For adult patients with active psoriatic arthritis (PsA).
Model not an actual patient.
ADEPT—Adult patients with active PsA who had an inadequate response to NSAIDs1,3
Adverse reaction rates observed in clinical trials and OLE studies may not predict the rates observed in a broader patient population in clinical practice.
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.
ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,3 285 patients from the RCT enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.4
ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TB=tuberculosis; TNF=tumor necrosis factor
Adverse reaction rates observed in clinical trials and OLE studies may not predict the rates observed in a broader patient population in clinical practice.
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.
ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,3 285 patients from the RCT enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.4
ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TB=tuberculosis; TNF=tumor necrosis factor
Adverse reaction rates observed in clinical trials and OLE studies may not predict the rates observed in a broader patient population in clinical practice.
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.
ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,3 285 patients from the RCT enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.4
ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open‑label extension; PYs=patient-years; RCT=randomized controlled trial; TB=tuberculosis; TNF=tumor necrosis factor
Adverse reaction rates observed in clinical trials and OLE studies may not predict the rates observed in a broader patient population in clinical practice.
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, or panuveitis
ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,3 285 patients from the RCT enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.4
ACR=American College of Rheumatology; AS=ankylosing spondylitis; CD=Crohn's disease; EOW=every other week; HS=hidradenitis suppurativa; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open‑label extension; Ps=plaque psoriasis; PsA=psoriatic arthritis; PYs=patient-years; RA=rheumatoid arthritis; RCT=randomized controlled trial; TB=tuberculosis; TNF=tumor necrosis factor; UC=ulcerative colitis
Rates displayed as events per 100 patient-years (PYs) as of December 31, 2016
a33 in RA, 5 in AS, 3 in PsA, 13 in Ps, 3 in HS, 11 in CD, 4 in UC, and 2 in NI uveitisb
bNon-infectious (NI) intermediate, posterior, or panuveitis
cExcludes oral candidiasis and tuberculosis
dExcludes lymphoma, hepatosplenic T-cell lymphoma, leukemia, non‑melanoma skin cancer (NMSC), and melanoma
The risks and benefits of HUMIRA should be carefully considered prior to initiating therapy.1
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.
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.
Anaphylaxis and angioneurotic edema have been reported. If a serious allergic reaction occurs, stop HUMIRA and begin appropriate therapy.
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.
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.
Rare reports of pancytopenia, including aplastic anemia, have been reported. Consider stopping HUMIRA in patients with significant hematologic abnormalities.
Worsening or new onset congestive heart failure (CHF) may occur. Exercise caution in patients with CHF and monitor them carefully.
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.
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.
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. ABVRRTI62919. 3. Mease PJ, Gladman DD, Ritchlin CT, et al, for the Adalimumab Effectiveness in Psoriatic Arthritis Trial 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. 4. Mease PJ, Ory P, Sharp JT, et al. Adalimumab for long‑term treatment of psoriatic arthritis: 2‑year data from Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68(5):702‑709. 5. 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. 6. Data on File. ABVRRTI68761.