Safety Considerations1

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.

Indications1

Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Juvenile Idiopathic Arthritis: HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Adult Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Pediatric Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

Ulcerative Colitis: HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti-TNF agents.

Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa.

Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.

Safety rates across global HUMIRA clinical trials2

Serious adverse events of interest across 6 indications2

Methodology

  • Evaluated nearly 12 years of long-term safety data in 23,458 patients from 71 HUMIRA global clinical trials including randomized, controlled, open-label and long-term extension studies
  • Assessed serious adverse events (SAEs) of interest
  • Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in a broader patient population in clinical practice
Serious adverse events of interest across 6 HUMIRA indications.

aData were derived from global clinical trials of HUMIRA, including randomized controlled and open-label trials and long-term extension studies—36 in RA, 4 in PsA, 4 in AS, 13 in Ps, 3 in JIA, and 11 in CD.
bMalignancies excluding lymphoma and non-melanoma skin cancer and malignancies not considered serious by investigators.

Juvenile Idiopathic Arthritis (JIA) Clinical Trials

In general, the adverse reactions in HUMIRA-treated JIA patients were similar in frequency and type to those seen in adult patients. In Study JIA-I, serious infections were observed in 4% of patients within approximately 2 years of initiation of treatment with HUMIRA and included cases of herpes simplex, pneumonia, urinary tract infection, pharyngitis, and herpes zoster. Reported severe adverse reactions, some that differ from adults, include neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia, and appendicitis. In Study JIA-II, serious infections were observed in 9% of patients receiving HUMIRA in the study and included dental caries, rotavirus gastroenteritis, and varicella.1

The risks and benefits of HUMIRA should be carefully considered prior to initiating therapy

Risk of 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.
  • Discontinue HUMIRA if a patient develops a serious infection or sepsis.
  • Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
  • 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.

Postmarketing Reports of Pediatric Malignancy

  • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including HUMIRA

Postmarketing Reports of Hepatosplenic T-cell Lymphoma (HSTCL)

  • Postmarketing cases of HSTCL, a rare type of fatal lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. The majority of these cases were in adolescent and young adult males with inflammatory bowel disease who had received concomitant or prior treatment with azathioprine or 6-mercaptopurine.

Patients treated with HUMIRA may be at risk for other serious adverse reactions including:

  • Malignancies – More cases were observed among HUMIRA-treated adult patients than in controls. Lymphoma, non-melanoma skin cancer (NMSC), acute and chronic leukemia, and others have been reported. Examine all patients for the presence of NMSC prior to and during treatment.
  • Hypersensitivity – Anaphylaxis or serious allergic reactions may occur. If a serious allergic reaction occurs, stop HUMIRA and begin appropriate therapy.
  • Hepatitis B virus (HBV) reactivation – Risk of reactivation may increase in patients who are chronic carriers. Monitor HBV carriers during and after treatment with HUMIRA. If reactivation occurs, stop HUMIRA and begin appropriate therapy.
  • Demyelinating disease – Exacerbation or new onset central nervous system or peripheral demyelinating disease may occur. Exercise caution when considering HUMIRA for patients with these disorders.
  • Cytopenias, pancytopenia – Consider stopping HUMIRA in patients with significant hematologic abnormalities.
  • Heart failure – Worsening or new onset congestive heart failure (CHF) may occur. Exercise caution in patients with CHF and monitor them carefully.
  • Lupus-like syndrome – Development of autoantibodies and lupus-like syndrome. Stop HUMIRA if syndrome develops.

HUMIRA: A comprehensive safety analysis in psoriasis (Ps)

Safety of HUMIRA across indications1

The safety assessed in the HUMIRA full Prescribing Information includes patients treated with HUMIRA for various immune-mediated diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, ulcerative colitis, and hidradenitis suppurativa). These data, therefore, differ from data in the present publication.

Adverse events of interest for HUMIRA from the full prescribing information.

aThe observed rate of lymphomas is approximately 0.11/100 PYs in clinical trials of HUMIRA-treated patients. This is approximately 3-fold higher than expected in the general population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers.
PYs=patient-years

Safety of HUMIRA in moderate to severe chronic plaque psoriasis across 13 trials3

Study objective: To assess the safety profile from 5 clinical trials, ranging from 12 weeks to 5 years, of patients with moderate to severe chronic plaque psoriasis. This analysis included patients who started HUMIRA 40 mg EOW beginning 1 week after an 80-mg initial dose or started on placebo treatment and switched to HUMIRA 40 mg EOW.

HUMIRA safety data evaluated up to 5 years in patients with moderate to severe chronic plaque psoriasis.

aSearch criteria for the MedDRA Preferred Term “congestive heart failure” were expanded after June 2007 and prior to April 2010 to include events with a clear diagnosis or indication of congestive heart failure reported (ie, symptoms indicated as secondary to congestive heart failure or action taken pertinent to the diagnosis of congestive heart failure).
bSearch criteria for the MedDRA Preferred Term “allergic reaction” were expanded after June 2007 and prior to April 2010 to include events developed in association with the injection of adalimumab and not caused by another agent/drug.
EOW=every other week; NMSC=non-melanoma skin cancer; PYs=patient-years; TB=tuberculosis

HUMIRA dosing in moderate to severe chronic plaque psoriasis1
The recommended dosage of HUMIRA for adult patients with moderate to severe chronic plaque psoriasis is an initial dose of 80 mg subcutaneously (SC) followed by 40 mg SC given every other week starting 1 week after the initial dose. The use of HUMIRA in plaque psoriasis beyond 1 year has not been evaluated in controlled clinical studies.

Safety Data from the REVEAL Clinical Trial in Moderate to Severe Chronic Plaque Ps4

Safety Data from the REVEAL clinical trial for patients with Ps.

aAll patients receiving at least 1 dose of adalimumab during the 52 weeks of study; includes safety data up to 70 days after last dose.
AE=adverse event; NMSC=non-melanoma skin cancer; PYs=patient-years

Adverse reaction rates observed in clinical trials may not predict the rates observed in a broader patient population in clinical practice. This is because clinical trials are conducted under controlled conditions (i.e., employing exclusion criteria such as co-morbid conditions and use of select concomitant medications, frequent monitoring of patients, etc).

Additionally, adverse reaction rates observed in open-label extension studies may not predict the rates observed in a broader patient population, as patients who experience significant adverse events may be more likely to discontinue.

REVEAL: RCT and OLE serious adverse event rates5

Adverse reaction rates observed in clinical trials and OLE studies may not predict the rates observed in a broader patient population in clinical practice.

Reveal: RCT & OLE serious adverse event rates: serious infection rates over 3 years.

OLE=open-label extension; RCT=randomized controlled trial

Risk of Serious Infection1
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.
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA.

  • Do not start HUMIRA in patients with an active infection, including localized infections
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection
Malignancy rates over 3 years.

*Excluding non-melanoma skin cancer and lymphoma
OLE=open-label extension; PYs=patient years; RCT=randomized controlled trial

Risk of Malignancy1
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.

  • More cases of malignancies were observed among HUMIRA-treated patients compared to control patients in clinical trials
  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in patients with a known malignancy
  • Examine all patients, especially patients with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of non-melanoma skin cancer (NMSC) prior to and during treatment with HUMIRA.
Active tuberculosis rates over 3 years.

OLE=open-label extension; PYs=patient years; RCT=randomized controlled trial

Risk of Tuberculosis1
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death, including:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use
  • Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the development of TB in patients who tested negative for latent TB infection prior to initiating therapy
Lymphoma rates over 3 years.

OLE=open-label extension; PYs=patient years; RCT=randomized controlled trial

Risk of Lymphoma1
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member.
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including HUMIRA.
The rate of lymphoma in controlled and uncontrolled clinical trials of HUMIRA in patients with RA, PsA, AS, CD, UC, and Ps was approximately 3-fold higher than expected in the general population.

ESPRIT: Year 5 interim results of a HUMIRA safety registry in moderate to severe chronic plaque psoriasis6

ESPRIT is an ongoing, 10-year-long postmarketing safety monitoring commitment to regulatory agencies for HUMIRA in the treatment of moderate to severe chronic plaque psoriasis

  • Data were collected from September 2008 through November 2013

6059 adult patients with moderate to severe chronic plaque psoriasis were enrolled and dosed with HUMIRA as recommended in the local product label

  • 83.5% of patients were registered in the US or Canada
  • 2580 of these had received their initial dose of HUMIRA ≤4 weeks prior to registry start
ESPRIT: Enrollment of patients analyzed in all-­Rx group given ≥1 dose of HUMIRA (N=6059) in the registry.

ESPRIT patients may resemble those in your practice

ESPRIT patients may resemble those in your practice. View baseline demographics and characteristics. Provided by HUMIRAPRO.com.

aIncludes American Indian/Alaska Native (all-treated, 0.3%; new-prescription, 0.3%), native Hawaiian or other Pacific Islander (all-treated, 0.7%; new-prescription, 0.9%), multiple races (all-treated, 0.4%; new prescription, 0.5%), other (all-treated, 4.2%; new-prescription, 4.5%). Missing (all-treated, n=63; new-prescription, n=20).
bNot analyzed because not all data were captured in the registry database.
cCalculated from start of registry.
BMI=body mass index

Limitations6

  • Observational data are subject to outcome-reporting bias and bias related to rules attributing safety events to HUMIRA despite exposure to other therapies
  • At entry into the registry, some patients were HUMIRA-naïve
  • For patients with long-term HUMIRA treatment before registry enrollment, the total exposure-adjusted incidence rate of TEAEs may be underestimated
  • The AEs of interest may result from differences in demographics and clinical characteristics that are not accounted for in the analysis and remain unadjusted, influencing rates of AEs of interest
Medical history at entry into the registry: ESPRIT.

Patients included in this ESPRIT registry may have medical histories that would otherwise exclude them from randomized, double-blind, placebo-controlled HUMIRA trials.

aMedical history at enrollment was summarized only for the new-prescription population.
bIn the CHAMPION study, subjects were excluded that had unstable heart disease, congestive heart failure, or uncontrolled diabetes.
cIn the REVEAL study, subjects were excluded that had unstable ischemic heart disease, congestive heart failure, or uncontrolled diabetes with document history of recurrent infections.
dIn both the CHAMPION and REVEAL studies, subjects were excluded that had recent cerebrovascular accidents, a history of untreated TB, a history of cancer of lymphoproliferative disease other than a successfully treated nonmetatastic cutaneous squamous cell, or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
CHF=congestive heart failure; CVA=cerebrovascular accident; MI=myocardial infarction; TB=tuberculosis.

To date, no new safety signals have been observed in this ongoing registry6

Incidence rates of treatment-emergent adverse events (TEAEs)a of interest in patients with different duration of exposure to HUMIRA and in all patients taking HUMIRA6

View incidence rates of TEAEs of interest in patients with different duration of exposure to HUMIRA and in all patients taking HUMIRA.

aTEAEs (treatment-emergent adverse events) were those that occurred from the date of initial dose of HUMIRA through 70 days after the last dose of HUMIRA in the registry, excluding AEs occurring during treatment interruptions.6
bEvents not coded (n=6). Excluding melanoma, lymphoma, hepatosplenic T-cell lymphoma, non-melanoma skin cancer, or leukemia.
cExcluding oral candidiasis and tuberculosis.
Some patients were exposed to adalimumab up to 6 years before entering the registry

HUMIRA safety data in psoriatic arthritis (PsA)

Safety data from the ADEPT clinical trial in PsA7

Safety Data from ADEPT clinical trial in PsA.

aAdverse events experienced by ≥5% of patients in either study arm
NOS=not otherwise specified

Most common adverse reactions1:

  • The most common adverse reactions in HUMIRA clinical trials (incidence >10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash.

HUMIRA safety data in moderate to severe hidradenitis suppurativa (HS)

The safety profile in weekly dosing was consistent with the known safety profile of HUMIRA.1

View safety data from the Pioneer I clinical trial.

Control=placebo.
Only Period A safety shown, as control patients were re-randomized to HUMIRA in Period B.

View the Pioneer II clinical trial data for hidradenitis suppurativa.

Control=placebo ± antibiotic.
Treatment-emergent adverse event is defined as any adverse event with an onset date on or after the first dose of study drug in Period A and prior to the first dose of Period B or up to 70 days after last dose of study drug if the patient discontinued prematurely from Period A.

Events with unknown severity were counted as severe. Events with unknown relationship to study drug were counted as drug related.

Adverse reaction rates observed in clinical trials may not predict the rates observed in a broader patient population in clinical practice. This is because clinical trials are conducted under controlled conditions (eg, employing exclusion criteria such as co-morbid conditions and use of select concomitant medications, frequent monitoring of patients, etc).

HUMIRA has been studied for HS in 2 controlled studies and 1 open-label extension study, and the safety profile for patients with HS treated with HUMIRA weekly dosing was consistent with the known safety profile of HUMIRA.

aAs assessed by investigator.
bAccording to AE analysis conventions, AEs that occurred for patients who were on HUMIRA in Period A and withdrawn to control in Period B are counted up to 70 days from the last EW dose.
AEs=adverse events; E/100PY=events per 100 patient-years; EOW=every other week; EW=every week; HSTCL=hepatosplenic T-cell lymphoma; NMSC=non-melanoma skin cancer; PYs=patient-years.

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)1

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:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

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.

  • Do not start HUMIRA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDS (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.
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.

  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
  • In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.
HYPERSENSITIVITY
  • Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
  • Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
  • Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
  • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.
NEUROLOGIC REACTIONS
  • TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
  • Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.
HEMATOLOGIC REACTIONS
  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
  • Consider stopping HUMIRA if significant hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.
AUTOIMMUNITY
  • Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
IMMUNIZATIONS
  • Patients on HUMIRA should not receive live vaccines.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.
ADVERSE REACTIONS
  • The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

INDICATIONS1
  • Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
  • Juvenile Idiopathic Arthritis: HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
  • Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
  • Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  • Adult Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
  • Pediatric Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.
  • Ulcerative Colitis: HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti-TNF agents.
  • Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
  • Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa.
  • Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.

For full Prescribing Information, visit rxabbvie.com/pdf/humira.pdf

1641190-1880520

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References: 1. HUMIRA Injection [package insert]. North Chicago IL: AbbVie Inc. 2. Burmester GR, Panaccione R, Gordon KB, McIIraith M, Lacerda AP. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn’s disease. Ann Rheum Dis. 2013;72(4):517-524. 3. Leonardi C, Papp K, Strober B, et al. The long-term safety of adalimumab treatment in moderate to severe psoriasis: a comprehensive analysis of all adalimumab exposure in all clinical trials. J Am Clin Dermatol. 2011;12(5):321-337. 4. Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58(1):106-115. 5. Data on file, AbbVie Inc. ABVRRTI61732. 6. Menter A, Thaci D, Papp KA, et al. Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab for moderate to severe psoriasis. J Am Acad Dermatol. 2015;73(3):410-419. E6. 7. Mease PJ, Gladman DD, Ritchlin CT, et al; for Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52(10):3279-3289.

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