Indication: Adalimumab-adaz is a tumor necrosis factor (TNF)-blocker indicated for: Rheumatoid Arthritis (RA) (1. 1) Juvenile Idiopathic Arthritis (JIA) (1. 2) Psoriatic Arthritis (PsA) (1. 3) Ankylosing Spondylitis (AS) (1. 4) Crohn’s Disease (CD) (1. 5) Ulcerative Colitis (UC) ( 1. 6 Limitations of Use Plaque Psoriasis (Ps) ( 1. 7 Hidradenitis Suppurativa (HS) ( 1. 8 Uveitis (UV) ( 1. 9 Adalimumab-adaz is indicated 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. Adalimumab-adaz can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab-adaz is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-adaz can be used alone or in combination with methotrexate. Adalimumab-adaz is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-adaz can be used alone or in combination with non-biologic DMARDs. Adalimumab-adaz is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Adalimumab-adaz is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. Adalimumab-adaz is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers [see Clinical Studies (14. 7) Adalimumab-adaz 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. Adalimumab-adaz should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) Adalimumab-adaz is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Adalimumab-adaz is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Indication: AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1. 1 Juvenile Idiopathic Arthritis (JIA) ( 1. 2 Psoriatic Arthritis (PsA) ( 1. 3 Ankylosing Spondylitis (AS) ( 1. 4 Crohn's Disease (CD) ( 1. Ulcerative Colitis (UC) ( 1. 6 Limitations of Use: Plaque Psoriasis (Ps) ( 1. 7 Hidradenitis Suppurativa (HS) ( 1. 8 Uveitis (UV) ( 1. 9 AMJEVITA is indicated 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. AMJEVITA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). AMJEVITA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate. AMJEVITA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. AMJEVITA can be used alone or in combination with non-biologic DMARDs. AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. AMJEVITA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. AMJEVITA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers [see Clinical Studies (14. 7) AMJEVITA 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. AMJEVITA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning Warnings and Precautions (5) AMJEVITA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. AMJEVITA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Indication: AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1. 1 Juvenile Idiopathic Arthritis (JIA) ( 1. 2 Psoriatic Arthritis (PsA) ( 1. 3 Ankylosing Spondylitis (AS) ( 1. 4 Crohn's Disease (CD) ( 1. Ulcerative Colitis (UC) ( 1. 6 Limitations of Use: Plaque Psoriasis (Ps) ( 1. 7 Hidradenitis Suppurativa (HS) ( 1. 8 Uveitis (UV) ( 1. 9 AMJEVITA is indicated 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. AMJEVITA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). AMJEVITA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate. AMJEVITA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. AMJEVITA can be used alone or in combination with non-biologic DMARDs. AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. AMJEVITA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. AMJEVITA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers [see Clinical Studies (14. 7) AMJEVITA 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. AMJEVITA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning Warnings and Precautions (5) AMJEVITA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. AMJEVITA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Indication: Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1. 1 Juvenile Idiopathic Arthritis (JIA) ( 1. 2 Psoriatic Arthritis (PsA) ( 1. 3 Ankylosing Spondylitis (AS) ( 1. 4 Crohn's Disease (CD) ( 1. 5 Ulcerative Colitis (UC) ( 1. 6 Limitations of Use: Plaque Psoriasis (Ps) ( 1. 7 Hidradenitis Suppurativa (HS) ( 1. 8 Uveitis (UV) ( 1. 9 Adalimumab-aaty is indicated 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. Adalimumab-aaty can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab-aaty is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-aaty can be used alone or in combination with methotrexate. Adalimumab-aaty is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-aaty can be used alone or in combination with non-biologic DMARDs. Adalimumab-aaty is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Adalimumab-aaty is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Adalimumab-aaty is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14. 7) Adalimumab-aaty 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. Adalimumab-aaty should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) Adalimumab-aaty is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Adalimumab-aaty is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Indication: IDACIO is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1. 1 Juvenile Idiopathic Arthritis (JIA) ( 1. 2 Psoriatic Arthritis (PsA) ( 1. 3 Ankylosing Spondylitis (AS) ( 1. 4 Crohn's Disease (CD) ( 1. 5 Ulcerative Colitis (UC) ( 1. 6 Limitations of Use: Plaque Psoriasis (Ps) ( 1. 7 Hidradenitis Suppurativa (HS) ( 1. 8 Uveitis (UV) ( 1. 9 IDACIO is indicated 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. IDACIO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). IDACIO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. IDACIO can be used alone or in combination with methotrexate. IDACIO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. IDACIO can be used alone or in combination with non-biologic DMARDs. IDACIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. IDACIO is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. IDACIO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14. 7 IDACIO 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. IDACIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 IDACIO is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. IDACIO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Indication: Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1. 1 Juvenile Idiopathic Arthritis (JIA) ( 1. 2 Psoriatic Arthritis (PsA) ( 1. 3 Ankylosing Spondylitis (AS) ( 1. 4 Crohn’s Disease (CD) ( 1. 5 Ulcerative Colitis (UC) ( 1. 6 Plaque Psoriasis (Ps) ( 1. 7 Hidradenitis Suppurativa (HS) ( 1. 8 Uveitis (UV) ( 1. 9 Adalimumab-fkjp is indicated 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. Adalimumab-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab-fkjp is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-fkjp can be used alone or in combination with methotrexate Adalimumab-fkjp is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-fkjp can be used alone or in combination with non-biologic DMARDs. Adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Adalimumab-fkjp is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older Adalimumab-fkjp is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14. 7 Adalimumab-fkjp 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. Adalimumab-fkjp should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) Adalimumab-fkjp is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. HULIO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Indication: INDICATIONS AND USAGE
ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1. 1 Juvenile Idiopathic Arthritis (JIA) ( 1. 2 Psoriatic Arthritis (PsA) ( 1. 3 Ankylosing Spondylitis (AS) ( 1. 4 Crohn''s Disease (CD) ( 1. 5 Ulcerative Colitis (UC) ( 1. 6 Limitations of Use: Plaque Psoriasis (Ps) ( 1. 7 Hidradenitis Suppurativa (HS) ( 1. 8 Uveitis (UV) ( 1. 9 ABRILADA is indicated 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. ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). ABRILADA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ABRILADA can be used alone or in combination with methotrexate. ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. ABRILADA can be used alone or in combination with non-biologic DMARDs. ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. ABRILADA is indicated for the treatment of moderately to severely active Crohn''s disease in adults and pediatric patients 6 years of age and older. ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14. 7) ABRILADA 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. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Uveitis Clinical Studies
Adalimumab has been studied in 464 adult patients with uveitis (UV) in placebo-controlled and open-label extension studies [see Clinical Studies (14.10)

Indication: Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1. 1 Juvenile Idiopathic Arthritis (JIA) ( 1. 2 Psoriatic Arthritis (PsA) ( 1. 3 Ankylosing Spondylitis (AS) ( 1. 4 Crohn’s Disease (CD) ( 1. 5 Ulcerative Colitis (UC) ( 1. 6 Plaque Psoriasis (Ps) ( 1. 7 Hidradenitis Suppurativa (HS) ( 1. 8 Uveitis (UV) ( 1. 9 Adalimumab-fkjp is indicated 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. Adalimumab-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab-fkjp is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-fkjp can be used alone or in combination with methotrexate Adalimumab-fkjp is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-fkjp can be used alone or in combination with non-biologic DMARDs. Adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Adalimumab-fkjp is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older Adalimumab-fkjp is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14. 7 Adalimumab-fkjp 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. Adalimumab-fkjp should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) Adalimumab-fkjp is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. HULIO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Indication: INDICATIONS AND USAGE
HULIO is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1. 1 Juvenile Idiopathic Arthritis (JIA) ( 1. 2 Psoriatic Arthritis (PsA) ( 1. 3 Ankylosing Spondylitis (AS) ( 1. 4 Crohn’s Disease (CD) ( 1. 5 Ulcerative Colitis (UC) ( 1. 6 Limitations of Use Plaque Psoriasis (Ps) ( 1. 7 Hidradenitis Suppurativa (HS) ( 1. 8 Uveitis (UV) ( 1. 9 HULIO is indicated 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. HULIO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). HULIO HULIO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HULIO can be used alone or in combination with non-biologic DMARDs. HULIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. HULIO is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older HULIO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14. 8) HULIO 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. HULIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) HULIO is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients HULIO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Rheumatoid Arthritis Clinical Studies
The data described below reflect exposure to adalimumab in 2468 patients, including 2073 exposed for 6 months, 1497 exposed for greater than one year and 1380 in adequate and well-controlled studies (Studies RA-I, RA-II, RA-III, and RA-IV). Adalimumab was studied primarily in placebo- controlled trials and in long-term follow up studies for up to 36 months duration. The population had a mean age of 54 years, 77% were female, 91% were Caucasian and had moderately to severely active rheumatoid arthritis. Most patients received 40 mg adalimumab every other week [see Clinical Studies (14.1) Table 1 summarizes reactions reported at a rate of at least 5% in patients treated with adalimumab 40 mg every other week compared to placebo and with an incidence higher than placebo. In Study RA-III, the types and frequencies of adverse reactions in the second year open-label extension were similar to those observed in the one-year double-blind portion. Table 1. Adverse Reactions Reported by >=5% of Patients Treated with Adalimumab During Placebo-Controlled Period of Pooled RA Studies (Studies RA-I, RA-II, RA-III, and RA-IV) Adalimumab 40 mg subcutaneous Every Other Week Placebo (N=705) (N=690) Adverse Reaction (Preferred Term) Respiratory Upper respiratory infection 17% 13% Sinusitis 11% 9% Flu syndrome 7% 6% Gastrointestinal Nausea 9% 8% Abdominal pain 7% 4% Laboratory Tests Laboratory test abnormalities were reported as adverse reactions in European trials Laboratory test abnormal 8% 7% Hypercholesterolemia 6% 4% Hyperlipidemia 7% 5% Hematuria 5% 4% Alkaline phosphatase increased 5% 3% Other Headache 12% 8% Rash 12% 6% Accidental injury 10% 8% Injection site reaction Does not include injection site erythema, itching, hemorrhage, pain or swelling 8% 1% Back pain 6% 4% Urinary tract infection 8% 5% Hypertension 5% 3%
Rheumatoid Arthritis and Ankylosing Spondylitis
In patients receiving 40 mg adalimumab every other week, adalimumab mean steady-state trough concentrations were approximately 5 mcg/mL and 8 to 9 mcg/mL, without and with MTX concomitant treatment, respectively. Adalimumab concentrations in the synovial fluid from five rheumatoid arthritis patients ranged from 31 to 96% of those in serum. The pharmacokinetics of adalimumab in patients with AS were similar to those in patients with RA.
Psoriatic Arthritis
In patients receiving 40 mg every other week, adalimumab mean steady-state trough concentrations were 6 to 10 mcg/mL and 8.5 to 12 mcg/mL, without and with MTX concomitant treatment, respectively.
Plaque Psoriasis
Adalimumab mean steady-state trough concentration was approximately 5 to 6 mcg/mL during adalimumab 40 mg every other week treatment.
Adult Uveitis
Adalimumab mean steady concentration was approximately 8 to 10 mcg/mL during adalimumab 40 mg every other week treatment.
Adult Ulcerative Colitis
Adalimumab mean trough concentrations were approximately 12 mcg/mL at Week 2 and Week 4 after receiving 160 mg on Week 0 followed by 80 mg on Week 2. Mean steady-state trough concentrations were approximately 8 mcg/mL and 15 mcg/mL at Week 52 after receiving a dose of adalimumab 40 mg every other week and 40 mg every week, respectively.
Rheumatoid Arthritis
A trend toward higher apparent clearance of adalimumab in the presence of anti-adalimumab antibodies was identified.

Indication: INDICATIONS AND USAGE
HULIO is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) 1. 1 J uvenile Idiopathic Arthritis (JIA) 1. 2 : Psoriatic Arthritis (PsA) 1. 3 : A nkylosing Spondylitis (AS) 1. 4 Crohn’s Disease (CD) 1. 5 Ulcerative Colitis (UC) 1. 6 Limitations of Use Plaque Psoriasis (Ps) 1. 7 Hidradenitis Suppurativa (HS) 1. 8 Uveitis (UV) 1. 9 HULIO is indicated 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. HULIO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). HULIO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HULIO can be used alone or in combination with non-biologic DMARDs. HULIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. HULIO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14. 8) HULIO 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. HULIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) HULIO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Rheumatoid Arthritis Clinical Studies
The data described below reflect exposure to adalimumab in 2468 patients, including 2073 exposed for 6 months, 1497 exposed for greater than one year and 1380 in adequate and well-controlled studies (Studies RA-I, RA-II, RA-III, and RA-IV). Adalimumab was studied primarily in placebo- controlled trials and in long-term follow up studies for up to 36 months duration. The population had a mean age of 54 years, 77% were female, 91% were Caucasian and had moderately to severely active rheumatoid arthritis. Most patients received 40 mg adalimumab every other week [see Clinical Studies (14.1) Table 1 summarizes reactions reported at a rate of at least 5% in patients treated with adalimumab 40 mg every other week compared to placebo and with an incidence higher than placebo. In Study RA-III, the types and frequencies of adverse reactions in the second year open-label extension were similar to those observed in the one-year double-blind portion. Table 1. Adverse Reactions Reported by >=5% of Patients Treated with Adalimumab During Placebo-Controlled Period of Pooled RA Studies (Studies RA-I, RA-II, RA-III, and RA-IV) Adalimumab 40 mg subcutaneous Every Other Week Placebo (N=705) (N=690) Adverse Reaction (Preferred Term) Respiratory Upper respiratory infection 17% 13% Sinusitis 11% 9% Flu syndrome 7% 6% Gastrointestinal Nausea 9% 8% Abdominal pain 7% 4% Laboratory Tests Laboratory test abnormalities were reported as adverse reactions in European trials Laboratory test abnormal 8% 7% Hypercholesterolemia 6% 4% Hyperlipidemia 7% 5% Hematuria 5% 4% Alkaline phosphatase increased 5% 3% Other Headache 12% 8% Rash 12% 6% Accidental injury 10% 8% Injection site reaction Does not include injection site erythema, itching, hemorrhage, pain or swelling 8% 1% Back pain 6% 4% Urinary tract infection 8% 5% Hypertension 5% 3%
Rheumatoid Arthritis and Ankylosing Spondylitis
In patients receiving 40 mg adalimumab every other week, adalimumab mean steady-state trough concentrations were approximately 5 mcg/mL and 8 to 9 mcg/mL, without and with MTX concomitant treatment, respectively. Adalimumab concentrations in the synovial fluid from five rheumatoid arthritis patients ranged from 31 to 96% of those in serum. The pharmacokinetics of adalimumab in patients with AS were similar to those in patients with RA.
Psoriatic Arthritis
In patients receiving 40 mg every other week, adalimumab mean steady-state trough concentrations were 6 to 10 mcg/mL and 8.5 to 12 mcg/mL, without and with MTX concomitant treatment, respectively.
Plaque Psoriasis
Adalimumab mean steady-state trough concentration was approximately 5 to 6 mcg/mL during adalimumab 40 mg every other week treatment.
Adult Ulcerative Colitis
Adalimumab mean trough concentrations were approximately 12 mcg/mL at Week 2 and Week 4 after receiving 160 mg on Week 0 followed by 80 mg on Week 2. Mean steady-state trough concentrations were approximately 8 mcg/mL and 15 mcg/mL at Week 52 after receiving a dose of adalimumab 40 mg every other week and 40 mg every week, respectively.
Rheumatoid Arthritis
A trend toward higher apparent clearance of adalimumab in the presence of anti-adalimumab antibodies was identified.