HUMIRA (adalimumab) Dermatology HCP Site

Please see Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis.

Rheumatoid Arthritis

Psoriatic Arthritis

Ankylosing Spondylitis

Non-radiographic Axial Spondyloarthritis

Atopic Dermatitis

Ulcerative Colitis

Crohn’s Disease

Visit RINVOQhcp.com

Plaque Psoriasis

Psoriatic Arthritis

Crohn's Disease

Visit SKYRIZIhcp.com

Please see Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy.

Hidradenitis Suppurativa

Juvenile Idiopathic Arthritis

Pediatric Crohn's Disease

Pediatric Ulcerative Colitis

Pediatric Uveitis

Uveitis (Adult)

Other Indications

Visit HUMIRApro.com

US-MULT-230356

Immunology Therapies

Full Prescribing Information

Patient Site

HUMIRA is approved for the treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older.

Not an actual HS patient

WITH HS, THE SURFACE DOESN’T ALWAYS SHOW

THE DISEASE YOU NEED TO TREAT BELOW

PROVEN

HUMIRA is proven as the first FDA-approved biologic for moderate to severe HS²

More than 50,000 patients with HS treated since 2015³

View Safety Data

POWERFUL

Significantly more HUMIRA-treated adult patients achieved HiSCR at Week 12 vs Control^1,4*

View Efficacy at Week 12

DURABLE

Durable primary endpoint HiSCR at Week 12¹

Response rates observed up to 3 years⁵

View 3-Year Data

EVERY-OTHER-WEEK DOSING

80 mg every-other-week maintenance dosing is available for adults and adolescents (≥12 years, ≥132 lb), after 2 initiation doses¹

View Dosing

*Many adults with moderate to severe HS achieved HiSCR at Week 12, defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess count and draining tunnel count.⁴

HUMIRA is FDA-approved to provide significant results in moderate to severe HS patients at Week 12

See data in PIONEER I and II trials:

HiSCR EFFICACY

Primary endpoint

FLARE DATA

LESION SPREAD DATA

Are you prescribing HUMIRA to patients in your practice?

Yes

View HUMIRA efficacy in HS

SEE EFFICACY DATA

View post hoc analysis of lesion spread in HUMIRA-treated patients

SEE LESION SPREAD DATA

View HUMIRA efficacy in HS

SEE EFFICACY DATA

Learn more about how HUMIRA works

SEE THE ROLE OF HUMIRA IN HS

I am not a prescriber of medicine

View and download helpful HUMIRA resources

SEE RESOURCES

Learn about access for your HUMIRA patients

SEE COVERAGE AND ACCESS

Every other week 80 mg maintenance dose for appropriate patients.

Half the injections with 80 mg every-other-week (EOW) maintenance dosing

Available for appropriate patients (≥12 years, ≥132 lb) after 2 initiation doses compared to 40 mg weekly maintenance dosing.¹

DOSING INFORMATION

Watch
"Navigating the Unknown"

Hear real stories of hidradenitis suppurativa from frontline physicians and actual patients. They are stories of systemic inflammation, lesions, and scarring.

99^%
preferred

1% non-preferred^†

99% of National Commercial patients have coverage for HUMIRA as a preferred, first-line^‡ targeted immunomodulator (TIM) on formulary.⁶

National Commercial Formulary coverage under the pharmacy benefit as of August 2022

ACCESS INFORMATION

^†Disadvantaged means a restriction (eg, prior authorization, step edit, quantity limits, or other medical policies) to a product that is not applied consistently across the entire therapeutic class.

^‡Formulary Definitions: Preferred means the product is placed on the plan's preferred formulary. Non-preferred products require a higher out-of-pocket cost or step edit or are placed on a higher tier. Preferred products may also require a step edit depending on the product’s label. First-line refers to a preferred or parity formulary status.

Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.

Male HS patient with arms crossed and smiling.

In addition to forms and resources for your practice, HUMIRA Complete provides support and tools to help patients start and stay on track with their treatment—including injection training, the HUMIRA Complete App, and more.

HUMIRA COMPLETE

INDICATION¹

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

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

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

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start HUMIRA during an active infection, including localized infections.
Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
If an infection develops, monitor carefully and initiate appropriate therapy.
Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

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

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.

AUTOIMMUNITY

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

IMMUNIZATIONS

Patients on HUMIRA should not receive live vaccines.
Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

INDICATIONS¹

Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Juvenile Idiopathic Arthritis: HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
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:

HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.
AbbVie's HUMIRA^® (adalimumab) receives first and only U.S. Food and Drug Administration approval for moderate to severe hidradenitis suppurativa. News release. PRNewswire; September 10, 2015.
Data on file, AbbVie Inc. HUMIRA Treated Hidradenitis Suppurativa Patient Counts. May 2022.
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.
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 a phase 3 open-label extension study. J Am Acad Dermatol. 2019;80(1):60-69.e2.
Data on file, AbbVie Inc., August 2022.

HUMIRA demonstrated significant improvements from baseline in ACR components of disease activity (P<0.001)¹

Touch & Drag Image

	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

^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

HUMIRA demonstrated significant improvements from baseline in every ACR component (P<0.001)¹

Touch & Drag Image

	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.

US-HUMD-200130

PIONEER I and II STUDY DESIGNS^1,3-5

Touch & Drag Image

Chart of PIONEER I and PIONEER II study design.

HUMIRA
40 mg EW
HUMIRA
40 mg EOW
Control

Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.

Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.

At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,^† or if they did not achieve HiSCR and experienced worsening or absence of improvement.^‡

Throughout the OLE, all patients received HUMIRA 40 mg weekly.

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

^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.

SELECT BASELINE PATIENT CHARACTERISTICS^3,6

Touch & Drag Image

	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)

SELECT BASELINE DISEASE CHARACTERISTICS^3,6,7

Touch & Drag Image

	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)

SELECT BASELINE LESION TYPE^3,6,7

Touch & Drag Image

	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 tunnels, mean (SD)		4.6 (5.2)	3.8 (4.4)	3.0 (4.1)	3.7 (5.2)

Baseline characteristics identified as different between PIONEER I and PIONEER II are³:

baseline weight
baseline lesion count

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-210291

PIONEER I and II STUDY DESIGNS^1,3,5,6

Touch & Drag Image

HUMIRA PIONEER I and PIONEER II study designs

HUMIRA
40 mg EW
HUMIRA
40 mg EOW
Control

Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.

Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.

At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,^† or if they did not achieve HiSCR and experienced worsening or absence of improvement.^‡

Throughout the OLE, all patients received HUMIRA 40 mg weekly.

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

^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.

SELECT BASELINE PATIENT CHARACTERISTICS^3,4

Touch & Drag Image

	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)

SELECT BASELINE DISEASE CHARACTERISTICS^3,4,7

Touch & Drag Image

	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)

SELECT BASELINE LESION TYPE^3,4,7

Touch & Drag Image

	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 tunnels, mean (SD)		4.6 (5.2)	3.8 (4.4)	3.0 (4.1)	3.7 (5.2)

Baseline characteristics identified as different between PIONEER I and PIONEER II are³:

Baseline weight
Baseline lesion count

These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.

US-HUMD-210291

PIONEER I and II STUDY DESIGNS^1,3,8,13

The first and only completed Phase 3 trials in HS.

Touch & Drag Image

Chart of the path of continuous EW population for PIONEER I and PIONEER II flare occurrence.

HUMIRA
40 mg EW
HUMIRA
40 mg EOW
Control

Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.

Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.

At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,^† or if they did not achieve HiSCR and experienced worsening or absence of improvement.^‡

Throughout the OLE, all patients received HUMIRA 40 mg weekly.

SELECT BASELINE PATIENT CHARACTERISTICS⁸

Touch & Drag Image

	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)

SELECT BASELINE DISEASE CHARACTERISTICS^8,15

Touch & Drag Image

	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)

SELECT BASELINE LESION TYPE^8.15

Touch & Drag Image

	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 tunnels, mean (SD)		4.6 (5.2)	3.8 (4.4)	3.0 (4.1)	3.7 (5.2)

Baseline characteristics identified as different between PIONEER I and PIONEER II are¹³:

baseline weight
baseline lesion count

These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.

US-HUMD-210291

IMPORTANT SAFETY INFORMATION¹

SERIOUS INFECTIONS

INDICATION¹

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

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

IMPORTANT SAFETY INFORMATION¹

SERIOUS INFECTIONS

INDICATION¹

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

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

INDICATION¹

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

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

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.

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

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

WITH HS, THE SURFACE DOESN’T ALWAYS SHOW

THE DISEASE YOU NEED TO TREAT BELOW

PROVEN

POWERFUL

DURABLE

EVERY-OTHER-WEEK DOSING

HUMIRA is FDA-approved to provide significant results in moderate to severe HS patients at Week 12

See data in PIONEER I and II trials:

Half the injections with 80 mg every-other-week (EOW) maintenance dosing

Watch "Navigating the Unknown"

99% of National Commercial patients have coverage for HUMIRA as a preferred, first-line‡ targeted immunomodulator (TIM) on formulary.6

INDICATION1

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)1

INDICATIONS1

References:

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

PIONEER I

PIONEER II

PIONEER I and II STUDY DESIGNS 1,3,8,13

SELECT BASELINE PATIENT CHARACTERISTICS8

PIONEER I

PIONEER II

SELECT BASELINE DISEASE CHARACTERISTICS8,15

PIONEER I

PIONEER II

SELECT BASELINE LESION TYPE8.15

PIONEER I

PIONEER II

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

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

INDICATION1

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

INDICATION1

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

INDICATION1

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)1

INDICATIONS1

Watch
"Navigating the Unknown"

99% of National Commercial patients have coverage for HUMIRA as a preferred, first-line^‡ targeted immunomodulator (TIM) on formulary.⁶

INDICATION¹

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

INDICATIONS¹

PIONEER I and II STUDY DESIGNS^1,3,8,13

SELECT BASELINE PATIENT CHARACTERISTICS⁸

SELECT BASELINE DISEASE CHARACTERISTICS^8,15

SELECT BASELINE LESION TYPE^8.15

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

INDICATIONS¹