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.
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.
Approximately 1 out of 3 patients with psoriasis can develop PsA3,4
In one study, 40% of patients are misclassified and are being treated only for skin symptoms.4
BSA=Body Surface Area
70% to 80% of patients with PsA have psoriasis before joint disease manifests6
ADEPT was a 24-week, randomized, double-blind, placebo-controlled study of 313 adults with moderately to severely active PsA. Upon study completion, an open-label extension study was undertaken.8,9
†Not all patients' disease is this severe. Joint damage occurs over time.
—Gottlieb et al. J Am Acad Dermatol. 2008
a315 patients were initially randomized; however, 2 patients did not receive study drug
EOW=every other week
A 24-week, randomized, double-blind placebo controlled trial of HUMIRA in adult patients with moderately to severely active PsA (≥3 swollen joints and ≥3 tender or painful joints) who had an inadequate response to NSAIDs.
Patients must have active psoriatic skin lesions or a documented history of psoriasis.
Primary endpoints were ACR 20 response at Week 12 and change in modified total Sharp score (mTSS) for HUMIRA-treated patients at Week 48 vs placebo at Week 24.
After Week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs.
aFor HUMIRA-treated patients who did not have an mTSS at Week 48, mTSS was imputed by linear extrapolation using the baseline and Week 24 scores.1
bP<0.001 for the difference between HUMIRA at Week 48 vs placebo at Week 24 (primary analysis)
mTSS=modified total Sharp score
Definition of mTSS: Measures erosions and joint space narrowing, as well as radiographic changes specific to PsA patients, including DIP joints, with a maximum score of 528.10
Radiographs were taken at baseline, Week 24, and Week 48.
†No radiographic progression defined as change in mTSS of ≤0.5 from baseline
At Week 24, 91% of HUMIRA-treated patients (n=144) had no radiographic progression* vs 71% of placebo-treated patients (n=152).9
Nearly 9 out of 10 (87%) HUMIRA-treated patients (n=133) had no radiographic progression* after 48 weeks.9
As with any long-term, open-label extension (OLE), there are several limitations with the OLE portion of this study. For example, there is the potential for enrichment of the long-term data in the remaining patient population, as those who remain in the study generally fare better than those who discontinue.
ACR=American College of Rheumatology; EOW=every other week; NRI=National Research Institute
The ACR response analysis is of the intention-to-treat (ITT) population, using NRI methodology. Patients who withdrew, had missing data, or received rescue therapy were counted as nonresponders.
Among patients with PsA who received HUMIRA, the clinical responses were apparent in some patients at the time of first visit (2 weeks) and were maintained up to 88 weeks in the ongoing open-label study.1
HAQ-DI (Health Assessment Questionnaire Disability Index) measured the patient's ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over the past week. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Improvement is measured in this trial by a mean percent decrease from baseline* of HAQ-DI score.
*Improvement is measured in this trial by a mean percent decrease from baseline of HAQ-DI scores. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled).
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
References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014;70(3):512-216. 3. Gladman DD. Epidemiology: psoriatic arthritis. In: Gordon KB, Ruderman EM, eds. Psoriasis and Psoriatic Arthritis: An Integrated Approach. Berlin Heidelberg: Springer-Verlag; 2005:57-65. 4. Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013;69(5):729-735. 5. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 2: psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008;58(5):851-864. 6. Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(suppl 2):ii14-ii17. 7. Bruce IN. Clinical features of psoriatic arthritis. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, eds. Rheumatology. 5th ed. Philadelphia, PA: Mosby Elsevier; 2011:183-1193. 8. Mease PJ, Gladman DD, Ritchlin CT, et al. 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. 9. Gladman DD, Mease PJ, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum. 2007;56(2):476-488. 10. van der Heijde D, Sharp J, Wassenberg S, Gladman DD. Psoriatic arthritits imaging: a review of scoring methods. Ann Rheum Dis. 2005;64(suppl2):ii61-ii64.