Observational studyJournal of Crohn's & colitis2021
Effectiveness and Safety of Adalimumab Biosimilar SB5 in Inflammatory Bowel Disease: Outcomes in Originator to SB5 Switch, Double Biosimilar Switch and Bio-Naïve SB5 Observational Cohorts.
Observational study in Journal of Crohn's & colitis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Pooled it
- The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune-Mediated Inflammatory Disease.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Trial
- Outcomes of adalimumab biosimilar nonmedical switches in children and young adults with inflammatory bowel disease.JPGN reports · 2026Article
- Comparable remission and health care use in real-world inflammatory bowel disease patients initiating originator biologicsWorld journal of gastroenterology · 2026Article
- Effectiveness and safety of adalimumab biosimilar in bio-naive patients with inflammatory bowel disease: a real-life multicenter observational study comparing ABP501, SB5, MSB11022, GP2017, and FKB327.Crohn's & colitis 360 · 2026Article
- Clinical outcomes and drug sustainability after non-medical switch from ustekinumab originator to biosimilars in inflammatory bowel disease.World journal of gastroenterology · 2025Observational
- A single-centre analysis of a biosimilar switching programme for adalimumab in inflammatory bowel disease.British journal of clinical pharmacology · 2025Article
- Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Innovative Formulation Strategies for Biosimilars: Trends Focused on Buffer-Free Systems, Safety, Regulatory Alignment, and Intellectual Property Challenges.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Biosimilars versus biological therapy in inflammatory bowel disease: challenges and targeting strategies using drug delivery systems.Clinical and experimental medicine · 2025Review
- Adalimumab Biosimilars Demonstrate Long-Term Durability and Cost-Effectiveness in Paediatric Inflammatory Bowel Disease: A Real-World Two-Centre European Cohort Study.Biologics : targets & therapy · 2025Article
- Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- Biosimilars in IBD: What Every Clinician Needs to Know.Current gastroenterology reports · 2024Review
- An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.Journal of the Canadian Association of Gastroenterology · 2024Article
- Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases.Advances in therapy · 2024Review
- Adalimumab Persistence and Its Biosimilar in Inflammatory Bowel Disease: A Real-World Study.Journal of clinical medicine · 2024Article
- Anti-TNFα in inflammatory bowel disease: from originators to biosimilars.Frontiers in pharmacology · 2024Review
- Effectiveness and Factors Associated with Response to Golimumab in Japanese Patients with Ulcerative Colitis in Real Clinical Practice: The Phoenix Study.Inflammatory intestinal diseases · 2023Article
- The Perception among Israeli Gastroenterologists Regarding Treatment of Patients with Biosimilar Medications.Medicina (Kaunas, Lithuania) · 2023Article
- Multiple infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort.United European gastroenterology journal · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 2 institutions in 2 countries.
Funding
Abstract
BACKGROUND AND
aimsMultiple 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].
methodsWe 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.
resultsIn 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.
conclusionSwitching from ADA originator to SB5 appeared effective and safe in this study with over 12 months of follow-up.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.