Golimumab: early experience and medium-term outcomes from two UK tertiary IBD centres

Abstract

Our experience mirrors previously reported real-world cohorts and demonstrates similar outcomes to those observed in randomised controlled trials. These data demonstrate a meaningful reduction in clinical, biochemical and endoscopic disease activity as well as a steroid-sparing effect in patients with previously refractory disease.

Golimumab for ulcerative colitis: adding perspective to the pursuit

“…The results are impressive: in a treatment refractory cohort (30% anti-TNF failures), 23/44 (52%), 15/44 (34%) and 13/44 (30%) achieved clinical response, remission and corticosteroid-free remission as defined by an Simple Clinical Colitis Activity Index (SCCAI) reduction >3 and<3, respectively 3. Their observations corroborate with PURSUIT and real-world observational studies 2 4–6.…”

“…Adding to our understanding, Samaan and colleagues present a timely ‘real-world’ experience with GLM from two tertiary inflammatory bowel disease (IBD) centres 3. The results are impressive: in a treatment refractory cohort (30% anti-TNF failures), 23/44 (52%), 15/44 (34%) and 13/44 (30%) achieved clinical response, remission and corticosteroid-free remission as defined by an Simple Clinical Colitis Activity Index (SCCAI) reduction >3 and<3, respectively 3.…”

“…Samaan and colleagues noted a statistically significant higher median dose (0.94 mg/kg) in responders than non-responders (0.79 mg/kg), affirming the potential for TDM in optimising GLM. We are learning that GLM levels of 2.5 µg/mL at week 6 and 1.4 µg/mL during steady state maintenance may be the aim for induction and maintenance of response 3. Prospective validation of proposed GLM concentrations will provide clarity.…”

UK National Survey of Gastroenterologists’ attitudes and barriers toward therapeutic drug monitoring of anti-TNF therapy in inflammatory bowel disease

“…Both these, may also be influenced by low or undetectable drug concentrations due to immune (antidrug antibodies) and non-immune clearance, determined significantly by inflammatory burden, body weight and serum albumin among other factors 12 14. A growing body of evidence supports the association of higher anti-TNF trough levels with objective therapeutic outcomes during maintenance therapy,15–25 but also through induction 26–29. Taken together, recognised differences in anti-TNF pharmacokinetics, that translate into pharmacodynamic effects through hard end-points such as mucosal healing and potential for treatment failure from PNR and SLR, make it clear that a ‘one-size fits-all’ approach with fixed dosing and schedules, even if practical, is not logical.…”

Endoscopy in inflammatory bowel disease: from guidelines to real life

“…Reliable and reproducible assessment of endoscopic disease activity has become an issue of paramount importance ever since mucosal healing has been shown to be a strong predictor of long-term patient outcome, 7,8 making it an important outcome measure in many studies. 9,10 The ECCO guidelines for endoscopy in IBD suggest that the Ulcerative Colitis Endoscopic Index of Severity (UCEIS), the Ulcerative Colitis Colonoscopic Index of Severity (UCCIS), or the Mayo endoscopic score could be used for the assessment of disease severity in UC, whereas the Simple Endoscopic Score for Crohn’s Disease (SESCD) or the Crohn’s Disease Endoscopic Index of Severity (CDEIS) could be used for CD; however, the guidelines recognize the fact that these instruments are rarely used outside of clinical trials. 2 Several limitations of these tools have been underlined, including the lack of formal validation for most of these scores, the lack of a clear-cut definition of mucosal healing or remission, as well as the fact that applying these scores in real life is time-consuming and cumbersome for the endoscopist.…”