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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

STELARA® (ustekinumab)

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STELARA - Use of STELARA in the Treatment of Adult Patients with Microscopic Colitis

Last Updated: 10/21/2024

SUMMARY

The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
Summarized in this response are relevant data from retrospective studies and case reports that describe the use of STELARA in the treatment of adult patients with microscopic colitis (MC; collagenous or lymphocytic).¹^-⁷

Clinical Data in Microscopic colitis

Data on the use of STELARA in the treatment of adult patients with MC is available through several retrospective studies. Please see Table: Summary of Retrospective Studies on the Use of STELARA in Adult Patients with MC.

Summary of Retrospective Studies on the Use of STELARA in Adult Patients with MC¹^-⁴

Primary Author and Year	Study Design	Patient Population	STELARA Dosing Regimen	Outcomes Specific to STELARA
Retrospective studies
Santiago et al (2023)¹	Retrospective, single-center study	Adult patients with MC treated with infliximab, adalimumab, certolizumab, vedolizumab, or STELARA between January 2000 and May 2022 (N=32) Clinical response was defined as an improvement in stool frequency of at least 50%	One patient treated with UST (dosing information not described)	Clinical response was observed in this patient
Boivineau et al (2022)²	Retrospective, multicenter, cohort study	Adult patients with MC, CC, or LC; budesonide-refractory, -intolerant, or -dependent and who were treated with anti-TNF agents between October 2018 and February 2019 (N=14; 9 CC and 5 LC) Clinical remission was defined as stool frequency of <3/day over a week Clinical response (or partial response) was defined as an improvement in stool frequency of at least 50%	One patient treated with UST (as a second-line therapy; dosing information not described)	No response was observed for MC. The patient was later switched to golimumab as a third-line agent
Pardi et al (2022)³	Retrospective	Patients with MC, LC, or CC who received at least 1 dose of STELARA (N=1) or vedolizumab (N=12). Median age at the start of biologic therapy was 47 years (range, 33-76 years) Complete response was defined as resolution of diarrhea Partial response was defined as an improvement of at least 50%	One patient treated with UST (dosing information not described)	Partial response was observed with q8w dosing and complete response was observed with dose escalation to q4w dosing
Daferera et al (2018)⁴	Retrospective, single-center study	Adult patients with budesonide-refractory MC, (N=16) Mean age at diagnosis: 47 years (range, 19-76 years), 14 with CC were investigated. Clinical remission was defined as < mean 3 and no watery stools/day/week Clinical response was defined as 50% reduction of mean stool frequency/day/ week)	All 16 patients had received anti-TNF agents Four patients did not respond to anti-TNF therapy One patient was started on STELARA 390 mg once	Clinical improvement was not achieved
Abbreviations: CC, collagenous colitis; IQR, interquartile range; LC, lymphocytic colitis; MC, microscopic colitis; q4w, every 4 weeks; q8w, every 8 weeks; TNF, tumor necrosis factor; UST, ustekinumab.

Additional data on the use of STELARA in the treatment of adult patients with MC is available through case reports. Please see Table: Summary of Case Reports on the Use of STELARA in Adult Patients with MC.

Summary of Case Reports on the Use of STELARA in Adult Patients with MC⁵^-⁷

Primary Author and Year	Patient	Case Description
Boneschansker and Burke (2023)⁵	A 75-year-old female patient with a history of watery diarrhea (4-8 bowel movements per day, BSS type 7) Based on colonoscopy with biopsies, CC was diagnosed after ruling out celiac disease and infectious causes	After initial treatment with budesonide, cholestyramine, bismuth subsalicylate, loperamide, and prednisone 40 mg daily, the patient experienced a slight decrease in stool frequency, but urgent liquid stools and fecal incontinence persisted The patient was then treated with adalimumab, vedolizumab, and STELARA 90 mg q8w, without meaningful improvement Subsequently, the patient was switched to upadacitinib 45 mg daily and achieved clinical remission within a week of treatment
Brenner et al (2021)⁶	A 64-year-old male patient with persistent diarrhea (>10 loose stools/day) and unintentional weight loss The patient was diagnosed with celiac disease at the age of 55 years and CC at the age of 59 years	Initial treatment with oral budesonide 9 mg daily and loperamide resulted in mild improvement but attempts to taper led to worsening diarrhea and weight loss The patient was then started on vedolizumab along with daily budesonide, which improved fecal calprotectin and CRP levels, and reduced the number of loose stools (2-4 daily), with no improvement in weight gain After 2 years of vedolizumab treatment, the patient was switched to STELARA (initial infusion followed by 90 mg q8w) plus daily budesonide 9 mg as the frequency of daily loose stools became difficult to maintain, along with an increase in inflammatory markers Initial response persisted for 1 year. At the time of this report, the patient had averaged 1-2 formed stools daily and a weight gain of 12 pounds An improvement in CRP (2.7 to <0.3) and fecal calprotectin (1225 to 93) was observed
Abughazaleh et al (2019)⁷	A 54-year-old female patient with a history of indeterminate colitis, diarrhea, severe fatigue, and abdominal pain in January 2019 Based on colonoscopy with biopsies in 2015, LC was diagnosed	The patient was treated with STELARA (dosing information not described) Ustekinumab drug levels were reported to be 9.9 At the time of this report, treatment regimen included STELARA q8w, budesonide, and methotrexate Azathioprine was added, budesonide was continued, and methotrexate was stopped After 3 months of treatment (March 2019), symptoms persisted, with the ustekinumab drug level at 2.2. An additional dose of STELARA 90 mg SC was administered, and budesonide was discontinued In May 2019, a colonoscopy revealed endoscopic and histologic remission of LC
Abbreviations: BSS, Bristol Stool Scale; CC, collagenous colitis; CD, Crohn’s disease; CRP, C-reactive protein; LC, lymphocytic colitis; MC, microscopic colitis; q8w, every eight weeks; SC, subcutaneous; UC, ulcerative colitis.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 25 July 2024.

References

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1	Santiago P, Pardi R, Braga-Neto MB, et al. Use of biologic therapies in patients with refractory microscopic colitis [abstract]. Gastroenterology. 2023;164(6):S-590-S-591. Abstract Su1355.
2	Boivineau G, Zallot C, Zerbib F, et al. Biologic therapy for budesonide-refractory, -dependent or -intolerant microscopic colitis: a multicentre cohort study from the GETAID. J Crohns Colitis. 2022;16(12):1816-1824.
3	Pardi R, Neto MBB, Santiago P, et al. Use of newer biologic therapies in patients with refractory microscopic colitis [abstract]. Am J Gastroenterol. 2022;117(10S):e644. Abstract S889.
4	Daferera N, Ignatova S, Münch A. Single-centre experience with biological treatment in budesonide-refractory microscopic colitis patients [abstract]. J Crohns Colitis. 2018;12(Suppl. 1):S421-S422. Abstract P617.
5	Boneschansker L, Burke KE. Upadacitinib as a novel treatment in therapy refractory collagenous colitis. Inflamm Bowel Dis. 2023;29(8):1352-1353.
6	Brenner A, Carey PJ, Barrett TA, et al. Remission of sprue-associated collagenous colitis with ustekinumab [abstract]. Am J Gastroenterol. 2021;116(1):S1015. Abstract S2435.
7	Abughazaleh S, Glassner K, Wilhite A, et al. A stellar case of STELARA in the treatment of lymphocytic colitis [abstract]. Am J Gastroenterol. 2019;114(1):S1154. Abstract 2063.