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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.

Could Oral Contraceptives Help Ease Rheumatoid Arthritis?
Source: MedicineNet Rheumatoid Arthritis Specialty [2015.08.28]
Title: Could Oral Contraceptives Help Ease Rheumatoid Arthritis?
Category: Health News
Created: 8/28/2015 12:00:00 AM
Last Editorial Review: 8/28/2015 12:00:00 AM

UNMC study: knee replacement viable option for rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2015.08.06]
Kaleb Michaud, Ph.D., has for a long time listened to patients with rheumatoid arthritis (RA) talking about improved quality of life after their total joint replacements.

Rheumatoid Arthritis: Test Your Arthritis IQ
Source: MedicineNet Arthritis Specialty [2015.08.06]
Title: Rheumatoid Arthritis: Test Your Arthritis IQ
Category: MedicineNet Quiz
Created: 1/31/2011 12:00:00 AM
Last Editorial Review: 8/6/2015 6:32:37 PM

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

Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: Data from ULTRA 1, 2, and 3. [2014]
are presented... CONCLUSIONS: Remission, mucosal healing, and improved quality of life were

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

more studies >>

Clinical Trials Related to Humira (Adalimumab)

Evaluation of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers [Recruiting]
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous injection in healthy volunteers.

Calprotectin-Directed Humira´┐Ż Maintenance Therapy (CADHUM) [Not yet recruiting]
This is a study that invites adults with Crohn's disease and have been responding well to Adalimumab (Humira «) for at least 6 months. Patients frequently discontinue maintenance medications in Crohn's disease, particularly when in remission. Patients want to know that they truly need to take a medication, yet they don't want to have flares. The purpose of this study is to see that if we monitor the patient, along with looking at changes in their stool samples, we can safely stop the maintenance medication Adalimumab for up to 48 weeks, or add as-needed dosing only, and keep them in remission.

A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis [Completed]
To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis [Completed]
Adalimumab is one of the pharmacological treatments for rheumatoid arthritis (RA) of more recent marketing authorization, and as a result of this, there are only efficacy and safety data from clinical trials with controlled conditions. The study will evaluate the safety and effectiveness of adalimumab in the common clinical practice of RA treatment in Spain, with several types of patients showing concomitant treatments or diseases and compliance. Among the tumor necrosis factor antagonists safety studies, adalimumab safety has been the less investigated in the common clinical practice because of, as a result of its recent marketing, it was not included in the BIOBADASER (Data Base for Biological Products in Spain, Rheumatology Spanish Society), Biologic Products Database of the Spanish Society of Rheumatology ) in which was determined an association between infliximab therapy and the risk of developing active tuberculosis. To ensure the maintaining of the strict common physician practice (no prescription induction), and following the recommendations of the SER (Sociedad Espa├▒ola de Reumatolog├şa, Spanish Society of Rheumatology) consensus documents, it will be selected only those patients that were already in treatment with adalimumab (HUMIRA),(except patients involved in clinical studies with Adalimumab), and had shown good response, or those that fulfilled treatment indication in accordance with the SER recommendations and following the Summary of Products Characteristics of adalimumab (HUMIRA).

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis [Completed]
The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.

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: 2015-08-28

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