A first-line biologic treatment that provides...
DURABLE REMISSION
through 56 weeks1
Week 4
CLASSIC‑I
Bio-naïve rapid remission*
in HUMIRA vs control1,2
36% vs 12%
24%
Treatment
Difference
GAIN
Bio-experienced patient remission
in HUMIRA vs control1,3
21% vs 7%
14%
Treatment
Difference
Weeks 26 & 56
CHARM
Durable remission
in HUMIRA
vs control1,4
40% vs 17%
23%
Treatment
Difference
36% vs 12%
24%
Treatment
Difference
Remission at Weeks 26 and 56 in
bio‑naïve and bio‑experienced patients4
Remission at Week 56 by disease duration5,6
Year 4
OLE remission data7
The use of HUMIRA in
CD beyond 1 year has
not been evaluated in
controlled clinical
studies.1
CLASSIC-I Study Design Intro: 4-week, randomized, double-blind, placebo‑controlled study in 299 adults who have had an inadequate response† to conventional therapy. Patients were randomized to one of four treatment arms (± concomitant therapy). Primary endpoint: percentage of patients achieving induction of clinical remission in the 2 higher doses vs control at Week 4.1,2
GAIN Study Design Intro: 4-week, randomized, double‑blind, placebo‑controlled study in 325 adults. Patients were randomized to receive HUMIRA or control (placebo), both ± concomitant conventional therapy. Primary endpoint: percentage of patients achieving induction of clinical remission at Week 4.1,3
CHARM Study Design Intro: 56-week, randomized controlled study in 854 adults. All patients received open-label HUMIRA 80 mg at Week 0 and 40 mg at Week 2. The 499 patients with CR-70 response at Week 4 were randomized to one of three treatment arms (± concomitant conventional therapy) and were included in the analysis. Co-primary endpoints: Clinical remission (Week 26, Week 56) for each HUMIRA group vs control in the 499 patients with CR-70 response at Week 4.1,4
OLE Study Design Intro: This subanalysis includes patients from the CHARM trial who were randomized responders, remained blinded on
HUMIRA 40 mg EOW therapy for the duration of the trial, and entered (n=75) and remained on HUMIRA 40 mg EOW in the OLE.7
EOW=every other week; OLE=open-label extension
*Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150 points.
†Clinical response (CR-70; symptom improvement) was defined as a reduction of ≥70 points from baseline CDAI score.
Week 4
Clinical remission* and response† were achieved as early as 4 weeks in CD patients1,2
Remission for Total Population at Week 4 (Primary Endpoint) – All Patients Were Bio‑naïve1,2
Response for Total Population at
Week 4 (Secondary Endpoint) – All Patients Were Bio‑naïve1,2
aP<0.001, HUMIRA vs control.
bP<0.01, HUMIRA vs control.
*Clinical remission was defined as a Crohn’s Disease Activity Index (CDAI) score <150 points.
†Clinical response (CR-70; symptom improvement) was defined as a reduction of ≥70 points from baseline CDAI score.
Dr. Casey Chapman hosts a panel of experts to discuss clinical trial data and additional analyses in bio-naïve and bio‑experienced CD patients.
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Weeks 26 & 56
HUMIRA delivered remission* and response1,†
Remission for Total Population at Weeks 26 and 56 (Co-primary Endpoints)1,4
~50% of Patients Were Bio-naïve and ~50% of Patients Were Bio-experienced
Double-blind, placebo-controlled period
EOW=every other week
aP<0.001, HUMIRA vs control.
Among patients not in response by Week 12, continued therapy did not result in significantly more responses.1
Statistical Considerations: Subgroup analyses are not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the exploratory nature of the analysis.
Subgroup Analysis Methodology: The subgroup analysis is of the modified intention-to-treat study population (all randomized patients who received ≥1 dose
of study drug and achieved CR-70 at Week 4) achieving clinical remission (decrease in CDAI score to <150) at Weeks 26 and 56, stratified by prior anti-TNF
exposure and using non-responder imputation for missing data. Patients who discontinued double-blind treatment were classified as not in clinical remission.6
CDAI=Crohn’s Disease Activity Index; EOW=every other week
*Clinical remission was defined as a CDAI score <150 points.
†Clinical response (CR-70; symptom improvement) was defined as a reduction of ≥70 points from baseline CDAI score.
~50% of Patients Were Bio-naïve and ~50% of Patients Were Bio-experienced
Statistical Considerations: Post‑hoc analyses are not powered or tested to demonstrate a statistically significant difference in treatment effect; no statistical inferences can be made due to the exploratory nature of the analysis.
Post-hoc Analysis Methodology: This post-hoc analysis was performed on patients in the modified intention‑to‑treat population (all randomized patients who received ≥1 dose of study drug and achieved CR-70 at Week 4) of CHARM who were divided into groups by disease duration: <2 years (n=48), 2 to <5 years (n=62), and ≥5 years (n=232). Clinical remission rates within each group for HUMIRA were compared with control at Week 56.5
EOW=every other week
*Clinical remission was defined as a Crohn’s Disease Activity Index score of <150 points.
Durable response* was achieved at Weeks 26 and 561,4
Response for Total Population at Weeks 26 and 56 (Prespecified Secondary Endpoints)1,4
~50% of Patients Were Bio-naïve and ~50% of Patients Were Bio-experienced
Double-blind, placebo-controlled period
EOW=every other week
aP<0.001, HUMIRA vs control.
*Clinical response (CR-70; symptom improvement) was defined as a reduction of ≥70 points from baseline Crohn’s Disease Activity Index score.
Year 4
Long-term Remission*
Remission Through 4 Years (56-Week RCT + 156-Week OLE)
Among patients not in response† by Week 12, continued therapy did not result in significantly more responses.1
The use of HUMIRA in CD beyond 1 year has not been evaluated in controlled clinical studies.1
OLE Study Design Intro: This subanalysis includes patients from the CHARM trial who were randomized responders, remained blinded on HUMIRA
40 mg EOW therapy for the duration of the trial, and entered (n=75) and remained on HUMIRA 40 mg EOW in the OLE.7
EOW=every other week; OLE=open-label extension; RCT=randomized controlled trial
*Clinical remission was defined as a CDAI score <150 points.
†Clinical response (CR-70; symptom improvement) was defined as a reduction of ≥70 points from baseline CDAI score.
Hear your fellow experts Drs. Miguel Regueiro, Asher Kornbluth, Casey Chapman, and Bincy Abraham discuss clinical trials and additional data analyses
Adult Crohn’s Disease (CD): HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T‑cell lymphoma (HSTCL), a rare type of T‑cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6‑mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
Rheumatoid Arthritis (RA): 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 (JIA): 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 (PsA): 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 (AS): HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Adult Crohn's Disease (CD): HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Pediatric Crohn's Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6‑mercaptopurine, or methotrexate.
Ulcerative Colitis (UC): HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6‑mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti‑TNF agents.
Plaque Psoriasis (Ps): 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 (HS): 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.
References: 1.HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trial. Gastroenterology. 2006;130(2):323-333. 3. Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn’s disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007;146(12):829–838. 4. Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007;132(1):52-65. 5. Data on File REF-43165. 6. Schreiber S, Reinisch W, Colombel JF, et al. Subgroup analysis of the placebo‑controlled CHARM trial: increased remission rates through 3 years for adalimumab‑treated patients with early Crohn’s disease. J Crohns Colitis. 2013;7(3):213-221. 7. Data on File ABVRRTI63406.