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 Moderate to Severe Chronic Plaque Psoriasis Clinical Data: Rapid, sustainable, retreatable results demonstrated in Ps clinical studies

REVEAL study: HUMIRA rapid efficacy at 16 weeks

REVEAL was a randomized, double-blind, placebo-controlled study of 1212 adult patients with chronic plaque psoriasis and ≥10% BSA involvement, PASI score ≥12 and PGA of at least moderate disease severity. Patients had a clinical diagnosis of psoriasis for at least 6 months and stable disease for at least 2 months before screening. Evaluations were performed over 3 treatment periods totaling 52 weeks. Primary efficacy endpoints at week 16 were the proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.2

Study Design Details

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

REVEAL: Study Design1,2

Period B
open-label
 
Period A
double-blind
placebo-controlled
Period C
double-blind,
placebo-controlled
 
n=578
 
n=26
 
arrows
arrows
 
 
 
HUMIRA 40mg EOW
n=814
 
Placebo
n=398
 
n=250
 
Placebo
n=240
 
n=22
≥PASI 75 response,
continue to Period B
≥PASI 75 response,
continue to Period C
Weeks
0
Baseline
16
33
52

Weeks

HUMIRA 40 mg EOWa
Placebo
Placebo to HUMIRA 40 mg EOWb

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 co-primary endpoints2:

  • 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 as2:

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

Before and after photos of HUMIRA-treated patients with moderate to severe chronic plaque psoriasis from the REVEAL study3-5

Tap on an image below to select a photo

Click on an image below to select a photo

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

PGA response: Severe to minimal*

Before photo of HUMIRA treated patient with moderate to severe chronic plaque psoriasis - PGA response: severe to minimal

Baseline status:
PGA Severe3,4

After photo of HUMIRA treated patient with moderate to severe chronic Ps - PGA response: severe to minimal

Week 16 Status:
PGA Minimal3,4

PASI 75 response†

REVEAL before photo of HUMIRA treated patient with moderate to severe chronic plaque psoriasis: PASI 75 response

Baseline status:
PASI: 12.83

REVEAL after photo of HUMIRA treated patient with moderate to severe chronic Ps: PASI 75 response

Week 16 Status:
PASI 75 Improvement3

PGA response: Severe to minimal*

REVEAL before photo of HUMIRA treated patient with moderate to severe chronic plaque psoriasis: PGA Plaque psoriasis on the back

Baseline status:
PGA Severe3,4

REVEAL after photo of HUMIRA treated patient with moderate to severe chronic plaque psoriasis

Week 16 Status:
PGA Minimal3,4

PASI 75 response†

Patient photo of plaque psoriasis

Baseline status:
PASI: 15.93

REVEAL patient photo of Ps at week 16

Week 16 Status:
PASI 75 Improvement3

PGA response: Moderate to clear*

Plaque psoriasis photo

Baseline status:
PGA Moderate5

PGA response: Moderate to clear

Week 16 Status:
PGA Clear5

PASI 75 response†

REVEAL before photo of HUMIRA treated patient with moderate to severe chronic plaque psoriasis: PASI 75 response

Baseline status:
PASI: 20.33

REVEAL clinical trial week 16 status: PASI 75 improvement

Week 16 Status:
PASI 75 Improvement3

PGA response: Moderate to clear*

Plaque psoriasis clinical trial photo

Baseline status:
PGA Moderate5

REVEAL PGA response at week 16: PGA clear

Week 16 Status:
PGA Clear5

PASI 90 response†

REVEAL before photo of HUMIRA treated patient with moderate to severe chronic plaque psoriasis: PASI 90 response

Baseline status:
PASI: 12.35

REVEAL clinical trial patient photo: PASI 90 response

Week 16 Status:
PASI 90 Improvement5

Tap play button to see baseline and Week 16

Move slider to see baseline and Week 16

Actual clinical trial patient. Individual results may vary.

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)1,6
  • 71% of HUMIRA-treated patients achieved a PASI† 75 improvement vs 7% of placebo-treated patients (P<0.001)1,2
  • 45% of HUMIRA treated patients achieved a PASI† 90 improvement vs 2% of placebo-treated patients (P<0.001)2

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.1,2

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

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 psoriasis

*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.1

Leading up to the primary endpoint measured 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

aPASI 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

aPASI 90 represents a ≥90% 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.

CHAMPION: Significant, rapid results achieved at Month 49

CHAMPION study design9

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 16.9

Study Design Details

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

Champion Study Design9
Screening period up to 28 days
Patients randomizeda
Double-blind, double-dummy,
placebo-controlled period
16 weeks
Adalimumab 40 mg EOW
n=108
Placebo
n=53
Statistical Analysis
Week 0
Week 16
Baseline
Every other week

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 16.9

Eligible adult patients had moderate to severe psoriasis (defined as ≥10% BSA and PASI ≥10)9

  • 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

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

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
HUMIRA's clinical experience safety
Safety in Ps

Extensively studied safety
profile in clinical
studies
and practice10,11

REVEAL 52-week clearance results

At the end of period C in REVEAL, more HUMIRA-treated patients maintained efficacy vs placebo1,12

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.2

52-week and OLE study designs

REVEAL 52-week and OLE Study Designs

REVEAL: 52-week and 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.1

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

REVEAL OLE data: observed analysis13,14

At 1 year
(OLE Week 0)

Patients (%)

  • 100
  • 80
  • 60
  • 40
  • 20
  • 0
70% 84% 57% 163
233 195
233 132
233
  • PGA: clear
    or minimal
  • PASI 75
  • PASI 90
  • Observed analysis of PGA and PASI 75 response in patients who received continuous HUMIRA through Week 52 and entered the OLE study
  • Observed analysis of PGA and PASI 75 response after 160 weeks of HUMIRA therapy (OLE Week 108)

number of responders

number observed

After 3 years (Week 160)
(OLE Week 108)

Patients (%)

  • 100
  • 80
  • 60
  • 40
  • 20
  • 0
71% 88% 57% 115
161 141
161  92
161
  • PGA: clear
    or minimal
  • PASI 75
  • PASI 90
  • The use of HUMIRA in moderate to severe chronic plaque psoriasis beyond one year has not been evaluated in controlled clinical trials.1
  • 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 regained15

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
Study design of the open-label retreatment trial1,15
1468 Patients
40 mg EOW a
104 weeks
up to 252 weeks
Period O
Open-label period (n=1468)
PGA≥3,
discontinued from study
PGA≤2,
withdrawn from treatment
40 weeks
or until relapse (PGA≥3)
Period W
Withdrawal period, during which eligible patients (those with PGA of 0/1/2 at the end of the Period O) were withdrawn from therapy and monitored for relapse (PGA ≥3) (n=608,mITT population,n=347)
80-mg initial dose,
then 40 mg EOW in weeks 1-15
16 weeks
Period R
Retreatment period
(mITT population, n=285)
End of study

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.1
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 period1,15
  • Median time to relapse (decline to PGA moderate or worse) was approximately 5 months1,15
  • 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.

*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 coloration1
  • 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

See loading and maintenance dosing schedules for HUMIRA (adalimumab)
Dosing for Ps

Just a single loading dose
for new starts or retreatments1

See loading and maintenance
dosing schedule

 HUMIRA (adalimumab) data for treating moderate to severe fingernail psoriasis

HUMIRA is the only biologic with FDA-approved data for moderate to severe fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis in its label1

HUMIRA offers meaningful improvement in fingernail psoriasis.1,16

  • The “lifetime” incidence of nail psoriasis among psoriatic patients is approximately 80% to 90%.17
  • A 26-week, Phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of HUMIRA in patients with moderate to severe chronic plaque psoriasis with moderate to severe fingernail psoriasis (n=109) vs placebo (n=108). Initial dose was 80 mg, followed by 40 mg EOW beginning 1 week later.1,16
  • A Phase 3 study of patients with moderate to severe chronic plaque psoriasis demonstrated that nearly half of adult patients treated with HUMIRA achieved clear or minimal signs and symptoms of fingernail psoriasis with at least a 2-grade improvement from baseline compared to 6.9% of patients receiving placebo (P<0.001).1,16
Nail Ps Study Design Details

The Only Biologic With Phase 3 Fingernail Psoriasis Data1,16

Phase 3, randomized, double-blind study evaluated adult subjects with moderate to severe fingernail psoriasis who also had moderate to severe chronic plaque psoriasis1

Nail Ps study design details: HUMIRA offers dramatic improvement in fingernail psoriasis Nail Ps study design details: HUMIRA offers dramatic improvement in fingernail psoriasis

a80 mg initial dose of adalimumab

Key Inclusion Criteria1,16

Adult subjects with:

  • Chronic plaque psoriasis ≥ moderate as measured by PGA-S scale
  • Fingernail involvement ≥ moderate as measured by 5-point PGA-F scale
  • mNAPSI score of target fingernail ≥8
  • BSA ≥10%, or ≥5% BSA with a total mNAPSI score for all fingernails ≥20

Primary Endpoint

  • Proportion of subjects achieving PGA-F of 0 (clear) or 1 (minimal) and at least 2-grade improvement from baseline at week 26

Select Secondary Endpoint

  • Proportion of subjects achieving ≥75% improvement from baseline in mNAPSI (mNAPSI 75) at week 26

Understanding PGA-F (Primary Endpoint)16,18

The PGA-F is a 5-point scale used to assess a subject’s fingernails separately for nail bed signs and nail matrix signs of disease. A global score between 0 (clear) and 4 (severe) is assigned for both nail bed involvement and nail matrix involvement.

Overall global score is determined by the highest of the nail bed and nail matrix scores. For example, a patient with a nail bed score of 2 and nail matrix score of 4 has an overall score of 4.

The PGA-F is a 5-point scale used to assess a subject’s fingernails separately for nail bed signs and nail matrix signs of disease The PGA-F is a 5-point scale used to assess a subject’s fingernails separately for nail bed signs and nail matrix signs of disease

PGA-F=Physician’s Global Assessment of Fingernail Psoriasis

Evidence of psoriatic leukonychia should be counted toward the presence of pits. Confluent pits causing marked indentation of the nail plate should be considered crumbling.

Extent of crumbling defined by % of nail plate surface area missing or abnormal due to crumbling.

Understanding mNAPSI 75 (A Select Secondary Endpoint)16,19
75% Improvement in mNAPSI score relative to baseline

The mNAPSI is a modification designed to enhance the reliability of the NAPSI (Nail Psoriasis Severity Index) by taking into account the amount or severity of the 7 most commonly seen features. Scores range from 0-13 for each fingernail and 0-130 for all fingernails.

The mNAPSI is a modification designed to enhance the reliability of the Nail Psoriasis severity index The mNAPSI is a modification designed to enhance the reliability of the Nail Psoriasis severity index

mNAPSI=Modified Nail Psoriasis Severity Index

PGA-F response: Moderate to minimal

Significantly more HUMIRA-treated patients demonstrated fingernail psoriasis improvement vs placebo at week 261,16

Before photo of HUMIRA treated patient with fingernail psoriasis

Baseline:
PGA-F score: 3
(Moderate)18

After photo of HUMIRA treated patient with fingernail psoriasis

Week 26:
PGA-F score: 1
(Minimal)18

Photo is of actual clinical trial patient. Individual results may vary.
Tap play button to see baseline and Week 26

Photo is of actual clinical trial patient. Individual results may vary.
Move slider to see baseline and Week 26

Achieving PGA-F (Physician’s Global Assessment of Fingernail Psoriasis) Clear or Minimal requires a PGA-F score of 0 or 1 with ≥2-grade improvement from baseline.1,18

Achieving PGA-F (Physician’s Global Assessment of Fingernail Psoriasis) Clear or Minimal requires a PGA-F score of 0 or 1 with ≥2-grade improvement from baseline.1,18

HUMIRA treated patients demonstrated fingernail psoriasis improvement vs placebo at week 26

Significantly more HUMIRA-treated patients achieved mNAPSI 75 at week 26 vs placebo1,16

More HUMIRA-treated patients achieved mNAPSI 75 at week 26 vs placebo

Achieving mNAPSI (Modified Nail Psoriasis Severity Index) requires ≥75% improvement in mNAPSI from baseline.

Nail pain was also evaluated, and improvement in nail pain was observed1

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 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.

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

US-HUM-181930

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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 ABVRRTI61639. 4. Data on File ABVRRTI61723. 5. Data on File ABVRRTI63561. 6. Data on File ABVRRTI63672. 7. Data on File ABVRRTI64647. 8. Wu JJ, Valdecantos WC. Adalimumab in chronic plaque psoriasis: a clinical guide. J Drugs Dermatol. 2017;16(8):779-790. 9. 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. 10. Burmester GR, Mease P, Dijkmans BAC, et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis. 2009;68(12):1863-1869. 11. Leonardi C, Papp K, Strober B, et al. The long-term safety of adalimumab treatment in moderate to severe psoriasis: a comprehensive analysis of all adalimumab exposure in all clinical trials. Am J Clin Dermatol. 2011;12(5):321-337. 12. Data on File ABVRRTI61764. 13. 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. 14. Data on File ABVRRTI61780. 15. 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. 16. Elewski BE, Rich PA, Okun MM, et al. Adalimumab for nail psoriasis: efficacy and safety from the first 26 weeks of a phase-3, randomized, placebo-controlled trial. Poster presented at: 5th Congress of the Psoriasis International Network (Psoriasis, 2016); July 7-9, 2016; Paris, France. Poster P131. 17. Samman PD, Fenton DA. Samman’s The Nails in Disease (Butterworth-Heinemann Ltd, 1995). 18. Data on File ABVRRTI64046. 19. Cassell SE, Bieber JD, Rich P, et al. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007;34(1):123-129.

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