For pediatric patients 2 years of age and older with non-infectious (NI) intermediate, posterior, or panuveitis

Disease control in pediatric patients 2 years of age and older with NI uveitis1,*

*Non-infectious (NI) intermediate, posterior, or panuveitis.

SYCAMORE

Pediatric patients 2 years of age or older with JIA-associated NI uveitis2,†

SYCAMORE study design intro: Multicenter, double-masked, randomized, placebo-controlled trial of pediatric patients 2 years of age or older with active JIA-associated non-infectious uveitis. 90 patients were randomized to receive placebo + MTX (n=30) or HUMIRA SC EOW (20 mg if <30 kg or 40 mg if ≥30 kg) + MTX (n=60). The primary endpoint was time to treatment failure.1,2,‡

SYCAMORE criteria for treatment failure

†HUMIRA is not indicated for anterior uveitis.
‡Treatment failure was a composite measure defined by worsening or sustained non-improvement in ocular inflammation, and/or worsening of ocular co-morbidities (reduction in vision, raised intraocular pressure, hypotony, disc swelling, or Cystoid Macular Edema).2

EOW=every other week; JIA=juvenile idiopathic arthritis; MTX=methotrexate; SC=subcutaneous; SUN=Standardization of Uveitis Nomenclature

EFFICACY

Disease control: time to treatment failure within 18 months1,2

Non-infectious (NI) uveitis disease control graph depicting the probability of treatment failure within 18 months.
  • HUMIRA + MTX (n=60)
  • Placebo + MTX (n=30)
SYCAMORE study design & baseline characteristics

HUMIRA + MTX prolonged time to treatment failure vs MTX alone.1

  • Median time to treatment failure not estimable for HUMIRA + MTX vs 24.1 weeks for MTX alone (95% CI, 12.4‑81.0).
  • Less than half of at‑risk patients treated with HUMIRA + MTX experienced a treatment failure.


Topical steroid-sparing efficacy: HUMIRA + MTX helped reduce the use of topical corticosteroids.1,2

  • Corticosteroids were permitted at study entry followed by a mandatory reduction in topical corticosteroids within 3 months.

CI=confidence interval; MTX=methotrexate

Safety data

The safety profile of HUMIRA for patients with NI* uveitis was similar to that in patients with rheumatoid arthritis.1

  • The most common adverse reactions in HUMIRA clinical trials (>10%) were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.1
  • There is a known association between intermediate uveitis and central demyelinating disorders.1

*Non-infectious (NI) intermediate, posterior, or panuveitis.

Serious adverse events (AEs) according to trial group2

Serious AEs

HUMIRA Group
(N=60)

Placebo Group
(N=30)

All Patients
(N=90)

 

No. of
events

No. of
patients (%)

No. of
events

No. of
patients (%)

No. of
events

No. of
patients (%)

Any serious AEs

17

13 (22)

3

2 (7)

20

15 (17)

Eye disordera

1

1 (2)

3

2 (7)

4

3 (3)

Gastrointestinal disorder

2

2 (3)

0

0

2

2 (2)

Infection or infestation

10

8 (13)

0

0

10

8 (9)

Nervous system disorder

1

1 (2)

0

0

1

1 (1)

Respiratory, thoracic, or mediastinal disorder

1

1 (2)

0

0

1

1 (1)

Surgical or medical procedure

2

2 (3)

0

0

2

2 (2)

aOne event in the HUMIRA group and two events in the placebo group were a flare of uveitis that resulted in hospitalization and treatment. One event in the placebo group was worsening of vision with a flare of uveitis and macular edema.

Adverse Events in SYCAMORE, According to Trial Group2

The most common adverse events in the HUMIRA group were minor infections, respiratory disorders, and gastrointestinal disorders. The rate of adverse events per patient-year was higher in the HUMIRA group than in the placebo group (10.07 vs 6.51 events per patient‑year).