For the treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older

Safety data in HS

Well-studied safety profile in clinical trials in adults^1,2

HUMIRA is the only FDA approved treatment for hidradenitis suppurativa.

Clinical trial experience across 11 immune-mediated diseases^1-5

8,000+ patients

treated in clinical studies.

24 years

of clinical trial experience
beginning with rheumatoid
arthritis in 1997.

3 years

Up to 3 years of safety data in HS,
including open-label extension.

Studied to compare weekly vs
every-other-week dosing

Analysis of 15 trials for 5 HUMIRA indications showed no new safety risks or increased rates of select adverse events with weekly vs every-other-week dosing.

No new safety signals in adults

The safety profile of HS was consistent with the safety profile of HUMIRA overall.

Anticipated safety in adolescents

Safety of the recommended HUMIRA dose in the adolescent HS population is anticipated to be consistent with the known safety profile of HUMIRA based on a cross-indication safety profile of HUMIRA in both adults and pediatric patients at similar or higher exposure determined through pharmacokinetic modeling.¹

Clinical trial safety data Clinical trial safety data

OLE safety data OLE safety data

Global safety data Global safety data

Select safety profile from clinical trials across 3 dermatology indications^1,6-13

Serious AE
Any AE leading to trial discontinuation
Serious Infection
Malignancy^a,b
Lymphoma
Active tuberculosis

REVEAL
Adverse events (AE) of interest rates at week 16
(Events/100 PYs)

	HUMIRA (N=814, PYs=250.2)	Placebo (N=398, PYs= 120.7)
Serious AE	6.8	5.8
Any AE leading to trial discontinuation	2.0	0.0
Serious Infection	2.8	3.3
Malignancy^a,b	0.8	0.8
Lymphoma	0.0	0.0
Active tuberculosis	0.0	0.0

REVEAL was a 52-week randomized, double-blind, placebo-controlled study of 1212 adult patients with moderate to severe chronic plaque psoriasis. CHAMPION was a 16-week randomized, double-blind, placebo-controlled study of 161 adult patients with moderate to severe plaque psoriasis.^9,10

PsA

ADEPT
Adverse events (AE) of interest rates at week 24
(Events/100 PYs)

	HUMIRA (N=151, PYs=66.8)	Placebo (N=162, PYs= 71.1)
Serious AE	7.5	15.5
Any AE leading to trial discontinuation	9.0	8.4
Serious Infection	1.5	1.4
Malignancy^a,b	0.0	0.0
Lymphoma	0.0	0.0
Active tuberculosis	0.0	0.0

ADEPT was a 24-week, randomized, double-blind placebo-controlled study in 313 adult patients with active PsA who had an inadequate response to NSAIDs. Co-primary endpoints were ACR 20 response at week 12 and mean change from baseline in mTSS* for HUMIRA-treated patients at week 48 vs placebo at week 24.^1,11,12

HS in adult patients

PIONEER I
Adverse events (AE) of interest rates at week 12 (Period A)
(Events/100 PYs)

	HUMIRA (N=153, PYs=34.9)	Placebo (N=152, PYs= 34.6)
Serious AE	8.6	20.2
Any AE leading to trial discontinuation	2.9	8.7
Serious Infection	2.9	0.0
Malignancy^a,b	0.0	2.9
Lymphoma	0.0	0.0
Active tuberculosis	0.0	0.0

PIONEER II
Adverse events (AE) of interest rates at week 36 (Periods A and B)
(Events/100 PYs)

	HUMIRA (N=163, PYs=57.3)	Placebo (N=163, PYs= 73.4)
Serious AE	14.0	30.0
Any AE leading to trial discontinuation	8.7	17.7
Serious Infection	3.5	5.4
Malignancy^a,b	0.0	0.0
Lymphoma	0.0	0.0
Active tuberculosis	0.0	0.0

PIONEER I (N=307) and II (N=326) were randomized, double-blind, placebo-controlled clinical trials in adult patients with moderate to severe HS receiving HUMIRA 40 mg weekly (after initial doses). Primary endpoint: HiSCR at week 12 (Period A), defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining-fistula count.¹³

Adverse reaction rates observed in clinical trials may not predict the rates observed in a broader patient population in clinical practice.

RISK OF SERIOUS INFECTION¹

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.

Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA.

Do not start HUMIRA in patients with 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

RISK OF MALIGNANCY¹

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.

More cases of malignancies were observed among HUMIRA-treated patients compared to control patients in clinical trials
Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in patients with a known malignancy
Examine all patients, especially patients with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of non-melanoma skin cancer (NMSC) prior to and during treatment with HUMIRA

RISK OF TUBERCULOSIS¹

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death; including active tuberculosis (TB), which includes 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
Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the development of TB in patients who tested negative for latent TB infection prior to initiating therapy

RISK OF LYMPHOMA¹

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including HUMIRA.

The rate of lymphoma in controlled and uncontrolled clinical trials of HUMIRA in patients with RA, PsA, AS, CD, UC, and Ps was approximately 3-fold higher than expected in the general population.

Select global safety profile from clinical trials

Serious adverse events of interest for HUMIRA from the full Prescribing Information¹

Results from 39 global, controlled portions of HUMIRA clinical trials in adult patients

	HUMIRA (n=7,973) Events/100 PYs	Control (n=4,848) Events/100 PYs
Serious infections	4.3	2.9
Non-melanoma skin cancer (NMSC)	0.8	0.2
Malignancies (excluding NMSC)	0.7	0.7

Results from 52 global, controlled and uncontrolled clinical trials

	HUMIRA (n=24,605) Events/100 PYs
Tuberculosis (active)	0.20
Serious opportunistic infections	0.05
Lymphoma^c	0.11

^cThe observed rate of lymphomas is approximately 0.11/100 PYs in clinical trials of HUMIRA-treated patients. This is approximately 3-fold higher than expected in the general population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF blockers.¹

The safety data assessed in the HUMIRA full Prescribing Information include adult patients treated with HUMIRA for various immune-mediated diseases including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS), and uveitis (UV).

^*mTSS or modified Total Sharp Score measures erosions and joint space narrowing, as well as radiographic changes specific to PsA patients, including DIP joints, with a maximum score of 570.¹¹
^aIn REVEAL and ADEPT, malignancies excluded lymphoma and non-melanoma skin cancer.
^bIn PIONEER I and II, malignancies excluded hepatosplenic T-cell lymphoma, leukemia, lymphoma, non-melanoma skin cancer, and melanoma.

AE=adverse event; EW=every week; EOW=every other week;
HSTCL=hepatosplenic T-cell lymphoma; PYs=patient years

No new safety signals were identified in the OLE period^3,16

Select adverse events in the OLE period

Data Table Below is Scrollable

	Continuous HUMIRA EW Population^a (Up to 168 Weeks, n=88, PYs=194.1)		Continuous HUMIRA EW Population^b (Starting in Period A, B, or OLE, n=326, PYs=654.6)
Adverse Event	n (%)	Events (Events/100 PYs)	n (%)	Events (Events/100 PYs)
Any serious AE	12 (13.6)	14 (7.2)	58 (17.8)	87 (13.3)
Any AE leading to discontinuation of study drug	13 (14.8)	15 (7.7)	51 (15.6)	62 (9.5)
Serious infection	3 (3.4)	3 (1.5)	18 (5.5)	20 (3.1)
Any TB (active or latent)	2 (2.3)	2 (1.0)	8 (2.5)	8 (1.2)
Any malignancy other than lymphoma, HSTCL, leukemia, NMSC, and melanoma	0	0	3 (0.9)	4 (0.6)
Any lymphoma	0	0	0	0

RISK OF MALIGNANCY¹

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.

More cases of malignancies were observed among HUMIRA-treated patients compared to control patients in clinical trials
Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in patients with a known malignancy

RISK OF TUBERCULOSIS¹

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death, including active tuberculosis (TB), which includes 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
Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the development of TB in patients who tested negative for latent TB infection prior to initiating therapy

OLE Limitations: As with any long-term OLE there are several limitations with the OLE portion of this study. For example, there is potential for enrichment of the long-term data in the remaining patient population, as those who remain in the study generally fare better than those who discontinue.

HUMIRA has been studied for HS in 2 phase 3 controlled studies and 1 OLE study, and the safety profile for patients with HS treated with HUMIRA weekly dosing was consistent with the known safety profile of HUMIRA.

^aStudy design dosing: HUMIRA EW/HUMIRA EW/HUMIRA EW.

^bContinuous HUMIRA EW population consisted of those who were maintained on HUMIRA EW therapy once they started regardless of whether it was period A, B, or during the OLE (study design dosing: HUMIRA EW/EW/EW, CTRL/HUMIRA EW/HUMIRA EW, and Control/Control/HUMIRA EW populations).

AE=adverse event; EW=every week; EOW=every other week; OLE=open-label extension; PYs=patient years; RCT=randomized controlled trial; TEAE=treatment-emergent adverse events

Well-studied global safety data^2*

Evaluated long‑term safety data from HUMIRA global clinical trials including randomized controlled, open‑label, and long‑term extension studies

Nearly 18 years

of safety data

In 28,939^† adult patients

receiving HUMIRA in select clinical trials^*

From 74 global clinical trials^*†

Serious adverse events of interest across 8 adult indications for HUMIRA^2*†

Adverse reaction rates observed in clinical trials may not predict the rates observed in a broader patient population in clinical practice.

The risks and benefits of HUMIRA should be carefully considered prior to initiating therapy.

Rates displayed as events per 100 patient-years (PYs) as of December 31, 2016

Touch & Drag Table

	Rheumatoid arthritis	Plaque psoriasis	Psoriatic arthritis	Hidradenitis suppurativa	Ankylosing spondylitis	Crohn's disease	Ulcerative colitis	NI Uveitis
SAEs of interest^*	37,106 PYs (n=15,512)	5,479 PYs (n=3,732)	998 PYs (n=837)	1,198 PYs (n=733)	2,120 PYs (n=2026)	4,359 PYs (n=3,896)	3,407 PYs (n=1,739)	1,151 PYs (n=464)
Serious infection	3.9	1.8	2.8	2.8	1.8	6.9	3.5	4.1
Tuberculosis (TB)	0.2	0.2	0.2	0	0.1	0.2	<0.1	0.4
Active TB	0.2	0.2	0.2	0	0.1	0.1	<0.1	0.2
Latent TB	<0.1	0	0	0	0	<0.1	0	0.3
Opportunistic infection^‡	<0.1	0	0	0	0	<0.1	<0.1	0.4
Malignancy^§	0.7	0.5	0.2	0.5	0.2	0.4	0.6	0.7
Lymphoma	0.1	<0.1	0.2	<0.1	<0.1	<0.1	<0.1	<0.1
NMSC	0.2	0.1	0.1	<0.1	0.2	<0.1	<0.1	0.2
Melanoma	<0.1	0.2	0	0	<0.1	0	<0.1	0
Sarcoidosis	<0.1	0	0	0	<0.1	0	0	<0.1
Demyelinating disorder	<0.1	0	0	0	<0.1	0.1	<0.1	0.3
Lupus-like syndrome	<0.1	0	0	0	<0.1	<0.1	<0.1	<0.1
Congestive heart failure	0.2	0.1	0	0.2	<0.1	0	<0.1	<0.1
New onset/ worsening of Ps	<0.1	<0.1	0.1	<0.1	<0.1	<0.1	<0.1	0
Any AE leading to death	0.6	0.2	0.3	0.5	<0.1	0.1	0.1	0.6

^*Total includes the 8 populations shown.
^†Data from 74 clinical trials and their long-term extension studies: 33 in RA, 5 in AS, 3 in PsA, 13 in Ps, 3 in HS, 11 in CD, 4 in UC, and 2 in NI uveitis.
^‡Excludes oral candidiasis and tuberculosis.
^§Excludes lymphoma, hepatosplenic T-cell lymphoma, leukemia, non-melanoma skin cancer, and melanoma.

SAE=serious adverse events; NMSC=non-melanoma skin cancer; Ps=plaque psoriasis; PYs=patient years; TB=tuberculosis

Additional Safety Considerations¹

RISK OF SERIOUS INFECTION¹

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.

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

Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.

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.

RISK OF MALIGNANCY¹

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA.

Postmarketing cases of HSTCL, a rare type of fatal lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. The majority of these cases were in adolescent and young adult males with inflammatory bowel disease who had received concomitant or prior treatment with azathioprine or 6-mercaptopurine.

More cases were observed among HUMIRA-treated adult patients than in controls. Lymphoma, non-melanoma skin cancer (NMSC), acute and chronic leukemia, and others have been reported. Examine all patients for the presence of NMSC prior to and during treatment.

PATIENTS TREATED WITH HUMIRA MAY BE AT RISK FOR OTHER SERIOUS ADVERSE REACTIONS INCLUDING¹:

HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported. If a serious allergic reaction occurs, stop HUMIRA and begin appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

Risk of reactivation may increase in patients who are chronic carriers. Some cases have been fatal. Monitor hepatitis B virus (HBV) carriers during and after treatment with HUMIRA. If reactivation occurs, stop HUMIRA and begin appropriate therapy.

NEUROLOGIC REACTIONS

Exacerbation or new onset central nervous system or peripheral demyelinating disease may occur, including multiple sclerosis, optic neuritis, and Guillain‑Barré syndrome. Exercise caution when considering HUMIRA for patients with these disorders. There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported. Consider stopping HUMIRA in patients with significant hematologic abnormalities.

CONGESTIVE HEART FAILURE

Worsening or new onset congestive heart failure (CHF) may occur. Exercise caution in patients with CHF and monitor them carefully.

AUTOIMMUNITY

Treatment with HUMIRA may result in formation of autoantibodies and, rarely, in development of lupus-like syndrome. Stop HUMIRA if symptoms of a lupus‑like syndrome develop.

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.

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.

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.

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.

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.

Helpful Links

HS efficacy data

HS dosing

Formulary coverage

INDICATION(S) and IMPORTANT SAFETY INFORMATION FOR HUMIRA (adalimumab)¹

INDICATION(S)¹

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.

IMPORTANT SAFETY INFORMATION¹

SERIOUS INFECTIONS

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.
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

References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Burmester, GR, Gordon, KB, Rosenbaum JT, Long-term safety of adalimumab in 29,967 adult patients from global clinical trials across multiple indications: an updated analysis. Adv Ther. 2020;37:364–380. 3. Zouboulis CC, Okun MM, Prens EP, et al. Long-term adalimumab efficacy in patients with moderate-to-severe hidradenitis suppurativa/acne inversa: 3-year results of phase 3 open-label extension study. J Am Acad Dermatol. 2019;80(1):60-69.e2. 4. 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. 5. Ryan C, Sobell JM, Leonardi CL, et al. Safety of adalimumab dosed every week and every other week: focus on patients with hidradenitis suppurativa or psoriasis. Am J Clin Dermatol. 2018;19(3):437-447. 6. Data on file, ABVRRTI61732. 7. Mease PJ, Ory P, Sharp JT, et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68(5):702-709. 8. Data on file, ABVRRTI61791. 9. Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase Ill trial. J Am Acad Dermatol. 2008;58(1):106-115. 10. 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. 11. Gladman DD, Mease PJ, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial. Arthritis Rheum. 2007;56(2):476-488. 12. Mease PJ, Gladman DD, Ritchlin CT, et al; for Adalimumab Effectiveness in Psoriatic Arthritis Study Group. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52(10):3279-3289. 13. 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. 14. 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. 15. Data on file, ABVRRTI61790. 16. Data on file, ABVRRTI66161. 17. Kimball AB, Okun MM, Williams DA, et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med. 2016;375(5)(suppl):1-27. 18. Data on file, ABVRRTI61787.

	HUMIRA^a 40 mg EOW (n=151)		Placebo EOW (n=162)
Parameter: median	Baseline	24 Weeks	Baseline	24 Weeks
Tender joint count^b	20.0	5.0	23.0	17.0
Swollen joint count^c	11.0	3.0	11.0	9.0
Physician global assessment^d	55.0	16.0	53.0	49.0
Patient global assessment^d	48.0	20.0	49.5	49.0
Pain^d	54.0	20.0	49.0	49.0
Disability index (HAQ)^e	1.0	0.4	1.0	0.9
CRP (mg/dL)^f	0.8	0.2	0.8	0.7

	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

	PIONEER I			PIONEER II
		HUMIRA EW(n=153) ^g	Control^e (n=154)^g	HUMIRA EW (n=163)^g	Control^f (n=163)^g
Gender, n (%)	Female Male	91 (59.5) 62 (40.5)	105 (68.2) 49 (31.8)	108 (66.3) 55 (33.7)	113 (69.3) 50 (30.7)
Race,^h n (%)	White Black Otherⁱ	116 (75.8) 33 (21.6) 4 (2.6)	118 (76.6) 29 (18.8) 7 (4.5)	143 (87.7) 9 (5.5) 11 (6.7)	130 (79.8) 20 (12.3) 13 (8.0)
Age in years: mean (SD)		36.2 (10.8)	37.8 (11.3)	34.9 (10.0)	36.1 (12.2)
Body weight in kg: mean (SD)	Female Male	(n=91)92.3 (23.2) (n=62)104.1 (25.8)	(n=105)97.5 (23.1) (n=49)103.1 (28.8)	(n=108)87.3 (21.8) (n=55)95.9 (20.7)	(n=113)90.9 (23.2) (n=50)106.5 (28.4)
Body mass index in kg/m²: mean (SD)		(n=152)33.0 (7.6)	(n=154)34.5 (7.9)	(n=163)31.3 (7.4)	(n=161)32.9 (7.9)

	PIONEER I			PIONEER II
		HUMIRA EW(n=153) ^g	Control^e (n=154)^g	HUMIRA EW (n=163)^g	Control^f (n=163)^g
Hurley Stage,^j n (%)	II III	80 (52.3) 73 (47.7)	81 (52.6) 73 (47.4)	86 (52.8) 77 (47.2)	89 (54.6) 74 (45.4)
Previous systemic treatment (%)	Any	71 (46.4)	63 (40.1)	82 (50.3)	76 (46.6)
Disease duration in years: median (range)		8.8 (1.1, 40.4)	9.4 (1.0, 43.0)	9.0 (1.0, 43.5)	9.9 (1.2, 68.5)
Family history of HS^k		39 (25.5)	32 (20.8)	39 (24.1)	43 (26.4)
hs-CRP in mg/L: mean (SD)^l		(n=152)20.3 (25)	(n=151)17.4 (20.2)	13.3 (18.0)	18.3 (30.7)

	PIONEER I			PIONEER II
		HUMIRA EW(n=153) ^g	Control^e (n=154)^g	HUMIRA EW (n=163)^g	Control^f (n=163)^g
Abscess and inflammatory nodule (AN) count categories, n (%)	≤5 6-10 ≥11	24 (15.7) 54 (35.3) 75 (49.0)	36 (23.4) 33 (21.4) 85 (55.2)	47 (28.8) 61 (37.4) 55 (33.7)	50 (30.7) 51 (31.3) 62 (38.0)
Abscess and inflammatory nodule (AN) count, mean (SD)		14.3 (11.9)	14.4 (14.8)	10.7 (8.1)	11.9 (11.0)
Abscesses, mean (SD)		2.8 (3.5)	2.7 (3.7)	2.0 (2.6)	2.4 (3.3)
Inflammatory nodules, mean (SD)		11.5 (10.9)	11.6 (13.9)	8.6 (6.9)	9.4 (9.6)
Draining fistulas, mean (SD)		4.6 (5.2)	3.8 (4.4)	3.0 (4.1)	3.7 (5.2)

Our Products

Rheumatology

Moderate to Severe

Rheumatoid Arthritis

Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Dermatology

Moderate to Severe

Chronic Plaque Psoriasis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Refractory, Moderate to Severe

Atopic Dermatitis

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Moderate to Severe

Pediatric Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

Safety data in HS

Well-studied safety profile in clinical trials in adults1,2

Clinical trial experience across 11 immune-mediated diseases1-5

8,000+ patients

24 years

3 years

Studied to compare weekly vs every-other-week dosing

No new safety signals in adults

Anticipated safety in adolescents

Select safety profile from clinical trials across 3 dermatology indications1,6-13

Select global safety profile from clinical trials

No new safety signals were identified in the OLE period3,16

Well-studied global safety data2*

Nearly 18 years

In 28,939† adult patients

From 74 global clinical trials*†

Serious adverse events of interest across 8 adult indications for HUMIRA2*†

Additional Safety Considerations1

Helpful Links

INDICATION(S) and IMPORTANT SAFETY INFORMATION FOR HUMIRA (adalimumab)1

INDICATION(S)1

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

MALIGNANCY

HYPERSENSITIVITY

HEPATITIS B VIRUS REACTIVATION

NEUROLOGIC REACTIONS

HEMATOLOGIC REACTIONS

CONGESTIVE HEART FAILURE

AUTOIMMUNITY

IMMUNIZATIONS

ADVERSE REACTIONS

INDICATIONS1

PIONEER I and II STUDY DESIGNS1,3,13,15

PIONEER I control=placebo PIONEER II control=placebo +/- antibiotic

PIONEER I control=placebo PIONEER II control=placebo +/- antibiotic

PIONEER I

PIONEER II

PIONEER I

PIONEER II

PIONEER I

PIONEER II

PIONEER I control=placebo PIONEER II control=placebo +/- antibiotic

PIONEER I

PIONEER II

PIONEER I

PIONEER II

Well-studied safety profile in clinical trials in adults^1,2

Clinical trial experience across 11 immune-mediated diseases^1-5

Studied to compare weekly vs
every-other-week dosing

Select safety profile from clinical trials across 3 dermatology indications^1,6-13

No new safety signals were identified in the OLE period^3,16

Well-studied global safety data^2*

In 28,939^† adult patients

From 74 global clinical trials^*†

Serious adverse events of interest across 8 adult indications for HUMIRA^2*†

Additional Safety Considerations¹

INDICATION(S) and IMPORTANT SAFETY INFORMATION FOR HUMIRA (adalimumab)¹

INDICATION(S)¹

IMPORTANT SAFETY INFORMATION¹

INDICATIONS¹

PIONEER I and II STUDY DESIGNS^1,3,13,15

PIONEER I and II STUDY DESIGNS^1,3,13,15

SELECT BASELINE PATIENT CHARACTERISTICS^13,17

SELECT BASELINE DISEASE CHARACTERISTICS^13,17,18

SELECT BASELINE LESION TYPE^13,17,18

IMPORTANT SAFETY INFORMATION¹

INDICATION(S)¹

IMPORTANT SAFETY INFORMATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION(S)¹

IMPORTANT SAFETY INFORMATION¹

INDICATION(S) and IMPORTANT SAFETY INFORMATION FOR HUMIRA (adalimumab)¹

INDICATION(S)¹