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 and Adverse Reactions]
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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 Approved for Ulcerative Colitis Treatment
Source: MedicineNet Ankylosing Spondylitis Specialty [2012.09.29]
Title: Humira Approved for Ulcerative Colitis Treatment
Category: Health News
Created: 9/29/2012 11:00:00 AM
Last Editorial Review: 9/29/2012 11:00:07 AM
Humira Might Help Kids With Tough-to-Treat Crohn's Disease
Source: MedicineNet adalimumab Specialty [2012.08.10]
Title: Humira Might Help Kids With Tough-to-Treat Crohn's Disease
Category: Health News
Created: 8/9/2012 4:06:00 PM
Last Editorial Review: 8/10/2012 12:00:00 AM
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.
In The Most Severe Form Of Rheumatoid Arthritis, Enzyme-Activating Antibodies Identified As A Marker
Source: Health News from Medical News Today [2013.05.25]
In a series of lab experiments designed to unravel the workings of a key enzyme widely considered a possible trigger of rheumatoid arthritis, researchers at Johns Hopkins have found that in the most severe cases of the disease, the immune system makes a unique subset of antibodies that have a disease-promoting role. Reporting in the journal Science Translational Medicine online, the Johns Hopkins team describes how it found the novel antibodies to peptidylarginine deiminase 4, or PAD4, in blood samples from people with aggressive inflammation and connective tissue damage...
Published Studies Related to Humira (Adalimumab)
Adalimumab significantly reduces inflammation and serum DKK-1 level but increases
fatty deposition in lumbar spine in active ankylosing spondylitis. [2012]
CONCLUSION: Our study found that adalimumab was highly effective in reducing
Adalimumab induces and maintains mucosal healing in patients with Crohn's
disease: data from the EXTEND trial. [2012]
and maintaining mucosal healing in patients with Crohn's disease (CD)... CONCLUSIONS: Following induction therapy with adalimumab, patients with
Abatacept for Crohn's disease and ulcerative colitis. [2012]
modulator, in Crohn's disease (CD) and ulcerative colitis (UC) is unknown... CONCLUSIONS: The studies showed that abatacept is not efficacious for the
Improved health-related quality of life and physical function in patients with
refractory chronic gout following treatment with pegloticase: evidence from phase
III randomized controlled trials. [2012]
health-related quality of life (HRQOL) in patients with refractory chronic gout... CONCLUSION: Pegloticase therapy resulted in statistically significant and
Effect of adalimumab on clinical laboratory parameters in patients with Crohn's
disease: results from the CHARM trial. [2012]
(CD)... CONCLUSIONS: Adalimumab therapy for moderately to severely active CD was
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
Reports of Suspected Humira (Adalimumab) Side Effects
Injection Site Pain (3359),
Arthralgia (1933),
Drug Ineffective (1901),
Pain (1672),
Fatigue (1596),
Pyrexia (1505),
Psoriasis (1406),
Headache (1299),
Crohn's Disease (1201),
Nausea (1177), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 11 ratings/reviews, Humira has an overall score of 7.82. The effectiveness score is 8.18 and the side effect score is 8.18. 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 53 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Rheumatoid Arthritis |
| Dosage & duration: | | 40 mg taken every 15 days..self administer injection for the period of 2 years |
| Other conditions: | | none |
| Other drugs taken: | | occassional Motrin and vitamin supplements | | |
Reported Results |
| Benefits: | | I was initially placed on this medication several years ago for RA when Vioxx was pulled. I religiously self administered the medication for two years and then decided to quit because I didn't believe that it was helping much. I took a "holiday" for 16 months and then checked in with my rheumatologist. She suggested that I restart the medicine based upon x-rays and blood work. I have been on it again for 3mos...I feel better...less pain..more energy. |
| Side effects: | | I have not experienced any side effects. |
| Comments: | | I am fortunate that I have good insurance coverage because it is very expensive. As with any medicine...I am concerned about possible long term side effects. However...my grandmother had RA and was severely crippled with the disease. This medication is supposed to prevent joint destruction...I am hoping that it will. |
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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: 2013-05-25
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