Biological drugs / biological medicine / biological drugs
Contents
- 1 Definition
- 2 Some biological drugs (trade names) used for rheumatic diseases
- 3 Indications in rheumatic disease
- 4 Effect
- 5 Side effects (a small selection)
- 6 Caution (a small selection)
- 7 Before start of treatment
- 8 Vaccines
- 9 Bio-similar drugs (bio-similars)
- 10 Follow-up
- 11 Scheduled operations, tooth extraction, implants and root canals
- 12 Literature
Definition
Biological drugs and bio-equivalent drugs (biosimilars) differs from other drugs because they are made from or purified from living cells or tissues. These can be microorganisms (bacteria / viruses / fungi), organs or tissues from plants or animals. The way they are produced is thus different from a traditional chemical drug. As production occurs in various living organisms / bacterial strains, this can give rise to small inequalities in the molecules of which the drug is made up. If a side effect occurs and one wants to know the cause, it is important to be able to track exactly where and when the drug was manufactured.
- Biological drugs are effective, immunosuppressive drugs when used in the right disease. They are also called selective immunomodulatory drugs.
Examples of biological drugs are (reference: Norwegian Medicines Agency, 2017)
- Vaccines
- Botulinum Toxin Type A (Botox)
- Antiserum (antidotes)
- Monoclonal antibodies, for example, newer drugs for the treatment of cancer diseases, Multiple sclerosis and rheumatic diseases such as:
- Interferons, for example for the treatment of multiple sclerosis
- Benepali (etanercept) (TNF inhibitor)
- Benlysta (belimumab) (BAFF inhibitor)
- Cimzia (certolizumab) (TNF inhibitor)
- Cosentyx (secukinumab) (IL 17A inhibitor)
- Enbrel (etaneercept) (TNF inhibitor)
- Flixabi (infliximab) (TNF inhibitor)
- Humira (adalimumab) (TNF inhibitor)
- Hyrimoz (adalimumab) (TNF inhibitor)
- Inflectra (Inflix Simab) (TNF inhibitor)
- Kireret (anakinra) (IL-1 inhibitor)
- MabThera (ritual simab) (B-cell inhibitor)
- Orencia (abatacept) (T-cell / CTLA-4 inhibitor)
- Remicade (Inflix Simab) (TNF inhibitor)
- Remsima (Inflix Simab) (TNF inhibitor)
- RoActemra (tocilizumab) (IL-6 inhibitor)
- Simponi (golimumab) (TNF inhibitor)
- Stellara (ustekinumab) (IL 12 and IL23 inhibitor)
- Zessly (infliximab) (TNF inhibitor)
Biological drugs can be divided according to what part of the immune system they work on.
- TNF inhibitors (adalimumab, certolizumab, etanercept, golimumab, infectious simab)
- B-cell inhibitors are ritual simab (MabThera, Riaxthon) og belimumab (benlysta)
- Interleukin (IL) inhibitors
- IL-1 anakira (Chirred) and canakinumab (Ilaris) against Systemic pediatric arthritis, Adult Stills syndrome, Fever Syndromes, Rheumatoid arthritis
- IL-4 receptor and IL-13 inhibitor, dupilumab (Dupixent) for asthma and severe nasal polyps / sinusitis
- IL-5 receptor antibody benralizumab (Fasenra) against eosinophil asthma
- IL-5 reslizumab (Cinqair) against asthma
- IL-5 relizumab (Cinqair) against eosinophil asthma
- IL-5 mepolizumab (Nucala) against EGPA (Churg-Strauss vasculitis)
- IL-6 tocilicumab (RoActemra) against Rheumatoid arthritis, Giant Cell Arteritis, Systemic child osteoarthritis
- IL-6 sarilumab (Kevzara) against Rheumatoid arthritis
- IL-12/23 inhibitor is ustekinumab (Stellara) against Psoriasis, Psoriatic arthritis, Crohn og Ulcerative colitis
- IL-17 secukinumab (Cosentyx) against Psoriatic arthritis og Anchovy / Ankylosing Spondylitis
- IL-17 brodaluzumab receptor antagonist also inhibits IL-25. Against Psoriasis
- IL-17 ixekizumab (Taltz) against Psoriasis, Psoriatic arthritis og Anchovy / Ankylosing Spondylitis
- IL-23 risankizumab (Skyrizi) against Psoriasis
- IL-23 guselkumab (Tremtua) against Psoriasis
- IL-23 tildrakizumab (Ilumya) against Psoriasis
- T-cell inhibitors abatacept (Orencia)
Indications in rheumatic disease
The drugs are different in mechanism of action and possible side effects. Always inform yourself of "your" current medication (patient information in norwegian here (in Danish)) (EULAR guidelines for doctors, for the drug treatment of rheumatoid arthritis here). Biological drugs are used against a variety of autoimmune, inflammatory rheumatic diseases, both inside and outside officially approved indications. The main rule of use is that the disease is severe and there is insufficient effect of other disease-modifying treatment. A biological drug is often combined with other treatments (for example methotrexate). Here are a selection of indications:
- Rheumatoid Arthritis (Arthritis)
- Juvenile Arthritis (Childhood Arthritis)
- Psoriatic arthritis
- Ankylosing Spondylitis (Bekhterevs)
- Systemic lupus erythematosus (SLE)
- Myositis
- IgG4-related disease
- Behcet's disease
- GPA (Wegener's granulomatosis)
- Takayasu arteritis
Effect
Advances in research on the immune system have enabled the production of biological drugs that reduce activity in particular parts of immune system so that the disease in question becomes less active and harmful. By arthritis (rheumatoid arthritis, RA) it has been shown that approximately XNUM% has the effect of biological drugs (reference: Kearsley-Fleet L, 2018).
Side effects (a small selection)
In general, biological drugs have fewer side effects than traditional immunosuppressive drugs. Nevertheless, it is important to be aware of the following
- Serious infections occur more easily. This applies to both newly acquired as pneumonia by pneumocystis (PCP), Tuberculosis) and fungal infections or disease of latent infection (for example Herpes zoster / shingles, hepatitis B / jaundice (also see Opportunistic infections here (in Danish)). PML caused by JC virus to be very rare.
- Allergic rashes may occur
- Itching, redness, swelling, fever
- Pain and redness at the insertion site
- Drop in number of blood cells (anemia, leukopenia, thrombocytopenia)
- Worsening of heart failure
Caution (a small selection)
- Infection disposal
- Weakened immune system
- Use in high age
- Allergy to the drugs
- Heart failure
- Pregnancy
Before start of treatment
- Inform yourself about the current medication ("your medication")
- A goal for the treatment must be clear (demonstrable evidence of lower disease activity, pain or lower cortisone doses, etc.)
- Investigations by a doctor on infections
- Blood tests (IGRA test, screening for hepatitis B and C, HIV)
- Urine
- X-ray or CT of lungs
- Tuberculosis screening: more here (in Danish)
- Vaccines (against influenza, pneumococci)
Vaccines
- Consider annual flu vaccine
- Evaluate pneumococcal vaccine before starting treatment (effect over 5-10 years)
- Consider hepatitis B vaccine before initiating treatment (exposed persons)
More about vaccines in rheumatic disease here (in Danish)
Bio-similar drugs (bio-similars)
These are also biological drugs. They are similar to the "original preparations" (both in effect and side effect), but are cheaper. More about bio-similar drugs here (in Danish).
Follow-up
Special department or specialists who start treatment, carry out controls as long as the drugs are used and determine when drug treatment can be terminated. The GP also makes checks so that no hospital or specialist is needed each time
- Correct dosage can often be calculated after measuring the drug level in the blood
Scheduled operations, tooth extraction, implants and root canals
If possible, it is recommended to discontinue the biological drug treatment a few weeks before the procedure. The drugs have different action times. It is therefore recommended to stop TNF inhibitors depending on the half-life (stop 4-5 times the half-life) of the individual drug.
- Etanercept (Enbrel, Benepali): 2 weeks prior to surgery
- Adalimumab (Humira): 6XXX weeks before surgery
- Influenza simab (Remicade, Rixaton): 4-XNUM weeks before surgery
- (reference: Radio L, XNUM)
After surgery, treatment begins when the risk of infection is over, often after 2-3 weeks. In case of emergency or major disease activity, individual adjustments must be made.
Literature
Find out about your "drug" here (in Norwegian) (Doctors' Association, patient information)
Medications, BINDEVEVSSYKDOMMER.no