Ep1317: Real-World Clinical Outcomes and Predictive Factors Accounting for Short- To Medium-Term Effectiveness of Ustekinumab in Treating Ulcerative Colitis: A Japan-Based Study

Ando, Koji; Fujiya, Mikihiro; Ueno, Nobuhiro; Motoya, Satoshi; Nasuno, Masanao; Tanaka, Hiroki; Ito, Teruaki; Maemoto, Atsuo; Sakurai, Kensuke; Katsurada, Takehiko; Orii, Fumika; Ashida, Toshifumi; Hirayama, Daisuke; Nakase, Hiroshi

doi:10.1016/s0016-5085(22)62640-4

Cited by 2 publications

(13 citation statements)

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“…In all, 11 studies [6][7][8][9]16,19,20,[22][23][24]26 Between-study heterogeneity was considerable at week 8 (I 2 = 87%) and month 12 (I 2 = 82%), might be not important at weeks 12-16 (I 2 = 26%), and was substantial at month 6 (I 2 = 65%) (Figure 1).…”

Section: Primary Endpoint: Clinical Remissionmentioning

confidence: 98%

“…Of the 254 citations identified, 19 studies including 3786 patients with UC were eligible for inclusion in this systematic review (Table S2). [5][6][7][8][9][15][16][17][18][19][20][21][22][23][24][25][26][27][28] In all, 13 studies were reported as full-text articles, and 6 were conference proceedings. According to JBI criteria for quality assessment, 14 studies showed low risk of bias, and 5 articles showed moderate risk (Table S3).…”

Section: Re Sultsmentioning

confidence: 99%

“…Across nine studies including 634 patients, 5,9,[18][19][20]24,26,7 the pooled rate of persistence with ustekinumab at month 12 was 73.3% (95% CI: 64.6-82) (Figure S4B). Between-study heterogeneity at this timepoint was substantial (I 2 = 85%, Cochrane's Q test p = 0.001).…”

Section: Drug Persistencementioning

confidence: 99%

“…In all, 12 studies reported a total of 13 serious AEs (SAEs) in 849 patients (1.5%; 95% CI: 0.6-2.4; range 0%-15.8%), 5,[7][8][9]15,16,[18][19][20][21]23,26 with 723 PY of exposure. Pooled IR was 0.8 SAE per 100 PY (95% CI: 0.26-1.81; range 0-16.7) (Figure 5C).…”

Section: Ustekinumab Safetymentioning

confidence: 99%

“…1%), 5,[7][8][9]15,16,[18][19][20][21]23,26 with 723 PY of exposure. Pooled IR was 0.3 serious infections per 100 PY (95% CI: −0.6 to 1.25) (Figure 5D).…”

Section: Ustekinumab Safetymentioning

confidence: 99%

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Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Taxonera

Olivares

López-García

et al. 2023

Aliment Pharmacol Ther

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Summary Background Evidence on real‐world outcomes of ustekinumab for ulcerative colitis (UC) patients is needed. Aims To summarise evidence on the real‐world outcomes of ustekinumab for UC and conduct a meta‐analysis of effectiveness and safety data. Methods A systematic search was conducted through September 2022 in electronic databases for observational studies evaluating ustekinumab for UC. A random‐effects meta‐analysis model was used to calculate the pooled effect sizes (percentages or incidence rates [IRs]) of effectiveness and safety outcomes. Results In all, 19 studies were included with 3786 patients. More than 92% of patients were previously treated with any biologic, 61.1% with both anti‐TNF and vedolizumab and 16.4% with any biologic and tofacitinib. Clinical remission was achieved in 45.4% at week 8 (95% CI: 30.1%–60.6%), 43.8% (38.4%–49.2%) at weeks 12–16, 44.6% (35.9%–53.3%) at month 6, and 50.6% (36.3%–64.8%) at month 12. Response was achieved in 61.2%, 59.4%, 65.2% and 76.8% at weeks 8, 12–16, month 6 and 12, respectively. CS‐free remission was achieved in 18.7%, 36.8%, 34.5% and 39% at weeks 8, 12–16, month 6 and 12, respectively. Overall, 58.2% of patients had endoscopic improvement at month 12. Almost 30% of the patients needed dose escalation, which was effective in 40% of these patients. The IRs of colectomy, adverse events (AEs), serious AEs and serious infections were 4.8, 7.9, 0.8 and 0.3 per 100 patient‐years, respectively. Conclusions This meta‐analysis confirms the effectiveness and safety of ustekinumab in a highly treatment‐refractory population of UC patients.

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Section: Primary Endpoint: Clinical Remissionmentioning

confidence: 98%

Section: Re Sultsmentioning

confidence: 99%

Section: Drug Persistencementioning

confidence: 99%

Section: Ustekinumab Safetymentioning

confidence: 99%

“…1%), 5,[7][8][9]15,16,[18][19][20][21]23,26 with 723 PY of exposure. Pooled IR was 0.3 serious infections per 100 PY (95% CI: −0.6 to 1.25) (Figure 5D).…”

Section: Ustekinumab Safetymentioning

confidence: 99%

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Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Taxonera

Olivares

López-García

et al. 2023

Aliment Pharmacol Ther

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Approach to loss of response to advanced therapies in inflammatory bowel disease

Vootukuru,

Vasudevan

2024

World J Gastroenterol

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BACKGROUND Remarkable progress over the last decade has equipped clinicians with many options in the treatment of inflammatory bowel disease. Clinicians now have the unique opportunity to provide individualized treatment that can achieve and sustain remission in many patients. However, issues of primary non-response (PNR) and secondary loss of response (SLOR) to non-tumour necrosis factor inhibitor (TNFi) therapies remains a common problem. Specific issues include the choice of optimization of therapy, identifying when dose optimization will recapture response, establishing optimal dose for escalation and when to switch therapy. AIM To explores the issues of PNR and SLOR to non-TNFi therapies. METHODS This review explores the current evidence and literature to elucidate management options in cases of PNR/SLOR. It will also explore potential predictors for response following SLOR/PNR to therapies including the role of therapeutic drug monitoring (TDM). RESULTS In the setting of PNR and loss of response to alpha-beta7-integrin inhibitors and interleukin (IL)-12 and IL-23 inhibitors dose optimization is a reasonable option to capture response. For Janus kinase inhibitors dose optimization can be utilized to recapture response with loss of response. CONCLUSION The role of TDM in the setting of advanced non-TNFi therapies to identify patients who require dose optimization and as a predictor for clinical remission is not yet established and this remains an area that should be addressed in the future.

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Ep1317: Real-World Clinical Outcomes and Predictive Factors Accounting for Short- To Medium-Term Effectiveness of Ustekinumab in Treating Ulcerative Colitis: A Japan-Based Study

Cited by 2 publications

References 0 publications

Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Approach to loss of response to advanced therapies in inflammatory bowel disease

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