BackgroundEvidence supports use of therapeutic drug monitoring (TDM) in improving efficacy and cost-effectiveness of anti-tumour necrosis factor (TNF) therapy in inflammatory bowel disease (IBD). Our objective was to assess attitudes and barriers towards TDM use with anti-TNF’s in the UK.MethodsA 17-question survey was distributed to members of the British Society of Gastroenterology by email.ResultsOf 243 respondents (51.6% male), 237 respondents met inclusion criteria. Of these, 46% were consultants (gastroenterologist, GI), 39.2% IBD nurse specialists (clinical nurse specialists, CNS), 14.8% registrars. TDM is used by 96.9% for secondary loss of response; 72.5% for primary non-response and 54.1% used TDM proactively. Barriers were time lag in receiving results (49.8%), lack of awareness of guidelines (46.4%) and cost (29.9%). Clinicians working at a teaching hospital (OR 2.6, 95% CI 0.71 to 9.8), IBD CNS and GI registrars (OR 2.6, 95% CI 0.7 to 10 and OR 1.5, 95% CI 0.3 to 7.2, respectively) were more likely to use TDM. Clinicians practising for >20 years (OR 4.1, 95% CI 0.4 to 41.8) and a large volume IBD practice (>50% IBD patients per month) were more likely to use TDM (OR 45.7, 95% CI 7.5 to 275). Proactive TDM, was more likely to be used in tertiary care (OR 2.25, 95% CI 0.84 to 6.1), IBD CNS (OR 1.2, 95% CI 0.7 to 2.1) and clinicians managing >50% IBD patients per month (OR 10.8, 95% CI 1.3 to 90.3). Clinicians with 5–9 years of experience in practice were more likely to use proactive TDM (OR 2.6 and CI 1.04 to 6.4).ConclusionValidation of point of care and lower cost assays, reduced time lag from test to result, lower cost of testing and dissemination of current recommendations may further optimise treatment strategies.
Background Evidence supports therapeutic drug monitoring (TDM) in improving efficacy and cost-effectiveness of anti-TNF therapy in inflammatory bowel disease (IBD). Data on perceptions and barriers to TDM use are limited and no data are available from India. Our objective was to assess clinicians' attitudes and barriers to TDM use in IBD. Methods A 16-question survey was distributed to members of the Indian Society of Gastroenterology. Information on clinician characteristics, demographics, use and barriers towards TDM with anti-TNFs was collected. Logistic regression was used to predict factors influencing TDM use. Results Two hundred and forty-two respondents participated (92.5% male); 83% were consultant gastroenterologists. Of 104 respondents meeting inclusion criteria (treating > 5 IBD patients and at least 1 with an anti-TNF per month), complete responses were available for 101 participants. TDM was utilized by 20% (n = 20) of respondents. Of them, 89.5% (n = 17) used TDM for secondary loss of response; 73.7% (n = 14) for primary non-response and 5.3% (n = 1) proactively. Barriers to TDM use were cost (71.2%), availability (67.8%), time lag in results (58.7%) and the perception that TDM is time-consuming (45.7%). Clinicians treating > 30 IBD patients were more likely to check TDM (OR = 4.9, p = 0.02). Of 81 respondents not using TDM, 97.5% (n = 79) would do so if all the barriers were removed. Conclusion Significant barriers to TDM use were availability, cost and time lag for results. If these barriers were removed, almost all the clinicians would use TDM at least reactively and 25% would use proactively. There is an urgent need to address these barriers and optimize anti-TNF therapy for optimal outcomes.
Despite advances in inflammatory bowel disease (IBD) therapies, a significant proportion of patients with quiescent disease experience persistent, debilitating symptoms of faecal incontinence (FI), urgency and defaecatory disorders due to anorectal dysfunction. Such symptoms are often underreported or misdiagnosed and can lead to potentially premature treatment ‘escalation’ and under-utilisation of pelvic floor investigations. In this review article, we consider putative pathophysiological post-inflammatory changes resulting in altered anorectal sensitivity, motility and neuromuscular coordination and how this may drive symptoms in quiescent IBD. Finally, we discuss a pragmatic approach to investigating and managing anorectal dysfunction and highlight areas for future research for this often-neglected group of patients.
Aim The role of anti-tumour necrosis factor (TNF) medications in inflammatory bowel disease (IBD) is now established. Recent studies have reported the incidence of dermatological adverse events with use of anti-TNFs in IBD. The aim of this study was to investigate the incidence of dermatological reactions in patients on anti-TNF therapy for IBD. Methods We searched MEDLINE, the Cochrane Library and EMBASE to identify studies reporting any dermatological reaction in patients exposed to anti-TNF for treatment of IBD. The incidence of dermatological complications in the entire review population was pooled by meta-analysis of data from individual studies using the random effects model. Pooled estimates in male and female patients and in patients treated with different anti-TNF agents were also calculated. We applied mixed effects (methods of moments) regression models to investigate between-study heterogeneity. Results Forty-eight studies reporting a total of 29 776 patients treated with anti-TNF medications for IBD were identified. Gender distribution was available for 18 960 participants with 45.3% females. Data on type of disease were available for 20 226 patients: 74.9% (n = 15 154) Crohn’s disease, 24.2% (n = 4901) ulcerative colitis and 0.9% (n = 171) IBD-unclassified. The type of anti-TNF used was mentioned for 17 085 individuals: 67.5% (n = 11 530) infliximab (IFX), 30.5% (n = 5203) adalimumab (ADA), 1.7% (n = 296) certolizumab and 0.3% (n = 56) golimumab. The pooled incidence of any dermatological reaction from 26 studies was 19.4% [95% confidence interval (CI): 15.2–24.4]. The pooled incidence for IFX and ADA was 23.7% (95% CI: 17.8–30.8) from 12 studies and 33.3% (95% CI 18.8–51.1) from seven studies, respectively. We found a trend of increased event rate with increasing percentage of male population (P = 0.08). The commonest reported event (39 studies) was psoriasis/psoriasiform rash with a pooled incidence of 5.6% (95% CI: 4.2–7.4). The incidence of psoriasis/psoriasiform rashes for IFX and ADA was 6.1% (95% CI 3.4–10.6) from 15 studies and 5.9% (95% CI: 2.5–13.5) from seven studies, respectively. Other reactions reported included eczema with a pooled incidence of 5.5% (95% CI: 3.3–8.9) from 17 studies and skin infections with pooled incidence of 7.9% (95% CI: 5.5–11.2) from 11 studies. Conclusion The incidence of dermatological events in patients with IBD treated with anti-TNF medications is high. The most commonly reported reaction is psoriasis/psoriasiform reaction. Clinicians should be vigilant to dermatological side effects following treatment of IBD with anti-TNF.
Inflammatory bowel diseases, comprising ulcerative colitis (UC) and Crohn's disease, are chronic, immune-mediated and progressive inflammatory disorders affecting the gastrointestinal tract. Tofacitinib is the first oral small-molecule Janus kinase (JAK) inhibitor licensed and approved by the National Institute for Health and Care Excellence (NICE) for use in moderately-to-severely active UC after intolerance, inadequate response, or loss of response to conventional treatment or biologic therapy. The pivotal OCTAVE studies demonstrated the efficacy and safety of tofacitinib for the induction and maintenance of remission in UC. A growing body of evidence from real-world data supports the positive clinical and endoscopic benefits observed with tofacitinib treatment in the OCTAVE trials. This narrative review summarizes the current literature regarding the mechanism of action of tofacitinib, data from registrational trials, emerging real-world evidence, and an overview of the most recent safety evidence. We explore evolving treatment paradigms, including the use of tofacitinib in the COVID-19 era, pregnancy and extraintestinal manifestations, as well as the emerging concept of combining tofacitinib with biological therapy. We will also present a brief overview of the next generation of JAK inhibitors in the pipeline.
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