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(ustekinumab)

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STELARA® (ustekinumab)

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Use of STELARA in Combination with Azathioprine, 6-Mercaptopurine, or Methotrexate in the Treatment of Adult Patients with Crohn's Disease or Ulcerative Colitis - Real World Evidence

Last Updated: 02/04/2026

Summary

  • The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
  • Prospective, retrospective studies, case series, and case reports evaluating the use of STELARA in combination with azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) in Crohn's disease (CD) and ulcerative colitis (UC) are summarized below.1-16

CLINICAL DATA

Prospective Studies

Lee et al (2025)1 conducted a prospective, real-world K-STAR (Post-MarKeting Surveillance for Crohn’s disease patients treated with STelARa) study to evaluate the 1-year effectiveness and safety of STELARA in patients with CD who had an inadequate response or intolerance to conventional or advanced therapies. The study also assessed the effectiveness of combination therapy with STELARA and immunomodulators (IMs) vs STELARA monotherapy.

Study Design/Methods

  • Patients who received ≥1 dose of STELARA, had a Crohn’s Disease Activity Index (CDAI) score of ≥150 at baseline, and completed ≥1 follow-up effectiveness evaluation were included.
  • At week 0, patients received weight-based intravenous (IV) infusions of STELARA (260 mg for body weight ≤55 kg, 390 mg for >55 kg to ≤85 kg, and 520 mg for >85 kg), followed by a 90 mg subcutaneous (SC) dose at week 8 and then every 8 or 12 weeks.
  • Safety and effectiveness of STELARA were evaluated from baseline to weeks 52-66.
  • Outcomes of STELARA monotherapy and combination therapy with IMs (AZA, MTX, cyclosporine, or 6-MP) were evaluated from baseline to week 52-66.

Results

Patient Characteristics
  • Of 455 patients receiving STELARA, 252 (55.4%) were receiving concomitant IMs at baseline.
Efficacy

No discernible difference between patients receiving STELARA monotherapy and those receiving combination therapy with IMs was observed. See Tables: Clinical Remission Rates of STELARA in Combination with IM vs STELARA Monotherapy and Clinical Outcomes of STELARA in Combination with IM vs STELARA Monotherapy Using Nonresponder Imputation.


Clinical Remission Rates of STELARA in Combination with IM vs STELARA Monotherapy1
STELARA in Combination Therapy with IM
STELARA Monotherapy
Week 0
Week 8
Weeks 16-20
Weeks 24-32
Weeks 52-66
Week 0
Week 8
Weeks 16-20
Weeks 24-32
Weeks 52-66
n
159
92
127
67
110
189
118
140
80
128
Clinical remissiona, %
-
71.7
82.7
70.1
78.2
-
78.8
77.9
77.5
71.1
Abbreviations: IM, immunomodulator.
aClinical remission was defined as CDAI <150.


Clinical Outcomes of STELARA in Combination with IM vs STELARA Monotherapy Using Nonresponder Imputation2
Weeks
STELARA in Combination Therapy with IM
(n=159)
STELARA Monotherapy
(n=189)
P-Value
Clinical response, n (%)
16-20
122 (76.7)
132 (69.8)
0.1494
52-66
97 (61.0)
115 (60.8)
0.9757
Clinical remission, n (%)
16-20
105 (66.0)
109 (57.7)
0.1101
52-66
86 (54.1)
91 (48.2)
0.2695
Corticosteroid-free remission, n (%)
16-20
103 (64.8)
107 (56.6)
0.1208
52-66
80 (50.3)
89 (47.1)
0.5488
Combined effectiveness, n (%)
16-20
53 (33.3)
54 (28.6)
0.3376
52-66
63 (39.6)
81 (42.9)
0.5417
Abbreviation: IM, immunomodulator.
Safety

AEs and ADRs with Combination Therapy vs Monotherapy2
Combination Therapy
(n=159)
Monotherapy
(n=189)
Incidence (%)
Incidence Rate per 100 PYs (95% CI)
Incidence (%)
Incidence Rate per 100 PYs (95% CI)
Total PYs years (median follow-up)
135.4 (1.0)
165.0 (1.0)
AEsa
26.4
51.7 (43.3-60.1)
27.5
66 (58.8-73.3)
ADRs
6.9
11.8 (6.4-17.3)
7.4
13.3 (8.1-18.5)
Any infections
2.5
3.7 (0.5-6.9)
1.1
1.2 (0.0-2.9)
SAEs
8.2
10.3 (5.2–15.5)
14.3
27.9 (21.0–34.7)
Serious ADRs
1.3
1.5 (0.0-3.5)
2.1
4.2 (1.2-7.3)
   Abdominal
   discomfort
0.6
0.76 (0.0-2.2)
0
0 (0.0-0.0)
   Abdominal pain
0.6
0.76 (0.0-2.2)
0.5
0.6 (0.0-1.8)
   Anastomotic
   stenosis
0
0.0 (0.0-0.0)
0.5
0.6 (0.0-1.8)
   Crohn's disease
0
0.0 (0.0-0.0)
1.1
1.8 (0.0-3.9)
   Hematochezia
0
0.0 (0.0-0.0)
0.5
0.6 (0.0-1.8)
   Small intestinal
   obstruction
0
0.0 (0.0-0.0)
0.5
0.6 (0.0-1.8)
Abbreviations: ADRs, adverse drug reactions; AEs, adverse events; CI, confidence interval; PYs, patient-years; SAE, serious adverse event.
aAdverse reaction was characterized as an occurrence assessed by a physician to have a causal relationship with STELARA
Note: No serious infections and deaths were reported in both the treatment groups.

Casas-Deza et al (2023)3 conducted an observational, multicenter study using data from the ENEIDA registry, a large prospective Spanish database by the Spanish Working Group in Crohn's and Colitis (GETECCU) to assess the effectiveness and safety of STELARA in elderly patients with CD.

Study Design/Methods

  • Elderly patients (aged >60 years) treated with at least 1 dose of STELARA for CD were included.
  • To avoid selection bias, each elderly patient was matched with 2 young controls (aged <60 years) selected randomly based on center, anti-tumor necrosis factor (anti-TNF) use, and smoking status.
  • The use of IMs was evaluated to determine if concomitant use had an influence on the occurrence of malignancies or infections.

Results

Patient Characteristics
  • No significant difference was found in the concomitant use of IMs between elderly patients and young adult controls (P=0.46). See Table: Baseline Characteristics.

Baseline Characteristics3
Cohort
Young Adults
(n=436)
Elderly Patients
(n=212)
P-value
IMs during induction, n (%)
139 (20.0)
61 (28.8)
0.46
   AZA, n (%)
94 (68.1)
34 (57.6)
-
   6-MP, n (%)
14 (10.1)
0
   MTX, n (%)
29 (21.0)
25 (42.4)
Abbreviations: 6-MP, 6-mercaptopurine; AZA, azathioprine; IM, immunomodulator; MTX, methotrexate.
Efficacy
  • Effectiveness results based on status of concomitant IM use was not reported in this publication.
Safety
  • The overall rate of AEs was 14.2% for elderly patients and 11.2% for young adult controls (P=0.350).
  • No statistically significant difference was found between the concomitant use of IMs and occurrence of infections (P=0.45) or neoplasms (P=0.38).

Yarur et al (2023)4 conducted a prospective cohort study to assess the impact of combination therapy of IMs and biologics (including STELARA) on pharmacokinetics in patients with inflammatory bowel disease (IBD).

Study Design/Methods

  • Patients ≥18 years of age with a confirmed diagnosis of CD or UC and receiving maintenance therapy with biologics (including STELARA) either as monotherapy or in combination with AZA, 6-MP, or oral MTX were included.
  • The primary outcomes were biologic drug level and detectable anti-drug antibodies (ADAs).
  • Secondary outcomes included steroid-free deep remission (Harvey-Bradshaw Index [HBI] of <5 in CD and partial Mayo score [pMayo] score of <2 in UC in combination with serum C-reactive protein <0.5 mg/dL and/or fecal calprotectin ≤150 µg/mg while off corticosteroids) and endoscopic remission (Simple Endoscopic Score of ≤2 for CD; endoscopic Mayo score ≤1 for UC).

Results

  • Of the 367 patients enrolled, 123 were receiving STELARA: 29 (23.6%) were on monotherapy, 64 (52%) were on combination therapy with thiopurine, and 30 (24.4%) were on combination therapy with MTX.
  • No significant differences were observed in ustekinumab levels among patients on STELARA monotherapy, 7.0 µg/mL (interquartile range [IQR], 4.9-10.2); MTX plus STELARA, 5.2 µg/mL (IQR, 2.7-11.4); or thiopurine plus STELARA, 5.4 µg/mL (IQR, 2.9-8.8); P>0.05 for each combination.
  • Differences remained nonsignificant between monotherapy and combination therapy when stratified by steroid-free deep remission status. See Table: Ustekinumab Trough Levels Stratified by Steroid-Free Deep Remission Status.

Ustekinumab Trough Levels Stratified by Steroid-Free Deep Remission Status5
Cohort
STELARA in Combination Therapy with IM (Thiopurines or MTX)
STELARA Monotherapy
P-value
All the population, µg/mL
5.3 (2.8-10.1)
7.0 (4.9-10.1)
0.11
In steroid-free deep remission, µg/mL
10.1 (5.6-14.4)
13.0 (7.3-16.0)
0.22
Not in steroid-free deep remission, µg/mL
3.7 (2.2-6.4)
5.8 (3.8-9.7)
0.05
Abbreviations: IM, immunomodulator; MTX, methotrexate.
  • Only 1 patient (<1%) developed ADAs to STELARA.
  • A total of 112 patients in the STELARA group continued into the longitudinal phase and were evaluated at the follow-up visit (median follow-up of 40 weeks [IQR, 32-42]). At follow-up, 10 of the 41 patients (26.3%) in steroid-free deep remission at baseline developed secondary nonresponse, and 31 (27.7%) discontinued the drug.

Retrospective Studies

Gagné et al (2024)6 studied the effectiveness of STELARA combination therapy with thiopurines vs STELARA monotherapy in patients with CD and UC.

Study Design/Methods

  • Patients with CD and UC on STELARA treatment after September 2016 (per data from French administrative healthcare databases 2008-2022) were included.
  • The study design (including confounding adjustment and outcome definitions) was previously validated in successful emulations of the SONIC (NCT00094458) and SUCCESS (NCT00537316) trials.
  • The primary endpoint was a composite endpoint of treatment failure (including hospitalizations/surgery related to CD or UC), treatment switch (to another advanced therapy), and continuation of corticosteroids at week 26.
  • Propensity scores (PSs; 1:1) were used to control for confounders including comorbidities, concomitant medication use, demographics, previous and baseline IBD disease activity.

Results

Patient Characteristics
  • Of 11,343 patients with CD and 2,529 patients with UC who were started on STELARA therapy, 1,315 (11.6%) and 260 (10.3%) patients received combination therapy with thiopurines, respectively. Overall, 1,295 patients with CD and 244 patients with UC on combination therapy were matched 1:1 with those on monotherapy using PSs.
Efficacy

Treatment Outcomes in Patients with CD or UC - Combination Therapy vs Monotherapy6
Treatment Outcomes
CD
Relative Risk
(95% CI)
UC
Relative Risk
(95% CI)
Treatment failure
0.97 (0.84-1.11)
1.05 (0.76-1.47)
   Hospitalization or surgery related to CD or UC
1.13 (0.91-1.40)
1.68 (0.56-5.03)
   Switch to another advanced therapy
0.82 (0.65-1.03)
1.11 (0.72-1.69)
   Corticosteroid exposure at week 26
0.89 (0.67-1.19)
0.84 (0.48-1.44)
Abbreviations: CD, Crohn’s disease; CI, confidence interval; UC, ulcerative colitis.
Safety

Safety Endpoints in Patients with CD or UC - Combination Therapy vs Monotherapy6
Safety Endpoints
CD
Relative Risk (95% CI)
UC
Relative Risk (95% CI)
Any hospitalization
1.03 (0.94-1.12)
1.16 (0.95-1.42)
Serious infections
0.87 (0.41-1.81)
0.75 (0.17-3.32)
Abbreviations: CD, Crohn’s disease; CI, confidence interval; UC, ulcerative colitis.

Al Bawardy et al (2021)7 conducted a multicenter, retrospective cohort study to evaluate the benefits of STELARA combination therapy with an IM vs monotherapy in patients with IBD, including CD and UC.

Study Design/Methods

  • Patients with IBD who received ≥1 dose of STELARA were included in the study.
  • The primary endpoint was the difference in rates of clinical remission (per Physician’s Global Assessment [PGA]) between combination therapy and STELARA monotherapy.
  • The secondary endpoint was rate of mucosal healing (defined as absence of erosions or ulcers in CD and Mayo score of 0/1 in UC).

Results

Patient Characteristics
  • A total of 142 patients were enrolled with 81% having CD. Among these patients, 19 (13.4%) received combination therapy (8 received thiopurines and 11 received MTX).
Efficacy
  • In the combination therapy vs monotherapy group, the rates of clinical remission and mucosal healing were 57.9% vs 50.4% (P=0.62) and 42.1% vs 27.4% (P=0.41), respectively.

Hu et al (2021)8 evaluated the impact of concomitant therapy with IMs (thiopurines or MTX) on clinical and endoscopic outcomes in STELARA-treated patients with CD or UC. The durability of long-term maintenance with these drugs was also assessed.

Study Design/Methods

  • A multicenter, retrospective cohort study was conducted in patients with CD or UC who were initiated on STELARA treatment, with a 1-year follow-up.
  • The primary endpoint was clinical response (decrease in HBI of ≥3 or Simple Clinical Colitis Activity Index [SCCAI]/pMayo] score of ≥2 from baseline) or clinical remission (HBI ≤4 or SCCAI/Mayo score <3) at weeks 14, 30, and 52.
  • Other endpoints included endoscopic healing (absence of ulcerations in CD or Mayo score 0 in UC) at 6-12 months post-treatment and treatment failure (defined as dose escalation, initiation of rescue corticosteroids, secondary addition of new IM therapy, or IBD-related hospitalization and/or bowel surgery).

Results

Patient Characteristics

Select Baseline Characteristics of Patients Initiated on STELARA Treatment in Combination with IM and as a Monotherapy8
Characteristics
STELARA in Combination Therapy with IM
(n=120)
STELARA Monotherapy
(n=243)
Age of diagnosis, years, mean (SD)
26.5 (15.1)
27.3 (13.6)
Disease duration, years, mean (SD)
15.2 (10.0)
15.4 (9.4)
On current AZA, n (%)
53 (44.2)
0
On current MTX, n (%)
63 (52.5)
0
On current 6-MP, n (%)
4 (8.5)
0
Baseline HBI, mean (SD)
7.80 (4.70)
7.40 (4.59)
Abbreviations: 6-MP, 6-mercaptopurine; AZA, azathioprine; HBI, Harvey-Bradshaw Index; IM, immunomodulator; MTX, methotrexate; SD, standard deviation.
Efficacy

Clinical and Endoscopic Outcomes with Combination Therapy vs Monotherapy for STELARA-Treated Patients with CD or UC8
Outcomes
n/N
STELARA in Combination Therapy with IM
(%)
STELARA Monotherapy
(%)
P-value
Clinical response or remission
   Week 14
151/246
54.6
65.8
0.08
   Week 30
169/225
71.6
77.4
0.33
   Week 54
106/163
62.1
67.0
0.52
Endoscopic remission
39/82
58.1
41.2
0.14
Treatment failurea
177/363
54.2
46.1
0.15
Abbreviations: CD, Crohn’s disease; IBD, inflammatory bowel disease; IM, immunomodulator; UC, ulcerative colitis.
aClinical relapse as defined by dose escalation, re-induction of STELARA, addition of IM, need for rescue steroids, IBD-related surgery, or hospitalization during 1-year follow-up.
  • A multivariable analysis was conducted and adjusted for disease duration, prior anti-TNF exposure, study site, use of steroids at baseline, and SC induction dosing. The results of this analysis demonstrated that baseline IM use was not a predictor of clinical response or remission at week 14, 30, or week 54.
  • Through a PS-adjusted model, baseline IM use did not predict week 14 clinical remission or response.

Wils et al (2016)9 conducted a multicenter, retrospective study using data from the Groupe d’Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to assess the efficacy and safety of SC STELARA in patients with CD who were refractory to anti-TNF therapy. Summarized below are data from patients who were receiving concomitant immunosuppressants.

Study Design/Methods

  • Patients with active CD who received ≥1 SC injection of STELARA, with a follow-up of ≥3 months, were included in the study.
  • Outcomes with the use of concomitant immunosuppressants included endoscopic response (reduction in visible ulcerations), mucosal healing (absence of visible ulcerations or friable mucosa), and predictive factors of STELARA-induced clinical benefit at 3 months.

Results

Patient Characteristics
  • Of the 135 patients with active CD who received ≥1 SC injection of STELARA, 122 were included in the study with a 3-month follow-up. Among these patients, concomitant therapy with thiopurines and MTX was received by 11 patients (9%) and 7 patients (6%), respectively.
Efficacy
  • The concomitant use of immunosuppressants (thiopurines and MTX) with STELARA was the only predictive factor of clinical benefit at 3 months in both univariate (odds ratio [OR], 5.21; 95% CI, 1.09-24.85; P=0.02) and multivariate analyses (OR, 5.43; 95% CI, 1.14-25.77; P=0.03), with no difference observed in patients receiving thiopurines or MTX.
  • At the 3-month follow-up, 17/22 patients (77%) achieved an endoscopic response, of whom 3 were receiving concomitant immunosuppressants (2 [12%] on thiopurine and 1 [6%] on MTX); 3/22 patients (14%) did not show an endoscopic response, of whom 1 (33%) was on concomitant thiopurine therapy.

Kopylov et al (2014)10 conducted a retrospective, open-label study to evaluate the real-world use of STELARA in treating patients with CD who were refractory to anti-TNF therapy. The study also assessed the correlation between the use of concomitant IM therapy and clinical response to STELARA.

Study Design/Methods

  • Patients with CD who received treatment with STELARA after loss of response to ≥1 anti-TNF therapy were included in the study.
  • Patients received induction and maintenance doses of STELARA SC (45 mg or 90 mg).
  • Outcomes assessed were clinical response at 3 months (first visit after starting treatment; initial response), 6 months, 12 months, and the last follow-up.
    • Clinical response was defined as an improvement in CD-related symptoms plus the decision to continue treatment with STELARA.

Results

Patient Characteristics
  • There were 38 patients included in this analysis. Patients were followed for a mean±standard deviation (SD) duration of 7.9±5.2 (range 3-21) months.
  • The most common induction regimen was 90 mg at 0, 1, and 2 weeks for 28/34 patients (82.4%); the most common maintenance regimen was 90 mg every 8 weeks for 28/38 patients (73.7%).
  • Among the 38 patients, 2 (5.3%) received AZA and 2 (5.3%) received MTX as concomitant therapy.
Efficacy
  • Clinical response at 3 months (initial response), 6 months, 12 months, and at the end of follow-up was achieved in 28/38 patients (73.7%), 20/31 patients (64.5%), 9/19 patients (47.4%), and 27/38 patients (71.1%), respectively.
    • No significant correlation was found between the use of concomitant IM (P=0.66) and initial response.
  • Concomitant IM use with STELARA was not significantly associated with clinical response to STELARA.
Safety
  • Clostridium difficile infection was reported in 1 patient who achieved clinical response 4 months after the initial STELARA dose while receiving concomitant MTX. Clinical response was regained after treatment with antibiotics.

Case Series and Case Reports

There are published case series and case reports of patients with CD or UC receiving treatment with STELARA and concomitant IM therapies. Please see Table: Concomitant Treatment with IM in STELARA-Treated Patients with CD or UC.


Concomitant Treatment with IM in STELARA-Treated Patients with CD or UC11,13-16
Publication
Patient
Case Description
Case Series
Park et al (2018)11
Case 1
  • 35-year-old female with ileocolonic CD and prior intestinal resections and colectomy with ileoanal pouch who failed prior therapies with IFX, ADA, and VDZ
  • Initially diagnosed with UC, and had undergone colectomy, later diagnosed with CD
  • The patient received weight-based therapy with STELARA SC, starting at 360 mg, followed by 90 mg q8w, in combination with AZA and corticosteroids. No improvement in disease activity was observed.
  • The patient was then given a re-induction dose of STELARA 6 mg/kg IV, followed by 90 mg q8w.
  • Pouchoscopy after 3 months revealed improved endoscopic disease activity, and the patient was able to taper off corticosteroids.
Case 2
  • 44-year-old male with a history of Crohn’s ileocolitis and perianal fistulas with prior small bowel resections
  • Primary nonresponder to IFX and also did not respond to VDZ and IFX combination therapy
  • The patient received weight-based therapy with STELARA SC, starting at 540 mg, followed by 90 mg q8w, concomitantly with AZA and corticosteroids.
  • The patient showed improvement in ulceration at the ileocolonic anastomosis and in neoterminal ileum but continued to experience ongoing abdominal pain, diarrhea, and perianal drainage.
  • The patient then received a re-induction dose of STELARA 390 mg IV, followed by 90 mg q8w. His clinical symptoms improved, and endoscopy revealed an improvement in ulcerations. The patient was also tapered off of steroids.
Case 3
  • 26-year-old male with a history of ileocolonic CD, primary nonresponse to ADA, and secondary loss of response to IFX
  • The patient received weight-based therapy with STELARA SC, starting at 360 mg, followed by 90 mg q8w, in combination with AZA and corticosteroids.
  • The patient was later hospitalized due to an intra-abdominal abscess that required drainage and antibiotics.
  • After receiving re-induction with STELARA 390 mg IV, followed by 90 mg q8w, the patient achieved clinical response and tapered off corticosteroids.
Case Reports
Vieujean et al (2025)12  
  • 30-year-old male with a history of AS, with an initial diagnosis of UC, which was later re-classified as CD
  • At the age of 17, the patient underwent ileal pouch-anal anastomosis and experienced disease recurrence.
  • The disease was re-classified as CD based on small bowel involvement and development of perianal abscesses.
  • The patient continued to experience symptoms of AS and persistent gastrointestinal complaints secondary to CD despite multiple lines of therapy, including anti-TNF agents, small molecules, VDZ, STELARA, and upadacitinib, and frequent courses of antibiotics for suspected pouchitis.
  • In April 2023, despite the use of antidiarrheal agents, the patient experienced up to 15-20 liquid bowel movements per day, including 1-3 nocturnal episodes.
  • The patient was initiated on a combination of certolizumab pegol and STELARA, along with MTX.
  • Although rheumatologic symptoms were well controlled on this treatment regimen, gastrointestinal symptoms persisted.
  • MTX was discontinued in May 2024, and a triple biologic therapy was initiated: certolizumab pegol, STELARA, and VDZ.
  • Due to a lack of alternative therapies and patient’s refusal to surgery, he continued to receive the same combination therapy for 10 months (ongoing as of mid-March 2025).
  • Although rheumatologic symptoms were controlled and the patient remained in remission, no clinical improvement in gastrointestinal symptoms was noted. The triple biologic therapy was well tolerated, with no significant AEs reported.
Madarame et al (2020)13
  • 40-year-old male with CD was hospitalized for the treatment of active ECFs
  • The patient initially received treatment with oral AZA and mesalazine, but his clinical condition remained refractory.
  • He developed multiple ileal stenoses and ECFs. ECFs did not heal despite IV hyperalimentation and antibiotic therapy.
  • After 7 years of treatment with IFX and AZA, he experienced a relapse with fever, recurrent ileal ulcers, and high-output draining ECFs.
  • IFX was discontinued, and STELARA treatment with IV infusion of 260 mg was initiated, followed by an SC infusion of 90 mg q8w.
  • After 8 weeks, fistula drainage decreased. After 20 weeks, 5 of 6 ECFs had completely closed, with resolution of drainage and absence of abscess formation.
  • At the 15-month follow-up while on maintenance STELARA with AZA, 5 fistulas had completely closed, and the patient gained 4 kg.
Nagra et al (2020)14
  • 22-year-old female with a history of small bowel CD with stricturing disease
  • The patient initially received treatment with anti-TNF agents and was receiving maintenance therapy with VDZ and MTX with modest clinical and endoscopic response.
  • The patient reported persistent symptoms, including vulvar involvement. Upon a colonoscopy, inflammation in the terminal ileum and 2 strictures requiring dilation were observed. CT enterography revealed active inflammation and a stricture in the terminal ileum.
  • Due to lack of response to therapy, the patient underwent ileocolic resection and was switched to STELARA and MTX.
  • At the 3- and 9-month follow-up, the patient reported substantial improvement in both her luminal symptoms and perivulvar disease.
Chen and Oz (2019)15
  • 52-year-old female with a 30-year history of primary left-sided colitis
  • Past treatment history included prednisone, mesalamine, AZA, metronidazole, and/or loperamide.
  • After serial hospitalizations and nonresponse to golimumab (primary nonresponder) and combination therapy of IFX and AZA, she was switched to VDZ and developed pancolitis.
  • Due to severe infusion reactions to VDZ, she was switched to STELARA.
  • One week after an initial STELARA IV infusion, the patient reported an improvement in symptoms. Remission was maintained with STELARA SC q6w in combination with AZA, which resolved previous symptoms.
  • Steroids were tapered off and discontinued; physical and laboratory markers revealed complete symptomatic response to STELARA.
  • After 1 year of STELARA treatment, the patient remained in remission and was able to resume her normal activities.
Nandy et al (2017)16
  • 30-year-old female with odynophagia and progressive dysphagia to liquids and solids
  • History of severe ileocolonic CD
  • Previous treatment history included combination therapy of IFX and AZA, which was discontinued due to serum sickness-like reaction, and loss of response to combination therapy with ADA, certolizumab, and VDZ.
  • She was referred to colorectal surgery for subtotal colectomy with loop ileostomy for steroid-refractory Crohn’s colitis.
  • The patient resumed combination therapy with VDZ and AZA postoperatively due to the severity of disease and the potential for future ileocolonic reanastomosis.
  • She remained asymptomatic for 6 months after tapering off prednisone. However, she later developed tenesmus with occasional bloody mucus per rectum.
  • Due to recurrent CD symptoms, a discussion on induction therapy with STELARA and AZA was held with the patient.
  • At the time of this discussion, the patient reported dysphagia that progressed to odynophagia with solid and liquids. Despite these symptoms, her appetite remained good, and her weight was stable. Examination of the oropharynx did not reveal any evidence of thrush.
  • An EGD revealed marked erythema, friability, nodularity, ulceration of entire esophageal mucosa and presence of a tight stricture. After a single infusion of IFX, the patient experienced near-complete resolution of esophageal disease.
  • She was initially prescribed 20 mg of prednisone daily, but it showed minimal effectiveness after 1 week. The dose was then increased to 40 mg daily, leading to significant improvement in the odynophagia.
  • The patient received an induction dose of STELARA and subsequently continued with maintenance therapy with AZA, which resulted in improvement.
Abbreviations: ADA, adalimumab; AZA, azathioprine; AS, ankylosing spondylitis; AE, adverse event; CD, Crohn’s disease; CT, computed tomography; ECF, enterocutaneous fistula; EGD, esophagogastroduodenoscopy; IFX, infliximab; IL-23, interleukin-23; IM, immunomodulator; IV, intravenous; MTX, methotrexate; q6w, every 6 weeks; q8w, every 8 weeks; SC, subcutaneous; TNF, tumor necrosis factor; UC, ulcerative colitis; VDZ, vedolizumab.

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 29 December 2025.

Summarized in this response are data on adult patients with CD or UC receiving concomitant treatment with AZA, 6-MP, or MTX.

References

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1 Lee CK, Moon W, Chun J, et al. One-year safety and effectiveness of ustekinumab in patients with Crohn’s disease: the K-STAR study. Inflamm Bowel Dis . 2025;31:1306-1316.
2 Lee CK, Moon W, Chun J. Supplement to: One-year safety and effectiveness of ustekinumab in patients with Crohn’s disease: the K-STAR study. Inflamm Bowel Dis. 2025;31:1306-1316.
3 Casas-Deza D, Lamuela-Calvo LJ, Gomollon F, et al. Effectiveness and safety of ustekinumab in elderly patients with Crohn’s disease: real world evidence from the Eneida registry. J Crohns Colitis. 2023;17(1):83-91.
4 Yarur AJ, McGovern D, Abreu MT, et al. Combination therapy with immunomodulators improves the pharmacokinetics of infliximab but not vedolizumab or ustekinumab. Clin Gastroenterol Hepatol. 2023;21(11):2908-2917.
5 Yarur AJ, McGovern D, Abreu M T, et al. Supplement to: Combination therapy with immunomodulators improves the pharmacokinetics of infliximab but not vedolizumab or ustekinumab. Clin Gastroenterol Hepatol. 2023;21(11):2908-2917.
6 Gagne VL, Beaugerie L, Wisniewski A, et al. Ustekinumab as monotherapy or in combination with thiopurines in the treatment of crohn’s disease and ulcerative colitis: emulation of two target trials using the French healthcare databases. Poster presented at: Digestive Disease Week (DDW); May 18-21, 2024; Washington D.C.
7 Al Bawardy BF, Petrov JC, Fine S. Mono vs combination ustekinumab therapy in inflammatory bowel disease [abstract]. Am J Gastroenterol. 2021;116:S393-S394. Abstract S847.
8 Hu A, Kotze PG, Burgevin A, et al. Combination therapy does not improve rate of clinical or endoscopic remission in patients with inflammatory bowel diseases treated with vedolizumab or ustekinumab. Clin Gastroenterol Hepatol. 2021;19(7):1366-1376.
9 Wils P, Bouhnik Y, Michetti P, et al. Subcutaneous ustekinumab provides clinical benefit for two-thirds of patients with Crohn’s disease refractory to anti-tumor necrosis factor agents. Clin Gastroenterol Hepatol. 2016;14(2):242-250.
10 Kopylov U, Afif W, Cohen A, et al. Subcutaneous ustekinumab for the treatment of anti-TNF resistant Crohn’s disease-the McGill experience. J Crohns Colitis. 2014;8(11):1516-1522.
11 Park S, Evans E, Sandborn WJ, et al. Ustekinumab IV 6 mg/kg loading dose re-induction improves clinical and endoscopic response in Crohn’s disease: a case series. Am J Gastroenterol. 2018;113(4):627-629.
12 Vieujean S, Peyrin-Biroulet L. Triple biologic therapy for refractory Crohn’s disease. J Crohns Colitis. 2025;19:jjaf067.
13 Madarame A, Kimura H, Kunisaki R, et al. Successful treatment with ustekinumab for enterocutaneous fistulas in Crohn’s disease. J Crohns Colitis. 2020;14(4):569-570.
14 Nagra NK, Kaplan J, Dorer R, et al. Vulvar involvement in Crohn’s disease successfully treated with ustekinumab [abstract]. Am J Gastroenterol. 2020;115:S1193. Abstract S2252.
15 Chen AY, Oz HS. Rapid induction and maintenance of remission in refractory ulcerative colitis with ustekinumab. Diseases. 2019;7(4):55.
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