Background and aims
Multiple adalimumab (ADA) biosimilars are now approved for use in IBD; however, effectiveness and safety data remain scarce. We aimed to investigate long-term outcomes of the adalimumab (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 biologic prescription database that prospectively registered all ADA start and stop dates including brand names. Data on IBD phenotype, CRP, drug persistence, ADA drug and antibody levels, and faecal calprotectin were collected.
Results
481 patients were treated with SB5, 256 in the SB5-switch cohort (median follow-up: 13.7 months [8.6-15.2]) and 225 in the SB5-start cohort (median follow-up: 8.3 months [4.2-12.8]). 70.8% of the SB5-switch cohort remained on SB5 beyond one 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 one 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.
Interleukin (IL)-17 and IL-23 are crucial for mediating gut mucosal inflammation in inflammatory bowel disease (IBD), which has led to new therapeutic strategies. We assessed the relevancy of IL-17 and IL-23 serum levels as potential biomarkers towards severe IBD discrimination and disease-related complications. Sixty-two patients diagnosed with Crohn’s disease (CD) and ulcerative colitis (UC) were included. Serum IL-17 and IL-23 were measured by sandwich enzyme-linked immunosorbent assays (ELISA). IL-23 and fecal calprotectin (FCal) were significantly higher in severe CD (p < 0.001) and UC (p < 0.001 and p = 0.001, respectively), compared to mild or moderate. Elevated C-reactive protein (CRP) was correlated with severe disease only in CD (p = 0.008), whereas for UC, disease severity was associated with increased IL-17 values (p < 0.001). Diagnostic role of IL-23 was superior to FCal in discriminating between severe and mild to moderate CD (p < 0.001). IL-23 levels were also significantly higher in CD patients with intestinal complications (p = 0.04). Both IL-17 and IL-23 correlate with IBD severity, and IL-23 might be a promising novel biomarker for severe CD. Identifying the dominant IL pathway involved in IBD severity could serve as guidance for clinical decision-making on biologic therapy.
Background and aims: Tofacitinib is a Janus kinase inhibitor (JAKi) recently approved for the treatment of moderate to severe ulcerative colitis (UC) based on robust efficacy and safety data derived from OCTAVE clinical trials. Evidence on the outcomes of tofacitinib therapy in real-world UC patients is needed, as a number of these patients would be deemed ineligible for clinical trials. We have therefore summarised data derived from observational, real-world evidence (RWE) studies on the effectiveness and safety of tofacitinib in moderate to severe UC patients. Methods: We searched the PubMed, EMBASE, Scopus, Web of Science and Cochrane databases for observational studies on the use of tofacitinib in UC patients, published between 30 May 2018 and 24 January 2021. Pooled induction (8–14 weeks) and maintenance (16–26 weeks) clinical response and remission rates were calculated, as well as the proportion of reported adverse events using random effects models. Results: Nine studies were included, comprising 830 patients, of which 81% were previously treated with anti-tumour necrosis factor (TNF) and 57% with vedolizumab. Induction of clinical response and remission were achieved in 51% (95% confidence interval, 41–60%) and 37% (26–45%) of patients, after a median follow-up of 8 weeks. At the end of a median follow-up of 24 weeks, maintenance of clinical response and remission were met in 40% (31–50%) and 29% (23–36%) of patients, respectively. Thirty-two percent of the patients had at least one adverse event, the most commonly reported being mild infection (13%) and worsening of UC, requiring colectomy (13%). A third of the patients (35%) discontinued tofacitinib, most frequently due to primary non-response (51%). Conclusion: Tofacitinib is a safe and effective therapy in real-world UC patients, as previously reported by clinical trials.
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