WARNING: RISK OF SERIOUS INFECTIONS
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections, have been observed in patients receiving HUMIRA. Some of these infections have been fatal. Anti-tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of reactivation in patients receiving treatment with HUMIRA. However, active tuberculosis has developed in patients receiving HUMIRA whose screening for latent tuberculosis infection was negative.
Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating HUMIRA and during therapy. Treatment of latent tuberculosis infection should be initiated prior to therapy with HUMIRA. Physicians should monitor patients receiving HUMIRA for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. [See Warnings and Precautions (5.1) and Adverse Reactions (6.1)]
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HUMIRA SUMMARY
Patient Information
HUMIRA (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). HUMIRA was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1: [kgr ] constant regions. HUMIRA is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps.
HUMIRA is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs. HUMIRA can be used alone or in combination with MTX or other DMARDs.
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NEWS HIGHLIGHTSMedia Articles Related to Humira (Adalimumab)
Humira receives FDA approval for psoriatic arthritis
Source: The Doctors Lounge - Rheumatology
The FDA approved HUMIRA® (adalimumab) for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis.
Adalimumab plus methotrexate effective for rheumatoid arthritis
Source: The Doctors Lounge - Rheumatology
Adalimumab and methotrexate is about five times more effective than methotrexate alone, according to a new systematic review of studies.
Rheumatoid Arthritis
Source: MedicineNet Arthritis Specialty [2010.02.08]
Title: Rheumatoid Arthritis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 2/8/2010
Long Before Symptoms, Blood May Reveal Rheumatoid Arthritis (HealthDay)
Source: Y! Health Arthritis News [2010.02.01]
HealthDay - MONDAY, Feb. 1 (HealthDay News) -- A blood test can predict rheumatoid
arthritis long before a person notices symptoms, say Swedish
researchers.
Long Before Symptoms, Blood May Reveal Rheumatoid Arthritis
Source: MedicineNet Arthritis Specialty [2010.02.01]
Title: Long Before Symptoms, Blood May Reveal Rheumatoid Arthritis
Category: Health News
Created: 2/1/2010 8:10:00 AM
Last Editorial Review: 2/1/2010
Published Studies Related to Humira (Adalimumab)
Evaluation of two strategies (initial methotrexate monotherapy vs its combination with adalimumab) in management of early active rheumatoid arthritis: data from the GUEPARD trial. [2009.11]
Objectives. In early and active RA despite MTX, continuous treatment with TNF blockers in combination with MTX is recommended.Initial combination of MTX and ADA and then an adjusted based on the disease activity status achieved a faster control of disease activity but did not increase the number of patients for whom anti-TNF-alpha treatment was not needed after 12 weeks nor a better subsequent clinical or radiological outcome than a 3-month delayed initiation of anti-TNF in patients with still active disease despite MTX.
Cost-effectiveness of adalimumab for the maintenance of remission in patients with Crohn's disease. [2009.11]
OBJECTIVE: Adalimumab is a fully human, monoclonal antibody clinically effective for the treatment of active Crohn's disease. The cost-effectiveness of adalimumab versus conventional, nonbiologic pharmacotherapies is unknown. This study evaluated the cost-effectiveness of adalimumab versus conventional, nonbiologic pharmacotherapies in the maintenance of Crohn's disease... CONCLUSION: Adalimumab maintenance therapy seems to be cost-effective versus conventional, nonbiologic therapies for the maintenance of remission in patients with active Crohn's disease.
A prospective, randomised, placebo-controlled study to identify biomarkers associated with active treatment in psoriatic arthritis: effects of adalimumab treatment on synovial tissue. [2009.08]
OBJECTIVE: To determine which of the changes in synovial tissue correlates best with clinical response associated with effective therapy (adalimumab) to facilitate the planning of future studies with therapeutic agents for psoriatic arthritis (PsA)... CONCLUSION: Adalimumab therapy in PsA is associated with a marked reduction in T cell infiltration and MMP13 expression in synovial tissue, suggesting that these parameters could be used as biomarkers that are sensitive to change after active treatment in small proof of concept studies in PsA.
Less radiographic progression with adalimumab plus methotrexate versus methotrexate monotherapy across the spectrum of clinical response in early rheumatoid arthritis. [2009.07]
OBJECTIVE: To determine the relationship between radiographic progression and clinical response for adalimumab plus methotrexate (MTX) versus either monotherapy in patients with early rheumatoid arthritis (RA) in the PREMIER study... CONCLUSION: In patients with early RA, adalimumab plus MTX resulted in less radiographic progression than MTX monotherapy across the spectrum of clinical response, including ACR20 non-responses and remission-like responses.
Adalimumab for the treatment of fistulas in patients with Crohn's disease. [2009.07]
OBJECTIVE: To evaluate the efficacy of adalimumab in the healing of draining fistulas in patients with active Crohn's disease (CD)... CONCLUSIONS: In patients with active CD, adalimumab therapy was more effective than placebo for inducing fistula healing. Complete fistula healing was sustained for up to 2 years by most patients in an open-label extension trial.
Clinical Trials Related to Humira (Adalimumab)
Humira in Rheumatoid Arthritis - Do Bone Erosions Heal? [Completed]
Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis
(RA) patients have found that erosive damage may "heal" in some RA patients treated with
anti-TNF. Repeated examinations of adalimumab (Humira) treated RA patients, using computed
tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and radiography will
allow detailed assessment of the extent of bone repair/healing during adalimumab (Humira)
therapy.
A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis [Active, not recruiting]
To evaluate the safety profile, the effectiveness and the economic impact of adalimumab when
used for the treatment of subjects with active plaque psoriasis who have not adequately
responded to prior psoriasis therapy.
Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis [Completed]
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal
virus in subject with RA receiving adalimumab or placebo
Trial of Adalimumab in Progressive Sarcoidosis [Terminated]
Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by
the buildup of immune-system (fights off infection in the body) cells in organs. These cells
form small groups called granulomas, which lead to inflammation of the surrounding tissue.
Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system).
The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs
in many patients can include redness and painful lumps on the skin, reduced eyesight, joint
pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged
adults.
There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid
hormone) therapy is considered the standard treatment. Only limited benefit has been shown
when using corticosteroid therapy to ease lung symptoms or improve lung function in patients
with sarcoidosis. Also, the effects of other therapies (for example: methotrexate,
cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that
suppress a body's natural defense system [immune system]) which have been used in a small
number of patients are not well known and can cause long term problems.
The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug
Administration) approved for patients with moderately to severely active rheumatoid
arthritis. However, adalimumab is not approved for the treatment of sarcoidosis.
Adalimumab is experimental in this study. The purpose of this study is to evaluate the safety
and effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary
(lung) involvement who show symptoms of the disease even though they are currently being
treated with medication.
Adalimumab in Adult Japanese Subjects With Psoriasis [Active, not recruiting]
To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with
psoriasis
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 5 ratings/reviews, Humira has an overall score of 7. The effectiveness score is 7.20 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Humira review by 35 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Rheumatoid Arthritis |
| Dosage & duration: | | 40 Mil Injection (dosage frequency: every other week) for the period of 3 years |
| Other conditions: | | previous hysterectomy |
| Other drugs taken: | | premarin | | |
Reported Results |
| Benefits: | | relieved pain, swelling, progression of damage to joints |
| Side effects: | | literally none...some mild itching at injection site |
| Comments: | | one injection every other week...only problem with medication was exhorbitant cost |
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| | Humira review by 28 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Crohn's Disease |
| Dosage & duration: | | 40 mil by injection (dosage frequency: every other week) for the period of almost 2 years now |
| Other conditions: | | Anemia |
| Other drugs taken: | | Asacol | | |
Reported Results |
| Benefits: | | Seemed to quiet the disease down especially during the first year. Colonoscopy showed most of the colon healed after that time. Fistulas no longer occurred and stayed healed and erythema on legs did not recur once I started taking this. |
| Side effects: | | Despite most of colon and rectal area healing, my sigmoid colon developed a bad stricture which may require surgery to remove. Was very disappointed that healing did not seem to be complete and now I may have to have surgery. Only side effects from taking the medication I noticed was a very high susceptibility to colds and other easily spread illness. Also length and severity of colds much worse than when not on it. |
| Comments: | | TNF blocker. |
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| | Humira review by 55 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Rheumatoid Arthritis |
| Dosage & duration: | | 40mg. taken every 2 weeks for the period of total of 4 injections Sub Q |
| Other conditions: | | Osteoarthritis, Sjogren's Syndrome, Lupus |
| Other drugs taken: | | Phenobarb, Topamax, Inderal, Zomig, Celebrex, Elavil | | |
Reported Results |
| Benefits: | | I was not on the drug lonng enough to recognize any benefits. Medication was
discontinued when first vessicle appeared. |
| Side effects: | | Acute psoritic rash accompanied by alopecia which required dermatologist care |
| Comments: | | Many creams all were ineffective. Because of the autoimmune disease process, light therapy could not be used. It more or less ran its own course. Took
over 6 months for all rash and outbreak to subside. |
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Page last updated: 2010-02-08
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