Biologics

Biologics, biologicals, biopharmaceuticals

What are they?

"any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of disease or injuries of man" 
US Food & Drug Administration

Medicinal products manufactured in, or extracted from a biological source

They are often generated by DNA recombinant biotechnology

Novel biological agents utilize the natural ability of the immune system to detect and destroy abnormal cells
Medical Conditions

Biological therapy is shown to be effective in ...

Cancer

Commonly used in many cancers

Auto-immune

E.g: Rheumatoid arthritis, psoriatic arthritis, systemic sclerosis, systemic lupus erythematosus, and .

Inflammatory

E.g: ankylosing spondylitis, Chron's Disease

Transplant Rejection

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Dermatological

E.g: psoriasis

Others

E.g: Asthma, cardiovascular, multiple sclerosis, macular degeneration

Monoclonal Antibodies

Antibodies that are identical


Produced by one type of immune cell


Clones of a single parent cell


Made by hybridoma technology

Hybridoma technology

Monoclonal antibodies drug names are made up of small snippets. 


The suffix allows identification of the medication

E.g: Adalinumab - Monoclonal AntiBody


Pre-suffix provides information about the chimerisation.

"-ximab" 50-90% human antibody e.g abciximab

"-zumab" 95% human antibody e.g omalizumab

"-mumab" 100% human antibody e.g adalimumab

"-momab" mouse antibody e.g ibritumomab


The middle section relects the disease that the  drug was initally intended to treat


 -li- for inflammatory e.g adalimumab

 -cir- for cardiovascular  e.g abciximab

 - tu- for tumours/neoplasia e.g ibritumomab

WHO Nomenclature scheme

Either intravenoulsy or subcutaneously


Regimes differ even with the same medication.


Regimes can be weekly, 2-weekly, monthly, 2-monthly, 3-monthly and 6-monthly

There are numerous conditions monoclonal antibodies are used for


Common conditions include:

  • Solid cancers (various)
  • Leukaemia
  • Chron's disease
  • Rheumatoid arthritis
  • Osteoporosis
  • Transplant rejection
  • Psoriasis

Dental Implications

Ulcerative disorders 


Chron's  & OFG


Sjogrens Syndrome


Oral Cancer

When providing dental treatment for patients on monoclonal antibodies the following should be considered:

  • Specific monoclonal antibody
  • Regime being adminsitered
  • Type of dental treatment being proposed - elective vs emergency

The three dental considerations regarding monoclonal antibodies treatment are:

  • risk of bleeding
  • risk of infection
  • risk of non-healing

All these risks do not apply to all monoclonal antibodies. 


These risks are of particular concern for invasive surgical procedures such as dental extraction, implant surgery and periodontal surgery. 


Where these risks may exist consider:

  • Corresponding with the prescriber
  • Whether pre-operative blood tests are required to check for neutropenia and thrombocytopenia
  • Timing the procedure within the regime to reduce the risks

TIP: If the patient has been on the same drug, same regime for over 12 months and had regular bloods with their prescriber then often no additional measures are required for dental surgery.


This suggests stability in the condition and blood results and therefore no need to consider changing/adjusting either.


Remember not all monoclonals are the same and many of them have little to no impact on dental care. The key is to conisder what cell is the monoclonal targetting.


To further risk manage consider any elevtive dental surgery towards the latter aspect of the drug regime.


If you have any concerns - contact the prescriber. Do not ask the patient to amend/stop the regime yourself.



Ulceration


Candida


Desquamation


Erythema Multiforme


Mucositis


Gingival inflammation


Lichenoid reaction


Delayed/Non-healing post dental extraction inc osteonecrosis of the jaw

Jaw Osteonecrosis

Commonly used medications such as amoxicillin, paracetamol and local anaesthesia appear to have no interactions with these agents


Awareness of providing dental treatment due to potential for predispostion to infections, bleeding and impaired wound healing


All interactions can be checked in the British National Formulary (BNF)

BNF