Bloody-slimy diarrhea, painful urge to defecate, lower abdominal pain and weight loss. The symptoms of ulcerative colitis severely restrict the everyday life of those affected. The symptoms are particularly pronounced during an active flare-up of the disease. The painful symptoms of ulcerative colitis arise from a severe inflammation of the intestinal mucosa. Simponi suppresses the inflammatory process and thus helps promote a longer symptom-free phase. The goal of therapy is to avoid flare-ups, or remission.
So-called TNF antibodies affect the human immune system. Simponi is one of these antibodies. Increased susceptibility to infections and numerous other side effects are the result. Therefore, they are only used if previous attempts at treatment have been unsuccessful.
What is Simponi?
Simponi is the trade name of the drug golimumab. It is a TNF antibody. These are genetically modified proteins. These artificially produced antibodies are used in severe autoimmune diseases. They specifically target the triggers of the inflammatory process and thus help sufferers to be free of symptoms.
How does Simponi work?
Antibodies are an important part of the human immune system. They recognize foreign cells, mark them and signal the immune system that these cells are attacking. The intruder is killed in the ensuing inflammatory process. This is how the body protects itself from harmful pathogens.
However, there can also be disruptions in this process. With autoimmune diseases, antibodies signal the immune system to attack structures in the patient's own body. Chronic inflammation develops then as in ulcerative colitis.
The function of the antibodies is used in medicine to have certain cells in the body attacked by the immune system. To this end, large quantities of specific antibodies are obtained in the laboratory and administered for therapeutic purposes. The antibody golimumab (Simponi) is directed against the tumor necrosis factor-alpha (TNF-alpha). TNF-alpha triggers inflammatory processes in the body and promotes their spread. Simponi binds to TNF-alpha and inactivates it. At the same time, the immune system is signaled that it should destroy TNF-alpha.
So Simponi suppresses the inflammation of the intestinal mucosa in ulcerative colitis and promotes the healing of lesions.
Which diseases does Simponi work on?
Simponi was approved for the treatment of rheumatic diseases in 2009. It improves the underlying inflammatory processes in rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis.
Since 2013, Simponi has also been used for the treatment of the inflammatory bowel disease ulcerative colitis. Large-scale studies are currently examining whether Simponi is also effective in patients with Crohn's disease. The drug is currently not yet approved for the treatment of Crohn's disease (as of June 2019).
At what stage of the disease is Simponi used?
For ulcerative colitis, therapy with TNF antibodies (Simponi) is considered if there is amoderate to severe course of the disease and previous anti-inflammatory therapy was unsuccessful.
TNF antibodies can also be used to treat intolerances to conventional anti-inflammatory drugs. Because the treatment can lead to numerous side effects, this decision should be made by an experienced doctor.
How is Simponi administered?
Simponi is administered in a syringe or autoinjector, in 50 or 100 mg. It is injected directly under the skin (subcutaneously), where the active ingredient is absorbed into the bloodstream comparatively slowly. The injection is initially carried out by the doctor. Later, in special training sessions, patients can learn to use the autoinjectors and syringes on themselves.
Treatment with Simponi for ulcerative colitis is divided into two different stages:
- Initial treatment: First 200 mg are injected, and after two weeks another dose of 100 mg follows.
- Maintenance treatment: Following the initial treatment, 50-100 mg Simponi are injected every four weeks. The amount depends on the body weight and the individual response to the treatment.
How quickly and for how long does Simponi work?
General statements on the onset of action of Simponi cannot be made. After the first intake, Simponi is slowly broken down in the body. If the recommended intake is followed, it takes an average of 14 weeks until a constant level of the active ingredient is reached and the best possible effects are obtained.
Therefore, some treatments should generally be undertaken before making statements about their effectiveness. However, Simponi already works in some patients after the first dose. After Simponi is stopped, it takes about 5 months until the active ingredient has been completely broken down by the body. So far, there is little knowledge as to whether recurrent episodes of illness occur after discontinuation.
What does Simponi cost?
Depending on the dosage and the form of administration, the costs for Simponi are between 2,000 euros for a pre-filled syringe and 6,300 euros for three injectors. The cost will be taken over by the health insurance companies if treatment is prescribed according to current therapy recommendations.
How well does Simponi work?
Two factors are important for long-term therapeutic success: On the one hand, the direct response to Simponi during an acute inflammation, on the other hand, the permanent maintenance of freedom from symptoms (maintenance of remission).
In two large-scale studies, about half of the patients responded to the active ingredient after only six weeks and showed a significant improvement in symptoms. Similarly high response rates were also found after 54 weeks.
The improvement in symptoms is due to the anti-inflammatory property attributed to Simponi. However, there may be a loss of effectiveness if the immune system fights the TNF-alpha blocker. If there is already permanent damage to the intestinal mucosa, Simponi cannot work fully.
What side effects can occur?
In clinical trials of Simponi efficacy, the most common side effects were upper respiratory tract infections. Local reactions at the puncture site, which manifested themselves as reddening, pain, itching and impaired sensation, were also observed.
This is because part of the human immune system is suppressed with the blockade of TNF-alpha which increases the risk of infectious diseases. The list of possible side effects includes numerous other diseases, since TNF-alpha is involved in many processes in the body.
When should Simponi not be taken?
Simponi should never be used in allergic reactions to components of the drug. Simponi should also not be used for severe infections and heart failure. In addition, if there is any suspicion of any of the contraindications mentioned, a doctor must be consulted immediately.
Simponi should be taken for the last time at least six months before pregnancy.
Because Simponi affects the immune system, even small infections can be much faster and more difficult to treat. Special attention should therefore be paid to fever, cough, shortness of breath, flu-like symptoms, diarrhea, wounds, dental problems and a burning sensation when urinating.
What are alternatives to Simponi?
The following TNF antibodies are currently approved for the treatment of severe chronic inflammatory diseases:
- Golimumab (Simponi)
- Adelimumab (Humira)
- Infliximab (Remicade)
All three drugs target TNF-alpha. However, they differ in their manufacture and application:
- Adalimumab (Humira) and Golimumab (Simponi) are human antibodies. They consist of human proteins that also occur in our body. Therefore, many patients tolerate them very well. Both antibodies are injectedd by the patient himself under the skin with a syringe.
- Infliximab (Remicade) is a chimeric antibody. Its components are partly human and partly from mouse cells. Infliximab has been used to treat inflammatory bowel disease for around 20 years. In contrast to adalimumab and golimumab, infliximab is not injected, it is administered by means of infusion into the bloodstream.
Which TNF antibody works best?
So far, there have been no studies that can prove that one of the three drugs works better. However, there is evidence that some people tolerate human antibodies better. In case of intolerance or a lack of effect, a change from a chimeric to a human antibody can help.
With infliximab, the antibody is given directly as an infusion. This can be an advantage for very seriously ill people.
Nutrition also plays a significant role in inflammatory bowel disease. Our Cara Care nutritionists support those affected to additionally improve their digestive health through an individual diet. Find out more about how we do it here.
Viola, A., Pugliese, D., Renna, S., Furfaro, F., Caprioli, F., D’Incà, R., ... & Fiorino, G. (2019). Outcome in ulcerative colitis after switch from adalimumab/golimumab to infliximab: A multicenter retrospective study. Digestive and Liver Disease, 51(4), 510-515.
Gensthaler, M. (2013). Colitis Ulcerosa: Neue Indikation für Golimumab. Pharmazeutische Zeitung. 47/2013. Downloaded on 08.05.2019 from: https://www.pharmazeutische-zeitung.de/ausgabe-472013/neue-indikation-fuer-golimumab/.
Wick-Urban, B. (2013). TNF-alpha-Antagonisten: Immunbiologika bei Entzündungen. Pharmazeutische Zeitung. 27/2013. Downloaded on 08.05.2019 from: https://www.pharmazeutische-zeitung.de/ausgabe-272013/immunbiologika-bei-entzuendungen/.
Europäische Arzneimittel-Agentur. Simponi. Downloaded on 08.05.2019 from: https://www.ema.europa.eu/en/medicines/human/EPAR/simponi.