HUMIRA® for HCPs
SkyRizi™ for HCPs
RINVOQ™ for HCPs
Rapidly induce remission in your bio-naïve UC patients Rapidly induce remission in your bio-naïve UC patients Rapidly induce remission in your bio-naïve UC patients

Rapid remission* in HUMIRA vs control at Week 81-3

18.5% vs 9.2%

16.5% vs 9.3%

Durable remission in HUMIRA vs control at Week 521,3

17.3% vs 8.5%

Remission at
Weeks 2, 4, 6, & 8 by PMS in bio‑naïve post-hoc analysis2,4

Endoscopic improvement, mucosal healing data at Week 8 (subgroup analysis)3

OLE remission data5

Only continue HUMIRA in patients who have shown evidence of clinical remission by 8 weeks of therapy.1

Limitation of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.1

Week 8 Study Design Intro: 8-week, randomized, double‑blind, placebo‑ controlled study in 390
anti‑TNF‑naïve adult patients with inadequate response to concurrent or prior immunosuppressant therapy and evaluated 3 treatment arms. Primary endpoint: percentage of patients achieving clinical remission at Week 8.1,2

Weeks 8 and 52 Study Design Intro: 52-week, randomized, double‑blind, placebo-controlled study in 518§ adult patients with inadequate response to concurrent or prior immunosuppressant therapy, as well as patients who lost response or were intolerant to anti‑TNF agents.|| Two treatment arms were evaluated (± concomitant therapy). Co‑primary endpoints: percentage of patients achieving clinical remission at Weeks 8 and 52.1,3

ULTRA 3 OLE Study Design Intro: 588 patients enrolled in ULTRA 3 OLE from ULTRA 1 (n=334/588) and ULTRA 2 (n=254/588). The primary endpoint was long-term remission of HUMIRA up to 4 years.5

PMS=partial Mayo score; OLE=open-label extension; TNF=tumor necrosis factor

*Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.
Mucosal healing is defined as an endoscopy subscore of 0 or 1 and did not include a histological analysis.
Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.
§24 patients were not included in the efficacy analysis due to site noncompliance.
IIPatients with prior exposure to HUMIRA were excluded from the study.

Rapid Remission & Response at Week 8

In two pivotal UC trials, patients treated with HUMIRA achieved rapid remission* at Week 8.

ULTRA 1: Remission for Total Population at Week 8 (Primary Endpoint)—All Patients Were Bio‑naïve1

18.5%
HUMIRA (n=130)
160 mg/80 mg/40 mg

9.2%
CONTROL
(n=130)

P<0.05

ULTRA 2: Remission for Total Population at Week 8 (Primary Endpoint)—Patients Were Bio‑naïve and Bio‑experienced1

16.5%
HUMIRA (n=248)
160 mg/80 mg/40 mg

9.3%
CONTROL
(n=246)

P<0.05

Limitation of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.1

ULTRA 1 Study Design Intro: 8-week, randomized, double-blind, placebo-controlled study in 390
anti-TNF-naïve adult patients with inadequate response to concurrent or prior immunosuppressant therapy and evaluated 3 treatment arms. Primary endpoint: percentage of patients achieving clinical remission at Week 8.1,2

ULTRA 2 Study Design Intro: 52-week, randomized, double‑blind, placebo-controlled study in 518 adult patients with inadequate response to concurrent or prior immunosuppressant therapy, as well as patients who lost response or were intolerant to anti-TNF agents.§ Two treatment arms were evaluated
(± concomitant therapy). Co-primary endpoints: percentage of patients achieving clinical remission at Weeks 8 and 52.1,3

TNF=tumor necrosis factor

*Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.
Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.
24 patients were not included in the efficacy analysis due to site noncompliance.
§Patients with prior exposure to HUMIRA were excluded from the study.

Weeks 2, 4, 6, & 8

Remission* for Total Population at Weeks 2, 4, 6, & 8 per Partial Mayo Score (Post‑hoc Analysis)—All Patients Were Bio‑naïve2,4

  • HUMIRA 160 mg/80 mg/40 mg EOW (n=130)
  • Control (n=130)

Clinical remission per partial Mayo score (≤2 with no subscore >1) over time in the ITT-A3 population (non‑responder imputation).

Statistical Considerations: Post-hoc analyses are 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.

Post-hoc Analysis Methodology: The post-hoc analysis is of the intention-to-treat study population of patients treated with HUMIRA EOW or placebo who achieved clinical remission per partial Mayo score (Mayo score ≤2 with no individual subscore >1 without an endoscopy score) at Week 8. Patients with missing data were classified as not achieving clinical response or clinical remission.

EOW=every other week; ITT-A3=intention-to-treat-Amendment 3

*Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.
Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.

Response* at Week 8 per Full Mayo Score3,†

Total Population

Patients with response at Week 8 (%)
(n=125/248) (n=85/246)
  • HUMIRA 160 mg/80 mg/40 mg EOW
  • Control

ULTRA 2 Subgroup Analysis

Bio-naïve Bio-experienced (n=89/150) (n=56/145) (n=36/98) (n=29/101)
  • HUMIRA 160 mg/80 mg/40 mg EOW
  • Control

Statistical Considerations: Subgroup analyses are 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.

Subgroup Analysis Methodology: The subgroup analysis is of the intention-to-treat study population of those patients treated with HUMIRA EOW or placebo who achieved clinical response (a decrease in Mayo score ≥3 points and ≥30% from baseline plus a decrease in the rectal bleeding subscore (RBS) ≥1 from baseline or an absolute RBS of 0 or 1) at Week 8, stratified by previous anti-TNF experience. Patients with missing data were classified as not achieving clinical response or clinical remission.

EOW=every other week; TNF=tumor necrosis factor

*Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.
Endpoints were non-prespecified.
Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.

Response* at Weeks 2, 4, & 8 per Partial Mayo Score7,†

Patients Were Bio-naïve and Bio-experienced

  • HUMIRA 160 mg/80 mg/40 mg EOW (n=248)
  • Control (n=246)

Statistical Considerations: Non-ranked secondary endpoints are not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the nature of the data.

Response Definitions:

  • Clinical response per full Mayo score was defined as a decrease of ≥3 points and at least 30% from baseline
  • Clinical response per partial Mayo score was defined as a decrease of ≥2 points and ≥30% from baseline
  • Both scores required a decrease in the rectal bleeding subscore of ≥1 or absolute rectal bleeding subscore of 1 or 0
  • Partial Mayo score does not include endoscopy component

EOW=every other week

*Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.
Response rates at Weeks 2, 4 and 8 per PMS were considered non‑ranked secondary endpoints.

Endoscopic Improvement

Mucosal Healing* Data at Week 8 (Subgroup Analysis)3

 

Total Population

Patients with endoscopic improvement at Week 8 (%)
(n=102/248) (n=78/246)
  • HUMIRA 160 mg/80 mg/40 mg EOW
  • Control

ULTRA 2 Subgroup Analysis

Bio-naïve Bio-experienced (n=74/150) (n=51/145) (n=28/98) (n=27/101)
  • HUMIRA 160 mg/80 mg/40 mg EOW
  • Control

Statistical Considerations: Subgroup analyses are 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.

Subgroup Analysis Methodology: The subgroup analysis is of the intention-to-treat study population of patients treated with HUMIRA EOW or placebo who achieved mucosal healing (endoscopy subscore of 0 or 1) at Week 8, stratified by previous anti-TNF experience. Patients with missing data were classified as not achieving clinical response or clinical remission.

Intention-to-treat (ITT) study population using non-responder imputation.
EOW=every other week; TNF=tumor necrosis factor

*Mucosal healing is defined as an endoscopy subscore of 0 or 1 and did not include a histological analysis.
Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.
Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.

Rates of Reduction in Rectal Bleeding and Stool Frequency at Week 2 (Post-hoc Analysis)8

Patients Were Bio-naïve and Bio-experienced

Patients with reduction (%)
Rectal Bleeding Stool Frequency
  • HUMIRA 160 mg/80 mg/40 mg EOW (n=248)
  • Control (n=246)

Statistical Considerations: Post-hoc analyses are 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.

ULTRA 2 Additional Results
at Week 83

PGA ≤1: HUMIRA 46% vs Control 37%

RBS ≤1: HUMIRA 70% vs Control 58%

SFS ≤1: HUMIRA 38% vs Control 29%

Ranked secondary endpoints of PGA ≤1, SFS ≤1 and RBS ≤1 were defined as: a PGA Mayo subscore of ≤1 (mild disease activity) at Week 8, a SF Mayo subscore of ≤1 (mild disease activity) at Week 8 and a RB Mayo subscore of ≤1 (mild disease activity) at Week 8 respectively. These Week 8 ULTRA 2 ranked secondary endpoints of PGA Mayo subscore of ≤1, SF Mayo subscore of ≤1 and RB Mayo subscore of ≤1 did not achieve statistical significance.

Rectal Bleeding

Based on amount of blood present in stools (worst of past 3 days)

Subscore Definitions

0 = Normal for patient

1 = Streaks less than 50% of the time

2 = Obvious blood most of the time

3 = Blood alone passed

Stool Frequency

Based on number of stools (worst of past 3 days)

Subscore Definitions

0 = Normal for patient

1 = 1–2 more than normal

2 = 3–4 more than normal

3 = 5 more than normal

Statistical Considerations: Post-hoc analyses are 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.

Post-hoc Analysis Methodology: The post-hoc analysis is of the intention-to-treat study population of those patients treated with HUMIRA EOW or placebo who achieved reductions in stool frequency and rectal bleeding scores (reduction from baseline ≥1 point in the rectal bleeding subscore or reduction from baseline ≥1 point in the stool frequency subscore) at Week 2. These results were patient reported. Patients with missing data were classified as not achieving clinical response* or clinical remission.

EOW=every other week; PGA=Physician's Global Assessment subscore; RB=rectal bleeding; RBS=rectal bleeding subscore; SF=stool frequency; SFS=stool frequency subscore

*Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.
Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.

Durable Remission & Response at Week 52

Week 52

After rapidly induced remission* at 8 weeks, durable remission in UC can follow

Remission for Total Population at Week 52 (Primary Endpoint)—Patients Were Bio‑naïve and Bio‑experienced1

17.3%
HUMIRA (n=248)
160 mg/80 mg/40 mg

8.5%
CONTROL
(n=246)

P<0.05

Study Design Intro: 52-week, randomized, double‑blind, placebo-controlled study in 518 adult patients with inadequate response to concurrent or prior immunosuppressant therapy, as well as patients who lost response or were intolerant to anti-TNF agents.§ Two treatment arms were evaluated (± concomitant therapy). Co-primary endpoints: percentage of patients achieving clinical remission at Weeks 8 and 52.1,3

Only continue HUMIRA in patients who have shown evidence of clinical remission by 8 weeks of therapy.1

EOW=every other week; TNF=tumor necrosis factor

*Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.
24 patients were not included in the efficacy analysis due to site noncompliance.
Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.
§Patients with prior exposure to HUMIRA were excluded from the study.

Remission* at Week 52 (Subgroup Analysis)3

Patients Were Bio-naïve and Bio-experienced

Total Population

Clinical remission rates at Week 52 (%)
(n=43/248) (n=21/246)
  • HUMIRA 160 mg/80 mg/40 mg EOW
  • Control

ULTRA 2 Subgroup Analysis

Bio-naïve Bio-experienced (n=33/150) (n=18/145) (n=10/98) (n=3/101)
  • HUMIRA 160 mg/80 mg/40 mg EOW
  • Control

Statistical Considerations: Subgroup analyses are 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.

Subgroup Analysis Methodology: The subgroup analysis is of the intention-to-treat study population of patients treated with HUMIRA EOW or placebo who achieved clinical remission (total Mayo score of ≤2 with no subscore >1) at Week 52, stratified by previous anti-TNF experience. Patients with missing data were classified as not achieving clinical response or clinical remission.

Intention-to-treat (ITT) study population using non-responder imputation.
EOW=every other week; TNF=tumor necrosis factor

*Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.
Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.

Endoscopic Improvement

Mucosal Healing* Data at Week 523

Total Population

Patients with endoscopic improvement at Week 52 (%)
(n=62/248) (n=38/246)
  • HUMIRA 160 mg/80 mg/40 mg EOW
  • Control

ULTRA 2 Subgroup Analysis

Bio-naïve Bio-experienced (n=47/150) (n=28/145) (n=15/98) (n=10/101)
  • HUMIRA 160 mg/80 mg/40 mg EOW
  • Control

Statistical Considerations: Subgroup analyses are 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.

Subgroup Analysis Methodology: The subgroup analysis is of the intention-to-treat study population of patients treated with HUMIRA EOW or placebo who achieved mucosal healing (endoscopy subscore of 0 or 1) at Week 52, stratified by previous anti-TNF experience. Patients with missing data were classified as not achieving clinical response or clinical remission.

EOW=every other week; TNF=tumor necrosis factor

*Mucosal healing is defined as an endoscopy subscore of 0 or 1 and did not include a histological analysis.
Clinical response is defined as a decrease in total Mayo score of ≥3 points from baseline and a decrease in total Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.
Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.

Corticosteroid-free Remission* at Week 52 (Prespecified Secondary Endpoint)3,†

Patients Were Bio-naïve and Bio-experienced

Patients with corticosteroid‑free remission at Week 52 (%)
  • HUMIRA 160 mg/80 mg/40 mg EOW (n=150)
  • Control (n=140)

Intention-to-treat (ITT) study population using nonresponder imputation.
EOW=every other week

aP=0.035.
*Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.
Restricted to patients using corticosteroids at baseline.

OLE Remission Data

ULTRA 3 Open-label extension: Observed Analysis9

  • % of patients with remission* per partial Mayo score (HUMIRA 160 mg/80 mg/40 mg EOW)

The use of HUMIRA in UC beyond 1 year has not been evaluated in controlled clinical studies.

OLE populations generally consist of treatment responders, as patients who are unable to tolerate the drug or who do not respond to the drug drop out.

Patients who dropped out of the OLE trial or who were missing Mayo scores were not included in the analysis at each time point.

ULTRA 3 OLE Study Design Intro: 588 patients enrolled in ULTRA 3 OLE from ULTRA 1 (n=334/588) and ULTRA 2 (n=254/588). The primary endpoint was long‑term remission of HUMIRA up to 4 years.5

EOW=every other week; OLE=open-label extension

*Clinical remission was defined as a total Mayo score of ≤2 with no subscore >1.

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INDICATION1

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.

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. 2. Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut. 2011;60(6): 780–787. 3. 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(2):257–265. 4. Data on File T20401_rem_pmayo. 5. Colombel JF, Sandborn WJ, Ghosh S, et al. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: data from ULTRA 1, 2, and 3. Am J Gastroenterol. 2014;109:1771–1780. 6. Data on File ABVRRT162223. 7. Sandborn WJ, Colombel, JF, D’Haens GD, et al. One-year maintenance outcomes among patients with moderately-to-severely active ulcerative colitis who responded to induction therapy with adalimumab: subgroup analyses from ULTRA 2. Aliment Pharmacol Ther. 2013;37:204-213. 8. Data on File M06827‑14‑2‑443. 9. Data on File, ULTRA 3 Partial Remission TNFi Sub. 29 April 2019.

Indications1

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.

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

Indications1

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.

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 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.

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.