SUMMARY  

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• A post hoc analysis of the UNITI clinical trial program reported the effect of STELARA vs placebo on extraintestinal manifestations (EIMs).¹
• An ad hoc analysis of the Post-Marketing Surveillance (PMS) study reported the safety and effectiveness of STELARA in patients with Crohn’s disease (CD) with and without perianal manifestations.²
• Additional data available from prospective studies, several retrospective cohort studies, and a registry are described below.^3-17
• An ongoing prospective study evaluates the real-world effectiveness of STELARA in patients with CD or ulcerative colitis (UC) with EIMs or immune-mediated inflammatory diseases (TENOR study). Additional details regarding the trial are available at clinicaltrials.gov: NCT03606499.¹⁸

CLINICAL DATA

UNITI Clinical Trial Program

Narula et al (2021)¹ conducted a post hoc analysis of the UNITI clinical trial program to assess the efficacy of STELARA for the treatment of EIMs in CD.

Study Design/Methods

• Data was obtained from the Yale Open Data Access (YODA) Project which included adult patients with moderately to severely active CD from the UNITI-1, UNITI-2 and IM-UNITI clinical trials.
  • Patients were randomized in a 1:1:1 ratio to receive a single intravenous (IV) dose of STELARA 130 mg, STELARA 6 mg/kg, or placebo.
  • At week 8, patients who responded to STELARA IV in UNITI 1 and 2 were eligible to participate in IM-UNITI and were randomized in a 1:1:1 ratio to receive subcutaneous (SC) STELARA 90 mg every 8 weeks (q8w), STELARA 90 mg every 12 weeks (q12w), or placebo.
• The Crohn’s Disease Activity Index (CDAI) was used to measure activity of CD. The CDAI captures the presence or absence of EIMs including anal fissures, fistulas, abscesses; aphthous stomatitis (AS); arthritis or arthralgia; erythema nodosum (EN); fever (temperature >100°) during the previous 7 days; iritis or uveitis; primary sclerosing cholangitis (PSC); and pyoderma gangrenosum (PG).
• CDAI was assessed at baseline, week 6 after induction, and week 52 after maintenance therapy.
• Presence of EIMs was evaluated based on individual components of the CDAI being reported as present or absent.
• Since anal disease such as fistula and abscesses are penetrating complications of CD and fever and AS are not conventionally considered to be EIMs, these were excluded from this analysis. Additionally, PSC was also excluded since it is not known to be responsive to any inflammatory bowel disease (IBD) treatments.
• Prevalence was defined as the presence of an EIM of interest at the respective visit and resolution was defined as the absence of an EIM that was previously present. The return or development of a new EIM at week 6 or week 52 that was not present at baseline was defined as de novo.
• The primary outcome was overall EIM resolution between STELARA-and placebo-treated patients at week 6.
• Secondary outcomes included overall EIM resolution between STELARA- and placebotreated patients at week 52, resolution of individual EIMs, and de novo EIM development at weeks 6 and 52.
• Patients who were re-randomized (received STELARA for induction and placebo for maintenance) were excluded.

Results

• A total of 504/941 (53.6%) patients treated with STELARA had EIMs at baseline. Among these 504 patients, there were 527 EIMs reported.
  • Of note, 339 (36.0%) patients had 1 EIM, 62 (6.6%) patients had 2 EIMs, 20 (2.1%) patients had 3 EIMs, and 1 (0.1%) patient had 4 EIMs.
• For baseline characteristics of EIMs, see Table: Baseline Characteristics of Patients with EIMs.

EIM Resolution at Week 6

• There was no significant improvement in EIMs among patients treated with STELARA (186/504, 36.9%) compared to placebo (90/230, 39.1%).
• Prevalence of de novo EIMs was similar among STELARA- (41/941, 4.4%) and placebo-treated patients (20/457, 4.4%).
• No significant improvements were seen for individual EIM resolution for any of arthritis/arthralgias, EN, or iritis/uveitis.
• No placebo-treated patients had PG; therefore, no comparison was performed.

EIM Resolution at Week 52

• Similar to week 6, there was no significant difference in overall EIM resolution among patients treated with STELARA (91/119, 76.4%) compared to placebo (72/90, 80%).
• De novo EIMs were reported in (3/263, 1.1%) of STELARA-treated patients and (0/133, 0%) of placebo-treated patients.
• For individual resolution, EN was significantly reduced in STELARA-treated patients (10/10) compared to placebo (0/3) (P<0.0001); there were no significant differences in resolution of arthritis/arthralgias or iritis/uveitis.

Overall Impact of STELARA on EIMs Compared to Baseline

• Of the 527 EIMs at baseline of UNITI-1 and UNITI-2, 186 resolved at week 6 (P<0.0001). Of the 147 EIMs at IM-UNITI baseline, 106 resolved at week 52 (P<0.0001).
• For individual EIM resolution at weeks 6 and 52, see Tables: EIM Outcomes of STELARATreated Patients at Week 6 and EIM Outcomes of STELARA-Treated Patients at Week 52.

• Subgroup analyses were conducted to evaluate the 309 patients receiving an induction dose of STELARA 130 mg IV and the 316 patients receiving an induction dose of STELARA 6 mg/kg IV. There was no difference in EIM resolutions at week 6 for both induction regimens. Similar EIM resolution was seen in both maintenance regimens (STELARA 90 mg SC q8w or q12w).

Ad Hoc Analysis

Nagano et al (2024)² conducted an ad hoc analysis of the PMS study to assess the safety and effectiveness of STELARA through 1 year among CD patients with and without perianal manifestations.

Study Design/Methods

• Data was obtained from a prospective, observational and multicenter PMS conducted in Japan between May 2017 and December 2021.
• Patients with moderate-to-severe active CD who failed or were intolerant to previous treatments were included in the PMS.
  • Patients received an initial weight based IV infusion of STELARA (~6 mg/kg) followed by 90 mg SC at week 8 and then 90 mg q8w or q12w.
• The ad hoc analysis included patients with CD who had an evaluation of perianal manifestations at baseline (anal fissure, fistula or perianal abscess).
• Effectiveness of STELARA was evaluated from baseline to week 52 in patients with or without perianal manifestations by:
  • Clinical remission (CDAI<150)
  • Prevalence of perianal manifestations

Results

• In the efficacy analysis set (full analysis set), CDAI scores were recorded for 197 patients:
  • With perianal manifestations (n=60)
  • Without perianal manifestations (n=137)
• There were 52/229 (22.7%) patients with reported EIMs and 200/229 (87.3%) patients with CDAI scores at baseline.

Effectiveness Findings

Clinical Remission

• Clinical remission rates were similar between patients with and without perianal manifestations: (95% CI, 68.3% [55.0-79.7]; n=60 and 95% CI, 59.9% [51.1%-68.1%]; n=137, respectively; P=0.269).

AP and GWB

• In patients with and without perianal manifestations, no significant difference was observed from baseline to week 52:
  • AP score:
    • With perianal manifestations: baseline (4.10 [3.1-5.1]; n=60); week 52 (1.98 [1.0-2.9]; n=48)
    • Without perianal manifestations: baseline (4.41 [3.5-5.3]; n=137); week 52 (2.15 [1.4-2.9]; n=103)
  • GWB score:
    • With perianal manifestations: baseline (7.03 [5.8-8.3]; n=60); week 52 (2.81 [1.6-4.0]; n=48)
    • Without perianal manifestations: baseline (6.87 [5.8-7.9]; n=137); week 52 (3.17 [2.4-4.0]; n=103)

Prevalence of Perianal Manifestations

• Of the 60 patients with perianal manifestations at baseline, 43 were biologic experienced while 17 were biologic-naive.
  • The proportion of patients with perianal manifestations decreased at week 52 after STELARA treatment in both subgroups,
    • Biologic-naive patients: 23.5% (4/17), biologic-experienced: 35% (14/40)
• In the entire set, the perianal manifestations rate at week 52 was 12.4% (23/186).
• The reduction in perianal manifestations rate from baseline to week 52 was similar between the following subpopulations:
  • Subpopulation with CDAI scores ≥150: 31.7% (13/41)
  • Subpopulation with CDAI scores <150 (in clinical remission): 31.3% (5/16)

Safety Findings

• At week 52, the incidence rates of ADRs and SADRs were as follows:
  • In patients with perianal manifestations: 9.1% and 4.5%
  • In patients without perianal manifestations: 15.3% and 9.8%
• The overall incidence of ADRs was highest for worsening of CD (2.6%, 6/229) followed by pyrexia (1.7%, 4/229), anal abscess (1.3%, 3/229), and upper respiratory tract inflammation (1.3%, 3/229) while the most frequently reported SADR was worsening of CD (2.6%, 6/229).

Prospective Study

Gonzalez Diaz et al (2024)³ conducted a prospective study at a single tertiary center to assess the incidence of previous spondyloarthritis (SpA) flare ups and the onset of undiagnosed SpA in patients with IBD undergoing treatment with STELARA or vedolizumab.

• The study included adult patients with IBD undergoing treatment with STELARA or vedolizumab.
• Clinical activity was assessed at baseline and 6 months using the Harvey-Bradshaw index (HBI) for CD and partial Mayo score for UC.
• During the rheumatology assessment, prior SpA or other joint involvement at the start of STELARA or vedolizumab treatment was recorded.
  • The types of SpA included ankylosing spondylitis (AS), axial non-radiographic SpA, and peripheral SpA.
  • The main symptomatic components included axial, peripheral, or enthesitis.
  • Clinical activity was assessed as either low activity or remission, defined by Axial Spondyloarthritis Disease Activity Score (ASDAS) >2.1 or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <4.
• Overall, 80 patients with IBD with history of SpA or joint symptoms were included in the study, of which 24 (30%) were treated with STELARA.
• Of the 24 patients, 12 patients each had a history of SpA and non-SpA, respectively.
• Among 12 patients with prior SpA undergoing treatment with STELARA:
  • Joint activity improved in 5 (42%) patients and remained stable in 6 (50%) patients with 1 (8%) patient reported flare-up.
• A multivariate analysis found that STELARA was associated with lower risk of SpA flare-ups (Odds ratio [OR], 0.6; standard error, 0.58; 95% CI, 0.14-2.98; P=0.57).

Lai et al (2021)⁴ conducted a prospective study to assess biologic therapy selection and efficacy in patients with IBD-associated SpA receiving STELARA, antitumor necrosis factor (TNF) therapy, vedolizumab, or tofacitinib.

• A collection of clinical and endoscopic scoring was used to assess the prevalence of axial/peripheral SpA in 1048 IBD patients (444 patients with UC, 604 patients with CD).
• Longitudinal assessment using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was performed in 27 patients (8 patients with UC, 19 patients with CD) with peripheral SpA symptoms initiating biologic therapy. BASDAI 20%, 50%, and 70% reductions were assessed after induction therapy.
• Of patients with SpA, 1.7% had axial and 18.1% had peripheral disease.
• Although a significant reduction in HBI was achieved (HBI 10.4 vs 7.5, P=0.049) in patients with CD treated with STELARA, there was no change in BASDAI (4.7 vs 4.8, P=0.92).
• A smaller proportion of STELARA-treated patients achieved a BASDAI 20/50/70 response vs anti-TNF-treated patients (36.4% vs 80.0%, P=0.044; 18.2% vs 60.0%, P=0.049, 9.1% vs 50.0%, P=0.038).

Retrospective Cohort Studies

Chaparro et al (2023)⁵ evaluated the impact of STELARA on EIMs in patients with UC through a retrospective, multicenter study (ULISES).

• Patients with UC who had received their first dose of STELARA at least 16 weeks prior to inclusion were eligible for the study.
• The evolution of EIMs and immunomediated diseases (IMIDs) were evaluated per the clinician’s judgement.
• Of the 376 patients enrolled, 122 (32%) had previous EIMs and/or IMIDs, 80 (21%) had at least one inactive EIM and/or IMID, and 65 (17%) had active EIMs and/or IMIDs at the start of STELARA treatment.
• Of the patients with inactive EIMs and/or IMIDs at initiation, 5 experienced worsening of these conditions: one with peripheral arthropathy, 2 with axial spondyloarthropathy, one with rheumatoid arthritis, and one with uveitis.
• A total of 15 patients developed EIMs and/or IMIDs after STELARA initiation, including peripheral arthropathy (n=6, 1.6%), EN (n=2, 0.5%), PSC (n=1, 0.3%), vasculitis (n=1, 0.3%), and other conditions (n=6, 1.6%).  
• For outcomes of patients with active EIMs and/or IMIDs, see Table: Active EIM and/or IMID Outcomes After STELARA Initiation.

Livne-Margolin et al (2023)⁶ compared the effectiveness of STELARA and vedolizumab for the treatment of EIMs in patients with IBD from a single center. The results specific to STELARA are described below.

• Patients with active EIM at the start of the treatment were included in the study.
• The primary outcome was clinical response at weeks 26 and 52 (defined as improvement or remission of EIM complaints per patient’s subjective description or per treating physician’s assessment).
• The secondary outcomes included steroid-free clinical response and clinical response of arthralgia at weeks 26-52.
• Overall, 53 (20%) patients treated with STELARA who had documented EIMs pre-treatment were included in this analysis.
• EIMs included arthralgia (n=50; 94%), arthritis (n=10; 20%), back pain (n=9; 17%), uveitis/iritis (n=4; 8%), PG (n=3; 5%), EN (n=2; 4%), sacroiliitis (n=2; 4%), and AS (n=1; 2%).
• Among STELARA-treated patients, 7 (13%) experienced primary treatment failure with subsequent treatment alteration.
  • Two patients underwent surgery due to an IBD exacerbation, 1 developed colorectal carcinoma, 1 died from an unrelated non-IBD cause, and 2 discontinued treatment at their own discretion.
• At weeks 26 and 52,
  • Clinical response of EIMs was achieved in 13/39 (33%) and 18/50 (36%) patients, respectively.
  • Steroid-free clinical response was achieved in 9/39 (23%) and 14/50 (28%) patients, respectively.
  • Clinical response of arthralgia was achieved in 15/37 (40%) and 18/46 (41%) of patients, respectively.
• Two patients developed arthralgia during follow-up.
  • One patient who had previously suffered from arthralgia and sacroiliitis-related complaints experienced recurrence of arthralgia in addition to back pain complaints. At follow-up, there was no improvement.
  • The other patient developed de novo arthralgia during follow-up.
• Two patients had uveitis prior to STELARA treatment, but experienced improvement after 6 weeks of treatment (1 patient experienced recurrent episodes of uveitis at the time of follow-up). Additionally, 2 patients developed uveitis despite treatment with STELARA.
• Three patients treated with STELARA had PG prior to starting therapy. Among patients with PG, 2 improved after 6 weeks and 1 improved after 14 weeks of treatment; recurrent episodes were observed in 2 patients during follow-up.
• Two patients developed EN despite treatment during follow-up.
• Two patients with sacroiliitis did not improve with treatment.

De Galan et al (2022)⁷ evaluated the effectiveness of STELARA treatment on the evolution of pre-existing and the development of new joint EIMs in patients with IBD through a retrospective, multicenter study.

• Assessments were conducted after induction (weeks 8-14), at 6 months, 1 year, and 2 years. A minimal follow-up duration of 8-14 weeks was required unless treatment was stopped earlier due to complications or non-responsiveness to treatment.
• A worsening of joint EIMs was defined as an increase in the frequency or intensity already reported at the start of STELARA.
• Other joint symptoms, without confirmed inflammation, were classified as arthralgia.
• Overall, 911 patients with IBD were included in the study, of whom 327 were treated with STELARA.
• Baseline joint EIMs in patients treated with STELARA included arthropathy (n=40; 12.2%) and arthralgia (n=30; 9.2%).
• For the impact of STELARA on EIMs, see Table: Evolution of Pre-existing and New-onset EIMs During STELARA Treatment at 6-Month, 12-Month, 24-Month and 2-year follow-up.
• Two (0.61%) patients treated with STELARA discontinued treatment due to arthropathy.

Aboubakr et al (2021)⁸ assessed the efficacy of STELARA for management of EIMs in patients with CD.

• Data were extracted from patients with active or prior EIM at the time of induction. EIMs were categorized as rheumatologic (eg, peripheral or axial arthritis/arthralgias), cutaneous (eg, EN, pyoderma, oral aphthae), or ocular (eg, uveitis).
• The primary outcome was complete resolution of active EIMs.
• Secondary outcomes included improvements in active EIMs, recurrence of inactive EIMs, and relation of EIMs to endoscopic/clinical response.
• For data regarding the resolution of EIMs, see Table: EIM and Resolutions with STELARA.

• A multivariate analysis found that corticosteroid use was associated with lower EIM response (OR: -0.02 to 0.98, P=0.047).

Tursi et al (2021)⁹ reviewed patients with refractory CD to biologic therapy treated with STELARA for CD EIMs.

• All patients with at least 1 induction treatment with STELARA were included in this analysis.
• There were 24 patients identified with EIMs who were treated with STELARA: 17 patients had articular disease (9 ankylosing spondylitis, 3 rheumatoid arthritis, 5 seronegative arthritis), 4 with EN, 1 with uveitis, 1 with sclerosing cholangitis, and 1 with hidradenitis suppurativa.
• The mean follow-up time was 6 months.
• Three patients with ankylosing spondylitis and all patients with seronegative arthritis reported arthralgia at STELARA initiation.
• At the 6-month follow-up, there were no reports of arthralgia.
  • Of the 3 patients with ankylosing spondylitis, 1 patient in remission at STELARA initiation developed de novo arthralgia at 3 months of treatment.
• One patient with sclerosing cholangitis who was in remission at STELARA initiation did not have recurrence of cholangitis during follow-up.
• Patients with EN, uveitis, and hidradenitis suppurativa had active disease at STELARA initiation and were reported to be in remission.
• Two patients developed arthritis during treatment (sacro-ileitis and psoriatic arthritis [PsA]) and were treated with anti-TNF therapy plus vedolizumab. STELARA treatment was not discontinued, and remission was reported in both cases during follow-up.

Bennett et al (2020)¹⁰ assessed the safety and efficacy of STELARA in patients with CD, including the efficacy of STELARA for the treatment of EIMs from a single center.

• There were 96 patients with refractory CD included in this study.
  • All patients failed prior anti-TNF therapy and 31 also failed prior vedolizumab therapy and 43 patients were on concurrent immunomodulator therapy.
• There were 56/96 patients with reported EIMs at baseline: 3 patients with uveitis, 3 with oral lesions, 33 with joint symptoms, and 17 had skin lesions.
• Following treatment with STELARA, 16 (29%) patients reported improvement with skin lesions and joint symptoms.
• In the subset of patients who failed prior anti-TNF therapy and vedolizumab (n=31), 17 reported EIMs prior to STELARA: 2 patients with oral lesions, 12 patients with join symptoms, and 3 patients with skin lesions.
  • Improvement in join symptoms and skin lesions was reported in 10 (59%) patients.

Macaluso et al (2020)¹¹ assessed the effectiveness of STELARA on CD-associated SpA in a cohort of patients in the Sicilian network for Inflammatory Bowel Diseases (SN-IBD).

• Of the 131 patients treated with STELARA, 30 (22.9%) patients had active SpA at baseline: (axial disease: 3 patients, peripheral disease: 18 patients, axial and peripheral disease: 9 patients). All patients had failed at least one biologic prior to initiating STELARA.
• The primary outcome was articular response, defined as the disappearance of objective signs of arthritis (swelling and/or articular stiffness) and resolution of pain, evaluated at weeks 8 and 24.
• After 8 weeks, 10 (33.3%) patients had articular response: (0 patients with axial disease, 7 [38.9%] patients with peripheral disease, and 3 [33.3%] patients with axial and peripheral disease).
• After 24 weeks, 13 patients (43.3%) had articular response: (0 with axial disease, 10 [55.5%] patients with peripheral disease, and 3 [33.3%] patients with axial and peripheral disease). These 13 patients included 9 patients with an initial response at week 8 in addition to 5 patients (with peripheral disease) who initially did not respond after 8 weeks. One patient lost response at 24 weeks after an initial 8-week benefit.
• Discontinuation by week 24 occurred in 2 (6.7%) patients due to lack of efficacy.
• There were 3 adverse events (AEs) reported including nonspecific sight disturbances after a single administration of STELARA which resolved after discontinuation, unexplained superficial lymphadenopathy which resolved without therapy discontinuation, and unexplained weight loss which led to STELARA withdrawal.

de Risi-Pugliese et al (2019)¹² reviewed the efficacy of STELARA in CD-associated neutrophilic dermatoses (NDs) at 9 hospitals.

• The efficacy of STELARA for CD-associated ND was assessed at week 16 using the HBI for a complete, partial (>50% reduction in symptoms) or no response.
• The reported analysis included 7 patients with active CD-associated ND. Of these 7 patients, 4 patients had PG, 2 patients had amicrobial pustulosis of the folds (APF), and 1 patient had chronic recurring Sweet syndrome.
• At the time of STELARA initiation, 4 patients had active CD and 6 of the 7 patients in this study previously received anti-TNF therapy.
• STELARA 90 mg q8w was subcutaneously administered with slight variations due to induction protocols for CD and ND treatment.
• At week 16, STELARA induced remission in 6 of the 7 cases (86%) with a complete response in 4 of the 7 cases (57%) and a partial response in 2 of the 7 cases (29%). No response occurred in the patient with refractory recurring Sweet syndrome.
• The median follow-up time was 36 months; one patient with ND eventually relapsed.
• No serious side effects were reported.

Liefferinckx et al (2019)¹³ assessed the efficacy of STELARA in patients with CD and comorbid ankylosing spondylitis.

• Data from 174 patients initiating STELARA were retrospectively analyzed at 14 medical centers.
• Of the total cohort, 17 (11.2%) patients had concomitant diagnosis of ankylosing spondylitis at baseline; 12 (70.6%) patients did not report any impact of STELARA on the intensity of their symptoms based on the visual analog scale (VAS).
• Patients with arthralgia at the time of initiation of STELARA (n=46) reported a gradual resolution in symptoms (VAS=0): 29 (63%) patients with symptoms at week 8, 21 (45.6%) patients with symptoms at week 16, and 8 (17.4%) patients with symptoms at week 52.
• Arthralgia resolution was significantly associated with clinical response at weeks 8, 16, and 52, respectively (P=0.03, 0.03, 0.04).
• No reduction in intensity was reported in patients with persistent arthralgia during follow-up based on VAS.
• De novo arthralgia developed in 16/89 (17.9%) patients at week 8, 17/89 (19.1%) patients at week 16, and 12/89 (13.5%) patients at week 52.
• One patient from the total cohort discontinued STELARA due to intense myalgia/arthralgia.

Pugliese et al (2019)¹⁴ reviewed patients with IBD who received STELARA for psoriasis or PsA at 12 centers affiliated with the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).

• A total of 70 IBD patients (64 with CD and 6 with UC) received STELARA for active psoriasis or PsA.
• Remission of psoriasis was defined by a Psoriasis Area and Severity Index (PASI) response of at least 75% from baseline. For remission of PsA, minimal disease activity (MDA) was determined.
• Clinical remission was observed in 37/45 (82.2%) patients with psoriasis and in 15/25 (60%) patients with PsA.
• No significant differences were seen in clinical remission between patients with wild psoriasis and anti-TNF agent induced forms.
• After a median of 7.4 months, 12 patients discontinued STELARA due to the lack of benefit for skin/joint disease (n=6), for the lack of benefit in IBD (n=4), and due to AEs (n=2).
• Ten AEs were reported in 9 patients, 2 of which discontinued STELARA due to intestinal obstruction and worsening of arthralgia.

Vizuete et al (2019)¹⁵ conducted a retrospective chart review in adult patients with IBD and arthropathy treated with STELARA.

• Data was collected using the MDA including joint tenderness, swollen joint count, tender points, standardized graphic pain scales (VAS, graphic rating scale [GRS]) and a global assessment score (GAS) from 0-5. At each visit, outcomes were evaluated for changes in arthritic symptoms.
• There were 15 patients (11 with CD, 4 with UC) included in the review with a mean follow-up time of 12 (range, 9-16) months.
• At the initiation of STELARA, 11/15 patients had joint tenderness on palpation with 1-3 affected joints per patient while other patients reported subjective tenderness. Visibly swollen joints occurred in 5 patients and 1 had both. The mean number of tender points was 3.
• The mean GAS was 3 (range, 2-4) and the pain GRS mean score was 4/10 (range, 2-8).
• After STELARA therapy, 14/15 patients had a drop in the GAS and the pain GRS score.
• Joint swelling and tenderness resolved in 14 patients.
• At the study’s conclusion, complete resolution of all 5 scales occurred in 6/15 patients, resolution in 3 of 5 scales occurred in 4 patients, and resolution in 2 of 5 scales occurred in 4 patients. No improvement in scales was seen in 1 patient.

Singh et al (2017)¹⁶ reported the clinical course of CD and EIM for patients treated with STELARA from a retrospective chart review analysis.

• Of the 17 patients with CD, 5/16 (31%) patients had concomitant seronegative spondyloarthropathies and 3/17 (18%) patients had dermatological manifestations prior to or at the initiation of STELARA.
• Seronegative arthritis improved in 2/5 (40%) patients and dermatologic manifestations improved in 2/3 (66%) patients.
• Infectious complications occurred in 2 patients which required hospitalization in 1 patient.

Registry Data

Straatmijer et al (2021)¹⁷ evaluated the long-term effectiveness (including effect on EIMs) and safety of STELARA in patients with CD who were enrolled in the nationwide Initiative on Crohn and Colitis [ICC], a prospective, nationwide and observational registry.

• Documented EIMs included arthralgia/arthritis, uveitis, AS, EN, and PG.
• Remission of EIMs was assessed by the treating physician.
• On October 1, 2020, 315 patients with CD were included in the ICC registry, of whom 252 completed ≥2 years of follow-up and were included in this study; the median treatment duration was 95 (interquartile range, 31-104) weeks.
• At baseline, 67 EIMs were reported in 59 patients (arthralgia, n=53; AS, n=8; uveitis, n=3; EN, n=2; PG, n=1).
  • Five patients reported both arthralgia and AS and 3 patients reported both arthralgia and uveitis.
• During follow-up, remission was achieved in 22 (32.8%) patients with arthralgia, in 1 (50%) patient with EN, and in all patients with uveitis, AS, and PG.
• When EIM remission was achieved, 23 of 35 (65.7%) patients were also in clinical remission.
• New EIMs were also reported during follow-up (arthralgia, n=39; transient AS, n=3; uveitis, n=2; EN, n=2; PG, n=1).
  • Of the 39 patients who developed arthralgia, 26 (66.7%) achieved remission before week 104.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 27 August 2024.

Summarized in this response are relevant clinical data from a post-hoc analysis of the UNITI clinical trial program, ad hoc analysis of the PMS, prospective studies, retrospective cohort studies, and a registry.