Safety Considerations1

Serious Infections: Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Malignancies: Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA.

Other Serious Adverse Reactions: Patients treated with HUMIRA also may be at risk for other serious adverse reactions, including anaphylaxis, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and a lupus-like syndrome.

Indications1

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.

Plaque Psoriasis Clinical Data

HUMIRA: Significant skin clearance in moderate to severe plaque psoriasis (Ps)

Rapid, sustainable, retreatable results demonstrated in clinical studies

REVEAL: HUMIRA rapid efficacy at 16 weeks in moderate to severe chronic plaque psoriasis

REVEAL study design1,2

REVEAL was a randomized, double-blind, placebo-controlled study of 1212 adult patients with moderate to severe chronic plaque psoriasis. Evaluations were performed over 3 treatment periods totaling 52 weeks. The co-primary efficacy endpoints at Week 16 were proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.

Study Design Details

REVEAL: A 52-week pivotal trial in moderate to severe chronic plaque psoriasis

The REVEAL study design for patients with moderate to severe chronic plaque psoriasis.

aAfter 80 mg at Week 0 and 40 mg at Week 1 for Period A.
bAfter 80 mg at Week 16 and 40 mg at Week 17 for Period B.

EOW=every other week

This multicenter study compared HUMIRA and placebo in 1212 adults with moderate to severe chronic plaque psoriasis who had a clinical diagnosis ≥6 months and stable disease ≥2 months before screening1,2

The study had 2 primary endpoints:

  • Percentage of patients with PASI 75 response at Week 16 vs baseline
  • Percentage of patients achieving a PGA score of clear or minimal disease at Week 16

Loss of adequate response after Week 33 on or before Week 52 was also evaluated in REVEAL.

Moderate to severe plaque psoriasis defined as:

  • ≥10% of body surface area (BSA) involvement
  • PGA of at least moderate disease severity
  • PASI score ≥12

Significant skin clearance your patients can see

HUMIRA delivered significant improvement vs placebo at Week 16 and responses were observed as early as Week 4 as measured by PASI and PGA1,2

Leading up to the primary endpoint measured at Week 16, significant skin clearance was observed in some patients as early as Week 4 and improved throughout Weeks 8 and 12, compared with placebo

PGA response rates for patients with plaque Ps.

*PGA of clear or minimal
Clear defined as no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration.
Minimal defined as possible but difficult to ascertain whether there is slight elevation of plaque above normal skin plus or minus surface dryness with some white coloration, plus or minus up to red coloration.

Leading up to the primary endpoint at Week 16, PASI 75† clearance was observed in some patients as early as Week 4 and improved throughout Weeks 8 and 12, compared with placebo

Time to achieve median PASI 75 responses for patients with plaque psoriasis.

†PASI 75 represents a ≥75% PASI improvement from baseline
EOW=every other week; PASI=Psoriasis Area and Severity Index; PGA=Physician's Global Assessment
This analysis was based on the intention-to-treat (ITT) population, with missing values imputed as nonresponders.

Time to achieve median PASI 90 responses for patients with plaque psoriasis.

‡PASI 90 represents a ≥90% PASI improvement from baseline
EOW=every other week; PASI=Psoriasis Area and Severity Index
This analysis was based on the intention-to-treat (ITT) population, with missing values imputed as nonresponders.

CHAMPION: Significant, rapid results achieved at Month 44

CHAMPION study design4

CHAMPION was a randomized, double-blind, double-dummy, placebo-controlled study of patients with moderate to severe plaque psoriasis. Patients were randomized to receive HUMIRA 80 mg followed by 40 mg every other week (EOW) beginning 1 week later (n=108), or placebo (n=53) in a 2:1 ratio. Co-primary endpoints were proportion of patients achieving PASI 75 relative to baseline and proportion of patients achieving a PGA of clear or minimal at Week 16.

Study Design Details

CHAMPION: A 16-week study in patients with moderate to severe plaque psoriasis

CHAMPION study design: screening period up to 28 days in patients with moderate to severe chronic plaque psoriasis.

aPatients were randomized to receive either HUMIRA 80 mg followed by 40 mg EOW beginning 1 week later, subcutaneously, or placebo in a 2:1 ratio.

Co-primary endpoints were proportion of patients achieving PASI 75 relative to baseline and proportion of patients achieving a PGA of clear or minimal at Week 16.

Eligible adult patients had moderate to severe psoriasis (defined as ≥10% BSA and PASI ≥10)

  • Patients were to have plaque psoriasis for at least 1 year and stable plaque psoriasis for at least 2 months
  • Patients were candidates for systemic therapy or phototherapy
  • All patients were naïve to anti-TNF therapy and MTX
  • Concomitant psoriasis therapies were not permitted during the study, with the exception of shampoos free of corticosteroids, bland emollients, and low-potency topical corticosteroids for the palms, soles, face, inframammary areas, and groin only, provided they were not used within 24 hours of a study visit.
Champion PGA results for patients with plaque psoriasis at Weeks 12 and 16.

†PGA response of clear or minimal
‡HUMIRA- vs placebo-treated patients

CHAMPION skin clearance at Week 16

The analysis was based on the intention-to-treat (ITT) population, with missing values imputed as nonresponders.

Champion PASI 75 skin clearance results at weeks 12 and 16 for patients with plaque psoriasis.

Clear defined as no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration. Minimal defined as possible but difficult to ascertain whether there is slight elevation of plaque above normal skin, plus or minus surface dryness with some white coloration, plus or minus up to red coloration.

EOW=every other week; PASI=Psoriasis Area and Severity Index; PGA=Physician's Global Assessment

Champion PASI 90 results for patients with plaque psoriasis.

From the full Prescribing Information for HUMIRA1
The data assessed in the HUMIRA full Prescribing Information included only patients with a baseline PASI ≥12 in Champion and, therefore, differ from the data shown here.

  • 78% of HUMIRA-treated patients (n=99) achieved PASI 75 improvement at Week 16 vs 19% of placebo-treated patients (n=48)1
  • 71% of HUMIRA-treated patients (n=99) achieved a PGA score of clear or minimal at Week 16 vs 10% of placebo-treated patients (n=48)1

REVEAL 52-week clearance results

At the end of period C in REVEAL, more HUMIRA-treated patients maintained efficacy vs placebo1,3

Period C: After 17 weeks of open-label therapy, patients who maintained at least a PASI 75 response at Week 33 and were originally randomized to HUMIRA in Period A were re-randomized to receive either HUMIRA 40 mg EOW or placebo for an additional 19 weeks.

52-week and OLE study designs

REVEAL 52-week and OLE Study Designs5

REVEAL 52 week and Open Label Extension (OLE) study designs.

aAfter 80 mg at Week 0 and 40 mg at Week 1 for Period A
bAfter 80 mg at Week 16 and 40 mg at Week 17 for Period B

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

Periods A and C: double-blind, placebo-controlled
Period B: open-label

REVEAL: Skin clearance at 52 weeks

REVEAL: PASI and PGA skin clearance at Week 52 for patients with plaque psoriasis.

PASI=Psoriasis Area and Severity Index; PGA=Physician's Global Assessment
aClear defined as no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration.
Minimal defined as possible but difficult to ascertain whether there is slight elevation of plaque above normal skin, plus or minus surface dryness with some white coloration, plus or minus up to red coloration.

REVEAL open-label extension (OLE) after 3 years of continuous HUMIRA therapy

REVEAL open-label extension (OLE) after 3 years of continuous HUMIRA therapy: observed analysis data.
  • The use of HUMIRA in moderate to severe chronic plaque psoriasis beyond one year has not been evaluated in controlled clinical trials.
  • OLE populations generally consist of treatment responders. Patients who are unable to tolerate or who do not respond to the drug often drop out.
  • The OLE observed analysis included patients who received continuous HUMIRA through Week 52 (PASI 75 responders at Weeks 16 and 32) and entered into the OLE study. Patient responses were analyzed relative to baseline of REVEAL.

Open-label retreatment study: Skin clearance regained3,6

Skin clearance regained at Week 16 of retreatment period in patients whose moderate to severe chronic plaque psoriasis was controlled before HUMIRA withdrawal and relapse

Retreatment Study Design Details
HUMIRA Open-label retreatment study: study design details of the open-label retreatment trial.

aOption to increase dosage to 40 mg weekly if patients had less than a PASI 50 response at Week 24 or thereafter.
EOW=every other week; mITT=modified intention to treat; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; PGA=Physician's Global Assessment

At entry into the retreatment period (Period R):

  • 96% of those who had relapsed had a PGA of moderate
  • 60% of those who had not relapsed had a PGA of clear or minimal, while 40% had a PGA of mild

For patients who relapsed, median time to relapse (decline to PGA of moderate to worse) was approximately 5 months.

Retreatment results: PGA response, PASI 75 and PASI 90 at week 16 for patients with plaque psoriasis.

aClear defined as no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration.
Minimal defined as possible but difficult to ascertain whether there is slight elevation of plaque above normal skin, plus or minus surface dryness with some white coloration, plus or minus up to red coloration.
bPatients received HUMIRA 40 mg EOW after 80 mg at Week 0 followed by 40 mg at Week 1, given subcutaneously.
EOW=every other week; mITT=modified intention to treat; PASI=Psoriasis Area and Severity Index;
PGA=Physician's Global Assessment

  • Of the 347 participants with stable psoriasis control in the mITT population, 178 (51%) patients relapsed and entered the retreatment period
  • Median time to relapse (decline to PGA moderate or worse) was approximately 5 months
  • PASI 75 clearance after retreatment was a post hoc analysis performed after study completion. Post hoc analyses cannot be used to demonstrate statistically significant differences between treatment groups.

REVEAL: Before and after photos of HUMIRA-treated patients with moderate to severe chronic plaque psoriasis

Click on an image below to select a photo

REVEAL before and after photos of HUMIRA treated patients with moderate to severe chronic plaque psoriasis: PASI 75 response. Before and after photos of HUMIRA treated patients with moderate to severe chronic plaque psoriasis - PGA response: severe to minimal. Patient photos of plaque psoriasis. REVEAL before and after photos of HUMIRA treated patients with moderate to severe chronic plaque psoriasis: PGA Plaque psoriasis on the back. REVEAL before and after photos of HUMIRA treated patients with moderate to severe chronic plaque psoriasis: PASI 75 response. Plaque psoriasis photos. REVEAL before and after photos of HUMIRA treated patients with moderate to severe chronic plaque psoriasis: PASI 90 response. Plaque psoriasis clinical trial photos.

PGA response: Severe to minimal*

before
after
Baseline Status:
PGA Severe1
Week 16 Status:
PGA Minimal1

Actual clinical trial patient. Individual results may vary.

PASI 75 response†

before
after
Baseline Status:
PASI: 12.81
Week 16 Status:
PASI 75 improvement

Actual clinical trial patient. Individual results may vary.

PGA response: Severe to minimal*

before
after
Baseline Status:
PGA Severe1
Week 16 Status:
PGA Minimal1

Actual clinical trial patient. Individual results may vary.

PASI 75 response†

before
after
Baseline Status:
PASI: 15.91
Week 16 Status:
PASI 75 improvement

Actual clinical trial patient. Individual results may vary.

PGA response: Moderate to clear*

before
after
Baseline Status:
PGA Moderate1
Week 16 Status:
PGA Clear1

Actual clinical trial patient. Individual results may vary.

PASI 75 response†

before
after
Baseline Status:
PASI: 20.3
Week 16 Status:
PASI 75 improvement

Actual clinical trial patient. Individual results may vary.

PGA response: Moderate to clear*

before
after
Baseline Status:
PGA Moderate1
Week 16 Status:
PGA Clear1

Actual clinical trial patient. Individual results may vary.

PASI 90 response†

before
after
Baseline Status:
PASI: 12.3
Week 16 Status:
PASI 90 improvement1

Actual clinical trial patient. Individual results may vary.

Click on an image above to select a photo.

Click here to view PGA and PASI definitions at the bottom of this section.

Results in plaque psoriasis: REVEAL data at 16 weeks

  • 62% of HUMIRA-treated patients achieved a PGA of clear or minimal*
    vs 4% of placebo-treated patients (P<0.001)
  • 71% of HUMIRA-treated patients achieved a PASI† 75 improvement
    vs 7% of placebo-treated patients (P<0.001)
  • 45% of HUMIRA-treated patients achieved a PASI† 90 improvement
    vs 2% of placebo-treated patients (P<0.001)

REVEAL evaluated 1212 adult patients with chronic plaque psoriasis with ≥10% BSA involvement, a PGA of at least moderate disease severity, and PASI† score ≥12 within 3 treatment periods. For the first 16 weeks, patients were randomized to receive HUMIRA (n=814) at an initial dose of 80 mg subcutaneously (SC) at Week 0 followed by 40 mg SC EOW starting at Week 1, or placebo (n=398). The co-primary endpoints were proportion of patients at Week 16 who achieved PASI† 75 and a PGA of clear or minimal.*

*Physician's Global Assessment (PGA): a static assessment of overall psoriasis severity.

  • Clear: no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration2
  • Minimal: possible but difficult to ascertain whether there is slight elevation of plaque above normal skin, plus or minus surface dryness with some white coloration, plus or minus up to red coloration1
  • Mild: slight but definite elevation, typically edges are indistinct or sloped; fine scale partially or mostly covering lesions; up to definite red coloration1
  • Moderate: moderate plaque elevation with rough or sloped edges; coarse scale covering most of all of the lesions; definite red coloration3
  • Severe: marked plaque elevation typically with hard or sharp edges; coarse, non-tenacious scale predominates, covering most or all of the lesions; very bright red coloration3
  • Very severe: very marked plaque elevation typically with hard sharp edges; coarse, thick tenacious scale over most or all of the lesions; extreme red coloration, dusky to deep red coloration3

†Psoriasis Area and Severity Index (PASI): A composite score based on the degree of body surface area (BSA) affected by psoriasis and the extent of the erythema, induration, and scaliness of the lesions.2



IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue HUMIRA if a patient develops a serious infection or sepsis.

Reported infections include:

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

Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

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

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

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

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

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

1641190-1880520

Legal Notices/Privacy Policy. ©2015 AbbVie Inc. North Chicago, IL 60064. If you have any questions about AbbVie's HUMIRAPro.com 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.

References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58(1):106-115. 3. Data on file, AbbVie Inc. 4. Saurat JH, Stingl G, Dubertret L, et al; for CHAMPION Study Investigators. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008;158(3):558-566. 5. Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012;66(2):241-251. 6. Papp K, Crowley J, Ortonne J-P, et al. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br. J Dermatol. 2011;164(2):434-441.

1641190-1516827


Important Safety Information New HUMIRA (adalimumab) data for treating moderate to severe fingernail psoriasis.

THIS IS WORTH POINTING OUT.

There's a treatment for moderate to severe chronic plaque psoriasis with new data for moderate to severe fingernail psoriasis.




  DOWNLOAD PRESCRIBING INFORMATION
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Indication1

Plaque Psoriasis: HUMIRA (adalimumab) 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.

Safety Considerations1

Serious Infections

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Malignancies

Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA.

Other Serious Adverse Reactions

Patients treated with HUMIRA also may be at risk for other serious adverse reactions, including anaphylaxis, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and a lupus-like syndrome.