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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.
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.
Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
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:
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.
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.
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.
Crohn’s Disease: HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Ulcerative Colitis: HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.
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.
Please see Full Prescribing Information.
US-HUM-210183
By clicking this link, you will be leaving this site and connecting to a site neither owned nor operated by AbbVie. AbbVie is not responsible for the contents of any such website or any further links from such website. AbbVie is providing these links as a convenience, and the inclusion of any link does not imply endorsement of the linked website by AbbVie. You should also be aware that the linked website may be governed by its own set of terms and conditions and privacy policy, for which AbbVie has no responsibility.
By clicking this link, you will be leaving this site and connecting to a site neither owned nor operated by AbbVie. AbbVie is not responsible for the contents of any such website or any further links from such website. AbbVie is providing these links as a convenience, and the inclusion of any link does not imply endorsement of the linked website by AbbVie. You should also be aware that the linked website may be governed by its own set of terms and conditions and privacy policy, for which AbbVie has no responsibility.
REVEAL was a randomized, double-blind, placebo-controlled study of 1212 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. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).
In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, 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 HUMIRA 40 mg EOW or placebo for an additional 19 weeks. 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.
Eligible adult patients had moderate to severe plaque psoriasis (defined as ≥10% BSA and PASI ≥10).
aPatients were randomized to receive HUMIRA (80 mg followed by 40 mg EOW beginning 1 week later) or placebo in a 2:1 ratio.
Co-primary efficacy endpoints were proportion of patients achieving PASI 75 relative to baseline and proportion of patients achieving a PGA of clear or minimal by week 16.
US-HUMD-200130
REVEAL was a randomized, double-blind, placebo-controlled study of 1212 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. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).8,9
In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, 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 HUMIRA 40 mg EOW or placebo for an additional 19 weeks. 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.
US-HUMD-190337
EOW=every other week
a315 patients were initially randomized; however, 2 patients did not receive study drug.11
US-HUMD-190337
EOW=every other week
a315 patients were initially randomized; however, 2 patients did not receive study drug.3
US-HUMD-200130
The first and only completed Phase 3 trials in HS
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
US-HUMD-190337
HUMIRA 40 mg EOW (n=151) | Placebo EOW (n=162) | |||
---|---|---|---|---|
Parameter: median | Baseline | 24 Weeks | Baseline | 24 Weeks |
Number of tender joints | 20.0 | 5.0 | 23.0 | 17.0 |
Number of swollen joints | 11.0 | 3.0 | 11.0 | 9.0 |
Physician global assessment | 55.0 | 16.0 | 53.0 | 49.0 |
Patient global assessment | 48.0 | 20.0 | 49.5 | 49.0 |
Pain | 54.0 | 20.0 | 49.0 | 49.0 |
Disability index (HAQ) | 1.0 | 0.4 | 1.0 | 0.9 |
CRP (mg/dL) | 0.8 | 0.2 | 0.8 | 0.7 |
aP<0.001 for HUMIRA vs placebo; comparisons based on mean changes.
bScale 0-78.
cScale 0-76.
dVisual analog scale; 0=best, 100=worst.
eDisability Index of the Health Assessment Questionnaire (HAQ-DI); 0=best, 3=worst; measures the patient’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity.
fNormal range: 0-0.287 mg/dL.
US-HUMD-200130
88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (periods A and B) and throughout the OLE.
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
US-HUMD-200052
EOW=every other week
a315 patients were initially randomized; however, 2 patients did not receive study drug.2
US-HUMD-200257
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
Baseline characteristics identified as different between PIONEER I and PIONEER II are:
These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.
eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln 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%).
jData 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 Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.
US-HUMD-190337
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
Baseline characteristics identified as different between PIONEER I and PIONEER II are3:
These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.
eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln 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%).
jData 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 Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.
US-HUMD-200052
The first and only completed Phase 3 trials in HS.
Baseline characteristics identified as different between PIONEER I and PIONEER II are13:
These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.
eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln 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%).
jData 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 Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.
US-HUMD-200257
88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (periods A and B) and throughout the OLE.
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
160 mg week 0; 80 mg week 2; 40 mg from week 4.
bRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
c160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
dWeeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
US-HUMD-200130
Adverse reaction rate observed in clinical trials and open-label extension (OLE) studies may not predict the rates observed in a broader HS patient population in clinical practice.
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.
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.
Adverse reaction rate observed in clinical trials and OLE studies may not predict the rates observed in a broader HS patient population in clinical practice.
*Safety data for PIONEER I, Period B not shown as there is no comparable control group.
†Study design dosing: HUMIRA EW/HUMIRA EW.
‡Study design dosing: HUMIRA EW/HUMIRA EW/HUMIRA EW.
§Other than lymphoma, HSTCL, leukemia, NMSC or melanoma.
US-HUMD-200130
a315 patients were initially randomized; however, 2 patients did not receive study drug.2
A 24-week, randomized, double-blind, placebo-controlled trial of HUMIRA in adult patients with moderately to severely active psoriatic arthritis (PsA) (≥3 swollen joints and ≥3 tender joints) who had an inadequate response to NSAIDs.2,4
Patients must have active psoriatic skin lesions or a documented history of psoriasis.2
Co-primary endpoints were American College of Rheumatology (ACR) 20 response at Week 12 and mean change from baseline in modified total Sharp score (mTSS) for HUMIRA-treated patients at Week 48 vs placebo patients at Week 24.1,2
After Week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs.2
Select additional endpoints include ACR20 response rates at week 2, VAS pain scores at Week 2 and 24, and change from baseline in individual ACR components by visit.2
Select secondary endpoints include ACR20 at Week 24, ACR 50/70 at Weeks 12 and 24, HAQ-DI score at Weeks 12 and 24, and PASI 75 at Week 24.2
Patients who completed the original 24-week double-blind ADEPT study (n=289) were eligible for open-label treatment through Week 144, for which over 98% (n=285) elected to enroll.3,4
US-HUMD-200130
REVEAL was a randomized, double-blind, placebo-controlled study of 1212 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. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).
In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, 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 HUMIRA 40 mg EOW or placebo for an additional 19 weeks. 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.
US-HUMD-190337
A Phase 3, randomized, double-blind study evaluated adult subjects with moderate to severe fingernail psoriasis who also had moderate to severe chronic plaque psoriasis.1,2
BSA=body surface area; EOW=every other week; mNAPSI=modified Nail Psoriasis Severity Index;
PGA-F=Physician’s Global Assessment of Fingernail Psoriasis; PGA-S=Physician’s Global Assessment of Skin Psoriasis.
Key inclusion criteria were adult subjects with2:
Primary endpoint was proportion of subjects achieving PGA-F of 0 (clear) or 1 (minimal) and at least 2-grade improvement from baseline at Week 26.
Key secondary endpoint was proportion of subjects achieving ≥75% improvement from baseline in mNAPSI (mNAPSI 75) at Week 26.
US-HUMD-200257
By clicking this link, you will be leaving this site and connecting to a site neither owned nor operated by AbbVie. AbbVie is not responsible for the contents of any such website or any further links from such website. AbbVie is providing these links as a convenience, and the inclusion of any link does not imply endorsement of the linked website by AbbVie. You should also be aware that the linked website may be governed by its own set of terms and conditions and privacy policy, for which AbbVie has no responsibility.
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
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.
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
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
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.
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
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.
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.
Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
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:
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.
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.
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.
Crohn’s Disease: HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Ulcerative Colitis: HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.
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.
Please see Full Prescribing Information.
US-HUM-210183