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STELARA® (ustekinumab)
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STELARA - Treatment of Adult Patients with Ulcerative Colitis - Real-world Evidence

Last Updated: 11/04/2026

SUMMARY

  • Summarized in this response are data focused on the clinical efficacy and safety in adult patients with ulcerative colitis from observational, prospective and retrospective studies and registries with a study population of >100 patients.1-13

Real-world data in adult patients with uLCERATIVE cOLITIS


Summary of Real-world Studies in Adult Patients with UC
Study Description and Select Baseline Characteristics
Results
Observational Study
Iborra et al (2024)1 evaluated the efficacy and safety of STELARA in Spanish patients with refractory UC through an observational, multicenter, open-label, cohort study.
Patients who received ≥1 IV infusion (6 mg/kg) were included.
Of the 108 patients included in the study, 2 received only the first IV dose.
The median (IQR) age at baseline was 44.2 (36.4-56.6) years, and the median (IQR) disease duration was 10.1 (6.01-14.9) years.
At baseline, the median (IQR) PMS score was 5.00 (3.00-7.00). The median (IQR) FCP and CRP levels were 1260 (461-2560) µg/g and 4.25 (1.03-11.4) mg/L, respectively.
Efficacy
  • Rates of clinical remission (PMS ≤2 with a combined rectal bleeding and stool frequency subscore of ≤1) at 8, 16, 24, and 52 weeks were 59%, 56.5%, 57%, and 69%, respectively, and at 18 and 24 months, clinical remission was maintained in 65% (28/43) and 80% (20/25), respectively.
  • FCP level decreased to normal (<250 µg/g) at 8, 16, 24, and 52 weeks in 40%, 38%, 41%, and 51% of patients, respectively, and at 18 and 24 months in 61% and 58% of patients, respectively.
  • CRP level decreased to normal (<5 mg/L) at 8, 16, 24, and 52 weeks in 77%, 82%, 80%, and 76.5% of patients, respectively, and at 18 and 24 months in 72.5% and 70% of patients, respectively.
  • Among patients (n=17) with available endoscopy data before and after treatment with STELARA, 53% (n=9) reported endoscopic improvement (Mayo endoscopic subscore of 0 or 1) after a median (IQR) treatment time of 53 (31-61) weeks.
Safety
  • AEs were reported in 4.6% (n=5) of patients.
  • Hospitalizations occurred in 18.5% (n=20) of patients. Of these patients, 8 were hospitalized due to a severe flare at the beginning of treatment.
  • Colectomy was performed in 9.3% (n=10) of patients.
  • Up to the last follow-up, 5 AEs were reported in 5 patients, which included asthenia, arthralgia, C. diff infection, relapsed uveitis and venous thromboembolism. Patients who experienced relapsed uveitis and venous thromboembolism discontinued STLEARA.
  • In total, 21% (n=23) of patients discontinued STELARA.
Retrospective Studies
Burbage et al (2025)2 evaluated the efficacy of STELARA in patients with UC through a retrospective, cross-sectional survey in the US (Adelphi Real World UC Disease Specific Programme™).
A total of 185 patients with UC receiving STELARA were included. The mean age (SD) was 39.7 (12.9) years and the median disease duration was 2.3 (IQR 0.5-4.9) years.
A total of 84.6% (n=121) had been treated with STELARA for at least 3 months.
The median treatment duration was 8.9 months. STELARA was primarily used as monotherapy (81.6%, n=151).
Efficacy
•At the time of assessment, 53.0% (n=98) of patients were in remission according to the Mayo score, while 61.9% (n=109) were considered to be in clinical remission by physician assessment.
•Among patients with available biochemical data, 55.0% (n=83) achieved biochemical remission. The median duration of physician-reported remission was 206.5 days (IQR 86.0-554.5 days).
•Overall, of the 185 patients receiving STELARA, 53% (n=98) of patients were in remission, defined by a Mayo score <2 with no single item >1.
•Physician reported remission, defined as reduction/absence of symptoms as determined by the physician, was reported in 61.9% (109/176) of patients.
•Biochemical remission, defined as the absence of inflammation as indicated by laboratory tests on blood or stool samples, was reported in 55% (83/151) of patients.
•Mayo score components also reflected symptomatic improvement, with 72.4% (n=134) of patients reporting no rectal bleeding and 47.0% (n=87) reporting a normal stool frequency at assessment.
Holvoet et al (2025)3 evaluated the efficacy and safety of STELARA in 120 patients with UC through a multicentric, retrospective, observational study in Belgium (SULTAN).
The primary endpoint was steroid-free remission at week 16 (defined as a PMS of ≤2 with a RBS of 0, no subscore of >1, and absence of corticosteroid therapy).
The secondary endpoints included clinical, endoscopic, histologic, and biochemical remission at weeks 8, 16, 52, and /or end of treatment.
Clinical response was defined as a reduction in the partial Mayo score of ≥3 points and ≥30% from baseline, accompanied by either a decrease in the RBS of ≥1 point or an absolute rectal bleeding subscore of ≤1. Endoscopic remission was defined as an endoscopic Mayo score of 0, and endoscopic response was defined as an endoscopic Mayo score of ≤1. Biochemical remission was defined as a CRP level <5 mg/L or fecal calprotectin level
<250 mg/kg, while biochemical response was defined as a ≥50% reduction in CRP or FCP from baseline. Histological response was defined as a Nancy score ≤1, and histological remission was defined as a Nancy score of 0.
The median age (IQR) of 44.5 (19-89) years and median (IQR) disease duration of 11 (1-74) years.
Efficacy
•Steroid-free clinical remission was achieved in 34.2% (41/120) of patients at week 16 and 44.7% (38/85) at week 52. Clinical response rates were 72.5% (87/120) and 87.5% (49/85) at weeks 16 and 52, respectively.
•Endoscopic response was achieved in 42.5% (51/120) and 50% (26/52) at week 16 and 52, respectively. Endoscopic remission was observed in 19.2% (23/120) and 25.0% (13/52) of patients, while histological remission was achieved in 8.1% (3/37) and 11.1% (5/45) at weeks 16 and 52, respectively. Histological response was achieved in 10.8% (4/37) and 26.7% (12/45) at weeks 16 and 52, respectively
•Treatment discontinuation occurred primarily due to primary non-response (15%) or secondary loss of response (8%).
Safety
•Serious infections requiring hospitalization occurred in 4.2% (n=5), Clostridium difficile infection in 0.8% (n=1), herpes zoster in 0.8% (n=1), peri-anal abscess in 0.8% (n=1), candidiasis in 0.8% (n=1), COVID-19 infection in 0.8% (n=1), UC-related hospitalizations in 9.2% (n=11), arthralgia in 5.0% (n=6), urticaria in 0.8% (n=1), and local reaction to injection in 0.8% (n=1) of patients.
•Malignancy occurred in two patients during follow-up (one cholangiocarcinoma [0.8%], one basal cell carcinoma [0.8%]) - neither required discontinuation of STELARA.
•Toxic/allergic adverse events were reported in
4 patients (3.3%), with elevated liver enzymes the most frequent (2 patients, 1.6%). None of these events required cessation of STELARA treatment.
•AEs led to discontinuation in 1.7% of patients.
Yarur et al (2025)4 evaluated the efficacy and safety of STELARA in patients with UC through a retrospective, multicenter study as part of the REBOOT-IBD (REal World Biologics/Small mOlecules OuTcomes in IBD).
The primary outcome was the cumulative rate of steroid-free clinical and biochemical remission (PMS <2 while off steroids, with a normal CRP [<0.5 mg/dL to <1 mg/dL]
and/or FCP [<150 ug/g]).
Secondary outcomes were endoscopic remission (MES=0) and clinical remission (PMS <2 independent of biomarkers or steroid use).
  • Throughout follow-up, steroid-free clinical and biochemical remission was reported in 37.1% (n=91) of patients.
  • Endoscopic remission was reported in 28.7% (39/136) of patients who underwent a follow-up endoscopic assessment.
  • At 12 months, the rates of steroid-free clinical and biochemical remission, clinical remission, and endoscopic remission were 23.8%, 54.3%, and 31.0%, respectively.

Colectomy was performed in 4.9% (n=12) of patients at the end of follow-up.
  • AEs attributed to STELARA were reported in 5.7% (n=14) of patients and included headaches (n=3), infection (n=3), arthralgias (n=6), and skin rash (n=2). One patient who experienced arthralgia was required to discontinue STELARA.

No SAEs or thrombotic or cardiovascular events were reported.
Ando et al (2024)5 evaluated the efficacy and safety of STELARA among patients with UC through a multicenter, observational, cohort study in Japan.
Patients who received STELARA for induction of remission were included.
Among the 125 patients included, the mean duration of disease was 75 months.
Efficacy
•Clinical response rates (clinical remission plus clinical improvement) in the overall population at weeks 8, 16, 32, and 56 were 72.8% (91/125), 71.1% (86/121), 71.7% (71/99), and 73.2% (60/82), respectively.
•Clinical remission rates (partial Mayo score of ≤2 with a stool score of 0 or 1 and a rectal bleeding score of 0) in the overall population at weeks 8, 16, 32, and 56 were 56% (70/125), 53.7% (65/121), 60.6% (60/99), and 63.4% (52/82), respectively.
Safety
•AEs were reported in 6.4% (n=8) of patients. AEs included 1 case each of pulmonary embolism, arthritis, paranasal sinusitis and COVID-19, fatigue and headache, herpes zoster, infectious colitis, CMV colitis, and pneumocystis pneumonia.
Chaparro et al (2024)6 evaluated the durability, efficacy, and safety of STELARA in patients with UC through a retrospective, multicenter study (ULISES).
Patient included were those had active disease (PMS >2) and received the first dose of STELARA ≥16 weeks prior.
Overall, 620 patients were included in the study.
Efficacy
•Steroid-free remission was reported in 20% (N=561), 34% (N=561), and 40% (N=561) of patients at weeks 4, 8, and 16, respectively.
•Steroid-free remission was reported in 50% (N=402), 49% (N=169), and 49% (N=78) of patients at 12, 24, and 36 months respectively
Safety
•AEs were reported in 28% (n=176) of patients (infections were the most common AE, [11%]).
•The main reasons for discontinuation were primary nonresponse (39%) and loss of response (35%).
Solitano et al (2024)7 evaluated the effectiveness and safety of STELARA in a multicenter Canadian real-world study that enrolled 198 patients with moderate to severe UC.
Primary outcomes included clinical remission (partial Mayo score ≤2 points) and endoscopic remission (MES of 0). Secondary outcomes included clinical and endoscopic response, the composite of clinical and endoscopic response, loss of response.
The mean (SD) disease duration was 10.9 (9.2) years.
Overall, 198 patients were included in the study.
Efficacy
•At 3, 6, and 12 months, respectively, clinical remission was achieved in 41.3% (69/167), 38.1% (56/147), and 43.6% (58/133) of patients, and the clinical response rate was 47.3% (79/167), 42.2% (62/147), and 48.1% (64/133).
•At 3, 6, and 12 months, respectively, endoscopic remission (MES=0) was observed in 8.0% (7/88), 18.7% (23/123), and 12.5% (11/88) of patients, and the endoscopic response (defined as any improvement in MES, or MES=0) rate was 23.9% (21/88), 42.3% (52/123), and 29.5% (26/88).
•A combined clinical and endoscopic response was achieved in 50.8% of patients during final follow-up. Additionally, 73.7% of patients remained on STELARA therapy at the last follow-up. Loss of response occurred in 19.2% of patients.
Safety
•AEs were reported in 14.1% (n=28) of patients. Most patients (12.1%; 24/198) experienced only a single AE.
•Mild to moderate AEs occurred in 8.1% (n=16) of patients, whereas severe AEs were reported in 6.1% (n=12) of patients.
•The incidence of any infection while on the treatment was reported in 3.0% (6/198), infections requiring hospitalization occurred in 1.0% (2/198), Clostridium difficile infection in 3.0% (6/198), and UC-related hospitalization in 6.1% (12/198) of patients and other AEs in 7.6% (15/198).
•The incidence of any infection was 3% (6/198) of patients.
•Overall, 1.5% of patients discontinued STELARA because of side effects.
Tursi et al (2024)8 evaluated the efficacy and safety of STELARA in patients with treatment-refractory UC through a multicenter, retrospective, observational cohort study.
Patients received a STELARA weight-based IV induction dose of ~6 mg/kg, followed by an SC maintenance dose of 90 mg q8w.
The primary outcome was clinical remission (defined as a PMS of ≤1) at 8 and 24 weeks.
Secondary outcomes included the following:
•Clinical response (defined as a reduction of ≥2 points in the PMS) at 8 and 24 weeks
•Steroid-free clinical remission (defined as a PMS of ≤1 plus absence of steroid treatment) at 8 and 24 weeks
•Mucosal healing (defined as a Mayo endoscopic subscore of ≤1) at 24 weeks
•Endoscopic response (defined as a change of ≥1 point in the MES at week 24 compared with week 0) at 24 weeks
Overall, 256 patients who failed standard or biologic therapies or tofacitinib were included in the study.
At baseline, the median (IQR) PMS, CRP level, and FCP level were 5.00 (4.00-6.00), 7 (3-19) mg/dL, and 663 (386-1425) μg/g, respectively.
Efficacy
•At 8 weeks, clinical remission, clinical response, and steroid-free clinical remission were achieved in 18.7% (44/235), 53.2% (125/235), and 18.3% (43/235) of patients, respectively.
•At 24 weeks, clinical remission, clinical response, and steroid-free clinical remission were achieved in 27.6% (42/152), 61.8% (94/152), and 26.3% (40/152) of patients, respectively.
•At 8 weeks, a statistically significant reduction from baseline was observed in CRP and FCP levels (P<0.0001 for both).
•At 24 weeks, mucosal healing and endoscopic response were achieved in 52% (26/50) and 69.38% (34/49) of patients, respectively.
Safety
  • AEs were reported in 2.34% (n=6) of patients.

•Four patients underwent colectomy (1 at 12 weeks, 2 at 24 weeks, and 1 at 48 weeks).
•One death due to severe COVID-19 pneumonia was reported in an 84-year-old patient with comorbid hypertension.
•One patient had CMV infection at the 8-week follow-up and another patient at 24 weeks. During the same timeframe, 1 case of itching post-STELARA administration, 2 cases of COVID-19 infection, and 1 case of cystitis were reported.
Ando et al (2022)9 evaluated the efficacy of STELARA and its predictive factors among patients with UC through a multicenter, observational study in Japan.
Outcomes evaluated included clinical remission (PMS of ≤2), clinical improvement (change in the PMS of -3 points and decreasing to
≥-30%), and clinical response (remission+ improvement).
Among the 132 patients included in the study, the mean age was 41.3±16.2 years, and the mean duration of disease was 69.8±87.3 months.
  • Efficacy
  • At weeks 8, 16, 32, and 56, clinical remission was achieved in 62.5% (60/96), 50.7% (35/69), 61% (36/59), and 72.2% (26/36) of patients, respectively.
  • At weeks 8, 16, 32, and 56, clinical response was achieved in 82.3% (79/96), 69/6% (48/69), 72.8% (44/59), and 80.6% (29/36) of patients, respectively.
  • Safety
  • AEs were reported in 9.3% (n=7) of patients including 1 case each of pulmonary embolism, arthritis, paranasal sinusitis, COVID-19, fatigue and headache, herpes zoster, infectious colitis, and CMV colitis.
Dalal et al (2021)10 evaluated baseline predicators of colectomy-free drug survival of STELARA among patients with UC through a multicenter retrospective cohort study.
Clinical response (reduction from baseline in the SCCAI score of ≥2 points) at 12-16 weeks after induction and corticosteroid-free response were among the secondary outcomes assessed.
Among the 108 patients included in the study, the median (IQR) age was 39 (30-56) years, median (IQR) disease duration was
9 (4-16) years, and the median (IQR) duration of follow-up was 290 (189-607) days after induction.
  • Efficacy
  • At 12-16 weeks, clinical response and corticosteroid-free response were achieved in 65.3% (64/98) and 43.9% (43/98) of patients, respectively.
  • Safety
  • There were no treatment discontinuations due to SAEs.
  • Two patients switched therapy due to lack of improvement and 1 patient underwent colectomy due to colorectal cancer and discontinued STELARA.
  • One patient had colonic reactivation of CMV but continued treatment.
Registries
Thunberg et al (2022)11 evaluated clinical outcomes among patients with UC without previous colectomy who received STELARA in a noninterventional cohort study using data from the SWIBREG registry.
The outcomes assessed included:
  • Clinical remission (a stool frequency subscore of ≤1 and a rectal bleeding subscore of 0 in the patient-reported Mayo score)
  • Corticosteroid-free clinical remission among patients with concomitant corticosteroid use at baseline
  • Biochemical remission (FCP level of <250 µg/g)
  • CRP and FCP levels
  • SHS (4 self-reported outcomes: symptom burden, functional status, disease-related worry, and general wellbeing) scores compared with those at baseline.

Among the 133 patients included in the study, the median (IQR) age was 38 (28-48) years, and the median (IQR) duration of disease was 7 (3-12) years.
Efficacy
Outcomes at week 16
  • Clinical and biochemical remissiSaon were achieved in 17% (n=22) and 14% (n=19) of patients, respectively. Seventy-nine and 80 patients lacked data for clinical remission and biochemical remission, respectively.
  • Among patients with concomitant corticosteroid use at baseline (n=23), 22% (n=5) were in corticosteroid-free clinical remission; clinical remission data for 10 of these patients was missing.
  • Among patients with available data, the median (IQR) patient-reported Mayo scores decreased from 4 (3-5) at baseline to 3 (2-4; P=0.03; n=31).
  • The median (IQR) FCP levels decreased from 875 (193-1561) µg/g at baseline to
    239 (56-908) µg/g (P=0.04; n=28) at 16 weeks.
  • The median (IQR) CRP levels did not demonstrate a statistically significant change from
    2.8 (2.0-8.0) mg/L at baseline to 2.8 (1.0-4.5) mg/L (P=0.32; n=29).
  • In the self-reported SHS, the “functional status” domain demonstrated a statistically significant improvement (P=0.02) from baseline.

Outcomes at the last follow-up
  • Information on clinical remission at the last follow-up was missing for 27/133 patients.
  • Clinical and biochemical remission were achieved in 32% (n=42) and 23% (n=31) of patients, respectively. Data for biochemical remission in 39 patients were not available.
  • Among patients with concomitant corticosteroid use at baseline (n=23), 48% (n=11) were in corticosteroid-free clinical remission.
  • The patient-reported median (IQR) Mayo scores decreased from 4 (3-5) at baseline to 2 (2-4; P<0.01; n=47).
  • The median (IQR) FCP levels decreased from 740 (278-1510) µg/g at baseline to
    98 (32-663) µg/g (P<0.01; n=37).
  • The median (IQR) CRP levels did not demonstrate a statistically significant change from
    2.8 (1.0-6.1) mg/L at baseline to 2.8 (1.0-5.3) mg/L (n=43).
  • In the self-reported SHS, all 4 domains demonstrated statistically significant improvements (n=46; P<0.01).
Safety
  • Patients discontinued STELARA treatment (data was not available in 6 patients) due to:
    • Lack or loss of response (n=32)
    • Intolerance (n=2)
    • Other reasons (n=4)
Chaparro et al (2021)12 evaluated the efficacy and safety of STELARA in patients with UC through an observational multicenter study using data from the ENEIDA registry.
A total of 95 patients were included in the study with a median (IQR) time of exposure to STELARA of 31 (18-59) weeks.
Patients received an IV dose of STELARA (∼6 mg/kg) and then standard maintenance doses (q12w or q8w).
Patients who discontinued STELARA due to lack of therapeutic effect, an AE, or worsening of UC prior to their last visit were considered as not having achieved the endpoint (remission or response) at subsequent timepoints and were considered failures.
Efficacy
  • At week 16, clinical remission and clinical response (including remission) were achieved in 35% (33/95) and 53% (50/95) of patients, respectively.
  • At week 24, clinical remission and corticosteroid-free clinical remission were achieved in 39% (32/84) and 30% (25/84) of patients, respectively. The corresponding values for week 52 were 33% (18/54) and 32% (17/54), respectively.
Safety
  • Three AEs were reported which included: dry skin and itching (probably related to STELARA; did not lead to treatment discontinuation), pneumonia (probably not related to STELARA; did not lead to treatment discontinuation), and death of a 54-year-old male patient with extensive UC and no comorbidities who had been treated with STELARA (90 mg q6w) for 43 weeks and developed severe SARS-CoV-2 pneumonia.
Fumery et al (2021)13 evaluated the efficacy and safety of STELARA maintenance therapy through a multicenter cohort study from GETAID.
Patients received 6 mg/kg IV STELARA at week 0 and then 90 mg SC q8w-q12w (per investigator’s discretion).
The primary outcome was steroid-free clinical remission at 12 months. Clinical remission was defined as a PMS (including stool frequency, rectal bleeding, and PGA subscores) of ≤2, with a combined stool frequency and rectal bleeding subscore of ≤1.
The secondary outcomes included Mayo clinic endoscopic subscore and UCEIS over the study period, colectomy, and occurrence of any AE or SAEs.
Among the 103 patients included in the study, the median (IQR) age was
39.3 (29.1-52.3) years, and the median (IQR) duration of disease was
7.6 (3.6-12.9) years.
Efficacy
  • The median (IQR) duration of follow-up was 12.0 (7.4-14.4) months.
  • At week 52, steroid-free clinical remission was achieved in 32% (n=33) of patients. Clinical remission was achieved in 34% (n=35) of patients.
    • A rectal bleeding subscore of 0 and a stool frequency subscore of 0 was reported in 24.3% (n=25) of patients.
    • A rectal bleeding subscore of 0 and a stool frequency subscore of 0 or 1 was reported in 33% (n=34) of patients.
  • Among the 93 patients with a baseline assessment of endoscopic activity, 63.1% (n=65) of patients were also re-evaluated between weeks 26 and 52.
  • The mean ± SD UCEIS score decreased from 5.0±1.1 at baseline to 3.6±1.1 between weeks 26 and 52 (P<0.001).
  • The mean Mayo endoscopic subscore decreased from 2.7±0.5 at baseline to 2.0±1.0 between weeks 26 and 52.
  • At week 52, among patients with endoscopic evaluation (n=30), 16.6% (n=5) and 33% (n=10) had a UCEIS score of 0 or 1 and a Mayo endoscopic subscore of 0 or 1, respectively.
  • After a median (IQR) duration of
    6.7 (4.3-10.6) months after STELARA initiation, 9.7% (n=10) of patients needed a colectomy.
  • After 3, 6, 9, and 12 months, the cumulative probabilities of colectomy were 1%, 5.2%, 7.7%, and 9.1%, respectively.
Safety
  • Through the induction phase, there were 8 and 4 AEs and SAEs reported, respectively.
  • Between weeks 12 and 52, 16 AEs were reported in 14.8% (n=15) of patients, which included SAEs in 3.9% (n=4; exacerbation of UC leading to hospitalization, n=3; death of a 62-year-old male due to myocardial infarction 4 months after STELARA initiation).
    • No cases of cancer were reported.
  • AEs that led to STELARA discontinuation were reported in 3.9% (n=4) of patients.
Abbreviations: AE, adverse event; AT, advanced therapy; CAI, Clinical Activity Index; CI, confidence interval; CMV, cytomegalovirus; COVID-19, coronavirus disease 2019; CRP, C-reactive protein; ENEIDA, Estudio Nacional en Enfermedad Inflamatoria Intestinal Sobre Determinantes Genéticos y Ambientales; FCP, fecal calprotectin; GETAID, Groupe d’Etude Thérapeutique des Affections Inflammatoires du Tube Digestif; HR, hazard ratio; IBD, inflammatory bowel disease; IQR, interquartile range; IV, intravenous; MES, Mayo endoscopic score; OR, odds ratio; PGA, Physician’s Global Assessment; PMS, partial Mayo score; q4w, every 4 weeks; q6w, every 6 weeks; q8w, every 8 weeks; q12w, every 12 weeks; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SC, subcutaneously; SCCAI, Simple Clinical Colitis Activity Index; SD, standard deviation; SHS, Short Health Scale; SWIBREG, Swedish Inflammatory Bowel Disease Register; UC, ulcerative colitis; UCEIS, Ulcerative Colitis Endoscopic Index of Severity; UK, United Kingdom; US, United States.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 28 August 2026.

Summarized in this response are data focused on clinical efficacy and safety from observational and retrospective studies with >100 patients receiving STELARA and registries.

 

References

Show
1 Iborra M, Ferreiro-Iglesias R, Maria Dolores MA, et al. Real-world long-term effectiveness of ustekinumab in ulcerative colitis: results from a spanish open-label cohort. Scand J Gastroenterol. 2024;59(3):260-268.  
2 Burbage S, Harvey N, Godwin B, et al. The real-world effectiveness of ustekinumab in patients with ulcerative colitis in the United States. Curr Med Res Opin. 2025;41(4):683-689.  
3 Holvoet T, Truyens M, Reenaers C, et al. Ustekinumab in ulcerative colitis: a real-life effectiveness study across multiple Belgian centers (SULTAN). J Clin Med. 2025;4(18):6506.  
4 Yarur AJ, Ungaro R, Huang K, et al. Real-world effectiveness of ustekinumab in ulcerative colitis in a United States multicenter cohort consortium. Inflamm Bowel Dis. 2025;31(1):131-139.  
5 Ando K, Fujiya M, Ueno N, et al. Effectiveness and persistency of ustekinumab treatment for ulcerative colitis: a phoenix retrospective cohort study. Crohns Colitis 360. 2024;6:otae024.  
6 Chaparro M, Hermida S, Acosta D, et al. Short and long-term effectiveness and safety of ustekinumab in ulcerative colitis in real life: the ULISES study [abstract]. J Crohns Colitis. 2024;18(Suppl. 1):i208-i210. Abstract DOP74.  
7 Solitano V, Narula N, Ma C, et al. Effectiveness of ustekinumab for patients with moderate-to-severe ulcerative colitis: a multicenter real-world Canadian Study. Am J Gastroenterol. 2024;120(7):1576-1584.  
8 Tursi A, Mocci G, Scaldaferri F, et al. Ustekinumab safety and effectiveness in patients with ulcerative colitis: results from a large real-life study. Expert Opin Biol Ther. 2024;24(1-2):101-109.  
9 Ando K, Fujiya M, Ueno N, et al. Clinical outcomes and predictive factors accounting for short- to medium-term effectiveness of ustekinumab in treating ulcerative colitis: a Japan-based study. Poster presented at: Digestive Disease Week (DDW); May 21-24, 2022; San Diego, CA.  
10 Dalal R, Eckilsen S, Barnes E, et al. Colectomy-free drug survival of ustekinumab in ulcerative colitis: a real-world, mutlicenter cohort study in the United States. Poster presented at: Digestive Disease Week (DDW); May 21-23, 2021; Virtual.  
11 Thunberg J, Björkqvist O, Hedin CRH, et al. Ustekinumab treatment in ulcerative colitis: real‐world data from the Swedish inflammatory bowel disease quality register. United Eur Gastroenterol J. 2022;10(7):631-639.  
12 Chaparro M, Garre A, Iborra M, et al. Effectiveness and safety of ustekinumab in ulcerative colitis: real-world evidence from the ENEIDA registry. J Crohns Colitis. 2021;15(11):1846-1851.  
13 Fumery M, Filippi J, Abitbol V, et al. Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study. Aliment Pharmacol Ther. 2021;54(7):944-951.  

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