For adult patients with moderate to severe
rheumatoid arthritis (RA)
Not an actual patient.
DE019—Adult patients with established moderate to severe RA
who had an inadequate response to MTX1,6
Adverse reaction rates observed in clinical trials and OLE studies 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.
DE019 study design intro: 1-year, double-blind, placebo-controlled study of adult patients with established moderate to severe RA who had an inadequate response to MTX. 619 patients were randomized to receive HUMIRA 40 mg EOW + MTX (n=207), HUMIRA 20 mg weekly + MTX (n=212), or placebo + MTX (n=200). The primary endpoints were ACR20 response at Week 24, mean change from baseline in mTSS at Week 52, and mean change from baseline in HAQ-DI physical function score at Week 52.1,6 457 patients from the RCT enrolled in the OLE at Year 1. All patients received HUMIRA 40 mg EOW + MTX.7
Adverse reaction rates observed in clinical trials and OLE studies may not predict the rates observed in a broader patient population in clinical practice.
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.
DE019 study design intro: 1-year, double-blind, placebo-controlled study of adult patients with established moderate to severe RA who had an inadequate response to MTX. 619 patients were randomized to receive HUMIRA 40 mg EOW + MTX (n=207), HUMIRA 20 mg weekly + MTX (n=212), or placebo + MTX (n=200). The primary endpoints were ACR20 response at Week 24, mean change from baseline in mTSS at Week 52, and mean change from baseline in HAQ-DI physical function score at Week 52.1,6 457 patients from the RCT enrolled in the OLE at Year 1. All patients received HUMIRA 40 mg EOW + MTX.7
Adverse reaction rates observed in clinical trials and OLE studies may not predict the rates observed in a broader patient population in clinical practice.
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), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease.
DE019 study design intro: 1-year, double-blind, placebo-controlled study of adult patients with established moderate to severe RA who had an inadequate response to MTX. 619 patients were randomized to receive HUMIRA 40 mg EOW + MTX (n=207), HUMIRA 20 mg weekly + MTX (n=212), or placebo + MTX (n=200). The primary endpoints were ACR20 response at Week 24, mean change from baseline in mTSS at Week 52, and mean change from baseline in HAQ-DI physical function score at Week 52.1,6 457 patients from the RCT enrolled in the OLE at Year 1. All patients received HUMIRA 40 mg EOW + MTX.7
Adverse reaction rates observed in clinical trials and OLE studies may not predict the rates observed in a broader patient population in clinical practice.
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.
*Non-infectious (NI) intermediate, posterior, and panuveitis
DE019 study design intro: 1-year, double-blind, placebo-controlled study of adult patients with established moderate to severe RA who had an inadequate response to MTX. 619 patients were randomized to receive HUMIRA 40 mg EOW + MTX (n=207), HUMIRA 20 mg weekly + MTX (n=212), or placebo + MTX (n=200). The primary endpoints were ACR20 response at Week 24, mean change from baseline in mTSS at Week 52, and mean change from baseline in HAQ-DI physical function score at Week 52.1,6 457 patients from the RCT enrolled in the OLE at Year 1. All patients received HUMIRA 40 mg EOW + MTX.7
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.
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. Data on File. ABVRRTI62270. 3. Data on File. ABVRRTI61956. 4. Breedveld FC, Weisman MH, Kavanaugh AF, et al, for the PREMIER Investigators. The PREMIER study: a multicenter, randomized, double‑blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54(1):26‑37. 5. Breedveld FC, Keystone EC, van der Heijde D, et al. Initial combination therapy with adalimumab plus methotrexate leads to better long‑term outcomes than with either monotherapy in patients with early rheumatoid arthritis: 8‑year results of an open‑label extension of a phase 3 trial. Poster presented at: 2011 ACR/ARHP Annual Scientific Meeting; November 5‑9, 2011; Chicago, IL. 6. Keystone EC, Kavanaugh AF, Sharp JT, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo‑controlled, 52‑week trial. Arthritis Rheum. 2004;50(5):1400‑1411. 7. Keystone EC, van der Heijde D, Kavanaugh A, et al. Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10‑year data in longstanding rheumatoid arthritis. J Rheumatol. 2013;40(9):1487‑1497. 8. Data on File. ABVRRTI63131. 9. Burmester GR, Panaccione R, Gordon KB, et al. Long‑term safety of adalimumab (HUMIRA) in adult patients from global clinical trials across multiple indications: an updated analysis in 29 987 patients representing 56 951 patient‑years. Poster presented at: 2017 ACR/ARHP Annual Meeting; November 3‑8, 2017; San Diego, CA. Poster 2481.
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.
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.
Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.