For adult patients with non-infectious (NI) intermediate, posterior, or panuveitis

Disease control in adult patients with NI uveitis1,*

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

VISUAL I &
VISUAL II

Adult patients with non-infectious (NI) intermediate, posterior, or panuveitis1-3

VISUAL I study design intro: Double-masked trial of adult patients with active non-infectious intermediate, posterior, or panuveitis. 217 patients were randomized to receive placebo (n=107) or HUMIRA 80 mg loading dose (Week 0) followed by HUMIRA 40 mg EOW starting at Week 1 after the initial dose (n=110). The primary endpoint was time to treatment failure assessed first at Week 6 and every visit thereafter.1,2,‡

VISUAL II study design intro: Double-masked trial of adult patients with inactive§ non-infectious intermediate, posterior, or panuveitis. 226 patients were randomized to receive placebo (n=111) or HUMIRA 80 mg loading dose (Week 0) followed by HUMIRA 40 mg EOW starting at Week 1 after the initial dose (n=115). The primary endpoint was time to treatment failure assessed first at Week 2 and every visit thereafter.1,3,‡

Active disease was defined as ≥1 of the following parameters in at least 1 eye despite ≥2 weeks of oral glucocorticoid use: active inflammatory chorioretinal or retinal vascular lesion, ≥2+ anterior chamber (AC) cell grade, ≥2+ vitreous haze (VH) grade.2
Treatment failure was defined as the presence of any 1 of the 4 markers of disease activity in at least 1 eye.1-3
§Inactive disease was defined as eyes with no inflammatory chorioretinal or vascular retinal lesions, anterior chamber (AC) cell grade of ≤0.5+, vitreous haze (VH) cell grade ≤0.5+.3

EOW=Every other week

EFFICACY

Time to treatment failure on or after Week 61,2,*,†

VISUAL I: Adults with active disease

Graph of adults with active disease.
  • HUMIRA (n=110)
  • Placebo (n=107)

*Mandatory steroid taper from Week 2 to Week 15.2

Treatment failure at or after Week 6 was counted as an event. Subjects who discontinued the study were censored at the time of dropping out.1


  • Differences in disease control between HUMIRA and placebo were seen as early as Week 6, the first time point measured1
  • At Month 3, the treatment failure rate for HUMIRA was nearly half the rate for placebo: 25% for HUMIRA (n=25) vs 48% for placebo (n=49)4
  • By Month 6, the treatment failure rate was 50% for HUMIRA (n=48) vs 78% for placebo (n=76)4

CI=confidence interval; EOW=every other week

Time to treatment failure on or after Week 21,3,*,†

VISUAL II: Adults with inactive disease

Graph of adults with inactive disease.
  • HUMIRA (n=115)
  • Placebo (n=111)

Hazard ratio=0.57

(95% CI, 0.39-0.84, P=0.004)

*Mandatory steroid taper from Week 2 to Week 19.3

Treatment failure at or after Week 2 was counted as an event. Subjects who discontinued the study were censored at the time of dropping out.1


  • Differences in disease control between HUMIRA and placebo were seen as early as Week 2, the first time point measured1
  • Median time to treatment failure: Not estimable for HUMIRA vs 8.3 months for placebo (95% CI, 4.8–12.0)1,3
  • HUMIRA patients had a 43% reduced risk of treatment failure vs placebo (hazard ratio=0.57 [95% CI, 0.39–0.84])1,3

CI=confidence interval; EOW=every other week

Safety data

  • The most common adverse reactions in HUMIRA clinical trials (>10%) were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash1
  • There is a known association between intermediate uveitis and central demyelinating disorders1

Summary of adverse events (AEs) during the randomized trial period (events per 100 patient-years)2,3

  VISUAL I2 VISUAL II3
Adverse Events HUMIRA
(n=111)
PYs=62.4
Placebo
(n=112)
PYs=44.3
HUMIRA
(n=115)
PYs=94.5
Placebo
(n=114)
PYs=71.0
Serious adverse events (SAEs) 18 (28.8) 6 (13.6) 13 (13.8) 10 (14.1)
AE leading to discontinuation 13 (20.8) 5 (11.3) 11 (11.6) 7 (9.9)
Serious infections 5 (8.0) 3 (6.8) 3 (3.2) 2 (2.8)
Malignancy 2 (3.2)a 0 1 (1.1)b 0
AE leading to death 1 (1.6)c 0 2 (2.1)d 0
Any active TB 1 (1.6) 0 0 0
Any latent TB 1 (1.6) 0 3 (3.2) 1 (1.4)
Injection site reactions 28 (44.9) 7 (15.8) 36 (38.1) 16 (22.6)
Any demyelinating disease 1 (1.6) 0 0 0

The safety profile for patients with NI uveitis* treated with HUMIRA was similar to the safety profile seen in patients with RA.1

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

aOne event each of carcinoid tumor of the gastrointestinal tract (Day 244; resolved on Day 251; HUMIRA treatment was not interrupted) and glioblastoma multiforme (Day 242; HUMIRA was discontinued due to this event; last HUMIRA dose, Day 248).2
bOne event of non-serious squamous cell carcinoma of skin (Day 210; resolved on Day 215; HUMIRA treatment was not interrupted).3
cOne death due to end-stage chronic renal disease (37 days after baseline).2
dOne death due to 2 fatal AEs of aortic dissection and cardiac tamponade (18 days after last HUMIRA dose).3

PYs=patient-years; TB=tuberculosis