placebo-controlled period
16 weeks
n=108
n=53
Serious Infections: Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Malignancies: Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA.
Other Serious Adverse Reactions: Patients treated with HUMIRA also may be at risk for other serious adverse reactions, including anaphylaxis, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and a lupus-like syndrome.
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.
REVEAL was a randomized, double-blind, placebo-controlled study of 1212 adult patients with chronic plaque psoriasis and ≥10% BSA involvement, PASI score ≥12 and PGA of at least moderate disease severity. Patients had a clinical diagnosis of psoriasis for at least 6 months and stable disease for at least 2 months before screening. Evaluations were performed over 3 treatment periods totaling 52 weeks. Primary efficacy endpoints at week 16 were the proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.2
Tap on an image below to select a photo
Baseline status:
PGA Severe3,4
Week 16 Status:
PGA Minimal3,4
Baseline status:
PASI: 12.83
Week 16 Status:
PASI 75 Improvement3
Baseline status:
PGA Severe3,4
Week 16 Status:
PGA Minimal3,4
Baseline status:
PASI: 15.93
Week 16 Status:
PASI 75 Improvement3
Baseline status:
PGA Moderate5
Week 16 Status:
PGA Clear5
Baseline status:
PASI: 20.33
Week 16 Status:
PASI 75 Improvement3
Baseline status:
PGA Moderate5
Week 16 Status:
PGA Clear5
Baseline status:
PASI: 12.35
Week 16 Status:
PASI 90 Improvement5
Tap play button to see baseline and Week 16
Move slider to see baseline and Week 16
Actual clinical trial patient. Individual results may vary.
REVEAL evaluated 1212 adult patients with chronic plaque psoriasis with ≥10% BSA involvement, a PGA of at least moderate disease severity, and PASI† score ≥12 within 3 treatment periods. For the first 16 weeks, patients were randomized to receive HUMIRA (n=814) at an initial dose of 80 mg subcutaneously (SC) at Week 0 followed by 40 mg SC EOW starting at Week 1, or placebo (n=398). The co-primary endpoints were proportion of patients at Week 16 who achieved PASI 75 and a PGA of clear or minimal.1,2
Click here to view PGA and PASI definitions at the bottom of this section.
Leading up to the primary endpoint measured at Week 16, significant skin clearance was observed in some patients as early as Week 4 and improved throughout Weeks 8 and 12, compared with placebo
*PGA of clear or minimal
Clear defined as no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration.
Minimal defined as possible but difficult to ascertain whether there is slight elevation of plaque above normal skin plus or minus surface dryness with some white coloration, plus or minus up to red coloration.1
Leading up to the primary endpoint measured at Week 16, PASI 75† clearance was observed in some patients as early as Week 4 and improved throughout Weeks 8 and 12, compared with placebo
aPASI 75 represents a ≥75% PASI improvement from baseline
EOW=every other week; PASI=Psoriasis Area and Severity Index; PGA=Physician's Global Assessment
This analysis was based on the intention-to-treat (ITT) population, with missing values imputed as nonresponders.
aPASI 90 represents a ≥90% PASI improvement from baseline
EOW=every other week; PASI=Psoriasis Area and Severity Index; PGA=Physician's Global Assessment
This analysis was based on the intention-to-treat (ITT) population, with missing values imputed as nonresponders.
CHAMPION was a randomized, double-blind, double-dummy, placebo-controlled study of patients with moderate to severe plaque psoriasis. Patients were randomized to receive HUMIRA 80 mg followed by 40 mg every other week (EOW) beginning 1 week later (n=108), or placebo (n=53) in a 2:1 ratio. Co-primary endpoints were proportion of patients achieving PASI 75 relative to baseline and proportion of patients achieving a PGA of clear or minimal at Week 16.9
§PGA response of clear or minimal
The analysis was based on the intention-to-treat (ITT) population, with missing values imputed as nonresponders.
EOW=every other week; PASI=Psoriasis Area and Severity Index; PGA=Physician's Global Assessment
The data assessed in the HUMIRA full Prescribing Information included only patients with a baseline PASI ≥12 in CHAMPION and, therefore, differ from the data shown here.
Extensively studied safety
profile in clinical
studies
and practice10,11
Period C: After 17 weeks of open-label therapy, patients who maintained at least a PASI 75 response at Week 33 and were originally randomized to HUMIRA in Period A were re-randomized to receive either HUMIRA 40 mg EOW or placebo for an additional 19 weeks.2
PASI=Psoriasis Area and Severity Index; PGA=Physician's Global Assessment
aClear defined as no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration.
Minimal defined as possible but difficult to ascertain whether there is slight elevation of plaque above normal skin, plus or minus surface dryness with some white coloration, plus or minus up to red coloration.1
Patients (%)
number of responders
number observed
Patients (%)
aClear defined as no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration.
Minimal defined as possible but difficult to ascertain whether there is slight elevation of plaque above normal skin, plus or minus surface dryness with some white coloration, plus or minus up to red coloration.1
bPatients received HUMIRA 40 mg EOW after 80 mg at Week 0 followed by 40 mg at Week 1, given subcutaneously.
EOW=every other week; mITT=modified intention to treat; PASI=Psoriasis Area and Severity Index; PGA=Physician's Global Assessment
*Physician's Global Assessment (PGA): a static assessment of overall psoriasis severity.
†Psoriasis Area and Severity Index (PASI): A composite score based on the degree of body surface area (BSA) affected by psoriasis and the extent of the erythema, induration, and scaliness of the lesions.2
Just a single loading dose
for new starts or retreatments1
See loading and maintenance
dosing schedule
Baseline:
PGA-F score: 3
(Moderate)18
Week 26:
PGA-F score: 1
(Minimal)18
Photo is of actual clinical trial patient. Individual results may vary.
Tap play button to see baseline and Week 26
Photo is of actual clinical trial patient. Individual results may vary.
Move slider to see baseline and Week 26
Achieving PGA-F (Physician’s Global Assessment of Fingernail Psoriasis) Clear or Minimal requires a PGA-F score of 0 or 1 with ≥2-grade improvement from baseline.1,18
Achieving PGA-F (Physician’s Global Assessment of Fingernail Psoriasis) Clear or Minimal requires a PGA-F score of 0 or 1 with ≥2-grade improvement from baseline.1,18
Achieving mNAPSI (Modified Nail Psoriasis Severity Index) requires ≥75% improvement in mNAPSI from baseline.
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
For full Prescribing Information, visit rxabbvie.com/pdf/humira.pdf
US-HUM-181930
Legal Notices/Privacy Policy. ©2017 AbbVie Inc. North Chicago, IL 60064. If you have any questions about AbbVie's HUMIRAPro.com website that have not been answered click here. This website and the information contained herein is intended for use by US physicians only and is provided for informational purposes only.
References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58(1):106-115. 3. Data on File ABVRRTI61639. 4. Data on File ABVRRTI61723. 5. Data on File ABVRRTI63561. 6. Data on File ABVRRTI63672. 7. Data on File ABVRRTI64647. 8. Wu JJ, Valdecantos WC. Adalimumab in chronic plaque psoriasis: a clinical guide. J Drugs Dermatol. 2017;16(8):779-790. 9. 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. 10. 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. 11. Leonardi C, Papp K, Strober B, et al. The long-term safety of adalimumab treatment in moderate to severe psoriasis: a comprehensive analysis of all adalimumab exposure in all clinical trials. Am J Clin Dermatol. 2011;12(5):321-337. 12. Data on File ABVRRTI61764. 13. 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. 14. Data on File ABVRRTI61780. 15. Papp K, Crowley J, Ortonne J-P, et al. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol. 2011;164(2):434-441. 16. Elewski BE, Rich PA, Okun MM, et al. Adalimumab for nail psoriasis: efficacy and safety from the first 26 weeks of a phase-3, randomized, placebo-controlled trial. Poster presented at: 5th Congress of the Psoriasis International Network (Psoriasis, 2016); July 7-9, 2016; Paris, France. Poster P131. 17. Samman PD, Fenton DA. Samman’s The Nails in Disease (Butterworth-Heinemann Ltd, 1995). 18. Data on File ABVRRTI64046. 19. Cassell SE, Bieber JD, Rich P, et al. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007;34(1):123-129.
1641190-1905426