SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• A prospective, open-label, single-center, single-arm study that investigated STELARA in patients with active new-onset or relapsing giant cell arteritis (GCA) is summarized below.¹
• A prospective, 52-week study that evaluated the efficacy and safety of STELARA in patients with refractory GCA is summarized below.²
• A case report of a 70-year-old patient with GCA who was treated with STELARA is summarized below.³

CLINICAL DATA

Prospective Studies

Matza et al (2021)¹ conducted a prospective, open-label, single-center, single-arm study of STELARA in patients with active new-onset or relapsing GCA.

Study Design/Methods

• The study included patients ≥50 years old with either new-onset (diagnosis within
  6 weeks of baseline) or relapsing disease (diagnosis >6 weeks from baseline) who met the following GCA diagnosis requirements:
  • Current or historical presence of cranial or polymyalgia rheumatic (PMR) signs or symptoms.
  • Elevated inflammatory markers: erythrocyte sedimentation rate (ESR;
    ≥50 mm/hour) or C-reactive protein (CRP; ≥10 mg/L) within 6 weeks of baseline.
  • Temporal artery biopsy or vascular imaging studies (computed tomography angiography, magnetic resonance angiography, or positron emission tomography).
• All patients received STELARA 90 mg subcutaneous (SC) at baseline, week 4, and every 8 weeks thereafter until week 44, and underwent a 24-week prednisone taper.
• The primary endpoint was prednisone-free remission, defined as the absence of relapse through week 52, normalization of ESR (<40 mm/hour) and CRP (<10 mg/L), and adherence to the protocol prednisone taper.
• Relapse was defined as the recurrence of GCA signs or symptoms requiring treatment intensification, regardless of the ESR and CRP levels.

Results

Patient Characteristics

• The study enrolled 13 patients, and enrollment was closed prematurely after 7 of the initial 10 patients relapsed.
• Mean age ± standard deviation (SD) was 71±7 years, 11 patients (85%) were female,
  5 patients (39%) had new-onset disease, 13 patients (100%) had cranial signs or symptoms, and 8 patients (62%) had PMR symptoms.
• Mean ± SD ESR and CRP were 41±16 mm/hour and 50±39 mg/L, respectively.

Efficacy

• All patients entered disease remission within 4 weeks of baseline.
• A total of 3 patients (23%) achieved the primary endpoint.
• Of the 10 patients (77%) who did not achieve the primary endpoint:
  • A total of 7 patients relapsed after a mean ± SD period of 23±7 weeks and
    4±1 STELARA injections.
    • Of these 7 patients, 6 patients relapsed after weaning off prednisone or when prednisone dose was <5 mg, and 1 patient relapsed on a dose of 9 mg/day.
    • At the time of relapse, 3 patients (43%) had cranial signs or symptoms,
      7 patients (100%) had PMR symptoms, mean ± SD ESR was 49±26 mm/hour, and mean ± SD CRP was 40±34 mg/L.
  • The remaining 3 patients did not have signs or symptoms of relapse but had elevated ESR and CRP at week 52.

Safety

• A total of 51 adverse events (AEs) occurred in 13 patients, and 12 patients (92%) reported at least 1 AE.
• A serious AE (mild diverticulitis requiring hospitalization) occurred at week 20 in a patient who had received 4 STELARA injections and was also taking prednisone.

Conway et al (2018)² conducted a prospective, 52-week study to evaluate the efficacy and safety of STELARA in patients with refractory GCA.

Study Design/Methods

• All patients had a diagnosis of refractory GCA, defined as experiencing a recurrence of active GCA symptoms when tapering glucocorticoids after an initial treatment response to high-dose glucocorticoids.
• STELARA 90 mg was administered SC at week 0, 4, and every 12 weeks thereafter, with a minimum follow-up period of 52 weeks.
• The primary outcome was the comparison of the median glucocorticoid dose to control disease before starting STELARA and at week 52.
• Relapse was defined as occurrence of active GCA symptoms, regardless of acute phase reactant (ESR, CRP) levels in a patient previously in remission.

Results

Patient Characteristics

• A total of 25 patients with GCA received STELARA and completed 52 weeks of
  follow–up.
• Mean ± SD age was 70±7.3 years, 20 patients (80%) were female, and 21 patients (84%) met American College of Rheumatology (ACR) criteria.
• At baseline, 5 patients (20%) had cranial-ischemic complications, median Vasculitis Damage Index was 1 (interquartile range [IQR], 0-2), median disease duration was
  29 months (IQR, 11.5-36.5 months), and patients had a median of 2 relapses (IQR,
  1-3 relapses).
• All patients had failed glucocorticoid monotherapy, and 17 patients (68%) had failed second-line immunosuppressive agents.

Efficacy

• Median daily prednisolone dose decreased significantly from baseline (15 mg; IQR,
  5-20 mg) to week 24 (7 mg; IQR, 3.5-9.5; P<0.001) and week 52 (5 mg; IQR,
  2.5-5.0 mg; P<0.001).
• Outcome measures at baseline and week 24 and week 52 after starting STELARA treatment are summarized in Table: Efficacy Measures at Baseline, Week 24, and Week 52 After STELARA Treatment.

• No patient experienced a relapse of GCA while receiving STELARA at week 24 and week 52.
• The STELARA dosing interval was reduced to every 8 weeks in 6 patients due to elevated acute phase reactants and persistent constitutional symptoms. Prednisolone was not increased in these cases.
  • Of these 6 patients, 4 patients had resolution of symptoms and normalization of acute phase reactants (attributed to persistent GCA disease activity), and 2 patients had no response to reduced dosing interval (attributed to end-stage renal disease, spondyloarthritis).
• Among the patients who remained in remission after discontinuing prednisolone,
  3 patients had a dose reduction of STELARA to 45 mg every 12 weeks due to clinical response, which was maintained in all 3 patients after dose reduction.
• STELARA treatment was stopped in 1 patient due to long-term remission; this patient remained in medication-free remission after 52 weeks of follow-up.

Safety

• A total of 8 AEs occurred in 8 patients (respiratory tract infection, n=2; urinary tract infection, n=1; cervical lymphadenopathy, n=1; dental abscess, n=1; alopecia, n=1; non-dermatomal limb paresthesia, n=1; and cold extremities, n=1).
  • STELARA was discontinued in 3 patients due to AEs (recurrent respiratory infections, alopecia, and non-dermatomal limb paresthesia).
• All AEs resolved after stopping STELARA.

Case Report

Samson et al (2018)³ reported a case of a 70-year-old patient with GCA who was treated with STELARA.

• After receiving the diagnosis of GCA for 3 years, the patient started azathioprine
  (100 mg/day) due to corticosteroid dependence, but then stopped.
• After stopping azathioprine, a relapse occurred, which resulted in weakness, aortitis, and a CRP level of 60 mg/L. Methotrexate was started in addition to prednisone.
• After 18 months, GCA remained active (weakness, headache, and CRP level of
  20 mg/L) despite receiving 20 mg/week of methotrexate and 10 mg/day of prednisone.
• STELARA 45 mg was administered at week 0, 4, and every 12 weeks thereafter in addition to prednisone (10 mg/day).
• After 4 months of treatment, prednisone was decreased to 8 mg/day, and it was reported that the patient was free of GCA symptoms with a CRP level of 12 mg/L.
• Blood samples were obtained before and after 16 weeks of STELARA treatment.
  • After 3 injections of STELARA, the proportion of both T helper 1 (Th1) and T helper 17 (Th17) cells decreased by 50% (Th1: from 2.15% to 1.18% of total CD4+ cells; Th17: from 0.38% to 0.18% of total CD4+ cells).
  • The percentage of circulating cytotoxic T lymphocytes also decreased from 32.3% to 11.4% of total CD3+ CD8+ T cells, and regulatory T cells increased from 0.47% to 2.54% of total CD4+ T cells.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) was conducted on 02 December 2025.