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

Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

HUMIRA (adalimumab) NOW APPROVED - Moderate to Severe HS Adolescents (≤ 12)

Clinically meaningful results in adult patients with moderate to severe hidradenitis suppurativa (HS)

Two pivotal studies evaluated HUMIRA for Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in adults1-3

PIONEER I and II represent the first and only completed Phase III trials in hidradenitis suppurativa (HS)

PIONEER I (N=307) and PIONEER II (N=326) were 36-week studies comparing HUMIRA 40 mg every week (after initial starting dose) with control in adult patients with moderate to severe HS defined by Hurley Stages II and III who were intolerant, had a contraindication, or inadequate response to systemic antibiotic therapy. Primary endpoint was the proportion of patients achieving HiSCR at 12 weeks. HiSCR was defined as at least a 50% reduction in the total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline. During Period B (Week 12 to Week 35), patients who received HUMIRA were re-randomized to HUMIRA 40 mg every week, HUMIRA 40 mg every other week, or control. Control patients were assigned to either HUMIRA 40 mg every week (PIONEER I) or control (PIONEER II).1-3

Study Design Details and Baseline Characteristics

Two pivotal studies evaluated HUMIRA for Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12 (primary endpoint)1,3

The pivotal trials studied HUMIRA with and without concomitant antibiotics

PIONEER I and PIONEER II evaluated HiSCR at Week 12 (primary endpoint)

Period A 12 Weeks

12 HiSCR

Period B 24 Weeks

  • WEEK
  • 0
  • 16
  • 36
  • 96
Pioneer I Screening N=307 Pioneer II Screening N=326 Control n=154 40 mg EW n=153 Control n=163 40 mg EW n=163 Statistical Analysis Statistical Analysis 40 mg EW EOW Control 40 mg EOW 40 mg EW Control EOW Control 40 mg EOW 40 mg EW End of RCT: All arms could enter OLE PHASE 40 mg EW 79% of patients (n=497/633) entered the OLE4
Loss of response=an AN count that was greater than the average AN counts at baseline and Week 12.4
Worsening or absence of improvement=an AN count that was greater than or equal to the baseline AS count at 2 consecutive visits (excluding Week 12) occurring at least 14 days apart.4
  • Period B explored the safety and efficacy of different maintenance regimens (continuation of HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.3
  • At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had loss of response, or if they did not achieve HiSCR and experienced a worsening or absence of improvement.3‡
  • The HUMIRA 40-mg EW OLE phase extended at least 60 weeks from the conclusion of Period B (Week 36). The Pioneer OLE study completed in August 2016.4,5
  • In PIONEER I, control group given placebo (n=154) during Period A was then given HUMIRA 40 mg EW for Period B. In PIONEER II, control group given placebo +/- antibiotic (n=163) during Period A continued the same regimen in Period B.3

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

Select baseline patient characteristics3,6
PIONEER I PIONEER II
Controla
(n=154)c
HUMIRA EW
(n=153)c
Controlb
(n=163)c
HUMIRA EW
(n=163)c
Gender, n (%) Female 105 (68.2) 91 (59.5) 113 (69.3) 108 (66.3)
Male 49 (31.8) 62 (40.5) 50 (30.7) 55 (33.7)
Race,d n (%) White 118 (76.6) 116 (75.8) 130 (79.8) 143 (87.7)
Black 29 (18.8) 33 (21.6) 20 (12.3) 9 (5.5)
Othere 7 (4.5) 4 (2.6) 13 (8.0) 11 (6.7)
Age, years; mean [SD] 37.8 [11.3] 36.2 [10.8] 36.1 [12.2] 34.9 [10.0]
Body weight, kg; mean [SD] Female (n=105)
97.5 [23.14]
(n=91)
92.3 [23.22]
(n=113)
90.9 [23.24]
(n=108)
87.3 [21.75]
Male (n=49)
103.1 [28.82]
(n=62)
104.1 [25.79]
(n=50)
106.5 [28.39]
(n=55)
95.9 [20.73]
Body mass index, kg/m2; mean
[SD]
34.5 [7.9] (n=152)
33.0 [7.6]
(n=161)
32.9 [7.9]
31.3 [7.4]
Hurley stage,f n (%) II 81 (52.6) 80 (52.3) 89 (54.6) 86 (52.8)
III 73 (47.4) 73 (47.7) 74 (45.4) 77 (47.2)
Previous systemic treatment, n (%) Any 63 (40.1) 71 (46.4) 76 (46.6) 82 (50.3)
Disease duration, yrs; median [range] 9.4
[1.0, 43.0]
8.8
[1.1, 40.4]
9.9
[1.2, 68.5]
9.0
[1.0, 43.5]
Family history of HSg 32 (20.8) 39 (25.5) 43 (26.4) 39 (24.1)
hs-CRP, mg/L; mean [SD]h (n=151)
17.4 [20.2]
(n=152)
20.3 [25.0]
(n=163)
18.3 [30.7]
(n=163)
13.3 [18.0]
Lesion types
AN count categories, n (%) ≤5 36 (23.4) 24 (15.7) 50 (30.7) 47 (28.8)
6-10 33 (21.4) 54 (35.3) 51 (31.3) 61 (37.4)
≥11 85 (55.2) 75 (49.0) 62 (38.0) 55 (33.7)
AN count; mean [SD] 14.4 [14.8] 14.3 [11.9] 11.9 [11.0] 10.7 [8.1]
Abscess, mean [SD] 2.7 [3.7] 2.8 [3.5] 2.4 [3.3] 2.0 [2.6]
Inflammatory nodules, mean [SD] 11.6 [13.9] 11.5 [10.9] 9.4 [9.6] 8.6 [6.9]
Draining fistulas, mean [SD] 3.8 [4.4] 4.6 [5.2] 3.7 [5.2] 3.0 [4.1]
Select baseline patient characteristics3,6
PIONEER I
Controla
(n=154)c
HUMIRA EW
(n=153)c
Gender, n (%) Female 105 (68.2) 91 (59.5)
Male 49 (31.8) 62 (40.5)
Race,d n (%) White 118 (76.6) 116 (75.8)
Black 29 (18.8) 33 (21.6)
Othere 7 (4.5) 4 (2.6)
Age, years; mean [SD] 37.8 [11.3] 36.2 [10.8]
Body weight, kg; mean [SD] Female (n=105)
97.5 [23.14]
(n=91)
92.3 [23.22]
Male (n=49)
103.1 [28.82]
(n=62)
104.1 [25.79]
Body mass index, kg/m2; mean
[SD]
34.5 [7.9] (n=152)
33.0 [7.6]
Hurley stage,f n (%) II 81 (52.6) 80 (52.3)
III 73 (47.4) 73 (47.7)
Previous systemic treatment, n (%) Any 63 (40.1) 71 (46.4)
Disease duration, yrs; median [range] 9.4
[1.0, 43.0]
8.8
[1.1, 40.4]
Family history of HSg 32 (20.8) 39 (25.5)
hs-CRP, mg/L; mean [SD]h (n=151)
17.4 [20.2]
(n=152)
20.3 [25.0]
Lesion types
AN count categories, n (%) ≤5 36 (23.4) 24 (15.7)
6-10 33 (21.4) 54 (35.3)
≥11 85 (55.2) 75 (49.0)
AN count; mean [SD] 14.4 [14.8] 14.3 [11.9]
Abscess, mean [SD] 2.7 [3.7] 2.8 [3.5]
Inflammatory nodules, mean [SD] 11.6 [13.9] 11.5 [10.9]
Draining fistulas, mean [SD] 3.8 [4.4] 4.6 [5.2]
PIONEER II
Controlb
(n=163)c
HUMIRA EW
(n=163)c
Gender, n (%) Female 113 (69.3) 108 (66.3)
Male 50 (30.7) 55 (33.7)
Race,d n (%) White 130 (79.8) 143 (87.7)
Black 20 (12.3) 9 (5.5)
Othere 13 (8.0) 11 (6.7)
Age, years; mean [SD] 36.1 [12.2] 34.9 [10.0]
Body weight, kg; mean [SD] Female (n=113)
90.9 [23.24]
(n=108)
87.3 [21.75]
Male (n=50)
106.5 [28.39]
(n=55)
95.9 [20.73]
Body mass index, kg/m2; mean
[SD]
(n=161)
32.9 [7.9]
31.3 [7.4]
Hurley stage,f n (%) II 89 (54.6) 86 (52.8)
III 74 (45.4) 77 (47.2)
Previous systemic treatment, n (%) Any 76 (46.6) 82 (50.3)
Disease duration, yrs; median [range] 9.9
[1.2, 68.5]
9.0
[1.0, 43.5]
Family history of HSg 43 (26.4) 39 (24.1)
hs-CRP, mg/L; mean [SD]h (n=163)
18.3 [30.7]
(n=163)
13.3 [18.0]
Lesion types
AN count categories, n (%) ≤5 50 (30.7) 47 (28.8)
6-10 51 (31.3) 61 (37.4)
≥11 62 (38.0) 55 (33.7)
AN count; mean [SD] 11.9 [11.0] 10.7 [8.1]
Abscess, mean [SD] 2.4 [3.3] 2.0 [2.6]
Inflammatory nodules, mean [SD] 9.4 [9.6] 8.6 [6.9]
Draining fistulas, mean [SD] 3.7 [5.2] 3.0 [4.1]

AN=abscess and inflammatory nodule; EW=every week; hs-CRP=high-sensitivity C-reactive protein; SD=standard deviation.
aControl=placebo.
bControl=placebo ± antibiotic.
cNumber of patients unless otherwise indicated EW.
dRace was self-reported.
eIn PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients, 1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
fData reflect actual assessments, not the Hurley Stage stratification factor. A patient’s overall Hurley stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage III as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
gData missing for PIONEER II, HUMIRA EW (n=1).
hHigher values indicate a higher level of systemic inflammation.

Baseline characteristics identified as different between PIONEER I and PIONEER II3

  • Baseline weight
  • Baseline lesion count

Differences in baseline characteristics may in part account for the observed difference in magnitude between the 2 studies.

What clinically meaningful improvement may look like for your adult patients with moderate to severe HS

Tap on an image below to select a photo

Click on an image below to select a photo

Click image of patient with moderate to severe HS in the armpit Click photo of patient with moderate to severe HS near the groin Click image of patient with moderate to severe HS in the breast Click picture of patient with moderate to severe HS on the scalp
Before treatment illustration of moderate to severe HS in the armpit

Baseline prior
to treatment

After treatment illustration of moderate to severe HS in the armpit

HiSCR achieved
at Week 12

Before treatment illustration of moderate to severe HS in the breast of women

Baseline prior
to treatment

After treatment illustration of moderate to severe HS in the breast of women

HiSCR achieved
at Week 12

Before treatment illustration of moderate to severe HS near the groin

Baseline prior
to treatment

After treatment illustration of moderate to severe HS near the groin

HiSCR achieved
at Week 12

Tap play button to see baseline and Week 12

Move slider to see baseline and Week 12

Computerized illustrations of 50% reduction in abscesses and nodules at 3 months. Individual results may vary.

Results in hidradenitis suppurativa: PIONEER data at 12 weeks in adult patients1,3

  • PIONEER I — 42% of HUMIRA-treated adult patients achieved HiSCR vs 26% of control* patients (P<0.003)
  • PIONEER II — 59% of HUMIRA-treated adult patients achieved HiSCR vs 28% of control patients (P<0.001)

*Control=placebo
Control=+/- antibiotic

Explore HUMIRA's mechanism of action video along with helful resources for HS diagnosis and staging
Mechanism of
Action

Explore the MOA video along
with helpful resources for
diagnosis and staging

HUMIRA Clinical Trial Data In Adults with Moderate to Severe HS

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HUMIRA Clinical Trial Data In Adults with Moderate to Severe HS

Learn more about HUMIRA, a biologic that targets TNF-α, and the first and only FDA-approved treatment for moderate to severe hidradenitis suppurativa (HS). See what meaningful improvement can look like for patients with moderate to severe HS.

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Clinically meaningful improvements in adult patients with moderate to severe hidradenitis suppurativa (HS) at Week 12

See how HUMIRA helped a greater proportion of patients with moderate to severe HS achieve HiSCR at week 12 vs. placebo

aFor PIONEER I, control=placebo; for PIONEER II, control=placebo ± antibiotic.
bP=0.003 vs control.
cP<0.001 vs control.

PIONEER I: Significantly greater proportion of HUMIRA adult patients achieved HiSCR vs control patients
PIONEER II: >2x as many adult patients treated with HUMIRA achieved HiSCR vs control patients

Flare in adult patients withdrawn from HUMIRA1
22% of patients who were withdrawn* from HUMIRA experienced flare of HS during Period B following the primary efficacy time point in both studies. Flare was defined as ≥25% increase from baseline in abscesses and inflammatory nodule counts and with a minimum of 2 additional lesions.

*Patients who were withdrawn from therapy received HUMIRA in Period A and were rerandomized to control in Period B (PIONEER I: n=49, PIONEER II: n=51).3

Co-manage the treatment of HS patients with a dermatologist - Find a dermatologist in your area
Not an actual HS patient.
Co-Manage the
Treatment of
Patients with a
Dermatologist

Find a dermatologist in your area

HiSCR requires counting abscesses and inflammatory nodules (ANs) and draining fistulas before and after an intervention, making it applicable in both research and clinical practice.2

HiSCR requires1,2:

  • At least a 50% reduction in the total AN count relative to baseline
  • No increase in abscess count AND
  • No increase in draining fistula count
Numerical assessment of HiSCR in a theoretical PIONEER patient2
AN count was reduced from 20 to 10 in both cases. In the HiSCR nonresponder, however, abscesses increased to 8.
Patient 1 Patient 2
Baseline Week 12 HiSCR
Criteria
Baseline Week 12 HiSCR
Criteria
Total AN
count
20 10 Total AN
count
20 10
Abscesses 5 5 Abscesses 5 8
Inflammatory nodules 15 5 Inflammatory nodules 15 2
Draining fistulas 4 4 Draining fistulas 4 2
 =meets criteria
  =does not meet criteria
Numerical assessment of HiSCR in a theoretical PIONEER patient2
AN count was reduced from 20 to 10 in both cases. In the HiSCR nonresponder, however, abscesses increased to 8.
Patient 1
Baseline Week 12 HiSCR
Criteria
Total AN
count
20 10
Abscesses 5 5
Inflammatory nodules 15 5
Draining fistulas 4 4
Patient 2
Baseline Week 12 HiSCR
Criteria
Total AN
count
20 10
Abscesses 5 8
Inflammatory nodules 15 2
Draining fistulas 4 2
 =meets criteria
  =does not meet criteria

AN=abscess and inflammatory nodule

HS & the Moderate to Severe HS Patient

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HS & the Moderate to Severe HS Patient

Dermatologist Dr. Cather discusses the chronic, progressive, inflammatory nature of HS disease, who it typically affects, and the importance of early diagnosis and treatment.

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HUMIRA (adalimumab) NOW APPROVED - Moderate to Severe HS Adolescents (≤ 12)

Efficacy in adolescents extrapolated from adult data

HUMIRA efficacy in adolescent HS patients is extrapolated from the adult HS patient data based on the likelihood that the disease course and drug effects are similar to that of adults at the same exposure levels determined through pharmacokinetic modeling.

HUMIRA's clinical experience safety
Safety in HS

See how the PIONEER Trials
added
to HUMIRA’s clinical
experience1

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. Kimball AB, Jemec GBE, Yang M, et al. Assessing the validity, responsiveness and meaningfulness of the Hidradenitis Suppurativa Clinical Response (HiSCR) as the clinical endpoint for hidradenitis suppurativa treatment. Br J Dermatol. 2014;171(6):1434-1442. 3. Kimball AB, Okun MM, Williams DA, et al. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016;375(5):422-434. 4. Data on File ABVRRTI61790. 5. Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER (OLE)). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT01635764?term=HUMIRA+OLE&rank=2. Accessed April 3, 2017. 6. Data on File ABVRRTI61787.

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