ther Date: 2016-08-18
Authors: Mathew Lyons; Lauranne A A P Derikx; James Fulforth; Sophie McCall; Nikolas Plevris; Philip W Jenkinson; Kathryn Kirkwood; Spyros Siakavellas; Laura Lucaciu; Nathan Constantine-Cooke; Ian D Arnott; Paul Henderson; Richard K Russell; David C Wilson; Charlie W Lees; Gareth-Rhys Jones Journal: Aliment Pharmacol Ther Date: 2022-03-17 Impact factor: 9.524