How Do Biologics Work?

 

Currently, the largest blockbuster drug in America, with about $110 billion dollars in total sales is called Humira (Adalimumab). Humira and an older variation called Remicade are considered the frontline and gold standard treatment for Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis) along with a host of other autoimmune conditions. The drug is a human manufactured antibody which selectively inhibits a key component of the immune system called Tumor Necrosis Factor Alpha (TNF). TNF is involved with the systemic acute-phase inflammatory response and is produced primarily by macrophages, a type of white blood cell. Simply TNF is a primary and secondary factor in protecting the body against foreign invaders like bacteria, viruses, and fungal parasites and additionally plays a role in the body’s prevention of cancer by causing early cancerous cells to die. For those biology nerds out there, here is graphic:

 

Source: http://www.haderermuller.com/portfolio-item/inflammatory-bowel-disease/

Considerations to discuss with your doctor

 

Crohn’s Disease and Ulcerative Colitis are believed to be caused in part by overactivity of TNF and from a scientific standpoint, it makes logical sense that by blocking TNF, the disease would be lessened. This seems accurate given the numerous studies that suggest the vast success of biologics including Humira and Remicade. Even for mild to moderate cases of IBD, biologics are often used, and although severe side effects are rare, the risks are something that you and your physician should consider together before going on the medication.

Here are some considerations to discuss with your doctor:

1) There can be serious allergic reactions to the medication, including the development of Lupus (an autoimmune condition) – like symptoms.

2) The medication can make people more susceptible to serious infections like TB or those caused by bacteria, viruses, and fungi.
3) Liver problems, heart failure, nervous system problems, blood issues, and psoriasis.
4) If you stop using Remicade or Humira, it is difficult to go back on the medication because your body can make its own antibodies against the drug which increases the probability of an adverse immune response.
The fact remains that drugs like Humira and Remicade are vitally needed in the treatment of IBD, however, there are issues when just blocking a vital component of the immune system like TNF. Another consideration is that immunosuppression may actually make symptoms worse given the inhibition of the immune system’s ability to fight inflammatory microbes in the body’s gut. One paper in Discovery Medicine states: “Immunosuppressive therapies for inflammatory disease allow pathogens driving these processes to spread with greater ease.” (1)
In my experience, lifestyle interventions are often not considered by prescribers of anti-TNF drugs and are not considered as a “first try” or even in combination, regardless of the numerous studies and self-reports showing the efficacy of lifestyle interventions. Secondly, like all drug companies Abbvie, the maker of Humira has made large payouts to doctors who prescribe the medicine or who may prescribe it. These payments in 2017 topped $40M. (2) The company is currently being sued by the state of California for giving doctors “…illegal kickbacks ranging from the classic – cash, gifts, and patient referrals, for example – to the more sophisticated professional services. (3)
Okay so in sum is this important for you to consider when starting a biologic like Humira?
I think the answer is yes, but this shouldn’t necessarily stop you from going on the medication if your doctor recommends it. I think it’s important to do your own research and come to your own conclusions. The fact remains that biologics are a life-saving treatment and can show promise for people with moderate to severe IBD.
At IBDCoach we believe that knowledge is power and arming yourself with the facts above (and beyond) will help you make an informed decision if a biologic is right to include into your treatment protocol. Remember, IBDCoach is for educational purposes only. Never make changes to your IBD or health protocol or stop/change your medications without consulting with your physician.
Source:
(1) http://www.discoverymedicine.com/Amy-D-Proal/2014/05/22/inflammatory-disease-and-the-human-microbiome/
(2) https://openpaymentsdata.cms.gov/company/100000000204/summary
(3) https://www.sokolovelawfirm.com/blog/abbvies-humira-pushed-patients-illegally/

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