Two pivotal psoriasis studies demonstrate secukinumab* achieves clear or almost clear skin in majority of patients
Author: Novartis Pharmaceuticals UK Ltd
Date: JUL 2014
Frimley, July 09, 2014 – New data published online in the New England Journal of Medicine (NEJM) today confirm the superior efficacy of secukinumab*, an interleukin-17A (IL-17A) inhibitor, over a NICE-recommended treatment (etanercept) by achieving high levels of clear or nearly clear skin for people with moderate to severe psoriasis at 12 Weeks. The secukinumab 300mg patients' rates of response continued to improve from Week 12 to Week 16 and stabilised thereafter, with sustained superiority over etanercept out to 52 Weeks.1
The NEJM reported on two pivotal studies (ERASURE and FIXTURE) that met all primary and secondary endpoints and are part of the largest Phase III clinical trial programme for moderate to severe plaque psoriasis completed to date. Seven UK centres were part of the FIXTURE study.
Professor Christopher Griffiths, Foundation Professor of Dermatology, University of Manchester and Consultant Dermatologist at Salford Royal NHS Foundation Trust, explains the impact of psoriasis on the lives of people living with the condition and the need for new options: “Currently, there is no cure for psoriasis and people affected by the condition live with life-long, debilitating symptoms that can significantly affect their physical and mental health. Patients want freedom from this so they can get on with their lives. Today's publication demonstrates that secukinumab delivers high levels of skin clearance and has the potential to be an important new treatment option for psoriasis in the future”.
Both published studies measured the number of patients who experienced a 75 per cent reduction in affected skin and severity of psoriasis (known as PASI 75) at Week 12. The ERASURE trial demonstrated 81.6% of patients treated with secukinumab 300mg achieved PASI 75 at week 12. The FIXTURE trial demonstrated similar results with 77.1 per cent of patients treated with secukinumab 300mg achieving PASI 75 at week 12, significantly more than those on etanercept (44.0 per cent), (p<0.001 for all comparisons).1
Secukinumab was also shown to clear skin more rapidly – on average, patients treated with secukinumab 300mg achieved 50 per cent reduction in affected skin and severity of psoriasis after three weeks treatment, vs. seven weeks with etanercept.1
The publication reported on the number of patients who achieved nearly clear (PASI 90) or completely clear skin (PASI 100) at Week 12. In FIXTURE, twice as many patients on secukinumab 300mg experienced nearly clear skin at 12 weeks compared to etanercept (54.2 per cent vs 20.7 per cent, p<0.001). Five times more patients treated with secukinumab 300mg experienced clear skin compared to those treated with etanercept (24.1 per cent vs. 4.3 per cent p<0.001). The majority of these patients maintained clear or nearly clear skin with treatment up to the end of the study at Week 52.1
Over 1,000 patients received secukinumab across both trials. In FIXTURE, incidences of adverse events (AEs) in the secukinumab groups during the entire 52-week treatment period were comparable with etanercept. In both studies, incidence of AEs were slightly higher for secukinumab than in the placebo group, mostly consisting of mild to moderate upper respiratory tract infections. Rates of serious infections were similar to etanercept. Mild and moderate candida infections were more common in patients treated with secukinumab than with etanercept, however none resulted in a chronic infection or discontinuation of the drug, and all resolved on their own or with standard therapy.1
The impact of psoriasis on quality of life has been demonstrated to be comparable to conditions such as cancer, arthritis and diabetes.5 In the UK, approximately 1.8 million people live with psoriasis and 20 per cent are thought have moderate to severe psoriasis.2,3
Obvious symptoms of psoriasis include red, itchy skin with scaly patches (plaques).6,7 People with moderate to severe psoriasis may have an increased risk of comorbidities, including psoriatic arthritis, obesity, metabolic syndrome, cardiovascular disease, psychiatric illness and cancer.8-11 Psoriasis has been shown to be associated with depression, anxiety and suicidality (350 cases per year).12
Secukinumab is the first IL-17A inhibitor with Phase III data published in psoriasis and regulatory submissions filed with global health authorities. The European Medicine's Agency Committee for Medicinal Products for Human Use (CHMP) opinion on secukinumab is expected late in 2014.
Novartis is committed to increasing clinical understanding of psoriasis treatment with secukinumab. Phase IIIb studies in different types of psoriasis are ongoing, including a local UK study, the SIGNATURE trial. The SIGNATURE trial is currently recruiting in the UK, more information can be found by contacting Novartis medical information on email@example.com.
- Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase three trials.New Engl J Med. 2014 [published online ahead of print 9 July 2014]
- The Psoriasis Foundation website. Accessed July 2014 https://www.psoriasis.org/about-psoriasis/treatments/severity
- The Psoriasis Association website. Accessed July 2014. Available at: https://www.psoriasis-association.org.uk/pages/view/about-psoriasis
- Gniadecki R, Kragbelle K, Dam TN, et al. Comparison of drug survival rates for adalimumab, etanercept and infliximab in patients with psoriasis vulgaris. Brit. J. Dermatol. 2011; 164:1091 1096
- Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. JAAD 1999; 41(3 Pt 1):401-7
- The Psoriasis Association. 'What is Psoriasis?' 2013. Accessed July 2014.
- NICE clinical guidelines 153. Accessed July 2014. Available at: https://www.nice.org.uk/guidance/CG153/chapter/1-Guidance
- Farley E, Menter A. Psoriasis: comorbidities and associations. J Italian Dermatology and Venereology. 2011; 146(1):9-15
- Kim N, Thrash B, Menter A. Comorbidities in psoriasis patients. Semin Cutan Med Surg 2010; 29(1):10-15
- Gisondi P, Girolomoni G. Psoriasis and atherothrombotic diseases: Disease-specific and non-disease-specific risk factors. Semin Thromb Hemost 2009; 1:313-324
- Miele L, Vallone S, Cefalo C, et al. Prevalence, characteristics and severity of non-alcoholic fatty liver disease in patients with chronic plaque psoriasis. J Hepatol 2009; 51:778-786
- Kurd SK, Troxel AB, Crits-Christoph P, et al. the risk of depression, anxiety and suicidality in patients with psoriasis: A population-based cohort study. Arch. Dermatol. 2010; 146(8):891-895
* Secukinumab is in development and not currently licensed for treatment in the United Kingdom
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