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HUMIRA® (adalimumab): For Healthcare Professionals Rheumatology

For adult patients with active psoriatic arthritis (PsA).

Safety

Safety data for patients with active PsA1,2

Model not an actual patient.

Tim, a fisherman with active psoriatic arthritis
PsA safety data

PsA safety data

ADEPT—Adult patients with active PsA who had an inadequate response to NSAIDs1,3

24-week RCT and 3-year open-label extension (OLE)
safety data2

Serious infection Serious infection
Malignancy Malignancy
Active TB Active TB
Lymphoma Lymphoma

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

PsA safety data: serious infection rates over 3.5 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

ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,3 285 patients from the RCT enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.4

ADEPT study design & baseline characteristics

ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TB=tuberculosis; 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.

PsA safety data: malignancy rates over 3.5 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

ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,3 285 patients from the RCT enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.4

ADEPT study design & baseline characteristics

ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TB=tuberculosis; 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.

PsA safety data: active tuberculosis rates over 3.5 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

ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,3 285 patients from the RCT enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.4

ADEPT study design & baseline characteristics

ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TB=tuberculosis; 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.

PsA safety data: lymphoma rates over 3.5 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

ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,3 285 patients from the RCT enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.4

ADEPT study design & baseline characteristics

ACR=American College of Rheumatology; AS=ankylosing spondylitis; CD=Crohn's disease; EOW=every other week; HS=hidradenitis suppurativa; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open‑label extension; Ps=plaque psoriasis; PsA=psoriatic arthritis; PYs=patient-years; RA=rheumatoid arthritis; RCT=randomized controlled trial; TB=tuberculosis; 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 indications5

  • 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

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.

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. ABVRRTI62919. 3. Mease PJ, Gladman DD, Ritchlin CT, et al, for the Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double‑blind, randomized, placebo‑controlled trial. Arthritis Rheum. 2005;52(10):3279‑3289. 4. Mease PJ, Ory P, Sharp JT, et al. Adalimumab for long‑term treatment of psoriatic arthritis: 2‑year data from Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68(5):702‑709. 5. Burmester GR, Panaccione R, Gordon KB, et al. Long‑term safety of adalimumab (HUMIRA) in adult patients from global clinical trials across multiple indications: an updated analysis in 29 987 patients representing 56 951 patient‑years. Poster presented at: 2017 ACR/ARHP Annual Meeting; November 3‑8, 2017; San Diego, CA. Poster 2481. 6. Data on File ABVRRTI68761.

©2019 AbbVie Inc. North Chicago, IL 60064. If you have any questions about this website that have not been answered, click here. This website and the information contained herein is intended for use by US physicians only and is provided for informational purposes only.

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ADEPT study design & baseline characteristics

Study design

ADEPT: A trial in patients with active PsA who had an inadequate response to NSAIDs1,3,4,6

ADEPT study design

a315 patients were initially randomized, although 2 patients did not receive study drug. After Week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs.3

Patient characteristics1,3

  • Mean disease duration ~9 years
  • History of inadequate response to NSAIDs
  • Evidence of joint damage and pain
  • At least 50% of all patients in the ADEPT trial were taking methotrexate (MTX) at baseline

Primary endpoints1,3

  • ACR20 responses at Week 12
  • Mean change from baseline in mTSS for HUMIRA at Week 48 vs placebo at Week 24

Select ranked secondary endpoints3

  • ACR 20 response rates at Week 24
  • ACR 50/70 response rates at Weeks 12 and 24
  • Change from baseline in HAQ-DI at Weeks 12 and 24
  • PASI 75 at Week 24 (for patients with psoriasis involvement of ≥3% BSA at study entry)

Select additional endpoints6

  • Change from baseline in SF-36 at Weeks 12 and 24
  • Proportion of patients with no radiographic progression (∆mTSS≤0.5) at Week 24
  • PASI 90 at Week 24 (for patients with psoriasis involvement of ≥3% BSA at study entry)

ADEPT OLE4

  • Over 90% of RCT patients elected to enroll in the open-label extension

ACR=American College of Rheumatology; BSA=body surface area; DMARDs=disease-modifying antirheumatic drugs; EOW=every other week; HAQ‑DI=Health Assessment Questionnaire Disability Index; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; RCT=randomized controlled trial; SF‑36=Short Form 36

Baseline characteristics

Patient characteristics at baseline in ADEPT3

  • Patients in ADEPT had evidence of inflammation and active disease
  • All 313 patients in ADEPT study had active psoriasis or a history of psoriasis at baseline
ADEPT baseline characteristics

an=161 for placebo
bn=150 for HUMIRA; n=161 for placebo

CRP=C-reactive protein; mTSS=modified total Sharp score; MTX=methotrexate; Ps=plaque psoriasis; PsA=psoriatic arthritis; RF=rheumatoid factor

US-HUMR-190189

Clinical trials experience

Serious adverse events of interest for HUMIRA® (adalimumab) from the full Prescribing Information

aThese data pertain to all adult FDA‑approved indications.
bNon-infectious (NI) intermediate, posterior, or panuveitis
cSerious infections observed included pneumonia, septic arthritis, prosthetic and postsurgical infections, erysipelas, cellulitis, diverticulitis, and pyelonephritis.
dThe observed rate of lymphomas is approximately 0.11/100 PYs in clinical trials of HUMIRA-treated patients. This is approximately 3‑fold higher than expected in the general US population according to the Surveillance, Epidemiology, and End Results database (adjusted for age, gender, and race).

AEs=adverse events; AS=ankylosing spondylitis; CD=Crohn's disease; HS=hidradenitis suppurativa; Ps=plaque psoriasis; PsA=psoriatic arthritis; PYs=patient‑years; RA=rheumatoid arthritis; UC=ulcerative colitis

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US-IMM-190077

INDICATIONS1

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.

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

INDICATIONS1

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.

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.

INDICATIONS1

Rheumatoid Arthritis (RA): HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs,

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

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.