Certolizumab for the treatment of psoriasis and psoriatic arthritis: a real-world multicentre Italian study.
Journal
Journal of the European Academy of Dermatology and Venereology : JEADV
ISSN: 1468-3083
Titre abrégé: J Eur Acad Dermatol Venereol
Pays: England
ID NLM: 9216037
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
26
02
2020
accepted:
21
04
2020
pubmed:
14
5
2020
medline:
15
5
2021
entrez:
14
5
2020
Statut:
ppublish
Résumé
Certolizumab, a pegylated tumour necrosis factor-α inhibitor, reduced disease activity in randomized trials of patients with psoriasis and psoriatic arthritis. Real-life data are missing. To confirm the effectiveness and safety of certolizumab in patients with psoriasis and psoriatic arthritis in routine clinical practice. In this retrospective study involving 11 Italian sites, patients with psoriasis and psoriatic arthritis received subcutaneous certolizumab (400 mg loading dose at 0, 2 and 4 weeks, followed by 200 mg every 2 weeks) for up to 52 weeks. Primary outcomes included mean change from baseline in Psoriasis Area and Severity Index (PASI) and modified Nail Psoriasis Severity Index (mNAPSI) scores, and the proportion of patients achieving a 75%, 90% or 100% reduction in PASI score. Other endpoints included Disease Activity Score computed on 44 joints correlated with the erythrocyte sedimentation rate during the first hour (DAS44-ESR), Tender Joint Count (TJC), Swollen Joint Count (SJC), pain [visual analogue scale (VAS) score], inflammatory markers and quality of life (QOL). In the study were enrolled 153 patients (mean age: 55 years). Certolizumab reduced the mean PASI score from baseline by 4.45, 6.30 and 7.58 at weeks 12, 24 and 52, respectively (P < 0.001 for all). At weeks 24 and 52, 69.6% and 83.3% of patients had a PASI score ≤3. DAS44-ESR, TJC, SJC and mNAPSI scores, and pain VAS were also all significantly improved from baseline at each time point. C-reactive protein levels decreased during treatment, being significant at week 24. On multivariate analysis, psoriasis duration, baseline PASI, mNAPSI and pain VAS scores were found to be predictive of the improvement in PASI score at week 12. Certolizumab displayed also in the real-life encouraging results in both psoriasis and psoriatic arthritis patients.
Sections du résumé
BACKGROUND
BACKGROUND
Certolizumab, a pegylated tumour necrosis factor-α inhibitor, reduced disease activity in randomized trials of patients with psoriasis and psoriatic arthritis. Real-life data are missing.
OBJECTIVE
OBJECTIVE
To confirm the effectiveness and safety of certolizumab in patients with psoriasis and psoriatic arthritis in routine clinical practice.
METHODS
METHODS
In this retrospective study involving 11 Italian sites, patients with psoriasis and psoriatic arthritis received subcutaneous certolizumab (400 mg loading dose at 0, 2 and 4 weeks, followed by 200 mg every 2 weeks) for up to 52 weeks. Primary outcomes included mean change from baseline in Psoriasis Area and Severity Index (PASI) and modified Nail Psoriasis Severity Index (mNAPSI) scores, and the proportion of patients achieving a 75%, 90% or 100% reduction in PASI score. Other endpoints included Disease Activity Score computed on 44 joints correlated with the erythrocyte sedimentation rate during the first hour (DAS44-ESR), Tender Joint Count (TJC), Swollen Joint Count (SJC), pain [visual analogue scale (VAS) score], inflammatory markers and quality of life (QOL).
RESULTS
RESULTS
In the study were enrolled 153 patients (mean age: 55 years). Certolizumab reduced the mean PASI score from baseline by 4.45, 6.30 and 7.58 at weeks 12, 24 and 52, respectively (P < 0.001 for all). At weeks 24 and 52, 69.6% and 83.3% of patients had a PASI score ≤3. DAS44-ESR, TJC, SJC and mNAPSI scores, and pain VAS were also all significantly improved from baseline at each time point. C-reactive protein levels decreased during treatment, being significant at week 24. On multivariate analysis, psoriasis duration, baseline PASI, mNAPSI and pain VAS scores were found to be predictive of the improvement in PASI score at week 12.
CONCLUSION
CONCLUSIONS
Certolizumab displayed also in the real-life encouraging results in both psoriasis and psoriatic arthritis patients.
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
2839-2845Subventions
Organisme : UCB
Informations de copyright
© 2020 European Academy of Dermatology and Venereology.
Références
Boehncke W-H, Schön MP. Psoriasis. Lancet 2015; 386: 983-994.
Kim WB, Jerome D, Yeung J. Diagnosis and management of psoriasis. Can Fam Physician 2017; 63: 278-285.
Santus P, Rizzi M, Radovanovic D et al. Psoriasis and respiratory comorbidities: the added value of fraction of exhaled nitric oxide as a new method to detect, evaluate, and monitor psoriatic systemic involvement and therapeutic efficacy. Biomed Res Int 2018; 23: 3140682.
Bocheńska K, Smolińska E, Moskot M, Jakóbkiewicz-Banecka J, Gabig-Cimińska M. Models in the research process of psoriasis. Int J Mol Sci 2017; 18: 2514.
Chiricozzi A, Zhang S, Dattola A et al. New insights into the pathogenesis of cutaneous autoimmune disorders. J Biol Regul Homeost Agents 2012; 26: 165-170.
Menter A, Strober BE, Kaplan DH et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019; 80: 1029-1072.
Lee EB, Amin M, Bhutani T, Wu JJ. Emerging therapies in psoriasis: a systematic review. Cutis 2018; 101: 5-9.
Ronholt K, Iversen L. Old and new biological therapies for psoriasis. Int J Mol Sci 2017; 18: 2297.
Gossec L, Smolen JS, Ramiro S et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis 2016; 75: 499-510.
Campanati A, Benfaremo D, Luchetti MM et al. Certolizumab pegol for the treatment of psoriasis. Expert Opin Biol Ther 2017; 17: 387-394.
Lee JU, Shin W, Son JY, Yoo KY, Heo YS. Molecular basis for the neutralization of tumor necrosis factor alpha by certolizumab pegol in the treatment of inflammatory autoimmune diseases. Int J Mol Sci 2017; 18: E228.
Goel N, Stephens S. Certolizumab pegol. MAbs 2010; 2: 137-147.
Mease PJ, Fleischmann R, Deodhar AA et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis 2014; 73: 48-55.
Gottlieb AB, Blauvelt A, Thaci D et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol 2018; 79: 302-314 e306.
Lebwohl M, Blauvelt A, Paul C et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol 2018; 79: 266-276 e265.
Reich K, Ortonne JP, Gottlieb AB et al. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol 2012; 167: 180-190.
Carubbi F, Fidanza R, Palmieri M et al. Safety and efficacy of certolizumab pegol in a real-life cohort of patients with psoriasis and psoriatic arthritis. J Dermatolog Treat 2019; 1-6.
Dattola A, Cannizzaro MV, Mazzeo M, Bianchi L. Certolizumab pegol in the treatment of psoriasis and psoriatic arthritis: preliminary real-life data. Dermatol Ther (Heidelb) 2017; 7: 485-492.
Mazzeo M, Dattola A, Cannizzaro MV, Bianchi L. Nail psoriasis treated with certolizumab pegol in patients with psoriatic arthritis: preliminary observation. Actas Dermosifiliogr 2019; 110: 169-171.
Nast A, Gisondi P, Ormerod A et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris-Update 2015-Short version-EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol 2015; 29: 2277-2294.
Gisondi P, Altomare G, Ayala F et al. Italian guidelines on the systemic treatments of moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol 2017; 31: 774-790.
Mease PJ. Measures of psoriatic arthritis: tender and swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res (Hoboken) 2011; 63(Suppl 11): S64-S85.
Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology 2015; 230: 27-33.
Blauvelt A, Reich K, Lebwohl M et al. Certolizumab pegol for the treatment of patients with moderate-to-severe chronic plaque psoriasis: pooled analysis of week 16 data from three randomized controlled trials. J Eur Acad Dermatol Venereol 2019; 33: 546-552.
van der Heijde D, Deodhar A, FitzGerald O et al. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open 2018; 4: e000582.
Kivelevitch D, Frieder J, Watson I, Paek SY, Menter MA. Pharmacotherapeutic approaches for treating psoriasis in difficult-to-treat areas. Expert Opin Pharmacother 2018; 19: 561-575.
Mease P, Deodhar A, Fleischmann R et al. Effect of certolizumab pegol over 96 weeks in patients with psoriatic arthritis with and without prior antitumour necrosis factor exposure. RMD Open 2015; 1: e000119.