NICE issues final guidance for Cimzia® (certolizumab pegol) as an option for treating plaque psoriasis in adults
- The National Institute for Health and Care Excellence (NICE) has shared its final guidance for the recommended use of Cimzia® (certolizumab pegol) for the treatment of severe plaque psoriasis in adults who have failed to respond to, or are unsuitable for, other systemic therapies
- Plaque psoriasis is the most common form of psoriasis; accounting for 80-90% of cases[ii]. It appears as raised red patches on the skin that can crack, bleed and cause pain[iii]
- In England, approximately 1.5 million people have psoriasis[iv], with around two percent of the UK population affected[v]
Slough, UK EMBARGOED FOR 14:00 Wednesday 17 April (GMT): NICE today issued its final guidance on the use of Cimzia® (certolizumab pegol) as a treatment option within the NHS in England for adults with severe plaque psoriasis, who have failed to respond to, or are unsuitable for, other systemic treatments. The guidance also notes that certolizumab pegol can be used as an additional treatment option for women before or during pregnancy if needed, as well as while breastfeeding.
The availability of certolizumab pegol in England is a significant step for patients in the country, as approximately 1.5 million people have psoriasis[vi]. Despite drug development advances in the past decade, patient survey data suggests that moderate to severe psoriasis continues to be undertreated[vii]. Certolizumab pegol now offers an additional treatment option for those needing systemic therapy.
Certolizumab pegol is a biologic medicine which works to prevent inflammation that may result from an overactive immune system. To date, more than 123,000 patients living with rheumatoid arthritis, psoriasis, psoriatic arthritis and axial spondyloarthritis have benefitted from Cimzia[viii]. Along with moderate to severe plaque psoriasis, certolizumab pegol is already approved by NICE for the treatment of: moderate to severe active rheumatoid arthritis in adults who have had a tumour necrosis factor-alpha inhibitor[ix]; active psoriatic arthritis after inadequate response to DMARDs[x]; and, severe active ankylosing spondylitis and severe non‑radiographic axial spondyloarthritis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs[xi].
Psoriasis is a common, chronic inflammatory disease of the skin and affects around two per cent of the population in the UK.[xii] The conditions’ symptoms vary from person to person, but for those who are more severely affected, it can have a major impact on their quality of life[xiii], in some cases comparable to those living with diabetes, heart disease and cancer.[xiv] Psoriasis can also present challenges for women during pregnancy, with 23% of women experiencing a worsening of symptoms during pregnancy[xv], and studies showing the condition can increase the risk of adverse outcomes[xvi],[xvii],[xviii].
“We regularly hear from patients that the highly visible nature of psoriasis can have a detrimental effect on the quality of life; in order to keep their skin covered, they sometimes choose to avoid doing certain activities. Any treatment that offers the potential to improve daily life for patients living with this condition is welcomed.” said Helen McAteer from The Psoriasis Association.
Certolizumab pegol has been shown to improve severe plaque psoriasis more than either placebo or etanercept. When compared indirectly, it appears to be as effective as other biological treatments for the condition and appears to be more effective than non-biological treatments[xix].
“I welcome NICE’s approval of Cimzia for the management of severe psoriasis. It is important that there is patient and physician choice in the medicines used to control this currently incurable, and frequently life-ruining disease; Cimzia adds to the choice on offer,” said Professor Chris Griffiths, Professor of Dermatology at the University of Manchester.
“Psoriasis can have a huge impact of a patient’s quality of life, so we are very pleased that NICE is able to recommend this as a new treatment option,’ said Abhinav Kumar, Head of Immunology, UK & Ireland at UCB Pharma. “We have a long-term commitment to improve care for people living with psoriasis and other dermatological conditions, and this latest recommendation is just part of our ongoing programme to help bring medicines to patients with high unmet need.”
The NICE guidance states that certolizumab pegol is recommended for treating severe plaque psoriasis in adults, only if the disease is severe (as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10), the disease has not responded to other systemic treatments, and the lowest maintenance dosage of certolizumab pegol is used (200 mg every 2 weeks) after the loading dosage. The first 12 weeks of certolizumab pegol are provided free of charge.
Cimzia was granted a label extension to include the indication in adults with moderate-to-severe plaque psoriasis by the European Medicines Agency in June 2018[xx]. This was based on data from a Phase 3 clinical development program consisting of CIMPASI-1, CIMPASI-2[xxi] and CIMPACT[xxii]. In all three trials, Cimzia demonstrated statistically significant improvements for all primary and co-primary endpoints compared to placebo at all treatment doses, and the clinical benefit was maintained through to week 48. The adverse event profile across all three trials appears consistent with the known safety profile of anti-TNF therapy and no new safety signals were observed with Cimzia at any dose over 48 weeks.[xxiii]
[iv] Psoriasis Association. Facts about psoriasis. Available at: http://www.pressat.co.uk/media/uploads/aec3d9a6488c271f242e92ae0c56fb6d.pdf Last accessed 25 March 2019
[v] NICE. Psoriasis: assessment and management. Available at: https://www.nice.org.uk/guidance/cg153/chapter/introduction. Last accessed 25 March 2019
[vi] Psoriasis Association. Facts about psoriasis. Available at: http://www.pressat.co.uk/media/uploads/aec3d9a6488c271f242e92ae0c56fb6d.pdf Last accessed 20 March 2019
[vii] Lebwohl MG, Bachelez H, Barker J, et al. Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. J Am Acad Dermatol. 2014;70(5):871-881
[viii] UCB 2018 Annual Report. Available at https://www.ucb.com/_up/ucb_com_ir/documents/2018%20integrated%20annual%20report%20-%20ENG.pdf. Last accessed 08 April 2019
[ix] NICE. Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor. Available at https://www.nice.org.uk/guidance/TA415/chapter/1-Recommendations. Last accessed 25 March 2019
[x] NICE. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. Available: https://www.nice.org.uk/guidance/ta445. Last accessed 26 March 2019
[xi] NICE. TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis. Available at: https://www.nice.org.uk/guidance/ta383/chapter/1-Recommendations. Last accessed 26 March 2019
[xii] NICE. Psoriasis: assessment and management. Available at: https://www.nice.org.uk/guidance/cg153/chapter/introduction. Last accessed 25 March 2019
[xiv] GMMMG, High cost drugs pathway for psoriasis http://gmmmg.nhs.uk/docs/guidance/HCD-pathway-for-psoriasis.pdf Last accessed 21 March 2019
[xv] Murase JE, Chan KK, Garite TJ, et al. Hormonal effect on psoriasis in pregnancy and post partum. Arch Dermatol. 2005;141(5):601-606
[xvi] Amiri N, et al. Pregnancy comorbibidities and outcomes in psoriasis and psoriatic arthritis: a prospective cohort study. Arthritis Rheum. 2016;68(suppl 10). Abstract 2443; p3219.
[xvii] Bobotsis R, Gulliver WP, Monaghan K, et al. Psoriasis and adverse pregnancy outcomes: a systematic review of observational studies. Br J Dermatol. 2016;175(3):464-472
[xviii] Lima XT, Janakiraman V, Hughes MD, et al. The impact of psoriasis on pregnancy outcomes. J Invest Dermatol. 2012;132(1):85-91
[xx] Cimzia. Summary of Product Characteristics (SmPC), 2019. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf. Last accessed: 25 March 2019
[xxi] Gottlieb et al. J Am Acad Dermatol 2018; 79: 302-14
[xxii] Lebwohl et al. J Am Acad Dermatol 2018 79 (2): 266-276
[xxiii] UCB data on file: https://www.ucb.com/stories-media/Press-Releases/article/UCB-Announces-the-Approval-of-CIMZIA-certolizumab-pegol-for-Moderate-to-Severe-Plaque-Psoriasis-Representing-an-Important-New-Option-for-Patients-in-the-U-S. Last accessed 08 April 2019