Effectiveness of Ustekinumab Dose Escalation in Patients With Crohn’s Disease

Ollech, Jacob; Normatov, Inessa; Peleg, Noam; Wang, Jingzhou; Patel, Shivani A.; Rai, Victoria; Yi, Yangtian; Singer, Jorie; Dalal, Sushila; Sakuraba, Atsushi; Cohen, Russell D.; Rubin, David T.; Pekow, Joel

doi:10.1016/j.cgh.2020.02.035

Cited by 68 publications

(77 citation statements)

References 18 publications

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“…Clinical remission rate at W48 in patients who received vedolizumab (38.3%) was similar to previous reports 14,15 while that of patients treated with ustekinumab was higher than previously reported, at 54.4% as compared with 27.9‐35% 24,30 . However, our patients all received an initial, intravenous infusion of ustekinumab at a dose of 6 mg/kg and were optimised up to 90 mg every 4 weeks in case of inadequate response 31,32 . Rates of adverse events were within the expected ranges for both drugs 14,33,34 …”

Section: Discussionsupporting

confidence: 88%

The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti‐tumour necrosis factor

Alric

Amiot

Kirchgesner

et al. 2020

Aliment Pharmacol Ther

105

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Background:There is no head-to-head trial comparing ustekinumab and vedolizumab in patients with Crohn's disease (CD) refractory to anti-tumour necrosis factor (anti-TNF). Aim:To compare the effectiveness and safety of ustekinumab and vedolizumab in patients with CD refractory to anti-TNF in a multicentre retrospective observational cohort.Methods: All consecutive patients with CD refractory or intolerant to anti-TNF who initiated either vedolizumab or ustekinumab were included between May 2014 and August 2018. Clinical remission, steroid-free clinical remission (SFCR) and treatment persistence were assessed at week 48 with intention-to-treat analysis and propensity scores weighted comparison.Results: A total of 239 patients were included, 107 received ustekinumab and 132 received vedolizumab. At week 48, ustekinumab was associated with a higher clinical remission rate (54.4% vs 38.3%; odds ratios, OR = 1.92, 95% CI [1.09-3.39]) and treatment persistence (71.5% vs 49.7%; OR = 2.54, 95% CI [1.40-4.62]) than vedolizumab.The rate of SFCR did not differ significantly between ustekinumab and vedolizumab (44.7% vs 34.0%; OR = 1.57, 95% CI [0.88-2.79]). Subgroup analyses showed that ustekinumab was associated with a higher clinical remission rates at week 48 in patients with ileal location (OR = 3.49, 95% CI [1.33-9.17) and penetrating behaviour (OR = 6.58, 95% CI [1. 91-22.68]). Regardless of the treatment group, combination therapy at initiation was associated with a higher clinical remission rate at week 48 (OR = 1.93, 95% CI [1.09-3.43]). Conclusion:This study suggests that ustekinumab is associated with a higher rate of clinical remission and treatment persistence than vedolizumab after 48 weeks of follow-up, in patients with CD refractory or intolerant to anti-TNF. The rate of SFCR was not significantly different. | 949 ALRIC et AL.

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Section: Discussionsupporting

confidence: 88%

The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti‐tumour necrosis factor

Alric

Amiot

Kirchgesner

et al. 2020

Aliment Pharmacol Ther

105

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“…A recently conducted study from the University of Chicago reported that dose escalation to Q4 week resulted in significant improvement in CRP, and 28% of patients with active disease went on to achieve clinical remission. 8 Clinical improvement was defined by a reduction in the Harvey Bradshaw Index. 8 These results are consistent with our study’s findings.…”

Section: Discussionmentioning

confidence: 99%

“… 8 Clinical improvement was defined by a reduction in the Harvey Bradshaw Index. 8 These results are consistent with our study’s findings. Together these results support the recommendation that UST dose escalation should be considered prior to switching therapeutic classes.…”

Section: Discussionmentioning

confidence: 99%

“… 2 , 5 – 7 Some clinicians report that Q8 week dose escalation to every 4 week dosing (Q4 week) improves clinical activity. 8 , 9 …”

Section: Introductionmentioning

confidence: 99%

“…2,[5][6][7] Some clinicians report that Q8 week dose escalation to every 4 week dosing (Q4 week) improves clinical activity. 8,9 Initial pharmaceutical clinical trials investigating UST for CD demonstrated improved responses to shorter dosing intervals in the maintenance phase (Q8 week versus Q12 week). 6 The UNITI-1 trial reported clinical improvement by Q6 weeks…”

Section: Introductionmentioning

confidence: 99%

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Ustekinumab dose escalation improves clinical responses in refractory Crohn’s disease

Haider

Yadav

Perry

et al. 2020

Therap Adv Gastroenterol

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Background: Clinicians often utilize off-label dose escalation of ustekinumab (UST) in Crohn’s disease (CD) patients with disease refractory to standard dosing. Previous studies report mixed results with dose escalation of UST. Methods: A retrospective observational study of 143 adult patients with CD receiving UST over a 33-month time period was conducted. Patients receiving UST at standard dosage for a minimum of 16 weeks were included in the analysis. Primary outcomes collected were clinical response [Physician Global Assessment Score (PGA) by >1] and remission (PGA = 0). Changes in clinical parameters were calculated for dose-escalated patients beginning with the time of dose switch (~42 weeks) and compared with a group of patients who were classified as “failing” standard dosing at 42 weeks who were not dose escalated. Results: Dose escalation improved PGA by 0.47 ± 0.19 compared with patients remaining on every 8 weeks dosing (Q8 week), who worsened by 0.23 ± 0.23 ( p < 0.05). Dose escalation decreased CRP 0.33 ± 0.19 mg/L and increased serum albumin 0.23 ± 0.06 g/dL ( p < 0.05). Surprisingly, disease duration and prior CD surgeries inversely correlated with the need for dose escalation. Conclusion: Our results support UST Q4 week dose escalation for selected CD patients who fail to achieve remission on standard Q8 week dosing. Dose escalation improves clinical outcomes, prevents worsening disease severity, and positively impacts CRP and albumin levels. Together these data indicate that clinicians should attempt Q4 week UST dosing in refractory CD patients before switching to an alternative class of biologic therapy.

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Leveraging ambulatory care pharmacist expertise in medication appeals to overcome access barriers: A descriptive report

Hvisdas

Goode

Lee

et al. 2022

J Am Coll Clin Pharm

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Introduction Prescription prior authorization (PA) and prohibitive out‐of‐pocket costs are encountered across all specialties of care. These barriers are burdensome for prescribers and patients due to the multiple steps required to gain approval for payer reimbursement for medications. Objectives The primary objective was to characterize clinical pharmacist impact on medication appeals and high cost resolution. Methods This was a retrospective review of medication access intervention data collected from January 1, 2021, through July 31, 2021, at an academic medical center where five clinical pharmacists are embedded across 11 specialty and family medicine clinics. Intervention data was documented for both specialty and nonspecialty prescriptions. The primary end point quantified and characterized interventions based on access issues, defined as insurance denial or high out‐of‐pocket cost. Additional end points included time to appeal determination, total time spent on appeal activities, the incidence of denials, duration of the interruption, and assistance dollars secured for cost‐related barriers. Results Over the 7‐mo period, there were 531 prescriptions identified for clinical pharmacist access intervention. Of the total interventions collected, 42% (n = 221) were appeals for insurance denials and 58% (n = 310) addressed high out‐of‐pocket cost. The approval rate of appeals was 94% (n = 208). The majority of appeals (89%) were submitted within 3 d. The median time to appeal determination was five calendar days. The estimated time spent on appeal activities by the clinical pharmacists was 6.8 work wk. There were 51 patients of therapy interruption. The total assistance dollars secured for high out‐of‐pocket costs reached an estimated $1 953 200 over the report period.ConclusionThis report characterizes an approach to effectively manage medication appeals and cost resolution through embedded clinical pharmacists. Leveraging embedded pharmacists' clinical knowledge and familiarity with payer processes in medication appeals achieved a 94% approval rate. The current payer process places a burden disproportionately on prescribers and patients, delaying or preventing medication access.

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Effectiveness of Ustekinumab Dose Escalation in Patients With Crohn’s Disease

Cited by 68 publications

References 18 publications

The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti‐tumour necrosis factor

The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti‐tumour necrosis factor

Ustekinumab dose escalation improves clinical responses in refractory Crohn’s disease

Leveraging ambulatory care pharmacist expertise in medication appeals to overcome access barriers: A descriptive report

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