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Frequently asked questions about HUMIRA
Introduction
 What is HUMIRA? What are the indications for HUMIRA? How extensive is clinical experience with HUMIRA?Efficacy in moderate-to-severe rheumatoid arthritis (RA)
Has HUMIRA + MTX achieved clinical remission (DAS28<2.6) in recent-onset RA patients? How effectively did HUMIRA + MTX improve ACR responses in recent-onset RA patients? Does HUMIRA + MTX inhibit radiographic progression in recent-onset RA patients? Does HUMIRA sustain its efficacy in long-standing RA?Efficacy in psoriatic arthritis (PsA)
How effective is HUMIRA in treating joint symptoms of PsA patients? How effective is HUMIRA in treating skin symptoms of PsA patients?Efficacy in ankylosing spondylitis (AS)
How effectively did HUMIRA reduce pain and inflammation in AS? Can HUMIRA be used for patients with total ankylosis? Is HUMIRA effective in reducing enthesitis?Safety profile
What were the rates of serious adverse events in the PREMIER RA trial? What are the rates of serious adverse events in long-standing, moderate-to-severe RA trials? What were the common (>5%) adverse events in the ADEPT PsA trial? What were the common (>5%) adverse events in the ATLAS AS trial?Dosing
How supplied
myHUMIRA Patient Support Program
Are reimbursement assistance services available through the myHUMIRA Support Program? Are nurse assistance services available through the myHUMIRA Support Program?Introduction What is HUMIRA? The Technology of HUMIRA What are the indications for HUMIRA? How extensive is clinical experience with HUMIRA?
From 1997 to 2007, clinical experience with HUMIRA moved into its 10th year.2,3 More than 190,000 patients worldwide are currently being treated with HUMIRA.3 HUMIRA was first approved for use in moderate-to-severe RA with the largest safety database of all TNF antagonists at the time of the 2002 submission.3 PREMIER, the pivotal trial of first-line use of HUMIRA in moderate-to-severe RA, studied ~800 patients.4 ADEPT is the largest biologic trial in PsA (N=313).5-7 And the ATLAS AS trial evaluated the safety and efficacy of HUMIRA in 315 patients.8 As of April 15, 2005, there are 10,050 patients from long-standing RA trials in the HUMIRA clinical database.2 Efficacy in moderate-to-severe RA
Has HUMIRA + MTX achieved clinical remission (DAS28<2.6) in recent-onset RA patients?
The PREMIER study demonstrated the clinical efficacy of HUMIRA in achieving clinical remission measure (DAS28<2.6) in patients with recent-onset, moderate-to-severe RA. At 2 years, ~1 out of 2 patients (49%) treated with HUMIRA + MTX achieved DAS28<2.6. This was ~2x greater than the number of patients achieving clinical remission with MTX alone (49% vs 25%) (P<0.001). At 1 year, the difference was also significant: DAS28<2.6 was achieved by 43% for HUMIRA + MTX vs 21% for MTX alone (P<0.001).4 How effectively did HUMIRA + MTX improve ACR responses in recent-onset RA patients?
PREMIER demonstrated the clinical efficacy of HUMIRA in patients with recent-onset, moderate-to-severe RA. At 2 years, ~2x as many patients achieved ACR70 and 90 vs MTX alone (P<0.001).4 In addition, ACR50 was achieved by 62% of HUMIRA + MTX patients at 1 year (vs 46% with MTX alone, P<0.001); at 2 years, 59% of HUMIRA + MTX patients achieved ACR50 (vs 43% with MTX alone (P<0.001).4 Does HUMIRA + MTX inhibit radiographic progression in recent-onset RA patients?
The PREMIER study demonstrated significant radiographic inhibition in patients who had early RA with aggressive progression. At 2 years, more HUMIRA + MTX patients showed no radiographic progression (Δ TSS<0.5) vs MTX alone.4 Radiographic progression in HUMIRA + MTX patients occurred less frequently across ACR responses vs patients taking MTX alone at 2 years.9 Inhibition of radiographic progression with HUMIRA + MTX was 5x greater than with MTX alone as measured by mean change in TSS at 2 years (1.9 vs 10.4) (P<0.001).4 Mean change in TSS at 1 year was 5.7 for MTX-treated patients vs 1.3 in HUMIRA + MTX treatment group (P<0.001).4 Does HUMIRA sustain its efficacy in long-standing RA patients?
For patients with long-standing RA and inadequate response to DMARD therapy, the long-term efficacy of HUMIRA + MTX has been proven in controlled trials and open-label extension studies. In controlled trials (ARMADA and DE019), improved clinical responses (as measured by ACR response rates) have been documented at 6 months (P<0.01 vs placebo).10,11 In open-label extension studies, long-term ACR responses have been sustained into Year 7 (DE010, n=15).2,10-12 Efficacy in PsA How effective is HUMIRA in treating joint symptoms of PsA patients?
In the ADEPT trial, HUMIRA produced a powerful response in the joints. The primary endpoint of ACR20 at 12 weeks was achieved by 58% of patients treated with HUMIRA vs 14% with placebo (P<0.001).1,5 70% improvement (ACR70) in joints was achieved in ~1 out of 4 HUMIRA-treated patients at Week 24. And at 48 weeks, ~1 out of 3 patients (30%) achieved ACR70.13 How effective is HUMIRA in treating skin symptoms?
In the ADEPT trial, HUMIRA achieved dramatic improvement in skin lesions. At Week 48, ~1 out of 2 (46%) HUMIRA-treated patients achieved PASI 90.13 PASI 90 was achieved by 42% of HUMIRA-treated patients at Week 24. Two weeks after the first dose, PASI 50 response was significant vs placebo.3 At 24 weeks, 75% of patients treated with HUMIRA had achieved PASI 50 vs 12% with placebo (P<0.001), and 59% had achieved PASI 75 vs 1% with placebo (P<0.001).1,5 Efficacy in AS How effectively did HUMIRA reduce pain and inflammation in AS?
In the ATLAS trial, HUMIRA provided rapid and sustained reduction of pain and inflammation. Significant first-dose ASAS20 response was seen as early as 2 weeks vs placebo.3,8 At Week 12, 58% of HUMIRA-treated patients achieved ASAS20 vs 20.6% with placebo, and improvement was sustained to Week 24 (P<0.001).8 ASAS70 was achieved in 23% of HUMIRA-treated patients vs 5% of placebo patients at Week 12 (P<0.001) and in ~1 out of 4 patients (24%) at Week 24 (P<0.001, HUMIRA vs placebo).3,8 ASAS50 was achieved in 38% of HUMIRA-treated patients vs 10% of placebo patients at Week 12 and in more than 1 out of 3 patients (35%) at Week 24 (P<0.001, HUMIRA vs placebo).3,8 Can HUMIRA be used for patients with total ankylosis?
Responses in patients with total ankylosis were similar to those without total ankylosis. In patients with total ankylosis in the ATLAS trial (n=11), 50% (3 out of 6) HUMIRA-treated patients achieved ASAS20 response at Week 12 compared to 0% (0 out of 5) placebo patients. And at Week 24, 67% of HUMIRA-treated patients (4 out of 6) experienced improvement in pain, inflammation, and function (based on ASAS20 responses) vs 0% (0 out of 5) placebo patients.8 Is HUMIRA effective in reducing enthesitis?
In the ATLAS trial, the efficacy of HUMIRA was shown in enthesitis, a major manifestation of AS.8 At Week 24, HUMIRA reduced enthesitis by 50%.8 The mean change from baseline in MASES score was 2x greater for HUMIRA patients than that seen in placebo patients at both Week 12 (-2.7 vs -1.3; P=0.02) and Week 24 (-3.2 vs -1.6; P=0.005).8 Safety profile What were the rates of adverse events in the PREMIER trial?
The rates of adverse events in the PREMIER trial in early RA were assessed for patients taking HUMIRA + MTX (n=268, 482 patient years of exposure), HUMIRA alone (n=274, 435 patient years of exposure), and MTX alone (n=257, 428.5 patient years of exposure).4,14,15 The rates per 100 patient years in these 3 groups respectively were: serious infection (2.9, 0.7, and 1.6), tuberculosis (0.2, 0, and 0), demyelinating disease (0, 0, and 0), lymphoma (0, 0, and 0.1), and malignancy (0.4, 0.9, and 0.9).4,14,15 What are the rates of serious adverse events in long-standing, moderate-to-severe RA trials?
The rates of serious adverse events in long-standing RA trials were assessed as of August 31, 2002 (N=2468, 4870 patient years of exposure) and as of April 15, 2005 (N=10,050, 12,506 patient years of exposure). The rates per 100 patient years at these 2 time points, respectively, were: serious infection (4.9 and 5.1), tuberculosis (0.27 and 0.27), lymphoma (0.21 and 0.12), demyelinating disease (0.08 and 0.08), SLE/lupus-like syndrome (0.08 and 0.10), congestive heart failure (0.29 and 0.28), and histoplasmosis (0.06 and 0.03).2 What were the common (>5%) adverse events in the ADEPT PsA trial?
Adverse events in the ADEPT PsA trial for patients taking HUMIRA (n=151) vs placebo (n=162) and in the open-label extension* for patients taking HUMIRA (n=285). Common adverse events (>5%) in these groups respectively were: upper respiratory tract infection† (12.6% vs 14.8%, 13.7%), nasopharyngitis (9.9% vs 9.3%, 10.9%), injection-site reaction† (6.6% vs 3.1%, 8.4%), headache† (6.0% vs 8.6%, 6.3%), hypertension† (5.3% vs 3.1%, 4.2%), PsA aggravated (3.3% vs 6.8%, 3.5%), Ps aggravated (2.0% vs 6.2%, 1.1%), diarrhea† (2.0% vs 5.6%, 2.1%), and arthralgia (2.0% vs 5.6%, 3.5%). No cases of tuberculosis, demylinating disease, SLE/lupus like syndrome, or congestive heart failure (CHF) were reported in patients treated with HUMIRA in the ADEPT trial and the *All patients who completed the 24-week trial were eligible for long-term treatment in an open-label extension study (OLE).6 Patients in the placebo group switched to HUMIRA treatment from Week 24 to Week 48. †Not otherwise specified. What were the common (>5%) adverse events in the ATLAS AS trial? Dosing What is the dosing regimen for HUMIRA in moderate-to-severe RA, PsA, and AS?
HUMIRA provides the convenience of every-other-week, at-home dosing. Patients with RA, PsA, or AS can use the recommended dose—40 mg administered every other week as a subcutaneous (SC) injection.1 HUMIRA is available in both convenient, prefilled syringes and the easy-to-use HUMIRA® Pen. It may be administered at home by patients or their caregivers.1 How supplied How is HUMIRA supplied and stored?
HUMIRA is supplied as a sterile, preservative-free solution for SC injection. It comes conveniently packaged for patient use in the new, easy-to-use HUMIRA® Pen, as well as in ready-to-use, prefilled glass syringes designed specifically for patients with limited manual dexterity. HUMIRA must be refrigerated at 36°F-46°F (2°C-8°C) prior to use. No reconstitution is required.1 What is the HUMIRA® Pen?
The HUMIRA® Pen is a single-use, disposable delivery system. It is easy to use and is supported by a range of patient training materials. In the TOUCH study, ~9 out of 10 RA patients preferred the new HUMIRA® Pen over the HUMIRA prefilled syringe, and ~8 out of 10 rated the HUMIRA® Pen as less painful than the HUMIRA prefilled syringe.17 myHUMIRA Patient Support Program
Are reimbursement assistance services available through the myHUMIRA Patient Support Program?
Skilled reimbursement specialists are available through myHUMIRA at 1-800-4HUMIRA (1-800-448-6472) to help patients get access to HUMIRA. They can assist patients in investigating insurance coverage and availability of benefits. They can also provide information and general assistance regarding insurers’ precertification and prior authorization for HUMIRA. And for uninsured and underinsured patients, they can help identify alternative funding sources. Are nurse assistance services available through the myHUMIRA Patient Support Program?
To help patients become more comfortable with their treatment, registered nurses are available to answer questions about HUMIRA at 1-800-4HUMIRA from 8 AM to 8 PM EST (Spanish services available). Registered nurses are also available to provide HUMIRA self-injection training. One-on-one training can be provided at patients’ homes, and workshops can be provided for patients at the physician’s office. Patients’ questions can be answered with follow-up calls. 06G-64C-Q352-11 |
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HUMIRA is indicated 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. HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. HUMIRA can be used alone or in combination with methotrexate. HUMIRA is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in adult patients with psoriatic arthritis. HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 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. 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.
Please see Important Safety Information. Serious and sometimes fatal side effects have been reported with HUMIRA, including tuberculosis and other serious infections.
Please see full prescribing information.
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