SUMMARY

• Please refer to the local labeling for relevant information on the use of STELARA in adult patients with Crohn’s disease (CD) or ulcerative colitis (UC).
• Summarized below is data from meta-analyses on the effectiveness and safety of STELARA and vedolizumab (VDZ) in patients with CD.^1-3
• Additionally, relevant data from prospective, retrospective and registry based studies that compared the effectiveness and safety of STELARA and VDZ in patients with CD or UC is also described below.^4-14

CLINICAL DATA

Meta-analyses

Parrot et al (2022)¹ conducted a systematic review with meta-analysis to compare the effectiveness of STELARA and VDZ in patients with CD refractory to anti-tumor necrosis factor (anti-TNF) therapies.

Methods

• Studies that compared the efficacy of STELARA and VDZ after failure or intolerance to anti-TNF in patients with CD were considered eligible.
• The search was conducted on March 27, 2021, across PubMed^®, EMBASE^®, and the Cochrane Library.
• Outcomes of interest for the meta-analysis included clinical remission at weeks 14 and 52 (Harvey-Bradshaw Index [HBI] ≤4 or Crohn’s Disease Activity Index [CDAI] <150), steroid-free clinical remission (SFR) at weeks 14 and 52, and biological remission (C-reactive protein [CRP] ≤5 mg/L or fecal calprotectin [FC] ≤250 µg/g) at weeks 14 and 52.
• The primary analysis was based on 5 studies with adjusted results.

Results

• A total of 1026 patients received either STELARA (n=659) or VDZ (n=367) and were included in the analyses.
• Follow-up duration ranged from 24 to 104 weeks.
• At week 14, the rates of clinical remission, SFR, and biological remission were similar between the 2 groups:
  • Clinical remission rate: odds ratio (OR), 1.36; 95% confidence interval (CI), 0.74-2.47
  • SFR rate: OR, 1.24; 95% CI, 0.79-1.92
  • Biological remission rate: OR, 0.80; 95% CI, 0.50-1.28
• At week 52, the rates of clinical remission, SFR, and biological remission were higher for the STELARA group:
  • Clinical remission rate: OR, 1.87; 95% CI, 1.18-2.98
  • SFR rate: OR, 1.56; 95% CI, 1.23-1.97
  • Biological remission rate: OR, 1.86; 95% CI, 1.03-3.37

Kawalec and Moćko (2018)² conducted an indirect comparison to evaluate the clinical efficacy and safety of STELARA and VDZ in patients with active CD who were intolerant or unresponsive to previous anti-TNF therapies.

Methods

• Randomized, double-blind studies comparing STELARA or VDZ with placebo in patients with CD were included.
• A systematic review was conducted up to April 30, 2017, across EMBASE^®, MEDLINE^® (via PubMed^®), and Cochrane Central Register of Controlled Trials (CENTRAL).
• Indirect comparison results were expressed as relative risks (RRs) with 95% CIs for efficacy outcomes and adverse events (AEs).
• To calculate relative parameters, the fixed effects model was applied when there was no statistical heterogeneity and the random effects model was applied when heterogeneity was present (P<0.10).

Results

• The systematic review revealed 5 randomized controlled trials. Three studies compared STELARA and placebo (CERTIFI, UNITI-1, and IM-UNITI) and 2 studies compared VDZ and placebo (GEMINI-2 and GEMINI-3).
• Clinical response was defined as ≥100-point decrease in the CDAI and was assessed during the induction phase.
  • At week 6, no statistically significant difference was observed between STELARA and VDZ in achieving clinical response during the induction phase (relative benefit [RB]: 1.14; 95% CI, 0.65-1.99; P=nonsignificant [NS]).
• Clinical remission was defined as a CDAI score of ≤150 and was assessed during the induction and maintenance phase.
  • At week 6, STELARA 6 mg/kg was as effective as VDZ 300 mg at inducing clinical remission (RB, 1.16; 95% CI, 0.54-2.48; P=NS).
  • After 52 weeks of treatment, no significant difference was observed between STELARA and VDZ in achieving clinical remission in the maintenance phase among patients intolerant or refractory to TNF-antagonist treatment (RB, 0.72; 95% CI, 0.30-1.68; P=NS).
• During the induction and maintenance phases, no significant differences were observed in the safety profile of STELARA and VDZ, with the RR of 0.93 during the maintenance phase (95% CI, 0.81-1.08; P=NS).

Hather et al (2017)³ conducted a network meta-analysis to evaluate the efficacy of STELARA and VDZ in patients with moderately to severely active CD.

Methods

• Induction and maintenance data were obtained from phase 3, randomized, double-blind, placebo-controlled studies: GEMINI II for VDZ and UNITI-1, UNITI-2, and IM-UNITI for STELARA.
• A Bayesian network meta-analysis was performed using OpenBUGS v3.2.2. To account for variability in placebo effects across trials, a binomial likelihood and a logit link function were used in a fixed effects model.
• Clinical remission was defined as a CDAI ≤150.
• Week 6 induction data were extracted for placebo, STELARA 6 mg/kg, and VDZ 300 mg, while week 52 maintenance data were extracted for placebo, STELARA 90 mg every 12 weeks (q12w) and every 8 weeks (q8w), and VDZ 300 mg q8w and every 4 weeks (q4w).

Results

• Results were stratified by prior exposure to anti-TNF therapies.
• At week 6, the OR for clinical remission between STELARA 6 mg/kg and VDZ 300 mg was not statistically significant and is reported below:
  • Anti-TNF-nonrefractory patients: 0.99
  • Anti-TNF-refractory patients: 1.63
• At week 52, the OR for clinical remission between STELARA 90 mg q8w and VDZ 300 mg q8w was not statistically significant and is reported below:
  • Anti-TNF-naive patients: 0.67 (95% CI, 0.23-1.99)
  • Anti-TNF-refractory patients: 0.73 (95% CI, 0.23-2.28)

Prospective Study

Bokemeyer et al (2024)⁴ presented 1-year maintenance therapy results from the prospective, observational real-world RUN-UC study that evaluated the effectiveness of STELARA compared with anti-TNF therapy and VDZ in patients with UC. Data reported below are results for STELARA and VDZ.

Methods

• A total of 476 patients with UC were included in the analysis.
  • STELARA: n=147 (bio-naïve, n=12)
  • VDZ: n=161 (bio-naïve, n=105)
• Propensity score (PS) adjustment eliminated systemic differences in baseline parameters among the groups, including sex distribution (STELARA/VDZ, 42.2%/50.3% males) and presence of extraintestinal manifestations (STELARA/VDZ, 25.2%/19.9%). The bio-experienced characteristic was also equalized among the groups.

Results

• The PS-weighted effectiveness (mITT analysis) of STELARA in terms of response and clinical and steroid-free remission at month 12 was similar to that of VDZ. This similarity was also observed without PS weighting, with a clinical remission rate of 33.1% for STELARA and 38.1% for VDZ.
• Patients in all treatment groups showed significant improvements in the quality of life, measured using the EuroQoL-visual analog scale (EQ-VAS), after 12 months of treatment.

Retrospective Studies

Amiot et al (2026)⁵ evaluated the effectiveness and safety of STELARA and VDZ at 5 years in patients with CD with previous failure to anti-TNF therapy.

Study Design/Methods

• Patients >18 years old with CD, treated with VDZ (May 2014-November 2016) or STELARA (December 2016-August 2018) were included in the study.
• STELARA was administered as 6 mg/kg intravenous (IV) infusions at week 0, followed by 90 mg subcutaneous (SC) q8w or q12w.
• VDZ was administered based on three IV infusions of 300 mg at week 0, 2, and 6, and q8w thereafter.

Results

• Overall, 239 patients (STELARA, n=107; VDZ, n=132) who failed anti-TNF therapy and started with second line anti-TNF therapy were included in the study.
• In the STELARA and VDZ groups, respectively, 51 (47.7%) and 26 (19.7%) patients remained on treatment after 5 years of follow-up.

Effectiveness

• Clinical outcomes of STELARA and VDZ through 5 years of treatment are summarized in Table: Clinical Outcomes of STELARA and VDZ through 5 Years.

Safety

• AEs were reported in 75 patients in the STELARA group and 173 patients in the VDZ group; most were mild to moderate infections (STELARA, n=19 [17.8%]; VDZ, n=53 [40.2%]).
  • Seven infections required hospitalization (STELARA, n=3; VDZ, n=4).
  • Three cases of herpes zoster infection were reported (STELARA, n=1; VDZ, n=2).
  • One case of neuromeningeal infection was reported in each group.
  • Malignancy was reported in 3 patients (STELARA, n=1; VDZ, n=2).
    • One case of multiple myeloma in a 59-year-old man, resulting in the discontinuation of STELARA.
  • One death was reported in the VDZ group.

Christensen et al (2025)⁶ evaluated the effectiveness and safety of STELARA and VDZ in biologic-naïve patients with CD based on disease duration (EVOLVE Expansion).

Study Design/Methods

• Biologic-naïve adult patients with CD who initiated STELARA or VDZ treatment between 2016 and 2021 were included in the study.
• STELARA was administered as a weight-based IV infusion at week 0 (260 mg for ≤55 kg, 390 mg for >55 to ≤85 kg, 520 mg for >85 kg), followed by STELARA 90 mg SC q8w thereafter.
• VDZ was administered at a dose of 300 mg IV infusion at weeks 0, 2, and 6 and q8w thereafter.

Outcomes and Definitions

• Outcomes evaluated included cumulative rates of clinical outcomes such as clinical response, clinical remission, and mucosal healing.
• Clinical response was defined as (i) a positive change in the CDAI category from baseline (<150, 151-219, 220-450, or >450); (ii) a decrease of ≥3 points in HBI from baseline; (iii) a decrease of ≥3 points from baseline in modified HBI; (iv) treatment response was recorded as “complete response” or “partial response.”
• Clinical remission was defined as (i) CDAI score of <150 points; (ii) HBI score of ≤4; (iii) modified HBI score of ≤4.
• Mucosal healing was defined as (i) endoscopic assessment score of 0 or 1; (ii) simple endoscopic score for CD (SES-CD) of <3; (iii) lack of ulceration; or (iv) ≥1 non-endoscopic procedure finding from the list of inactive diseases.

Results

• Of the 249 and 371 patients with early and late CD, respectively, 108 and 168 patients were treated with STELARA and 141 and 203 were treated with VDZ.

Efficacy

Patients with Early CD

• Clinical responsefor STELARA and VDZ over 36 months was 80.7% and 81.6%, respectively (P=0.31).
• Clinical remissionfor STELARA and VDZ over 36 months was 85.0% and 87.9%, respectively (P=0.74).
• Mucosal healingfor STELARA and VDZ at 24 months was 57.8% and 86.9%, respectively (P=0.02), and at 36 months was 89.0% and 92.3%, respectively (P=0.03).

Patients with Late CD

• Clinical response for STELARA and VDZ over 36 months was 86.5% and 83.7%, respectively (P=0.31).
• Clinical remission for STELARA and VDZ over 36 months was 90.6% and 91.9%, respectively (P=0.96).
• Mucosal healing for STELARA and VDZ over 36 months was 87.2% and 89.4%, respectively (P=0.77).

Safety

• Over 36 months, the incidence rate of first occurrence of SAE per 100 person-years (PY) in patients receiving STELARA and VDZ was 5.6% and 5.8%, respectively, for early CD and 5.2% and 4.3%, respectively, for late CD.
• The incidence rate of first serious infections (SIs) in patients receiving STELARA and VDZ was 0.5% and 1.8%, respectively, for early CD and 0.3% and 0.9%, respectively, for late CD.

Sachar et al (2025)⁷ conducted a single-center retrospective cohort study comparing the safety and efficacy of STELARA and VDZ in younger and older adults with inflammatory bowel disease (IBD).

Study Design/Methods

• This single-center retrospective cohort study compared younger (aged 18-59 years) and older adults (aged ≥60 years) with a biopsy-proven diagnosis of IBD receiving STELARA or VDZ from 2014 to 2022.

Outcomes and Definitions

• Primary outcome was endoscopic remission.
  • Endoscopic remission was defined as an endoscopic Mayo subscore of 0 in patients with UC, and in patients with CD, it was defined as clinician documentation of absence of ulcerations, inactive ileitis and/or colitis or SES-CD <3 points.
• Secondary outcomes were partial endoscopic response, clinical remission, and partial clinical response.
  • Partial endoscopic response was defined as a decrease in Mayo subscore of ≥1 or clinical documentation of endoscopic improvement in patients with UC, and >50% improvement in SES-CD or endoscopic documentation of improvement in ulceration size or number in patients with CD.
  • Clinical remission was defined as a clinical documentation of complete resolution of IBD-related symptoms.
  • Clinical response was defined as a clinician report of improvement in ≥1 IBD-related symptoms.

Results

• A total of 948 patients were included (<60 years old, n=779 [82.2%]; ≥60 years old, n=169 [17.8%]). Overall, 57.8% and 38.7% patients had CD and UC, respectively.
  • A total of 545 (57.5%) patients received STELARA, and 403 (42.5%) patients received VDZ.

Efficacy

• Younger and older patients receiving STELARA and VDZ showed similar rates of endoscopic remission; see Table: Efficacy Outcomes Across Treatment Groups.

Safety

• The primary safety outcome, serious infections during the study between younger and older patients receiving STELARA (P=0.58) and VDZ (P=0.58) were not statistically significant; see Table: Safety Outcomes Across Treatment Groups.

Scharl et al (2024)⁸ evaluated the effectiveness and safety of STELARA and VDZ in biologic-naïve patients by CD location.

Study Design/Methods

• This multicenter, observational, retrospective EVOLVE expansion study included patients with CD aged ≥18 years who were treated with STELARA or VDZ in Australia, Belgium, or Switzerland between 2016 and 2021.

Outcomes and Definitions

• Clinical outcomes (clinical response, clinical remission, and mucosal healing) were evaluated for 36 months.
• Safety outcomes, including Serious adverse events (SAEs), SIs, and healthcare resource utilization (HCRU; CD exacerbations, CD-related hospitalizations, and CD-related surgeries) were also evaluated for 36 months.

Results

• A total of 293 patients with ileal CD (STELARA, n=135; VDZ, n=158), 185 patients with ileocolonic CD (STELARA, n=94; VDZ, n=91), and 121 patients with colonic CD (STELARA, n=37; VDZ, n=84) were included.

Effectiveness

• The clinical outcomes in between STELARA and VDZ for ileal, ileocolonic, and colonic subgroups were similar; see Table: Comparative Effectiveness of STELARA and VDZ at 36 months.

Safety

• No differences were reported in the SAEs, SIs, CD exacerbations, and cases of CD-related hospitalization between the STELARA and VDZ groups across disease location; see Table: Safety and HCRU Outcomes of STELARA and VDZ at 36 Months.

Yang et al (2023)⁹ evaluated the effectiveness of STELARA and VDZ in patients with CD, including both TNFi-naïve and TNFi-exposed patients with CD.

Study Design/Methods

• This multicenter, observational, real-world study included adult patients with CD between May 2020 and July 2023 who received ≥1 dose of STELARA or VDZ for luminal disease.
• STELARA was administered as an IV induction (~6 mg/kg) followed by a maintenance dose of 90 mg SC q8w or q12w.
• VDZ 300 mg IV was administered at weeks 0, 2, and 6 for induction, followed by a maintenance dose q8w.

Outcomes and Definitions

• Clinical outcomes were evaluated at weeks 0, 26, and 52.
• Primary outcome: steroid-free remission at weeks 26 and 52
• Secondary outcomes: clinical remission at weeks 26 and 52 and AEs during follow-up
• Clinical remission was defined as CDAI ≤150.
• Steroid-free remission was defined as CDAI ≤150 with steroid use below the equivalent of prednisolone 10 mg/day.
• CRP normalization: <5 mg/L

Results

• A total of 654 patients were included (STELARA, n=475; VDZ, n=179), of whom 536 met the inclusion criteria (STELARA, n=386; VDZ, n=150).

Clinical and Steroid-Free Remission

• At week 26, in the overall adjusted population, STELARA was more effective than VDZ in the TNFi-exposed patients:
  • Steroid-free remission (55.4% vs 46.1%; P=0.003; OR, 1.451; 95% CI, 1.140-1.850)
  • Clinical remission (56.4% vs 47.8%; P=0.005; OR, 1.413; 95% CI, 1.109-1.800)
• Among TNFi-naïve patients, no significant difference was observed between STELARA and VDZ:
  • Steroid-free remission (65.5% vs 59.6%; P=NS; OR, 1.289; 95% CI, 0.900-1.848)
  • Clinical remission (66.5% vs 59.6%; P=NS; OR, 1.348; 95% CI, 0.940-1.935).
• Among TNFi-exposed patients, STELARA was superior to VDZ:
  • Steroid-free remission (46.0% vs 33.4%; P=0.003; OR, 1.698; 95% CI, 1.203-2.404)
  • Clinical remission (47.0% vs 36.7%; P=0.015; OR, 1.531; 95% CI, 1.089-2.158)
• At week 52, in the overall adjusted population, STELARA was significantly more effective than VDZ:
  • Steroid-free remission in the overall adjusted population (65.8% vs 37.5%; P<0.001; OR, 3.207; 95% CI, 2.364-4.369)
• Subgroup analyses showed superiority of STELARA to VDZ for steroid-free remission in both TNFi-naïve patients (79.4% vs 49.0%; P<0.001; OR, 4.029; 95% CI, 2.437-6.780) and TNFi-exposed patients (55.6% vs 29.7%; P<0.001; OR, 2.965; 95% CI, 1.985-4.464).

Safety

• The rate of AEs was not statistically significant between the STELARA and VDZ groups (4.9% and 6.7%, respectively; P=NS).
  • STELARA-treated patients: Clostridium difficile associated symptomatic enteritis (n=1), secondary tuberculosis infection and suspended treatment (n=1), rashes that resolved after anti-allergic treatment (n=8), joint pain (n=5), upper respiratory tract infection (n=4)
  • VDZ-treated patients: C. difficile associated symptomatic enteritis (n=3), rashes (n=4), joint pain (n=1), fatigue (n=2).

Meyer et al (2022)¹⁰ evaluated the efficacy of STELARA and VDZ in patients with UC who failed anti-TNF therapy, using data from 2 multicenter cohort studies conducted at French Groupe d’Etudes Therapeutiques des Affection Inflammatoires du tube Digestif (GETAID) centers.

Study Design/Methods

• Patients with active UC who had an inadequate response to, lost response to, or were intolerant to conventional therapy and at least 1 anti-TNF agent between June 2014 and December 2014 (OSERV-IBD) and January 2019 and September 2019 (UC-USTEK) were included in the study.
• STELARA was administered as 6 mg/kg IV infusions at week 0 for induction therapy; this was followed by maintenance therapy every 4 to 8 weeks per the investigator’s discretion. Patients receiving modified 270 mg SC induction therapy were also included.
• VDZ was administered as 300 mg IV infusions at weeks 0, 2, and 6 for induction therapy; this was followed by maintenance therapy every 4 to 8 weeks per the investigator’s discretion.
• The primary endpoint was SFR, defined by a partial Mayo Clinic score of ≤2, with a combined stool frequency and rectal bleeding subscore of <1.
  • For induction therapy, SFR was evaluated at week 14 in the VDZ group and between weeks 12 and 16 in the STELARA group. For maintenance therapy, SFR was evaluated at week 52 in both groups.

Results

• A total of 121 patients with UC (OBSERV-IBD) who received VDZ and 97 patients with UC (UC-USTEK) who received STELARA were included.

Efficacy

• For comparative effectiveness between STELARA and VDZ at weeks 14 and 52, see Table: Comparative Effectiveness of STELARA and VDZ.

Lenti et al (2022)¹¹ conducted a retrospective cohort study that compared the clinical effectiveness and safety of STELARA and VDZ as second-line treatment in patients with CD who failed anti-TNFα therapy.

Study Design/Methods

• This multicenter study (Cross Pennine study II) conducted across 8 IBD centers included adult patients through the electronic medical records who initiated STELARA from January 2017 to January 2020, or VDZ from August 2014 to June 2017.
• STELARA was initially administered as a weight-based IV infusion followed by 90 mg SC injection after 8 weeks and thereafter a maintenance dose of 90 mg SC q8w or q12w.
• VDZ was given as 300 mg IV infusion at weeks 0, 2, and 6, and q8w thereafter, with an additional dose at week 10 for 7 patients.

Outcomes and Definitions

• Primary outcome: 3- and 12-month short- or medium-term clinical effectiveness and safety profile of STELARA
• Clinical remission at 14 and 52 weeks (±2 weeks): physician global assessment (PGA) score of 0 (complete relief or marked improvement)
• Clinical response at 14 and 52 weeks (±2 weeks): PGA score of 1 (partial though significant improvement)
• HBI score: remission defined by HBI ≤4; response defined by reduction of at least 3 points
• Primary failure: inadequate clinical response after induction
• Loss of response: inadequate response after induction
• Treatment failure: patients who stopped STELARA in weeks 14-52 in the 52-week analysis

Results

• In total, 282 and 118 patients were included in the final STELARA and VDZ groups, respectively.
• Of 282 patients, 200 (70.9%) achieved clinical response or remission at 14 weeks, and of 259 patients, 162 (62.5%) achieved clinical response or remission at 52 weeks.
• A total of 101 of 282 (35.8%) patients discontinued STELARA, with primary failure and loss of response being the most common reasons, followed by AEs and need for surgery.

Safety Outcomes

• A total of 74 AEs were reported in 69 (24.5%) patients treated with STELARA, with 26 classified as serious (life-threatening or requiring hospital admission).
• Among these SAEs, 6 neoplastic disorders and 1 obstetric complication (premature rupture of membranes) were reported.
• Most patients reporting an AE were on STELARA monotherapy (STELARA vs VDZ, 81.1% vs 28.6%); while few patients were on immunosuppressant or systemic steroid (STELARA vs VDZ,18.9% vs 71.4%).
• The cumulative incidence of severe AEs and infectious diseases in the STELARA and VDZ groups was 8.3 and 17.2 per 100 PY, respectively.

Onali et al (2022)¹² conducted a retrospective cohort study that compared the effectiveness of STELARA and VDZ as second-line treatments in patients with CD across 20 Italian IBD referral centers.

Study Design/Methods

• This observational, real-world, multicenter cohort study included patients with a confirmed diagnosis of CD for at least 3 months with primary or secondary failure or intolerance to TNFi between January 2016 to December 2020.
• STELARA 6 mg/kg IV was administered at induction, followed by a maintenance dose of 90 mg SC q8w or q12w.
• VDZ was administered as 300 mg IV at weeks 0, 2, and 6 for induction, followed by maintenance doses q4w or q8w.

Outcomes

• Primary outcome was clinical response at week 26, defined as a reduction in HBI by ≥3 from baseline or achievement of HBI <5 in those with baseline HBI ≤7.
• Secondary outcomes:
  • Clinical response at week 52
  • Clinical remission and SFR at weeks 26 and 52, defined as HBI ≤4 with or without steroids

Results

• A total of 470 patients were included in the study: STELARA, n=239 (50.9%); VDZ, n=231 (49.1%).

Effectiveness: Overall Population Analysis

• At week 26, in the weighted overall population treated with STELARA and VDZ, respectively:
  • Clinical response: 60.1% and 65.4% (P=NS)
  • Clinical remission: 42.1% and 44.8% (P=NS)
  • SFR: 38.3% and 40.7% (P=NS)
• At week 52, STELARA and VDZ, respectively:
  • Clinical response: 64.6% and 68.4% (P=NS)
  • Clinical remission: 42.5% and 55.5% (P=0.010)
  • SFR: 40.6% and 51.1% (P=0.038)
• At week 26, STELARA and VDZ, respectively:
  • CRP normalization: 50.0% and 54.0%
  • Mean±standard deviation (SD) FC: 294±46 and 296±59 mg/kg
• At week 52, in the weighted overall population treated with STELARA and VDZ, respectively:
  • CRP normalization: 56.3% and 61.5%
  • Mean±SD FC: 204±38 and 261±73 mg/kg
• At baseline, in the weighted overall population treated with STELARA and VDZ, respectively:
  • Mean±SD FC: 741±160 and 516±83 mg/kg

Safety Outcomes

• AEs were reported in 35 (14.6%) patients in the STELARA group and 39 (16.3%) patients in the VDZ group, most of which were related to disease activity: STELARA, n=17 (7.1%); VDZ, n=24 (10.4%).
• STELARA group:
  • The most common AEs were arthralgia (n=2) and pneumonia (n=2).
  • One SAE required hospitalization for abdominal abscesses, which resolved after radiologic drainage and antibiotic therapy.
• VDZ group:
  • The most common AEs were nasopharyngitis (n=5), arthralgia (n=2), and pneumonia (n=2).
  • Two patients had more than 1 AE (cellulitis and eczema; cholestasis and hyperamylasemia).
  • One SAE required hospitalization for sepsis related to a central venous catheter infection, which was controlled with IV antibiotic therapy.
• No deaths were reported in either treatment group.

Registry Data

Helm-Wiken et al (2025)¹³ evaluated the effectiveness and dosing of STELARA vs VDZ in patients with UC after failure of at least 1 TNF inhibitor (TNFi) therapy.

Study Design/Methods

• Patients who were started on either VDZ (2016-2019) or STELARA (2020-2022) were followed for 1 year after the initiation of therapy or until discontinuation. Data were obtained from electronic patient journal and a local IBD registry in Norway.

Results

• A total of 116 patients were included in the study: STELARA, n=57; VDZ, n=59.
• The clinical remission rate increased significantly in both groups, with no difference between STELARA and VDZ at weeks 0 (OR, 2.1 [0.9-4.5]) and 52 (0.9 [0.3-2.3]). For further details, see Table: Clinical Outcomes at Weeks 0 and 52 for STELARA vs VDZ.

García et al (2024)¹⁴ evaluated the short-term and long-term effectiveness and safety of STELARA and VDZ in patients with CD and also identified the predictive factors of clinical response and remission.

Study Design/Methods

• This multicenter study included adult patients between January 1, 2012, to December 30, 2020, from the ENEIDA registry, a prospectively maintained nationwide database supported by the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis (GETECCU).
• Patients included in the study were treated for CD with STELARA or VDZ after anti-TNF (primary or secondary) failure or intolerance.
• STELARA induction therapy consisted of a 6 mg/kg weight-based IV dose followed by 90 mg SC q8w or q12w.
• VDZ was administered as an initial induction IV infusion of 300 mg at weeks 0, 2, and 6 followed by 300 mg q8w. An additional dose of 300 mg at week 10 was permitted.
• Effectiveness was assessed at weeks 8 and 16 during the induction period and every 6 months during the maintenance phase.
• CD was classified as per the Montreal classification, and clinical activity and treatment response were assessed using HBI.
  • Active disease was defined as an HBI score of ≥5 points, and clinical remission was defined as an HBI score of <5.
  • Corticosteroid-free clinical remission was defined as an HBI score of <5 with no corticosteroid administration at a certain visit.
  • Clinical response was defined as a reduction in HBI by ≥3 points from baseline alongside clinical remission criteria.
• Loss of response:
  • HBI >4 leading to dose escalation, addition of another medication, change to another drug, or surgery

Results

• A total of 835 patients were included in the study (STELARA, n=628; VDZ, n=207).
• The median follow-up time from start of therapy to database lock was 2.8 years (interquartile range [IQR], 2.0-3.6) and 4.7 years (IQR, 3.2-5.5) for patients treated with STELARA and VDZ, respectively.

Short-term Effectiveness

• Effectiveness was evaluated in 597 patients (STELARA, n=445; VDZ, n=152) with active disease at the start of treatment (HBI >4 points).
• A total of 13 patients discontinued treatment during the induction phase: 12 in the STELARA group and 1 in the VDZ group.
• In a multivariate analysis through week 16, STELARA was associated with a higher likelihood of clinical outcomes below compared with VDZ:
  • Clinical response: OR, 1.84; 95% CI, 1.27-3.18
  • Clinical remission: OR, 2.01; 95% CI, 1.27-3.18
  • Corticosteroid-free clinical remission: OR, 1.84; 95% CI, 1.12-3.03

Long-term Effectiveness

• Effectiveness was evaluated in 584 patients followed up for at least 6 months.
• In the multivariate analysis through 1 year, the likelihood of achieving the clinical outcomes below was significantly higher in patients receiving STELARA vs VDZ:
  • Clinical response: OR, 1.80; 95% CI, 1.17-2.79
  • Clinical remission: OR, 1.73; 95% CI, 1.10-2.70
  • Corticosteroid-free clinical remission: OR, 1.69; 95% CI, 1.07-2.68

Loss of Response and Therapy Discontinuation

• Overall, 770 patients reached remission at week 16 and 514 lost responses over time (STELARA, n=360; VDZ, n=154; P<0.001).
• A total of 350 patients discontinued treatment at the last study visit:
  • STELARA: n=202 (95% CI, 28.5-35.8)
  • VDZ: n=148 (95% CI, 65.3-77.6)
• The discontinuation ratio was 19 per 100 PY and 49 per 100 PY for STELARA and VDZ, respectively (P<0.001).
• The primary reason for treatment discontinuation was primary nonresponse, followed by secondary nonresponse.

Safety

• Overall, 11.6% (n=97) of patients experienced at least 1 AE: STELARA, n=67; VDZ, n=30 (P=NS); incident rate of AEs (5.3 and 6.6 per 100 PY for STELARA and VDZ, respectively).
• Infection was the most common AE, followed by arthralgia and skin disorders.
• SAEs occurred in 22 patients: STELARA, n=13; VDZ, n=9 (P=NS).
• AEs leading to treatment discontinuation were reported in 17 patients in the STELARA group vs 13 in the VDZ group (P>0.05).
• One patient died in the VDZ group due to infectious arthritis complicated by septic shock.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 25 December 2025.