With changing time the treatment for psoriasis is also changing,with new treatments coming into the market for this disease. Biologics is the new treatment that has come into the world of psoriasis.
Biologics is another word for “Biologic drugs”. This is a new mode of treatment for psoriatic arthritis as well as psoriasis. These drugs are administered through intravenous infusion or by injections. Biologics are derived from proteins and are made in a laboratory extracting fom living cells like bacteria which are engineered to create protein.
The differentiating factor between the normal drugs for the immune system and biologics, is biologics affects only particular parts of the immune system whereas the normal drugs of the immune system affect the complete immune system.Biologics has the capability of blocking the affect of proteins on our immune system,also it may also stop the affect of T cells on the immune system.Proteins that are blocked by biologics may include TNF or tumor necrosis factor alpha or some interleukins in our immune system. These proteins and cells play a major role why people suffer from psoriasis and psoriatic arthritis.
Types of Biologics
At present there are 6 biologics approved by the U.S FDA or Food and Drug Administration for the treatment of psoriatic arthritis and psoriasis:
Why Raptiva was pulled from the shelf
Raptiva (efalizumab) the seventh biologic was pulled out of the market in 2009 as it was related to the outbreak of a severe nervous system infection termed as progressive multifocal leukoencephalopathy or PML. Initially Raptiva was used by a number of patients for a long time, which proves that unless a drug has been used by a handful of patients for a long time, we cannot know of its possible side effects.
Even though the biologics Remicade, Enbrel,Simponi and Humira differ in their makeup details they target the same part of immune system, a molecule named as Tumor Necrosis Factor-alpha (TNF-alpha). These drugs are also called “TNF-inhibitors”.It is a substance that promotes inflammation and is formed in large quantities in the patients suffering from psoriasis.
Amevive affects immune cells or T-cells that form in the joints and skin of patients suffering from psoriasis. T-cells are indirectly or directly the reason behind the formation of the substances that cause inflammation, and it also includes TNF-alpha.
The targets of Stelara are interleukin-23 (IL23) and interleukin-12 (IL12), molecules of immune system that are found in large quantities at affected areas of psoriasis.
For adults suffering from considerable to severe psoriasis the biologics approved by the FDA are Enbrel, Ameive, Stelara, Humira, and Remicade. Remicade, Humira, Simponi and Enbrel are the ones that are prescribed for psoriatic arthritis. Researches are still in progress to find advanced treatments.There are no biologics approved yet for children/minors suffering from psoriasis,although there are some approved but for different diseases. The point to be noted here is that biologics come with strict warnings alerting medical professionals about the risks of lymphoma and different malignancies in adolescents and children who are being treated with TNF blockers. Its yet to be proved if this risk is also prevalent in IL-23/12 inhibitors as we don’t have enough data.
The biologic agents have proved to be very effective treatment for psoriasis, healing a number of people suffering from severe disease with side effects that are tolerable in most of the cases. In simple words, number of people have taken this drug,experienced huge improvement with very less or no side effects.Even though the U.S FDA keeps tab of the percentage of people who got cured up to 75% in twelve weeks of their treatment,patients who even get cured “just” 50% get thrilled seeing the results.There are cases where patients have seen an improvement of even 90% with these biologics.
Risks of Biologics
But they do not come without risks. In worst cases,the side effects are severe,which have led to quite a few casualties.( But if the person is “not” suffering from heart disease, hepatitis B,tuberculosis or any other severe preexisting illness, the chances of the side effects gets unlikely). And the fact that Remicade, the oldest biologic had been approved by the FDA in 1998 for Crohn’s disease, its yet to be established as to how safe they are in the long term.There are debates and concerns, about the chances for aggravating risk of cancer by affecting the immune system because of the biologic treatment. As a matter of fact,product labels also reflect that there are increased chances of lymphoma or different forms of cancer.( Patients suffering from rheumatoid arthritis who were administered Enbrel for a period of 10 years have shown no traces of cancer. This is a good news and we can hope that the fact remains true).
Cost of Biologics treatment
Lastly, biologics do not come cheap. They are very expensive and can be afforded only by few patients who do not have an insurance coverage.To help the people suffering from these diseases there are many companies which offer programs so that patients can afford the treatments.
But for people suffering from significant psoriasis,these drugs offer many powerful options and chances of major improvements in the emotional and physical well being.
TNF-Inhibitors: Remicade,Simponi,Humira and Enbrel.
The TNF-Inhibitors (Remicade,Simponi,Humira and Enbrel) are very highly efficient drugs for plaque psoriasis. Patients ranging from half to three quarters have seen an improvement of 75% in their illness after using the drugs for few months. These drugs are also very efficient in cases of psoriatic arthritis or (PsA).
This section of biologics reduces the amount of active TNF-alpha present in the patient’s body. TNF-alpha is a molecule of the immune system which promotes inflammation. If regulated properly, it plays a major role in protecting the body from outside infection, but if produced in excess amount,its harmful, leading to psoriasis type of diseases. Symptoms of psoriasis gets aggravated dramatically if the level of TNF-alpha gets reduced by a TNF-inhibitor.
All the TNF-inhibitors come with very uncommon but severe side effects.The side effects include: re-surfacing of previously existing infections like hepatitis B and tuberculosis, serious infections, multiple sclerosis(disease affecting the brain and spinal cord),congestive heart failure,cancer and decreased WBC count.Its not necessary that every TNF-inhibitor has the same side effects,but since all of them are known to work in the same way,doctors feel that all of them have the chances of bring out similar side effects. By differentiating patients with conditions that put them at risk for severe side effects and carefully monitoring patients with these medications, the risk can be minimized by the doctors.
Biologics with Different Targets: Stelara and Amevive
In 2003, Amevive was the first biologic which got the green signal for treating of plaque psoriasis from FDA. In 2009,Stelara also got the approval from FDA thus becoming the most recent of all. Both these drugs are administered in the office of physician,which can be either good or bad thing depending on the kind of insurance coverage the patient has.
Stelara received quite a buzz as it became the first treatment to be approved by FDA that targets IL-23 and IL-12,also because of the fact that after the initial doses, in a year it can be taken as few as 4 times. Amevive, even though is used less compared to other biologics, is interesting as it leads to a remission that lasts for quite a few months even though the treatment ends. In most of the treatments of psoriasis,once the treatment stops it may come back again.
Even though biologics has changed many lives,there are others who still suffer with this disease.There are patients who cannot afford these treatments because of high cost and/or insurance issues;some cannot use them because of preexisting conditions (HIV,TB,cancer etc); some have issues with the side effects or the uncertainties in the long run; and some do not even know about the new treatments. There are people for whom the biologic do not work in the first try(as,no biologic works in all cases).
There are cases when it appears that the biologic is not working on the patients, then the leading physicians have to consider that case. There have been instances when the patients are advised to keep patience, as there have been cases of improvement of clinical response for few patients after 16 weeks or 24 or even 12. It may also happen that one biologic fails for a psoriasis patient whereas the other will succeed. This may be because for each biologic the action mechanism varies slightly.
Yet it is evident that at present whatever is the product landscape, that would not work for everyone. There are biologics which patients can self inject. There are physicians who are ready to experiment with the medications that are prescribed for other problems so that they can try and help psoriasis patients who do not get the right response from the medicines prescribed for psoriasis. This is called “off-label”use, in which patients are administered with medications that are prescribed for different immune diseases. This idea of trying different medications is also used for Crohn’s disease and rheumatoid arthritis.Even treatments of MS and diabetes are also considered as they also have immunological roots.
Initially it was perceived that the treatment for diabetes Avandia (rosiglitazone maleate) may work for the patients of psoriasis but it was disproved by the Phase Three studies which was good enough for the patients as there was controversy about the safety of the drug. Orencia (abatacept), accepted by FDA for rheumatoid arthritis, was known to improve the symptoms of psoriasis many years ago.With the improvement in the treatments for Crohn’s and RA and different immune diseases there are more options for patients with psoriasis,as the pipeline for psoriasis treatment is full of potential options.Many of them may not be accepted as they have to go through medical trials and tests but few of them are sure to join the list of treatments.
It is important that the study on psoriasis continues until and unless all patients are safe and cured.People who have been cured with the current treatment should also stay committed to help those who are still suffering.
The advent of biologics has helped many patients with the disease to regain a new life,thanks to the pharmaceutical, biotech communities to make this possible.