Humira

Contents


About

Humira, also known as Adalimumab is a fully humanised monoclonal antibody targeting the Tumor Necrosis Factor (TNF), subtype TNFα, implicated in a number pro-inflammatory and autoimmune diseases, such as Crohn's Disease (CD).[1]

Humira may be offered as a treatment when Remicade (Inflixmab) treatments fail. Patients may be non-responsive or "intolerant" to Remicade treatments but achieve Remission after treatment with Humira (21% Remission rates at 1 month; 39% at 6 months; 29% at 1 Year, Humira treatment)[1]

Patients that respond to Humira treatment initially have a 20.3% annual risk of becoming nonresponsive to Humira treatments. In patients that become nonresponsive, 71.4% are able to reduce symptoms, and 39.9% are able to obtain Remission, if Humira doses are increased.

Humira Treatment

Humira is used to treat a number of conditions in which the immune system is highly inflammatory.
-Humira is an approved treatment for:
- Psoriatic Arthritis
- Psoriasis (Severe / Chronic Cases)
- Rheumatoid Arthritis (RA)
- Ankylosing Spondylitis
- Crohn's Disease

Humira Treatment in Crohn's Disease

Humira is an effective treatment for use in Crohn's Disease. Humira is also an effective treatment for inducing and maintaining closure of perianal fistulas in patients with Crohn's Disease.[1][2]
Humira Treatment in Children
- Approximately half of Humira treated children obtain Remission after 6 months of therapy (RESEAT Study, 43% Remission; English Study, 58% Remission).

- Children that were treated with immunosupressants, thiopurine or methotrexate, during Humira treatment had higher rates of remission, but also had a greater number of cases with severe side effects.
Mucosal Healing
Intestinal mucosa healing is thought to be an important factor in long term remission rates. In one study, Humira-treated patients did not significantly differ from placebo-treated patients after 3 months of treatment (Humira treated group, 16% Remission / Mucosal Healing; Placebo treated group, 10% Remission / Mucosal Healing; p=0.34), at 52 weeks of treatment, the Humira treatment group had highly significant Remission Rates (19% Remission / Mucosal Healing), versus the placebo treated patients (0% Remission / Mucosal Healing).[1]

In another study, Humira was shown to induce mucosal healing in 27% of patients at week 12 (versus 13% for placebo) and 24% at week 52 versus 0% of the placebo.[8]

Side Effects

Compared to some other drugs used in the treatment of Crohn's, Humira has relatively few side effects. However, due to it's action of suppressing the immune system it may allow the reactivation of latent infections, such as Tuberculosis, which can spiral out of control with fatal consequences. Screening blood tests are now routinely carried out before patients can access the drug.

Although Humira is used to treat severe cases of Psoriasis, it is possible for patients to develop Drug Induced Psoriasis, a potential risk factor of any TNF-blocker treatment.[3]

Treatment with Humira has side effect risks similar to other TNF-blocker therapies. These include:
  • injection site reaction
  • allergic reactions - rash, difficulty breathing
  • infections - bacterial, viral or fungal
  • lymphoma
  • certain types of skin cancer

Advantages of Humira Over Other Treatments

- Humira specifically targets the pro-inflammatory molecule, TNF-α. As a result, Humira exhibits fewer side effects over more conventional therapies which are more broadly acting immunosupressants.

- Humira is a "fully humanised" monoclonal antibody. This is advantageous over other TNF-blocker therapies that are only "partially humanised" because Humira has fewer side effects due to the immune system reacting to the drug as a "foreign" antigen. Patients have lower rates of allergic responses, and injection-site reactions with Humira versus other TNF-blocker therapies in which the drug is only "partially humanized".

Dose

Humira comes in two forms; an automatic injector pen, or pre-filled syringes, containing 40mg of Adalimumab in 0.8ml of liquid for adults, or 20mg of Adalimumab in 0.4ml of liquid for children.

Humira for Crohn's disease is usually prescribed as four initial, or loading, injections over one or two days, followed by another two injections two weeks later. Then a maintenance rate of one injection every two weeks. However, it can be taken weekly where required.

How to Use the Humira Pen (How to Inject Humira)

For detailed instructions on how to Inject Humira or how to use the Humira Pen for Injections [7], please visit Abbott Labs website located here:

How To Use the Humira Pen for Injections.

Humira Payment Assistance

If you need help paying for your Humira medication you may qualify for a prescription assistance plan.
- Assistance Through Abbott

Humira or Adalimumab Clinical Trials


- Tumor Necrosis Factor Alpha Inhibitor (Lnfliximab, Adalimumab) Treatment for Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease More Information Identifier#: NCT00325078 Bethesda, MD, USA

- Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa (boil-like nodules typically affecting sweat gland areas) USA More Information Identifier#: NCT01468207

- Open-label Study on Small Bowel Lesions Suggestive of Crohn's Disease in Patients With Moderate to Severe Plaque Psoriasis Treated With Adalimumab More Information Identifier#: NCT01556672 Quebec, Canada.

- Switching From Adalimumab to Infliximab (ADA-IFX) More Information Identifier#: NCT01338740 Belgium.

- Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy More Information Identifier#: NCT01144156 Israel.

- Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut (FA-Crohn) More Information Identifier#: NCT01275508 Medizinische Klinik I, University Hospital Erlangen

- The Influence of Adalimumab on Cardiovascular and Metabolic Risk in Psoriasis (CASTIP) Vienna, Austria More Information

Humira Questions?

Abbott offers a telephone service for any questions you may have about your Humira medication. Nurses will answer your call between 8am and 8pm EST (USA). If you are not calling during these times, a nurse will return your call in 30 minutes to 1 hour.[6]

- For Humira Questions Call: 1-800-4-HUMIRA

References and External Links

1. Guidi L, Pugliese D, and Armuzzi A. Update on the management of inflammatory bowel disease: specific role of adalimumab. Clin Exp Gastroenterol. 2011;4:163–172. http://www.ncbi.nlm.nih.gov/pmc/arti.../ceg-4-163.pdf
2. Colombel JF, Schwarts DA, Sandborn WJ, et al. Adalimumab for the treatment of fistulas in patients with Crohn’s disease. Gut. 2009;58:940–948. http://www.ncbi.nlm.nih.gov/pmc/arti...58-07-0940.pdf
3. Fiorino G, Allez M, Malesci A, et al. Review article: TNFα induced psoriasis in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2009;29:921–927. http://onlinelibrary.wiley.com/doi/1...09.03955.x/pdf
4. Humira (adalimumab) Abbott Laboratories Drug label. http://dailymed.nlm.nih.gov/dailymed...a-7159aa5f933d
5. Manufacturers site - http://www.humira.com
6. Humira 24 Hour Nursing Services. http://www.humira.com/myhumira/Nurse...t/Default.aspx
7. How To Use the Humira Pen for Injections.
[pos]8a[/pos][8] http://www.gastrojournal.org/article...159-X/fulltext

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