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Biologics for Psoriasis

Biologics are revolutionizing how psoriasis is treated, and what psoriasis patients are coming to expect from their psoriasis treatments. Biologics are generated from living things–human and/or animal proteins. Anti-psoriasis biologics have been developed based on current understanding of the abnormal immune system responses that contribute to the disease. As such, they are designed to ‘target’ specific parts of the immune system. The goal is to weaken or immobilize those features of the immune system that are triggering psoriasis without the adverse side effects that can come from broadly weakening the immune system.

Currently six biologics are U.S. Food and Drug Administration (FDA) approved for approved for psoriasis and/or psoriatic arthritis treatment (generic names are given in parentheses):
Amevive (alefacept)
Enbrel (etanercept)
Humira (adalimumab)
Remicade (infliximab)
Simponi (golimumab)
Stelara (ustekinumab)

[A seventh, Raptiva (efalizumab), was withdrawn from the market by its manufacturer in the summer of 2009 because it was linked to the occurrence of a fatal viral infection of the nervous system called progressive multifocal leukoencephalopathy or PML. Raptiva had helped tens of thousands of patients for several years, a reminder that we do not always know until a treatment has been used by many patients for many years what possible longer-term risks might emerge.]

Although they differ in the details of their makeup, Enbrel, Remicade, Humira, and Simponi all target the same piece of the immune system—a molecule called Tumor Necrosis Factor-alpha (TNF-alpha). Hence, these drugs are sometimes referred to as ‘TNF-inhibitors.’ TNF-alpha is an inflammation-promoting substance that is produced abnormally in psoriasis patients.

Amevive targets T-cells, immune cells that accumulate in the skin and joints of psoriasis patients. T-cells are directly and indirectly responsible for the production of a variety of inflammation-causing substances, including TNF-alpha.

Stelara targets interleukin-12 (IL-12) and interleukin-23 (IL-23), immune system molecules found in high amounts at sites of active psoriasis.

Amevive, Enbrel, Remicade, Humira and Stelara are FDA approved for adults with moderate to severe plaque psoriasis; Enbrel, Remicade, Humira, and Simponi are approved for psoriatic arthritis. scientific research to find new treatmentsNo biologics are currently approved for psoriasis in minors/children, although some of them are approved for pediatric use for other diseases. Note that biologics carry strong warnings to alert healthcare professionals of an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers. There is not yet enough data to know if this risk will also appear in IL-12/23 inhibitors.

These biologic agents are proving to be highly effective at treating psoriasis, helping even many people with severe disease, and they are delivering these results with tolerable side effects in most cases. Simply put, many people take their biologic, see major improvement in their psoriasis, and experience no known side effects. While the U.S. Food and Drug Administration looks at what percentage of patients achieve a 75% improvement after 12 weeks of treatment, many patients who achieve “just” a 50% improvement are thrilled with the results; and some patients even see 90% improvement with each of these biologics.

But they are not without risks. In rare cases, their side effects can be serious, and there have even been fatalities. (Although if a patient does *not* have tuberculosis, heart disease, hepatitis B, or other serious preexisting conditions, the rare side effects are even more unlikely to occur). And given that the oldest of the biologics, Remicade, received FDA approval in 1998 (for Crohn’s Disease), their long-term safety record is still being established. There is concern, and considerable debate, about the potential for increasing cancer risk by impacting the immune system with a biologic treatment; in fact, the product labels reflect that their use may increase the chances of getting lymphoma or other cancers. But we yet know the extent of this risk. (The good news is there are rheumatoid arthritis patients, for example, who have been using Enbrel for 10 years straight, with no cancer surge yet detected. Let’s hope that fact holds.)

Finally, biologics are very expensive; few patients can afford them without good insurance coverage. [The companies do offer programs to help people afford these treatments. Learn more here: Psoriasis and Psoriatic Arthritis Prescription Payment Assistance Programs.]

But for those with significant psoriasis, biologics offer powerful options and the possibility of dramatic improvements in physical–and emotional–well-being. Click here to read a biologics success story.

The TNF-Inhibitors: Enbrel, Remicade, Humira, and Simponi

The TNF-inhibitors (Enbrel, Remicade, Humira, and Simponi) are all highly effective against plaque psoriasis. Between half and three-quarters of patients see a 75% improvement in their symptoms after a few months of use. They have also proven to be very effective against psoriatic arthritis (PsA).

This class of biologics works by reducing the level of active TNF-alpha in the body. TNF-alpha is an immune system molecule that promotes inflammation. When properly regulated, TNF-alpha has an important role in defending the body against outside infection; however, when it is produced in excessive amounts, it can be harmful, contributing to diseases such as psoriasis. Reducing the amount of TNF-alpha in the body with a TNF-inhibitor often dramatically alleviates psoriasis symptoms.

All of the TNF-inhibitors are associated with a number of very rare but serious side effects. These include: serious infections, re-activation of pre-existing infections including tuberculosis and hepatitis B, central nervous system demyelinating disorders (like multiple sclerosis), lupus-like autoimmune disease, worsening of congestive heart failure, decreased white blood cell count, and cancer. Not every TNF-inhibitor has been directly linked to every side effect on the list, but because all of the TNF-inhibitors work in very similar way, doctors assume that they all have the potential to cause the same side effects. By screening patients for conditions that would put them at high risk for serious side effects and by careful monitoring of patients using these medications, doctors can minimize the risk.

More info: Enbrel * Humira * Remicade * Simponi

Biologics with Other Targets: Amevive and Stelara

Amevive, in 2003, became the first biologic to get the green light from the FDA for treatment of plaque psoriasis. Stelara, in 2009, became the most recent to receive FDA approval. Both are administered in a physician’s office, which, depending on the type of insurance coverage you have, could be a good or bad thing.

Stelara has received considerable buzz as the first FDA-approved treatment that target IL-12 and IL-23, as well as for the fact that after introductory doses, it can be taken as few as four times per year. Amevive, while used less often than the other biologics, is interesting in that it often leads to a remission that can last several months after treatment ends. With most psoriasis treatments, once treatment stops the psoriasis comes back pretty quickly.

More info: Stelara * Amevive

Conclusion

Even as these biologics transform many lives, others continue to suffer with psoriasis. Some patients cannot access these treatments due to their high cost and/or insurance coverage issues; some are precluded from using them due to preexisting conditions (TB, HIV, cancer, etc.); some are concerned about side effects or long term uncertainties; and some are simply not aware of these new treatments. For still others, their first try with a biologic does not work. (After all, no biologic works in 100% of cases.)

This is leading physicians to consider what to do in cases when a biologic does not appear to be working. In some instances, the answer is for a patient to have patience, as clinical response has been shown to continue improving for some patients after 12 weeks, or 16, or even 24. Other psoriasis patients will fail with one biologic but succeed with another (or even a third), probably because the mechanism of action for each is slightly different.

And yet it also appears clear that the current landscape of products will not work for everyone. many  biologics are self-injected by the patientSome physicians are willing to experiment with medications approved for other diseases to try to help a desperate psoriasis patient who is not having an adequate response to treatments approved for psoriasis. Known as “off-label” use, it typically involves trying a patient on medications approved for other immune diseases that are known to respond to similar treatments. For example, several treatments are used not just for psoriasis but also for rheumatoid arthritis and Crohn’s disease. Even treatments for diabetes and MS are considered, because of the immunological roots of these diseases.

For a while, it was thought that the diabetes treatment Avandia (rosiglitazone maleate) might work for psoriasis patients, but major, Phase Three studies disproved that theory (perhaps a fortunate break for psoriasis patients given controversy that has developed around the safety of Avandia). Orencia (abatacept), FDA approved for rheumatoid arthritis, was shown several years ago in a very small study to improve psoriasis symptoms. (We spoke in support of FDA approval of Orencia for this reason.) As treatments improve for RA, Crohn’s and other immune diseases, options for psoriasis patients may continue to expand as well. And the psoriasis treatment pipeline is brimming with additional potential options. Many of them will not ultimately prove effective as they wind their way through the rigors of clinical trials, but some of them are indeed likely to be added to the treatment arsenal in the years ahead.

But until every psoriasis patient has found safe and effective relief, it is essential that research on psoriasis continue. Even those of us finding relief with a current treatment must stay committed to help the others of us still searching for relief. Will you take two minutes right now to write your lawmakers and ask for expanded psoriasis research?

The biologics revolution is helping many psoriasis patients with moderate to severe disease reclaim a rich quality of life. Hats off to the biotech, pharmaceutical, scientific and medical communities for making these treatments possible.

[Learn more about continuing clinical trials of these FDA-approved biologics that are currently recruiting psoriasis patients.]

More detailed information from us on all these biologics can be found here:
Amevive (alefacept)
Enbrel (etanercept)
Humira (adalimumab)
Remicade (infliximab)
Simponi (golimumab)
Stelara (ustekinumab)

Selected References:

Boehncke, W-H et al. “Biologic Therapies for Psoriasis. A Systematic Review.” Journal of Rheumatology. 2006 Jul;33(7):1447-51.

Nelson, AA et al. “New treatments for psoriasis: Which biologic is best?” Journal of Dermatological Treatment. 2006;17(2):96-107.

Information on drug approval from the Food and Drug Administration’s website.

Here are links to the biologics companies’ product websites:

Remicade (infliximab)

Stelara (ustekinumab)

Humira (adalimumab)

Enbrel (etanercept)

Amevive (alefacept)

Simponi (golimumab)

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