- Chronic plaque psoriasis is a chronic skin condition characterized by red scaly lesions that often requires lifelong treatment
- Current treatment options are not wholly satisfactory and also have unwanted side effects
- New targeted therapy using a biological agent is effective against psoriasis and exhibits minimal toxicity
A biological agent or an antibody named tildrakizumab that specifically targets an inflammatory pathway
involved in the pathogenesis of psoriasis has been shown to be effective in the treatment of psoriasis
in two Phase 3 clinical trials.
It is well tolerated by patients with few side effects, according to research conducted by a team of scientists from Harvard Medical School.
"In these two trials, we tested whether this new, very targeted approach to a selected part of the inflammatory pathway would be effective in treating psoriasis, and it was - dramatically so."
‘Tildrakizumab therapy, that is well tolerated with few side effects, might be a potential cure for chronic plaque psoriasis.’
The study was led by Alexa B. Kimball, MD, President and CEO of Harvard Medical Faculty Physicians (HMFP) at Beth Israel Deaconess Medical Center (BIDMC) and a Professor of Dermatology at Harvard Medical School and was published in the journal, The Lancet,
and represents a major breakthrough in psoriasis treatment.
Evolution of Psoriasis Treatment Over The Last Two Decades
Until the 1990s, treatment options were limited. In the last 15 years, research has identified inflammatory molecules called interleukins
that are involved in the pathogenesis of psoriasis. Further research led to the development of antibodies or biologic therapy targeting or inhibiting these interleukins
to treat psoriasis. Though these agents were effective in some patients, they were associated with severe toxicities.
This was because interleukins involved in several other immune pathways
were also disrupted leading to severe infections and immune system dysfunctions.
Biological agents differ from traditional drugs in that they resemble molecules made by the body's immune system naturally, and are adapted for therapeutic purposes.
How Tildrakizumab Therapy May Be Better, Compared To Current Psoriasis Therapy
Dr Kimball and her team through their research and observations have succeeded in identifying another interleukin specifically relevant to psoriasis. They developed a biological agent, tildrakizumab, an antibody that inhibits the specific interleukin involved in psoriasis.
Trials have shown this drug to be effective in controlling symptoms of psoriasis with minimal side effects and could be a major milestone in the treatment of this debilitating condition.
The current study team hopes their drug tildrakizumab would overcome the current gaps in psoriasis treatment and prove to be a game changer.
Testing Tildrakizumab In Humans - Details of the Study
The double-blind randomized controlled parallel studies, named reSURFACE 1 and 2, tested the efficacy of an antibody called tildrakizumab to control psoriasis in patients with moderate to severe disease.
- Overall, more than 1,800 patients were included in trials conducted at 250 locations in the United Kingdom, the United States, Austria, Australia, Belgium, Canada, the Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, and Poland.
- Participants were randomly assigned to one of three groups:
- First group received 200 mg tildrakizumab
- Second group received 100 mg tildrakizumab
- Third group received an inactive placebo
- At the start of the study, all patients had a minimum of 30 percent of their body covered by psoriasis.
- At the end of the study, 12 weeks later, 65 percent of the participants demonstrated clear or almost clear skin, representing a 75 percent improvement. This was measured by the standard Psoriasis Area Severity Index (PASI).
- Less than 10 percent of the participants in the placebo group showed this level of improvement.
"The breakthrough here is that we have continued to refine our treatments to those that are likely to be most effective against psoriasis but less likely to affect other important pathways at the same time," Kimball said. "The study also suggests that the 12-week end point may be too early to see optimal efficacy. Patients may continue to improve and that's going to be important to show over time."
What Is Psoriasis?
Psoriasis is a chronic, sometimes lifelong, autoimmune skin condition, affecting both men and women. It is characterized by red itchy plaques and silvery scales, occurring anywhere in the body. The disease can be of varying severity, and is characterized by periods of remissions followed by flare-ups. Currently there is no cure though treatments keep the disease under check.
- Alexa B Kimball, MD et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. The Lancet, June 2017 DOI: 10.1016/S0140-6736(17)31279-5