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.
US-MULT-230356
US-MULT-230356
For adult patients with non-infectious (NI) intermediate, posterior, or panuveitis
*Non-infectious (NI) intermediate, posterior, or panuveitis.
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
CI=confidence interval; EOW=every other week
CI=confidence interval; EOW=every other week
| 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
Uveitis (UV): HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
SERIOUS INFECTIONS
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
HYPERSENSITIVITY
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGIC REACTIONS
CONGESTIVE HEART FAILURE
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
Please see Full Prescribing Information.
US-HUM-210183
References:
The use of topical corticosteroids was allowed at study entry, but subjects using this therapy were to undergo a mandatory taper schedule, regardless of the type of agent used. Depending on the dose that the subject was on at the baseline visit, the number of drops per day had to be decreased weekly at the increments indicated above. Subjects were to start to taper beginning at Week 1. The maximum duration of concomitant topical steroid use during the study was 9 weeks.
US-HUM-210672
The use of topical corticosteroids was allowed at study entry, but subjects using this therapy were to undergo a mandatory taper schedule, regardless of the type of agent used. Depending on the dose that the subject was on at the baseline visit, the number of drops per day had to be decreased weekly at the increments indicated above. Subjects were to start to taper beginning at Week 1. The maximum duration of concomitant topical steroid use during the study was 9 weeks.
US-HUM-210672
cPrednisone was tapered from Weeks 2 to 19. Patients may have been using 1 immunosuppressive therapy and/or topical corticosteroids at predefined, stable doses. All patients using a topical corticosteroid at baseline underwent a mandatory taper schedule from Weeks 1 to 9.3
dThe study ended when the 106th treatment failure occurred.3
*Non-infectious (NI) intermediate, posterior, or panuveitis.
| Parameter | HUMIRA (n=115) |
Placebo (n=111) |
| Sex, female; n (%) | 66 (57) | 72 (65) |
| Race, white; n (%) | 96 (83) | 93 (84) |
| Age, years; mean ± SD | 42.9 ± 12.9 | 42.2 ± 14.0 |
| Type of uveitis, n (%) | ||
| Intermediate | 17 (15) | 30 (27) |
| Posterior | 39 (34) | 34 (31) |
| Panuveitis | 57 (50) | 46 (41) |
| Diagnosis, n (%) | ||
| Idiopathic uveitis | 29 (25) | 40 (36) |
| Birdshot choroidopathy | 15 (13) | 15 (14) |
| Multifold choroiditis and panuveitis | 5 (4) | 2 (2) |
| Vogt–Koyanagi–Harada disease | 26 (23) | 25 (23) |
| Sarcoidosis | 18 (16) | 14 (13) |
| Behçet’s disease | 10 (9) | 6 (5) |
| Other | 12 (10) | 9 (8) |
| Duration of uveitis, months; mean ± SD | 59.5 ± 64.5 | 62.9 ± 67.7 |
| Eye affected, n (%) | ||
| Left only | 2 (2) | 3 (3) |
| Right only | 1 (1) | 4 (4) |
| Both | 112 (97) | 104 (94) |
| Number of flares in past 12 months, n (%) | ||
| 0-1 | 48 (42) | 46 (41) |
| 2 | 43 (37) | 40 (36) |
| ≥3 | 24 (21) | 25 (23) |
| Concomitant immunomodulators, n (%) | ||
| Mycophenolate mofetil | 17 (15) | 17 (15) |
| Cyclosporine | 15 (13) | 11 (10) |
| Methotrexate | 19 (17) | 14 (13) |
| Azathioprine | 3 (3) | 11 (10) |
ITT=intent-to-treat; SD=standard deviation
US-HUM-210672
US-HUM-210672
US-HUM-210672
cPrednisone was tapered from Weeks 2 to 15. Patients may have been using 1 immunosuppressive therapy and/or topical corticosteroids at predefined, stable doses. All patients using a topical corticosteroid at baseline underwent a mandatory taper schedule from Weeks 1 to 9.2
dThe study ended when the 138th treatment failure occurred.2
*Non-infectious (NI) intermediate, posterior, or panuveitis.
| Parameter | HUMIRA (n=110) |
Placebo (n=107) |
| Sex, female; n (%) | 59 (54) | 65 (61) |
| Race, white; n (%) | 88 (80) | 86 (80) |
| Age, years; mean ± SD | 42.7 ± 15.6 | 42.6 ± 14.2 |
| Type of uveitis, n (%) | ||
| Intermediate | 24 (22) | 23 (21) |
| Posterior | 36 (33) | 37 (35) |
| Panuveitis | 50 (45) | 47 (44) |
| Diagnosis, n (%) | ||
| Idiopathic uveitis | 36 (33) | 45 (42) |
| Birdshot choroidopathy | 24 (22) | 20 (19) |
| Multifold choroiditis and panuveitis | 8 (7) | 3 (3) |
| Vogt–Koyanagi–Harada disease | 11 (10) | 14 (13) |
| Sarcoidosis | 10 (9) | 8 (7) |
| Behçet’s disease | 12 (11) | 4 (4) |
| Other | 9 (8) | 13 (12) |
| Duration of uveitis, months; mean ± SD | 40.2 ± 51.2 | 51.0 ± 72.2 |
| Eye affected, n (%) | ||
| Left only | 5 (5) | 5 (5) |
| Right only | 7 (6) | 3 (3) |
| Both | 98 (89) | 99 (93) |
| Number of flares in past 12 months, n (%) | ||
| 1 | 18 (16) | 19 (18) |
| 2 | 54 (49) | 46 (43) |
| ≥3 | 38 (35) | 42 (39) |
| Concomitant immunomodulators, n (%) | ||
| Mycophenolate mofetil or equivalent | 11 (10) | 14 (13) |
| Cyclosporine | 10 (9) | 3 (3) |
| Methotrexate | 9 (8) | 12 (11) |
| Azathioprine | 4 (4) | 4 (4) |
ITT=intent-to-treat; SD=standard deviation
US-HUM-210672
HUMIRA has >90% preferred national commercial and Medicare Part D formulary coverage under the pharmacy benefit as of January 20231*
*Preferred means HUMIRA is on a preferred tier or otherwise has preferred status on the plan’s formulary.
Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
Questions about access for your patients?
Learn more about how to help your patients access HUMIRA
1. Data on file, AbbVie Inc., January 2023.
US-HUM-220513
