Autoimmune diseases are defined as diseases caused by an excessive and incorrect response of the immune system against the body itself. They include more than 80 species, which can affect almost any part of the body. It is the third most common category of diseases after cancer and heart disease.

Autoimmune diseases – including rheumatoid arthritis, inflammatory bowel diseases, psoriasis, etc. – are characterized by dysregulation of various aspects of normal immunity and the generation of inflammation.

They affect it 3%-10% of the general population. The causes of autoimmune diseases are not well understood. What is hypothesized is that environmental factors increase the risk of developing autoimmune diseases when genetic factors are also present. Many genetic risk factors for autoimmune diseases have been identified, but relatively little progress has been made in deciphering the deeper effects of environmental influences.

“The treatment of systemic autoimmune diseases aims to control the inflammation of the disease on the one hand and to prevent the comorbidities of a chronic disease (e.g. heart diseases, etc.) on the other. Recent advances in the understanding of disease pathogenesis and new drug preparation techniques have led to the widespread use of targeted immunotherapy for the treatment of autoimmune diseases. In addition, advanced molecular engineering has enabled the emergence of recombinant protein therapeutics – such as mAbs (Monoclonal Antibodies) and receptor-Ab (Antibody) fusion proteins – that target soluble mediators or cell surface markers of the cells of the Immune System, which are the causes of inflammation”, she points out Mrs. Eleni Komninou Rheumatologist, Director of the Clinic for Autoimmune Rheumatic Diseases Metropolitan General.

What are biological agents?

Biological agents are drug-protein molecules that modify or block the function of cells and mediators of the inflammation that characterizes these diseases. They are modern and specialized treatments, have been used since 1999 and are called “biological” because they are products of biotechnology.

They are specially designed molecules (antibodies) and act on specific factors – they induce inflammation in contrast to classic older drugs (conventional drugs) such as methotrexate etc. – which have a generalized effect on the inflammation process.

How are biologic agents administered?

Because they are protein molecules they are quickly destroyed in the stomach – and for this reason they are administered parenterally, either subcutaneously or intravenously – at regular intervals.

What is their effectiveness?

When the biological agent begins its action most patients show significant improvement, 3-6 months from the start of treatment.

So depending on the type of autoimmune disease and the patient’s body – there will be a reduction in joint pain and swelling, an improvement in morning stiffness and fatigue, and a general improvement in quality of life and functionality.

Although biological agents have a beneficial effect on most patients (50-70%), unfortunately they are not effective for all (primary failure), while in a percentage they are initially effective, but after some time they lose their effectiveness (secondary failure). So more often a patient changes his treatment because of failure and not because of side effects.

So, the recent data prove the great progress in the treatment of Autoimmune Diseases and lay the foundations for future new treatments.
“After the successful introduction of biological factors in the treatment of autoimmune diseases, molecular targets are constantly expanding. Thus the blockade of immune signals by Immune System kinase-inhibitors small molecules and thus also innovative biological drugs, (eg intracellular kinases) is of great interest in terms of therapeutic efficacy and long-term safety.

So it seems that maybe the future is not too far when the scientific community will talk about healing treatments”, he says.

What are their side effects?

Biological agents affect our immune system and therefore infections may occur more often, mainly common respiratory or skin infections and less often opportunistic infections. Pre-start screening includes tests for tuberculosis, hepatitis, blood tests and a chest x-ray. Other possible side effects are allergic reactions, local injection reactions and more rarely generalized allergic reaction.

What about procreation?

Current guidelines call for treatment to be stopped for at least three months before trying to conceive for both sexes. However, there are reports from biologic agent registries and cases from the literature that show safety in administration of some agents up to the second trimester of pregnancy. In any case, individualization and co-decision should be made between the therapist, the couple and the gynecologist.

In conclusion

“The use of biological drugs represents a major advance in the treatment of Autoimmune Diseases. Biological agents that target key components of the dysregulated immune response have dramatically improved the quality of life of patients with Autoimmune Diseases and have transformed treatments for a range of systemic inflammatory autoimmune diseases,” concludes Ms. Komninou.