Serious Infections: Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Malignancies: Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA.
Other Serious Adverse Reactions: Patients treated with HUMIRA also may be at risk for other serious adverse reactions, including anaphylaxis, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and a lupus-like syndrome.
Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
The safety and efficacy of HUMIRA + MTX vs placebo + MTX were evaluated in 90 patients with regard to controlling disease activity in pediatric patients with JIA-associated NI uveitis.1
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 IOP, hypotony, disc swelling, or CME).
†Ocular co-morbidities are defined as: i) disc swelling and/or cystoid macular edema (CME) as gauged clinically and where possible by OCT evidence; and/or ii) raised intraocular pressure (IOP) (>25 mmHg) sustained over 2 consecutive visits not responding to single ocular hypotensive agent, and/or iii) hypotony (<6 mmHg) sustained over 2 consecutive visits, and/or iv) development of unexplained reduction in vision (logarithm of the minimum angle of resolution [LogMAR]) over two consecutive visits of 0.3 LogMAR units (in the event of cataract, participants will remain in trial, also if cataract surgery is required. Failure will still remain as described in endpoints above).
EOW=every other week; JIA=juvenile idiopathic arthritis; SC=subcutaneous; AC=anterior cell; OCT=optical coherence tomography; SUN=Standardization of Uveitis Nomenclature.
The SYCAMORE trial was stopped early after 90 patients been randomized because efficacy analysis met the pre-specified statistical stopping guidelines2
HUMIRA is not indicated for anterior uveitis.
The SYCAMORE trial was stopped early after 90 patients been randomized because efficacy analysis met the pre-specified statistical stopping guidelines 2
The safety and efficacy of HUMIRA were evaluated in 2 randomized, multicenter, double-masked, placebo-controlled trials (VISUAL l and VISUAL ll) of adult patients with NI uveitis.1,3,4*
Adult patients received placebo or HUMIRA at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose.1,3,4
The primary efficacy endpoint in both VISUAL I and VISUAL II was time to treatment failure.1
Treatment failure (TF) was defined by a multi-component outcome based on development of new inflammatory chorioretinal and/or inflammatory retinal vascular lesions, an increase in anterior chamber (AC) cell grade or vitreous haze (VH) grade or a decrease in best corrected visual acuity (BCVA).1,3,4
†To be considered a treatment failure, ≥1 of these 4 criteria need to be present in at least 1 eye.
‡A 2-step increase is represented by a change of Grade 0 to Grade 2+; or Grade 0.5+ to Grade 3+.
NEI=National Eye Institute; SUN=Standardization of Uveitis Nomenclature.
VISUAL I evaluated 217 adult patients with active disease in at least 1 eye while being treated with oral prednisone at a dose of 10 to 60 mg/day for 2 weeks or longer.1,3
There was a 50% decrease in the risk for treatment failure in the HUMIRA group compared with the placebo group.1
VISUAL II evaluated 226 adult patients with inactive NI uveitis* while being treated with oral prednisone 10 to 35 mg/day for ≥28 days at baseline.1,4
*Non-infectious intermediate, posterior and panuveitis.
*Non-infectious intermediate, posterior, and panuveitis.
During the study, less than half of at-risk patients treated with HUMIRA experienced a treatment failure.1
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.
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.
For full Prescribing Information, visit rxabbvie.com/pdf/humira.pdf
References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Ramanan AV, Dick AD, Jones AP, et al. Adalimumab plus methotrexate for uveitis in juvenile idiopathic arthritis. N Engl J Med. 2017;376(17):1637-1646. 3. Jaffe GJ, Dick AD, Brezin AP, et al. Adalimumab in patients with active noninfectious uveitis. N Engl J Med. 2016;375(10):932-943. 4. Nguyen QD, Merrill PT, Jaffe GJ, et al. Adalimumab for prevention of uveitic flare in patients with inactive non-infectious uveitis controlled by corticosteroids (VISUAL II): a multicentre, double-masked, randomised, placebo-controlled phase 3 trial. Lancet. 2016;388(10050):1183-1192.