Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

For adult patients with moderate to severe rheumatoid arthritis (RA).

Safety

A well-known safety profile and breadth of experience1‑3

Model not an actual patient.

Representation of a patient with moderate to severe rheumatoid arthritis

Early moderate to severe RA

PREMIER—Adult patients with early moderate to severe RA
(less than 3 years' duration) who were MTX‑naïve1,4

2‑year RCT and 8‑year open-label extension (OLE)
safety data2,4

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

PREMIER early moderate to severe rheumatoid arthritis: serious infection rates over 10 years

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

PREMIER study design intro: 2-year,
double-blind, active comparator‑controlled study of adult patients with early moderate to severe RA (<3 years' duration) and who were MTX-naïve. 799 patients were randomized to receive HUMIRA 40 mg EOW + MTX weekly (n=268), HUMIRA 40 mg EOW (n=274), or MTX weekly (n=257). Co-primary endpoints were ACR50 response and change from baseline in mTSS at Week 52.1,4 497 patients from the RCT entered the OLE at Year 2. All patients received HUMIRA 40 mg EOW. Physicians could add MTX at any time based on clinical judgment.5

ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; MTX=methotrexate; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TNF=tumor necrosis factor

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

PREMIER early moderate to severe rheumatoid arthritis: malignancy rates over 10 years

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.

  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in patients with a known malignancy
  • More cases of malignancies were observed among HUMIRA-treated patients compared to control patients in clinical trials

PREMIER study design intro: 2-year,
double-blind, active comparator-controlled study of adult patients with early moderate to severe RA (<3 years' duration) and who were MTX-naïve. 799 patients were randomized to receive HUMIRA 40 mg EOW + MTX weekly (n=268), HUMIRA 40 mg EOW (n=274), or MTX weekly (n=257). Co-primary endpoints were ACR50 response and change from baseline in mTSS at Week 52.1,4 497 patients from the RCT entered the OLE at Year 2. All patients received HUMIRA 40 mg EOW. Physicians could add MTX at any time based on clinical judgment.5

ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; MTX=methotrexate; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TNF=tumor necrosis factor

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

PREMIER early moderate to severe rheumatoid arthritis: active tuberculosis rates over 10 years

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

PREMIER study design intro: 2-year,
double-blind, active comparator-controlled study of adult patients with early moderate to severe RA (<3 years' duration) and who were MTX-naïve. 799 patients were randomized to receive HUMIRA 40 mg EOW + MTX weekly (n=268), HUMIRA 40 mg EOW (n=274), or MTX weekly (n=257). Co-primary endpoints were ACR50 response and change from baseline in mTSS at Week 52.1,4 497 patients from the RCT entered the OLE at Year 2. All patients received HUMIRA 40 mg EOW. Physicians could add MTX at any time based on clinical judgment.5

ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; MTX=methotrexate; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TNF=tumor necrosis factor

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

PREMIER early moderate to severe rheumatoid arthritis: lymphoma rates over 10 years

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, Ps, HS and NI uveitis* was approximately 3‑fold higher than expected in the general population.
  • Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma.

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

PREMIER study design intro: 2-year,
double-blind, active comparator-controlled study of adult patients with early moderate to severe RA (<3 years' duration) and who were MTX-naïve. 799 patients were randomized to receive HUMIRA 40 mg EOW + MTX weekly (n=268), HUMIRA 40 mg EOW (n=274), or MTX weekly (n=257). Co-primary endpoints were ACR50 response and change from baseline in mTSS at Week 52.1,4 497 patients from the RCT entered the OLE at Year 2. All patients received HUMIRA 40 mg EOW. Physicians could add MTX at any time based on clinical judgment.5

ACR=American College of Rheumatology; AS=ankylosing spondylitis; CD=Crohn's disease; EOW=every other week; HS=hidradenitis suppurativa; mTSS=modified total Sharp score; MTX=methotrexate; OLE=open‑label extension; Ps=plaque psoriasis; PsA=psoriatic arthritis; PYs=patient-years; RA=rheumatoid arthritis; RCT=randomized controlled trial; TNF=tumor necrosis factor; UC=ulcerative colitis

Established moderate to severe RA

DE019—Adult patients with established moderate to severe RA who had an inadequate response to MTX1,6

1‑year RCT and 9‑year open‑label extension (OLE)
safety data3,6

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

DE019 early moderate to severe rheumatoid arthritis: serious infection rates over 10 years

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

DE019 study design intro: 1-year,
double-blind, placebo-controlled study of adult patients with established moderate to severe RA who had an inadequate response to MTX. 619 patients were randomized to receive HUMIRA 40 mg EOW + MTX (n=207), HUMIRA 20 mg weekly + MTX (n=212), or placebo + MTX (n=200). The primary endpoints were ACR20 response at Week 24, mean change from baseline in mTSS at Week 52, and mean change from baseline in HAQ-DI physical function score at Week 52.1,6 457 patients from the RCT enrolled in the OLE at Year 1. All patients received HUMIRA 40 mg EOW + MTX.7

ACR=American College of Rheumatology; EOW=every other week; HAQ‑DI=Health Assessment Questionnaire Disability Index; mTSS=modified total Sharp score; MTX=methotrexate; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TNF=tumor necrosis factor

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

DE019 early moderate to severe rheumatoid arthritis: malignancy rates over 10 years

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.

  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in patients with a known malignancy
  • More cases of malignancies were observed among HUMIRA-treated patients compared to control patients in clinical trials

DE019 study design intro: 1-year,
double-blind, placebo-controlled study of adult patients with established moderate to severe RA who had an inadequate response to MTX. 619 patients were randomized to receive HUMIRA 40 mg EOW + MTX (n=207), HUMIRA 20 mg weekly + MTX (n=212), or placebo + MTX (n=200). The primary endpoints were ACR20 response at Week 24, mean change from baseline in mTSS at Week 52, and mean change from baseline in HAQ-DI physical function score at Week 52.1,6 457 patients from the RCT enrolled in the OLE at Year 1. All patients received HUMIRA 40 mg EOW + MTX.7

ACR=American College of Rheumatology; EOW=every other week; HAQ‑DI=Health Assessment Questionnaire Disability Index; mTSS=modified total Sharp score; MTX=methotrexate; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TNF=tumor necrosis factor

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

DE019 early moderate to severe rheumatoid arthritis: active tuberculosis rates over 10 years

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

DE019 study design intro: 1-year,
double-blind, placebo-controlled study of adult patients with established moderate to severe RA who had an inadequate response to MTX. 619 patients were randomized to receive HUMIRA 40 mg EOW + MTX (n=207), HUMIRA 20 mg weekly + MTX (n=212), or placebo + MTX (n=200). The primary endpoints were ACR20 response at Week 24, mean change from baseline in mTSS at Week 52, and mean change from baseline in HAQ-DI physical function score at Week 52.1,6 457 patients from the RCT enrolled in the OLE at Year 1. All patients received HUMIRA 40 mg EOW + MTX.7

ACR=American College of Rheumatology; EOW=every other week; HAQ‑DI=Health Assessment Questionnaire Disability Index; mTSS=modified total Sharp score; MTX=methotrexate; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TNF=tumor necrosis factor

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

DE019 early moderate to severe rheumatoid arthritis: lymphoma rates over 10 years

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, Ps, HS and NI uveitis* was approximately 3‑fold higher than expected in the general population.
  • Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma

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

DE019 study design intro: 1-year,
double-blind, placebo-controlled study of adult patients with established moderate to severe RA who had an inadequate response to MTX. 619 patients were randomized to receive HUMIRA 40 mg EOW + MTX (n=207), HUMIRA 20 mg weekly + MTX (n=212), or placebo + MTX (n=200). The primary endpoints were ACR20 response at Week 24, mean change from baseline in mTSS at Week 52, and mean change from baseline in HAQ-DI physical function score at Week 52.1,6 457 patients from the RCT enrolled in the OLE at Year 1. All patients received HUMIRA 40 mg EOW + MTX.7

ACR=American College of Rheumatology; AS=ankylosing spondylitis; CD=Crohn's disease; EOW=every other week; HAQ‑DI=Health Assessment Questionnaire Disability Index; HS=hidradenitis suppurativa; mTSS=modified total Sharp score; MTX=methotrexate; OLE=open‑label extension; Ps=plaque psoriasis; PsA=psoriatic arthritis; PYs=patient-years; RA=rheumatoid arthritis; RCT=randomized controlled trial; TNF=tumor necrosis factor; UC=ulcerative colitis

Global safety data: Largest safety analysis published for an anti-TNF drug

Serious adverse events (SAEs) of interest across
8 adult indications9

  • Evaluated long‑term safety data from HUMIRA global clinical trials including randomized controlled, open‑label, and long‑term extension studiesa
  • 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

Rates displayed as events per 100 patient-years (PYs) as of December 31, 2016

 
 
SAEs of interest
Serious infections
Tuberculosis
  • Active
  • Latent
Opportunistic infectionc
Demyelinating disorder
Lupus-like syndrome
Congestive heart failure
Ps new onset/worsening
Malignancyd
Lymphoma
NMSC
Melanoma
Sarcoidosis
Any AE leading to death
Rheumatoid
arthritis
(RA)
Ankylosing
spondylitis
(AS)
Psoriatic
arthritis
(PsA)
Plaque
psoriasis
(Ps)
Hidradenitis
suppurativa
(HS)
Crohn's
disease
(CD)
Ulcerative
colitis
(UC)
NI
uveitisb
« SWIPE
37,106 PYs
N=15,512
2,120 PYs
N=2,026
998 PYs
N=837
5,479 PYs
N=3,732
1,198 PYs
N=733
4,359 PYs
N=3,896
3,407 PYs
N=1,739
1,151 PYs
N=464
3.9
1.8
2.8
1.8
2.8
6.9
3.5
4.1
0.2
0.1
0.2
0.2
0
0.2
<0.1
0.4
0.2
0.1
0.2
0.2
0
0.1
<0.1
0.2
<0.1
0
0
0
0
<0.1
0
0.3
<0.1
0
0
0
0
<0.1
<0.1
0.4
<0.1
<0.1
0
0
0
0.1
<0.1
0.3
<0.1
<0.1
0
0
0
<0.1
<0.1
<0.1
0.2
<0.1
0
0.1
0.2
0
<0.1
<0.1
<0.1
<0.1
0.1
<0.1
<0.1
<0.1
<0.1
0
0.7
0.2
0.2
0.5
0.5
0.4
0.6
0.7
0.1
<0.1
0.2
<0.1
<0.1
<0.1
<0.1
<0.1
0.2
0.2
0.1
0.1
<0.1
<0.1
<0.1
0.2
<0.1
<0.1
0
0.2
0
0
<0.1
0
<0.1
<0.1
0
0
0
0
0
<0.1
0.6
<0.1
0.3
0.2
0.5
0.1
0.1
0.6

a33 in RA, 5 in AS, 3 in PsA, 13 in Ps, 3 in HS, 11 in CD, 4 in UC, and 2 in NI uveitisb
bNon-infectious (NI) intermediate, posterior, or panuveitis
cExcludes oral candidiasis and tuberculosis
dExcludes lymphoma, hepatosplenic T-cell lymphoma, leukemia, non‑melanoma skin cancer (NMSC), and melanoma

The risks and benefits of HUMIRA should be carefully considered prior to initiating therapy.1

Risk of Serious Infection1

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.

Risk of Malignancy1

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

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.

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.

PATIENTS TREATED WITH HUMIRA MAY BE AT RISK FOR OTHER SERIOUS ADVERSE REACTIONS INCLUDING1:

Hypersensitivity

Anaphylaxis and angioneurotic edema have been reported. If a serious allergic reaction occurs, stop HUMIRA and begin appropriate therapy.

Hepatitis B Virus Reactivation

Risk of reactivation may increase in patients who are chronic carriers. Some cases have been fatal. Monitor hepatitis B virus (HBV) carriers during and after treatment with HUMIRA. If reactivation occurs, stop HUMIRA and begin appropriate therapy.

Neurologic Reactions

Exacerbation or new onset central nervous system or peripheral demyelinating disease may occur, including multiple sclerosis, optic neuritis, and Guillain‑Barré syndrome. Exercise caution when considering HUMIRA for patients with these disorders. There is a known association between intermediate uveitis and central demyelinating disorders.

Hematologic Reactions

Rare reports of pancytopenia, including aplastic anemia, have been reported. Consider stopping HUMIRA in patients with significant hematologic abnormalities.

Congestive Heart Failure

Worsening or new onset congestive heart failure (CHF) may occur. Exercise caution in patients with CHF and monitor them carefully.

Autoimmunity

Treatment with HUMIRA may result in formation of autoantibodies and, rarely, in development of lupus-like syndrome. Stop HUMIRA if symptoms of a lupus‑like syndrome develop.

Indication1

Rheumatoid Arthritis (RA): 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.

IMPORTANT SAFETY INFORMATION1

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 (RA): 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 (JIA): 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 (PsA): 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 (AS): HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Adult Crohn's Disease (CD): 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 (UC): 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 (Ps): 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 (HS): HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

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.

Please see full Prescribing Information.

References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on File. ABVRRTI62270. 3. Data on File. ABVRRTI61956. 4. Breedveld FC, Weisman MH, Kavanaugh AF, et al, for the PREMIER Investigators. The PREMIER study: a multicenter, randomized, double‑blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54(1):26‑37. 5. Breedveld FC, Keystone EC, van der Heijde D, et al. Initial combination therapy with adalimumab plus methotrexate leads to better long‑term outcomes than with either monotherapy in patients with early rheumatoid arthritis: 8‑year results of an open‑label extension of a phase 3 trial. Poster presented at: 2011 ACR/ARHP Annual Scientific Meeting; November 5‑9, 2011; Chicago, IL. 6. Keystone EC, Kavanaugh AF, Sharp JT, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo‑controlled, 52‑week trial. Arthritis Rheum. 2004;50(5):1400‑1411. 7. Keystone EC, van der Heijde D, Kavanaugh A, et al. Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10‑year data in longstanding rheumatoid arthritis. J Rheumatol. 2013;40(9):1487‑1497. 8. Data on File. ABVRRTI63131. 9. Burmester GR, Gordon KB, Rosenbaum JT, et al. Long-term safety of adalimumab in 29,967 adult patients from global clinical trials across multiple indications: an updated analysis. Adv Ther. 2019; doi:10.1007/s12325-019-01145-8.

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HUMIRA® (adalimumab) Citrate-free: Redesigned with your patients in mind Learn more
HUMIRA® (adalimumab) Citrate-free: Redesigned with your patients in mind

INDICATION1

Rheumatoid Arthritis (RA): 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.

IMPORTANT SAFETY INFORMATION1

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.

IMPORTANT SAFETY INFORMATION AND INDICATION1

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

INDICATION1

Rheumatoid Arthritis (RA): 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.

IMPORTANT SAFETY INFORMATION1

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.

IMPORTANT SAFETY INFORMATION AND INDICATION1

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

Indication1

Rheumatoid Arthritis (RA): 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.

  

IMPORTANT SAFETY INFORMATION1

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 (RA): 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 (JIA): 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 (PsA): 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 (AS): HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Adult Crohn's Disease (CD): 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 (UC): 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 (Ps): 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 (HS): HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

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.

Please see full Prescribing Information.

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.