“…Bressler et al[20] presented in the form of an abstract the preliminary results of a nationwide study in Canada that included 136 UC patients treated with golimumab, 72.1% of which were anti-TNF treatment naïve, which might explain why they did not find differences. In accordance with our results, Taxonera et al[17] had a sample that included 80% of anti-TNF experienced patients; they observed significantly lower clinical response and remission rates in anti-TNF experienced patients when compared to naïve.…”
Section: Discussionsupporting
confidence: 93%
“…They observed that, after a median follow-up of 10 mo, 67 patients (47%) maintained clinical response, and, of these, 49 (35%) were in corticosteroid-free remission[17], with a long-term partial loss of response, which is similar to other anti-TNF[18,19]. Therefore, the current limited published data (Castro-Laria’s retrospective and our prospective study) point to a very good initial response to golimumab, which enables steroid withdrawal; preliminary unpublished data show a decrease in the steroid-free percentage of patients over time.…”
AIMTo evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response.METHODSWe conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at week 0 and 14 with the physician’s global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database.RESULTSThirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naïve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at week 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 μg/g, and 170.5 μg/g at week 14. Being anti-TNF treatment naïve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of follow-up. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted.CONCLUSIONThis real-life practice study endorses golimumab’s promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.
“…Bressler et al[20] presented in the form of an abstract the preliminary results of a nationwide study in Canada that included 136 UC patients treated with golimumab, 72.1% of which were anti-TNF treatment naïve, which might explain why they did not find differences. In accordance with our results, Taxonera et al[17] had a sample that included 80% of anti-TNF experienced patients; they observed significantly lower clinical response and remission rates in anti-TNF experienced patients when compared to naïve.…”
Section: Discussionsupporting
confidence: 93%
“…They observed that, after a median follow-up of 10 mo, 67 patients (47%) maintained clinical response, and, of these, 49 (35%) were in corticosteroid-free remission[17], with a long-term partial loss of response, which is similar to other anti-TNF[18,19]. Therefore, the current limited published data (Castro-Laria’s retrospective and our prospective study) point to a very good initial response to golimumab, which enables steroid withdrawal; preliminary unpublished data show a decrease in the steroid-free percentage of patients over time.…”
AIMTo evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response.METHODSWe conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at week 0 and 14 with the physician’s global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database.RESULTSThirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naïve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at week 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 μg/g, and 170.5 μg/g at week 14. Being anti-TNF treatment naïve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of follow-up. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted.CONCLUSIONThis real-life practice study endorses golimumab’s promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.
“…Our results corroborate a previously reported (abstract) observational study by Taxonera et al in which 60% of patients treated with golimumab were anti-TNF experienced 23. Like us, they conducted a retrospective, multicentre cohort study and described a significant difference in initial response rates based on prior anti-TNF experience.…”
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.
Introduction
Dose escalation is one of the treatment approaches studied and suggested in advanced therapies for Crohn’s disease (CD) and ulcerative colitis (UC). This study aimed to identify and characterize the dosing escalation patterns of advanced therapies in CD and UC.
Methods
Two systematic literature reviews (SLRs) were conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE
®
, Embase
®
, and Cochrane Library were searched for articles published between January 2011 and October 2021 and limited to non-interventional studies in English language. Congress and bibliographic searches were also conducted. Articles were screened by two independent researchers. Dose escalation patterns were described and summarized considering the regional regulatory label recommendation (in North America [NA] or outside of North America [ONA]).
Results
Among 3190 CD and 2116 UC articles identified in the Ovid searches, 100 CD and 54 UC studies were included in the SLR, with more studies conducted ONA. Most studies reported an initial maintenance dose pattern aligned with the lower starting dose per local regulatory label; however, several ONA studies (
n
= 13 out of 14) reported ustekinumab every 8 weeks as starting maintenance pattern in CD. In ONA studies, the median within-guideline escalation rates in CD and UC were 43% in ustekinumab (CD only), 33% and 32% for vedolizumab; 29% and 39% for adalimumab; and 14% and 10% for infliximab. Evidence regarding dose escalation patterns for tofacitinib, certolizumab pegol, and golimumab was limited. Some dose escalation patterns outside of label recommendations were observed including ustekinumab every 8 weeks to every 4 weeks and vedolizumab every 8 weeks to every 6 weeks.
Conclusion
Dose escalation strategies are widely documented in the literature. The reported dose escalation patterns and escalation rates vary by region and by CD and UC. Most escalation patterns reported were aligned with regulatory recommendations while some reported more diverse or aggressive dose escalation.
Prospero Registration
CRD42021289251.
Supplementary Information
The online version contains supplementary material available at 10.1007/s12325-023-02457-6.
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