SUMMARY

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• Prospective, retrospective, and registry-based studies conducted in patients with perianal Crohn’s disease (CD) and perianal fistulizing Crohn’s disease are described below.^1-17

REAL-WORLD DATA ON PATIENTS WITH PERIANAL CD AND PFCD

Prospective Studies

Huang et al (2025)¹ conducted a prospective study to compare the effectiveness of STELARA and infliximab in achieving radiological outcomes in biologic-naïve patients with perianal fistulizing Crohn’s disease.

• Of the 195 patients included in the study, 184 had complex fistula and 72 received STELARA.
• The primary endpoint evaluated was radiologic remission (Van Assche Index [VAI] inflammatory subscore ≤6) at weeks 14-26.
• At weeks 14-26, the mean (standard deviation) reductions in VAI score and modified VAI scores from baseline in patients treated with STELARA were -4.9 (4.6) and -4.3 (4.1), respectively.
• For the radiologic, clinical and endoscopic outcomes, see Table: Radiologic, Clinical and Endoscopic Outcomes at Weeks 14-26

Bar-Gil Shitrit et al (2020)² conducted a prospective, multicenter study to evaluate the efficacy and safety of STELARA for the induction of remission in patients with active CD.

• Of the 106 patients included in the study, 26 had active perianal disease (defined as any actively draining perianal fistula) and 7 had undergone perianal surgery.
• Among patients with active perianal disease at baseline, 77% of patients remained with an active disease at week 8, and 69% of patients at week 24 (P<0.001).

Matsumoto et al (2022)³ conducted a prospective, multicenter, observational, postmarketing surveillance study in Japan to evaluate the effectiveness and safety of STELARA through 52 weeks for the treatment of perianal manifestations of CD.

Study Design/Methods

• Patients with moderately to severely active CD with a history of failure or intolerance to previous treatment from medical facilities were included.

Results

• Among the 341 patients enrolled in the study, 197 and 229 were included in the efficacy and safety analysis sets, respectively.
• Clinical remission rates among patients with (n=60) vs without (n=137) baseline perianal disease were not significantly different (68.3% vs 59.9%).
• Similar improvement in CDAI scores from baseline through week 52 was observed between patients with and without perianal disease.
• Common adverse drug reactions (ADRs) occurring in >0.5% of patients were worsening of CD, anal abscess, upper respiratory tract inflammation, pyrexia, influenza, and intestinal obstruction. No new safety signals were identified.

Retrospective Studies

Chen et al (2025)⁴ conducted a retrospective, real-world cohort study to evaluate the effectiveness of STELARA in patients with perianal fistulizing Crohn’s disease through 2 years at a Chinese referral center.

Study Design/Methods

• The patients received intravenous STELARA induction based on body weight (260 mg for <55 kg, 390 mg for 55-85 kg and 520 mg for >85 kg) followed by STELARA subcutaneous (SC) 90mg every 8 or 12 weeks.
• Clinical remission was defined as the absence of pain and no drainage through the fistula tract upon gentle pressure.
• Radiological healing was defined as the absence of high signal-intensity trajectories on fat-saturated T2-weighted sequences.
• Deep remission was defined as the achievement of both clinical remission and radiological healing.
• Clinical recurrence was defined as the recurrence of an active fistula that requires an additional medical or surgical intervention after clinical remission.

Results

• Overall, 143 patients with perianal fistulizing Crohn’s disease were included and the median follow-up duration was 136 weeks (interquartile range [IQR], 108-156).
• STELARA was discontinued in 31 (21.7%) patients. The main reasons were perianal disease (12.9%; n=4), intestinal disease (32.3%; n=10), combined perianal and intestinal disease (19.4%; n=6), and drug-induced atopic dermatitis (3.2%; n=1).
• Among patients with active PFCD (n=119), clinical remission was achieved in 73.9% (n=88) of patients and maintained in 69.7% (n=83) of patients.
• Among patients who underwent pelvic MRI examination in active PFCD cohort (n=100), deep remission was achieved by 40% (n=40) of patients with a median time to deep remission of 116.9 weeks (IQR, 68.2-151.6).
  • Deep remission was maintained among 17 patients with follow-up MRI within a median of 66 weeks (IQR, 53-106) after healing.
  • The remaining 23 patients, who did not have follow-up MRI, had no clinical recurrence during 64 weeks (IQR, 35.1-87.5) of median follow-up.
• Among patients with clinical remission (n=112), recurrence was shown by 6.3% (n=7) of patients over 94.3 weeks of median follow-up.
• A total of 12 adverse events (AEs) were reported: mild rash (n=5), allergic purpura (n=1), liver function abnormalities (n=1), lymphadenopathy (n=1), headache (n=1), dysgeusia (n=1), folliculitis (n=1), and pulmonary tuberculosis (n=1, led to temporary STELARA discontinuation), which stabilized after temporary STELARA discontinuation.

Ayoub et al (2025)⁵ conducted a multicenter cohort study to compare the effectiveness of STELARA, infliximab, adalimumab, and vedolizumab in biologic-naïve patients with perianal CD using data from the TriNetX United States (US) collaborative network.

• Cox proportional hazard models estimated hazard ratios (HR) for 1-year post-treatment composite outcomes (corticosteroid, antibiotic use; hospitalizations; emergency room visits; perianal surgeries).
• STELARA compared with vedolizumab was associated with a lower risk of the composite outcome (HR, 0.85; P<0.001) and reduced corticosteroid use (HR, 0.81; P<0.001). Adalimumab compared with STELARA showed lower risk of the composite outcome (HR, 0.92; P<0.001), reduced corticosteroid use (HR, 0.87; P<0.001), and lower rates of perianal surgeries.
• Infliximab compared with STELARA showed higher risk of the composite outcome (HR, 1.16; P<0.001) and increased corticosteroid use (HR, 1.24; P<0.001).

Casanova et al (2024)⁶ conducted a retrospective, multicenter, noninterventional study to evaluate the effectiveness, and safety of STELARA and vedolizumab in the treatment of active complex perianal fistula (CPF) in patients with CD (the HEAL Study). Results specific to patients treated with STELARA are reported below.

Study Design/Methods

• Clinical remission of CPF was defined as no drainage through the fistula upon gentle pressure (per the Fistula Drainage Assessment Index) per the physician’s appreciation.
• Clinical response of CPF was defined as a reduction from baseline of ≥50% in the number of draining tracts after initiating STELARA or vedolizumab therapy (per physician’s criteria).
• Clinical relapse of CPF was defined as the appearance of drainage through fistulas that were previously in remission (per Fistula Drainage Assessment). The initiation of concomitant therapy or modification of adjuvant therapy for fistulas to maintain remission was also considered relapse.
• Radiological remission was defined based on pelvic magnetic resonance imaging (MRI) as an absence of activity in perianal fistulous tracts and as an absence of local complications (per the radiologist’s judgement).
• Combined remission was defined as closure of all external openings that were draining at baseline (per Fistula Drainage Assessment) and radiological remission of perianal fistulas confirmed during MRI (per the radiologist’s judgement).

Results

• Among 155 patients with CD, 136 received STELARA; the median age at inclusion was 45 years (IQR, 35-54 years), and the median follow-up duration was 27 months (IQR, 15-38 months).
• After the median follow-up period, 24 (18%) patients were discontinued from STELARA. The incidence rate of STELARA discontinuation was 8% per patient-year (PY; 95% CI, 5-11). The cumulative incidence of STELARA discontinuation was 11% (at the 1-year follow-up) and 18% (at the 2-year follow-up). The primary reason for STELARA discontinuation was primary nonresponse (46%, N=11).
• By week 24, clinical remission and clinical response of CPF were achieved in 36% (95% CI, 27-45) and 65% (95% CI, 55-73) of patients, respectively.
• Overall, 74 patients (54%; 95% CI, 46-64) achieved clinical remission of CPF during follow-up; the median time to achieve clinical remission was 6 months (IQR, 4-9).
  • Among these, 20/74 (27%) patients experienced a relapse during follow-up after a median of 27 months (IQR, 16-38 months).
  • The incidence rate of CPF relapse was 11% per PY (95% CI, 7-17). The cumulative incidence of CPF relapse was 10% (at the 1-year follow-up) and 25% (at the 2-year follow-up).
• Among 20 patients who experienced a relapse, 8 had STELARA dose escalation. Of these, 3 patients regained clinical remission and 5 patients showed a clinical response.
• At the final follow-up visit, 61 (45%) patients maintained clinical remission.
• Pelvic MRI data were available for 30/74 patients in clinical remission, with 9 (30%) achieving combined remission (clinical and radiological) and 15 achieving a radiological response.
• A total of 17 (13%) patients reported 23 AEs, with 6% of the overall study population experiencing AEs (as per physician’s criteria) related to STELARA.
• Infections were the most common AEs, but none resulted in STELARA discontinuation. One patient had mantle cell lymphoma, which was related to STELARA as per physician’s criteria. AEs are reported in Table: STELARA-Related AEs.

Yao et al (2023)⁷ conducted a retrospective cohort study to evaluate the short-term efficacy of STELARA in patients with PFCD.

Study Design/Methods

• Crohn’s Disease Activity Index (CDAI), perianal CDAI, and Crohn’s anal fistula quality of life (CAF-QoL) were assessed at baseline and at week 16/20.
• Outcomes assessed were as follows:
  • Intestinal clinical remission (CDAI score of <150) and response (reduction of >70 points in CDAI score and/or CDAI score of <150).
  • Fistula clinical remission (absence of any draining fistula) and response (>50% reduction in the number of draining fistulas based on the fistula drainage assessment index).
  • Endoscopic remission (Rutgeerts score ≤i1 or a simple endoscopic score for Crohn’s disease [SES-CD] of ≤2) and response (reduction of 1 grade from baseline in Rutgeerts score or a >50% reduction in SES-CD).
  • C-reactive protein (CRP) normalization (CRP level of <4 mg/L).
  • Radiological fistula healing (the absence of a high-signal track on fat saturated T2 sequences).
    • Improvement was defined as a reduction in the number and volume of fistula and >10% reduction in the MRI signal.
    • No change was defined as the same number of fistulas and volume of inflammation vs baseline.
    • Deterioration was defined as an increase in the size and number of fistula tracks.

Results

• A total of 108 patients were included in the study.
• At week 16/20, intestinal clinical remission and response were achieved in 65.7% and 71.3% of patients, respectively.
• Fistula clinical remission and response were achieved in 40.7% and 63.0% of patients, respectively.
  • Fistula clinical remission/response was achieved in 80.3% vs 43.2% of patients who achieved intestinal clinical remission vs those who did not.
• Among patients who underwent endoscopic re-examination (n=99), endoscopic remission and response were achieved in 31.5% and 45.4% of patients, respectively.
• CRP normalization was achieved in 55.6% of patients.
• Among patients who underwent MRI re-examination (n=67), radiological outcomes of healing, partial response, no change, and deterioration were achieved in 44.8%, 31.4%, 13.4%, and 10.4% of patients, respectively.
• The amelioration in fistula radiological outcomes was confirmed by the significant reduction in the VAI from 9 (IQR, 7.0-14.0) at baseline to 5.5 (IQR, 0.0-10.0) after STELARA treatment (P<0.001).
• Rate of intestinal clinical remission was significantly higher in patients who were anti-tumor necrosis factor (TNF) naïve vs those who were anti-TNF exposed (78.9% vs 58.6%; P=0.033). There was no significant difference in intestinal clinical response and fistula, endoscopic, and radiological evaluations in anti-TNF naïve vs anti-TNF exposed patients.

Fumery et al (2021)⁸ conducted a retrospective, multicenter study to evaluate the effectiveness and safety of DI of STELARA from 90 mg every 8 weeks (q8w) to every 4 weeks (q4w) in patients with CD who had incomplete or loss of response to STELARA.

• Of the 100 patients included in the study, 47 had perianal CD at baseline.
• Sixteen patients underwent DI with STELARA for perianal disease and 7 for both perianal and luminal CD.
  • Among these patients, 14 (61%) showed an immediate response according to physician judgement, 5 (22%) had closure of perianal fistula at the end of follow-up, and 4 experienced worsening perianal CD requiring perianal surgery during follow-up.

Kamperidis et al (2021)⁹ conducted a retrospective, observational, multicenter study to evaluate the effect of STELARA in patients with moderate to severe CD.

• Of the 134 patients included in the study, 49 (36.6%) had perianal disease and 19 (14.2%) had perianal fistulating disease.
• According to the univariate analysis conducted at the last follow up, 4 (20%) patients who discontinued STELARA and 16 (80%) patients who continued STELARA required dose escalation.
• Data on the outcomes were available in 16 of 19 patients with perianal fistulating disease.
  • Thirteen patients had no evidence of fistula response (improvement or closure of fistula on examination, removal of seton or radiological improvement on pelvic MRI) and 3 demonstrated a response on examination or imaging.

Plevris et al (2021)¹⁰ conducted a retrospective, multicenter, cohort analysis study to evaluate the real-world efficacy and safety of STELARA in patients with CD.

Study Design/Methods

• Of the 216 patients included in the study, 37 (17.1%) had active perianal disease (defined by MRI) at STELARA initiation.
• Perianal response was determined by reduction in enhancement, closure, or fibrosis of tract as observed on follow-up MRI vs baseline MRI.

Results

• Among patients with active perianal disease, the cumulative perianal fistula response rate was 12.5% at 6 months and 53.1% at 12 months.
• Surgical procedures for perianal disease were performed in 13 patients, including fistulotomy in 1 patient and examination under anesthesia with drainage of the abscess and seton insertion in 12 patients.
• The HR for primary loss of response by univariable analyses for patients with perianal disease was 0.37 (95% CI, 0.09-1.60; P=0.18).
• A patient >60 years old, with a history of complex CD with multiple operations for severe penetrating and perianal disease, died while receiving STELARA. The patient received 2 doses of STELARA as a last attempt to control disease as he was not a further surgical candidate. Following the first SC dose of STELARA, he developed intra-abdominal/perianal sepsis, which did not respond to therapy.

Chapuis-Biron et al (2020)¹¹ conducted a retrospective, multicenter, observational study (BioLAP) in centers affiliated with Groupe d’Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the effectiveness of STELARA and identify the predictors of successful treatment (clinical success assessed by the investigator at 6 months of therapy and no medical/surgical intervention on perianal disease) in patients with perianal CD.

• Of the 207 patients included in the study, 148 and 59 had active and inactive perianal disease, respectively, at STELARA initiation.
• Treatment success was achieved in 57 (38.5%) patients with active perianal disease.
• In patients with inactive perianal CD at initiation, 13/59 patients had recurrence of perianal disease, 12/13 had secondary lesions, and 8/59 required perianal disease treatment while on STELARA.
• Treatment-related AE was observed in 2/56 patients which required drug discontinuation, and 1 malignancy was reported.

Ma et al (2017)¹² conducted a retrospective, multicenter, observational cohort study to evaluate the clinical, endoscopic, and radiographic responses and remission outcomes in patients with refractory CD who were receiving STELARA.

• Of the 167 patients included in the study, 45 (26.9%) had perianal disease at STELARA initiation.
• Among the patients with perianal disease, 14 (31.1%) achieved complete healing, as demonstrated by pelvic MRI or dedicated pelvic contrast-enhanced ultrasound.

Khorrami et al (2016)¹³ conducted a retrospective, observational, open-label study to evaluate the effectiveness and safety of STELARA in patients with refractory CD.

• Of the 116 patients included in the study, 58 (50%) had perianal disease, and 18 had active perianal disease at STELARA initiation.
• Perianal disease improved (based on physician judgment) in 11 of 18 (61%) patients with perianal fistulas.
• New perianal abscesses were reported in 2 patients during the treatment with STELARA.
• In the univariate analysis, perianal disease was not considered to be a predictive factor for the initial (OR, 1.98; 95% CI, 0.72-5.46; P=0.18) or long-term (OR, 1.77; 95% CI, 0.84-3.74; P=0.13) response with STELARA.

Registries

Barreiro-de Acosta et al (2023)¹⁴ conducted a retrospective study to evaluate the effectiveness of biologic agents, including STELARA, in patients with CD complicated with internal fistulizing disease, from the Estudio Nacional en Enfermedad Inflamatoria intestinal sobre Determinantes genéticos y Ambientales (ENEIDA) registry. Summarized below are data pertinent to STELARA.

Study Design/Methods

• The primary endpoint was surgical procedures performed for intra-abdominal penetrating complications during follow-up.
• Secondary outcomes included the development of a new abdominal abscess, need for percutaneous drainage, change in the number of fistulous tracts, and the proportion of patients with fistula healing.
• Fistula closure was defined as closure of the fistulous tract as evident on cross-sectional imaging.

Results

• Of the 760 patients included in the study, 69 were receiving STELARA.
• At baseline, among patients who received STELARA, the median number of fistulas was 1 (IQR, 1-3).
• For outcomes observed during follow-up in each treatment group, see Table: Primary and Secondary Outcomes in Each Treatment Group.

• The cumulative probability of remaining free of surgery at 1, 3, and 5 years of follow-up, respectively, was 81%, 72%, and 67% for anti-TNF agents; 82%, 70%, and 70% for STELARA; and 73%, 64%, and 64% for vedolizumab.
• There were no differences in the risk of surgery between the adalimumab, infliximab, STELARA, and vedolizumab groups at a median duration of 13, 7, 5, and 6 months, respectively, over time (HR, 1.06; 95% CI, 0.43-2.61; P=0.89 for STELARA; HR, 1.13; 95% CI, 0.14-9.29; P=0.91 for vedolizumab).
• Among the patients treated with STELARA, there were no factors associated with a risk of surgery.
• The median duration of drug persistence for anti-TNF agents, STELARA, and vedolizumab was 15 months (IQR, 4-36), 3 months (IQR, 2.5-6.3; HR, 1.83; 95% CI, 1.07-3.13; P=0.03), and 11.5 months (IQR, 2-27; HR, 1.99; 95% CI, 0.82-4.83; P=0.13), respectively.
• Patients in the anti-TNF group required subsequent therapy with another anti-TNF agent (80%), STELARA (15%), or vedolizumab (5%) following drug withdrawal. All patients in the STELARA and vedolizumab groups requiring subsequent therapies received anti-TNF agents.
• No AEs were reported with STELARA treatment.

Straatmijer et al (2021)¹⁵ conducted a prospective study of patients enrolled in the Initiative on Crohn and Colitis (ICC) registry to evaluate the 2-year effectiveness and safety of STELARA in patients with CD.

Study Design/Methods

• Of the 252 patients included in the study, 33 (13.1%) had perianal disease and 29 (11.5%) had ≥1 active fistulas.

Results

• Eighteen (62.1%) patients had spontaneous drainage of fistulas, and 11 (37.9%) patients had fistula drainage after gentle manual pressure.
• Fistula remission was observed in 5 (17.2%), 11 (37.9%), 11 (37.9%), and 6 (20.7%) patients after 12, 24, 52, and 104 weeks of treatment, respectively.
• Six of these patients underwent perianal surgery during follow-up. In 2 of these patients, surgery occurred after 52 weeks while in clinical remission.
• Seven patients developed new perianal fistulas during follow-up, of whom 5 developed fistulas within 24 weeks of treatment initiation.
• Five of these patients achieved fistula remission within 2 years of follow-up and 1 patient developed perianal fistula after 52 weeks of therapy while in steroid-free remission.
• Four patients had perianal abscesses at baseline which were absent at week 12.

Iborra et al (2020)¹⁶ conducted a retrospective, multicenter study to evaluate the long-term effectiveness of STELARA in patients with refractory CD from the ENEIDA registry.

• Of the 407 patients included in the study, 126 (31%) had perianal involvement.
• A total of 33 (8%) patients experienced exacerbation of perianal disease (25 with a history of perianal disease and 8 with de novo disease).
  • Treatment was discontinued in 15 patients, and 3 patients underwent perianal surgery during follow-up.
• During the 1-year follow-up, 53 patients required surgery, 3 due to perianal disease.

Noa et al (2018)¹⁷ described the rates of perianal improvement in patients who received STELARA. Patients with perianal fistulas at STELARA initiation were evaluated for improvement at the 6-month follow-up based on standard clinical assessment (cessation of drainage and no abscess).

• Of the 74 patients included in the study, 29 (39%) had perianal disease.
• Overall, 10 of 16 (62.5%) patients with active perianal fistulas at baseline showed improvement by the 6-month follow-up.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 23 October 2025.

Summarized in this response are data from prospective studies, registry-based studies, and retrospective studies with >100 patients.