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Humira (Adalimumab) - Summary

 
 



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]

 

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.


See all Humira indications & dosage >>

NEWS HIGHLIGHTS

Media 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.

Positive top-line results from Phase 3 trial of baricitinib in moderate to severe rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2014.12.11]
Eli Lilly and Company and Incyte Corporation have announced that the Phase 3 RA-BEACON study of the investigational medicine baricitinib met its primary endpoint of improved ACR20 response compared...

Patient Story: Rheumatoid Arthritis and Pregnancy
Source: MedicineNet Arthritis Specialty [2014.12.09]
Title: Patient Story: Rheumatoid Arthritis and Pregnancy
Category: Doctor's Views
Created: 1/26/2012 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM

Rheumatoid Arthritis: Which Patients Do Best?
Source: MedicineNet Rheumatoid Arthritis Specialty [2014.12.09]
Title: Rheumatoid Arthritis: Which Patients Do Best?
Category: Doctor's Views
Created: 1/19/2012 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM

more news >>

Published Studies Related to Humira (Adalimumab)

Escalation to weekly dosing recaptures response in adalimumab-treated patients with moderately to severely active ulcerative colitis. [2014]
week 8 response (i.e. response after adalimumab induction therapy)... CONCLUSIONS: Escalation to weekly adalimumab dosing demonstrated clinical

Randomized, placebo controlled and double-blind trials of efficacy and safety of adalimumab for treating ankylosing spondylitis: a meta-analysis. [2014]
Adalimumab is a fully human, anti-TNF monoclonal antibody of proven efficacy and safety in the treatment of the signs, symptoms and functional disability of ankylosing spondylitis (AS). A systematic review and meta-analysis was performed to assess the efficacy and safety of adalimumab treatment, relative to a placebo, in adult patients with AS...

Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI). [2014]
disease (CD)... CONCLUSIONS: Combination therapy of adalimumab and ciprofloxacin is more

Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE. [2013]
years of treatment... CONCLUSIONS: Prolonged adalimumab therapy maintained clinical remission and

Serum adalimumab concentration and clinical remission in patients with Crohn's disease. [2013]
Studied as Induction Therapy in Crohn's Disease (CLASSIC) I/II... CONCLUSIONS: A positive association between serum adalimumab concentration and

more studies >>

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

more trials >>

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based 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

 

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.

 

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.

See all Humira reviews / ratings >>

Page last updated: 2014-12-11

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