What are biologics?
Biologics are therapeutic agents that isolated from living organism through biotechnology and recombinant DNA methods. Biologics composed of proteins that are identical to the body’s signaling proteins. Biologics target specific parts of the immune system, blocking the activity of a key chemical or cell involved in inflammation to treat rheumatoid diseases. Compared to conventional drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Administration methods of most biologics are by injection.
| |
Biologics Agents |
Chemical synthetic drug |
| Molecular structure |
Complicated |
Simple |
| Product inspection |
More difficult |
Easier |
| Price |
More expensive |
Cheaper |
| Administration |
Most are injection |
Variety of formulation |
| Immunogenicity |
Possible |
Unlikely |
Know more about biologic agents
Biologic agents are composed of proteins that are identical to the body’s signaling proteins, which are usually manufactured by biotechnology. Biologic agents target specific parts of the immune system, blocking the activity of a key chemical or cell to reduce inflammation or control disease progression.
In the treatment of rheumatoid arthritis, conventional DMARDs are normally used first. When the patient has not improved enough with conventional DMARDs, Biologic agents are considered. When compared with conventional DMARDs, Biologic agents had a faster onset and relatively less side effects. However, they also cost much higher than conventional DMARDs.
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Mechanism of Action
Biologic agents work by blocking the activity of inflammatory cytokines or cells involved in inflammation. They target the specific components of the immune system that involved in rheumatoid arthritis, e.g. Tumor necrosis factor (TNF), Interleukin (IL), B cell, T cell, etc.
Type of biologic agents
| Tumor Necrosis Factor (TNF) Inhibitors |
Interleukin(IL) 6/17/12/23 inhibitors |
B Cell depletion medication |
T cell inhibitor |
Janus Kinase Inhibitor |
| Adalimumab
Infliximab
Etanercept
Certolizumab
Golimumab |
IL 6
Tocilizumab |
Rituximab |
Abatacept |
Tofacitinib |
| IL 17
Secukinumab*
Ixekizumab*
IL 12/23
Ustekinumab* |
*Agents that are not indicated for rheumatoid arthritis
Points to note
Some biologic agents that require intravenous infusion may cause infusion-related reactions such as flushing, fever, chills, rash, and difficulty breathing. You should notify your health care provider immediately if any of these conditions occur.
These symptoms can be alleviated by drugs or by slowing the rate of infusion.
The use of biologic agents may increase the risk for infections. Before starting biologic agents, the patients need to be screened for latent tuberculosis, hepatitis B and C viruses, and HIV infection. Patients should also maintain proper personal hygiene and avoid going to crowded places. A proper vaccination program should be applied, but live attenuated vaccines are not recommended for patients being treated with biologic agents.
Tumor Necrosis Factor (TNF) Inhibitors*
The combination of a TNF inhibitor and methotrexate was superior to either methotrexate or a TNF blocker alone. According to systematic reviews and meta-analysis, TNF inhibitors used in monotherapy were equally efficacious and similar to methotrexate regarding clinical signs. These agents can be considered for monotherapy in patients who are intolerance or non-adherence to methotrexate.
| Drug Name |
Very Common Side Effects (≥10%) |
Other Considerations |
| Adalimumab |
Headache
Skin rash
Increase risk of infection
Hematologic disorders
Musculoskeletal pain
Injection site reactions |
- Subcutaneous injection every two weeks
- Caution in patients with heart failure or decreased left ventricular function
- Caution in patients with a history of hematologic abnormalities
- Caution and close monitoring when used in elderly (due to increased incidence of infection and malignancy)
- No live vaccines
- Adalimumab crosses the placenta and present in breast milk
|
| Infliximab |
Headache
Abdominal pain
Affect liver function
Antibody development
Increase risk of infection
Infusion-related reaction |
- Intravenous injection every 8 weeks
- Monitor infusion-related reactions
- Caution in patients with heart failure or decreased left ventricular function
- Caution in patients with a history of hematologic abnormalities
- Caution in patients with a history of seizures
- No live vaccines
|
| Etanercept |
Skin rash
Diarrhea
Increase risk of infection
Injection site reaction
Antibody development |
- Subcutaneous injection every one or two weeks
- Caution in patients with heart failure or decreased left ventricular function
- Caution in patients with a history of hematologic abnormalities
- Caution in patients with moderate to severe alcoholic hepatitis
- Caution in patients with a history of seizures
- No live vaccines
- Etanercept crosses the placenta and present in breast milk
|
| Certolizumab pegol |
Nausea
Antibody development
Increase risk of infection |
- Subcutaneous injection with various dosing schedules
- Caution in heart failure patients
- Caution in patients with a history of hematologic abnormalities
- Monitor hypersensitivity reaction
- Certolizumab crosses the placenta and may be present in breast milk
|
| Golimumab |
Hematologic disorders
Antibody development
Increase risk of infection |
- Indicated in combination with methotrexate
- Intravenous injection at week 0, 4 and then every 8 weeks or subcutaneous injection once a month (switching between routes have not been studied)
- Caution in patients with heart failure or decreased left ventricular function
- Caution in patients with a history of hematologic abnormalities
- Monitor hypersensitivity reaction
- Monoclonal antibodies cross the placenta during the third trimester. It is not known if golimumab is present in breast milk
- No live vaccines
|
*Secondary malignancies have been reported in patients receiving TNF inhibitors.
Disclaimer:
The tables of drug information are not exhaustive, for a more comprehensive list or further detailed information; please refer to product information provided by health care professional.
References:
- Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.lexi.com.
- Biologics (Biologic Response Modifiers) Overview | Treatments and Medication | Arthritis.org [Internet]. Arthritis.org. 2018. Available from: https://www.arthritis.org/living-with-arthritis/treatments/medication/drug-types/biologics/drug-guide-biologics.php
- Burmester GR. Overview of biologic agents and kinase inhibitors in the rheumatic diseases. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com
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