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

Moderate to Severe

Pediatric Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

RAPID AND DURABLE REMISSION with the first and only SubQ biologic for pediatric UC2 RAPID AND DURABLE REMISSION with the first and only SubQ biologic for pediatric UC2 RAPID AND DURABLE REMISSION with the first and only SubQ biologic for pediatric UC2

Rapid Remission at Week 8
by PMS1,a

HUMIRA: 59.6%
(Co-primary endpoint)

Durable Remission at Week 52
by FMS in 8-week responders1,b

HUMIRA: 45.2%
(Co-primary endpoint)

Response at
Week 52

by FMS in 8-week responders
(Secondary endpoint)1

Endoscopic Improvement

at Week 52 in
8-week responders
(Secondary endpoint)1

Remission at
Week 52

by FMS in 8-week remitters
(Secondary endpoint)1

A multicenter, randomized, double-blind, 52-week trial in 93 pediatric patients from 5 to 17 years of age with moderate to severe ulcerative colitis who had an inadequate response or intolerance to conventional therapy. Co-primary endpoints: clinical remission per PMS (partial Mayo score) at Week 8, and clinical remission per FMS (full Mayo score) at Week 52 in patients who achieved clinical response per PMS at Week 8. Only the high induction dose and every week maintenance dose are depicted. See Study Details and Additional Results for additional data.1

aClinical remission defined as partial Mayo score (PMS) ≤2 and no individual subscore >1; no endoscopic component.1,2
bClinical remission per full Mayo score defined as a Mayo score ≤2 and no individual subscore >1.1

 

FMS=full Mayo score; PMS=partial Mayo score; UC=ulcerative colitis

Co-Primary endpoints

Help your pediatric UC patients achieve rapid remissiona

Patients treated with HUMIRA who achieved clinical remission per PMSa as early as Week 81,*

graph PMS Response graph PMS Response graph PMS Response

~84% of patients in the study were bio-naïve1,‡

Study Design Intro: A multicenter, randomized, double-blind, 52-week trial in 93 pediatric patients from 5 to 17 years of age with moderate to severe ulcerative colitis who had an inadequate response or intolerance to conventional therapy. Co-primary endpoints: clinical remission per PMS (partial Mayo score) at Week 8, and clinical remission per FMS (full Mayo score) at Week 52 in patients who achieved clinical response per PMS at Week 8. Only the high induction dose is depicted. See Study Details and Additional Results for additional data.1

aClinical remission defined as partial Mayo score (PMS) ≤2 and no individual subscore >1; no endoscopic component.1,2
*Intent-to-treat (ITT-E) population, non-responder imputation (NRI).
Max 160 mg at Week 0, Max 160 mg at Week 1, Max 80 mg at Week 2.
Bio-naïve refers to patients who were anti-TNF naïve.

Pediatric UC patients who achieved remission on maintenance therapya

Patients treated with HUMIRA who achieved remission at Week 52 in Week 8 PMSb responders1,*

graph PMS Response graph PMS Response graph PMS Response

~84% of patients in the study were bio-naïve1,‡

Study Design Intro: A multicenter, randomized, double-blind, 52-week trial in 93 pediatric patients from 5 to 17 years of age with moderate to severe ulcerative colitis who had an inadequate response or intolerance to conventional therapy. Co-primary endpoints: clinical remission per PMS (partial Mayo score) at Week 8, and clinical remission per FMS (full Mayo score) at Week 52 in patients who achieved clinical response per PMS at Week 8. Only the every week maintenance dose is depicted. See Study Details and Additional Results for additional data.1

 

At Week 8, patients who demonstrated clinical response per PMS were randomized equally to receive double-blind maintenance treatment at a dose of 0.6 mg/kg (maximum 40 mg) every week or every other week.1

aClinical remission per full Mayo score defined as a Mayo score ≤2 and no individual subscore >1.1
bClinical response per partial Mayo score (PMS) defined as a decrease in PMS ≥2 points and ≥30% from baseline.1
*Modified intent-to-treat (m-ITT-E) population, non-responder imputation (NRI).
Max 40 mg Every Week.
Bio-naïve refers to patients who were anti-TNF naïve.

Secondary endpoints

Help your pediatric UC patients achieve durable symptom relief

Patients treated with HUMIRA who achieved clinical responsea at Week 52 in Week 8 PMSb responders1,*

graph PMS Response graph PMS Response graph PMS Response

~84% of patients in the study were bio-naïve1,‡

aClinical response per full Mayo score defined as a decrease in Mayo score ≥3 points and ≥30% from baseline.1
bClinical response per partial Mayo score (PMS) defined as a decrease in PMS ≥2 points and ≥30% from baseline.1
*Modified intent-to-treat (m-ITT-E) population, non-responder imputation (NRI).
Max 40 mg Every Week.
Bio-naïve refers to patients who were anti-TNF naïve.

Help your patients achieve endoscopic improvement

Pediatric UC patients treated with HUMIRA who achieved endoscopic improvementa at Week 52 in Week 8 PMSb responders1,*

graph PMS Response graph PMS Response graph PMS Response

~84% of patients in the study were bio-naïve1,‡

aEndoscopic improvement at Week 52 measured by Mayo endoscopic subscore
(defined as ≤1).1
bClinical response per partial Mayo score (PMS) defined as a decrease in partial Mayo score ≥2 points and ≥30% from baseline.1
*Modified intent-to-treat (m-ITT-E) population, non-responder imputation (NRI).
Max 40 mg Every Week.
Bio-naïve refers to patients who were anti-TNF naïve.

~84% of patients in the study were bio-naïve1,‡

Pediatric UC patients treated with HUMIRA who achieved remission at Week 8 and at Week 52

Clinical Remissiona at Week 52 in Week 8 PMSb remitters1,*

graph PMS Response graph PMS Response graph PMS Response

~84% of patients in the study were bio-naïve1,‡

aClinical remission per full Mayo score defined as a Mayo score ≤2 and no individual subscore >1.1
bClinical remission per partial Mayo score (PMS) defined as a partial Mayo score ≤2 and no individual subscore >1; no endoscopic component.2
*Modified intent-to-treat (m-ITT-E) population, non-responder imputation (NRI).
Max 40 mg Every Week.
Bio-naïve refers to patients who were anti-TNF naïve.

Study Design Intro: A multicenter, randomized, double-blind, 52-week trial in 93 pediatric patients from 5 to 17 years of age with moderate to severe ulcerative colitis who had an inadequate response or intolerance to conventional therapy. Co-primary endpoints: clinical remission per PMS (partial Mayo score) at Week 8, and clinical remission per FMS (full Mayo score) at Week 52 in patients who achieved clinical response per PMS at Week 8. Only the every week maintenance dose is depicted. See Study Details and Additional Results for additional data.1

 

At Week 8, patients who demonstrated clinical response per PMS were randomized equally to receive double-blind maintenance treatment at a dose of 0.6 mg/kg (maximum 40 mg) every week or every other week.1

Additional analyses by pms and PUCAI

Week 2, 4 and 8 Analysis by PMS

Week 2, 4 and 8 Analysis by PMS

Response Ratesa for pediatric UC patients treated with HUMIRA at Weeks 2, 4, and 8 per PMS1,*

graph PMS Response graph PMS Response graph PMS Response

Secondary Endpoint - Clinical Response at Week 52 in Week 8 PMS Responders: 68%

~84% of patients in the study were bio-naïve1,†

 

Statistical Considerations: Exploratory analyses were not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the exploratory nature of the analysis.

PMS=partial Mayo score

aClinical response per partial Mayo score defined as a decrease in partial Mayo score ≥2 points and ≥30% from baseline.1
*Modified intent-to-treat (m‑ITT‑E) population, non-responder imputation (NRI).
Bio-naïve refers to patients who were anti-TNF naïve.

Week 2, 4 and 8 Analysis by PMS

Remission Ratesa for pediatric UC patients treated with HUMIRA at Weeks 2, 4, and 8 per PMS1,*

graph PMS Remission graph PMS Remission graph PMS Remission

Co-Primary Endpoint - Clinical Remission at Week 52 in Week 8 PMS Remitters: 45%

~84% of patients in the study were bio-naïve1,†

 

Statistical Considerations: Exploratory analyses were not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the exploratory nature of the analysis.

PMS=partial Mayo score

aClinical remission defined as partial Mayo score ≤2 and no individual subscore >1; no endoscopic component.1,2
*Modified intent-to-treat (m‑ITT‑E) population, non-responder imputation (NRI).
Bio-naïve refers to patients who were anti-TNF naïve.

~84% of patients in the study were bio-naïve1,†

Statistical Considerations: Exploratory analyses were not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the exploratory nature of the analysis.

PMS=partial Mayo score

aClinical response per partial Mayo score defined as a decrease in partial Mayo score ≥2 points and ≥30% from baseline.1
*Modified intent-to-treat (m‑ITT‑E) population, non-responder imputation (NRI).
Bio-naïve refers to patients who were anti-TNF naïve.

PMS=partial Mayo score

aClinical remission defined as partial Mayo score ≤2 and no individual subscore >1; no endoscopic component.1,2
*Modified intent-to-treat (m‑ITT‑E) population, non-responder imputation (NRI).
Bio-naïve refers to patients who were anti-TNF naïve.

Week 2, 4 and 8 Analysis by PUCAI

Week 2, 4 and 8 Analysis by PUCAI

Response Ratesa for pediatric UC patients treated with HUMIRA at Weeks 2, 4, and 8 per PUCAI1,*

graph PUCAI Response graph PUCAI Response graph PUCAI Response

~84% of patients in the study were bio-naïve1,†

 

Statistical Considerations: Exploratory analyses were not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the exploratory nature of the analysis.

aClinical response per the Pediatric Ulcerative Colitis Activity Index (PUCAI) defined as a decrease in PUCAI ≥ 20 points from baseline.1
*Modified intent-to-treat (m‑ITT‑E) population, non-responder imputation (NRI).
Bio-naive refers to patients who were anti-TNF naïve.

Week 2, 4 and 8 Analysis by PUCAI

Remission Ratesa for pediatric UC patients treated with HUMIRA at Weeks 2, 4, and 8 per PUCAI1,*

graph PUCAI Remission graph PUCAI Remission graph PUCAI Remission

~84% of patients in the study were bio-naïve1,†

 

Statistical Considerations: Exploratory analyses were not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the exploratory nature of the analysis.

aClinical remission per the Pediatric Ulcerative Colitis Activity Index (PUCAI) remission is defined as PUCAI < 10.1
*Modified intent-to-treat (m‑ITT‑E) population, non-responder imputation (NRI).
Bio-naive refers to patients who were anti-TNF naïve.

~84% of patients in the study were bio-naïve1,†

Statistical Considerations: Exploratory analyses were not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the exploratory nature of the analysis.

aClinical response per the Pediatric Ulcerative Colitis Activity Index (PUCAI) defined as a decrease in PUCAI ≥ 20 points from baseline.1
*Modified intent-to-treat (m‑ITT‑E) population, non-responder imputation (NRI).
Bio-naive refers to patients who were anti-TNF naïve.

aClinical remission per the Pediatric Ulcerative Colitis Activity Index (PUCAI) remission is defined as PUCAI < 10.1
*Modified intent-to-treat (m‑ITT‑E) population, non-responder imputation (NRI).
Bio-naive refers to patients who were anti-TNF naïve.

Study Design Intro: A multicenter, randomized, double-blind, 52-week trial in 93 pediatric patients from 5 to 17 years of age with moderate to severe ulcerative colitis who had an inadequate response or intolerance to conventional therapy. Co-primary endpoints: clinical remission per PMS (partial Mayo score) at Week 8, and clinical remission per FMS (full Mayo score) at Week 52 in patients who achieved clinical response per PMS at Week 8. See Study Details and Additional Results for additional data.1

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Indication1

Ulcerative Colitis (UC): HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

Humira Connect Professional ISI

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: 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.

Crohn’s Disease: HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis: HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

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 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.

US-HUM-210183

Please see full Prescribing Information.

References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142:257-265. 3. Data on File, AbbVie Inc. ABVRRTI71632.

Indication1

Ulcerative Colitis (UC): HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

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.

Important Safety Information
and Indications1

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

Ulcerative Colitis (UC): HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

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.

Important Safety Information
and Indications1

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

Ulcerative Colitis (UC): HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

Humira Connect Professional ISI

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: 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.

Crohn’s Disease: HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis: HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

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 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.

US-HUM-210183

Please see full Prescribing Information.

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