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5 th World Psoriasis & Psoriatic Arthritis Conference 2018
Michael Rissler 5 , Christian Sieder 6 , Roberto Orsenigo 7 , Kamel
Chaouche-Teyara 5 1
SCIderm Research Institute Hamburg and Dermatologikum Berlin , Germany , 2 Department of Dermatology , Hospital de la Santa Creu I Sant Pau , Barcelona , Spain , 3 Department of Dermatology , Venereology and Allergology , Wroclaw Medical University , Wroclaw , Poland , 4 Department of Dermatology , Larrey University Hospital , Toulouse , France , 5 Novartis Pharma AG , Basel , Switzerland , 6 Novartis Pharma GmbH , Nuernberg , Germany ,
7
Novartis Farma S . p . A , Origgio , Italy
Introduction : Secukinumab is a fully human monoclonal antibody that selectively neutralizes IL-17A , a key cytokine involved in the development of psoriasis . Heterogeneity in clinical response to targeted therapies such as secukinumab may be addressed by flexible dosing . Objectives : To compare downtitration of PASI90 responders to 6-weekly and uptitration of PASI≥75 to < 90 responders to twoweekly secukinumab dosing with standard 4-weekly dosing . Methods : OPTIMISE was a randomized , multicenter , open-label , rater blinded Phase 3b study . 1647 subjects received secukinumab 300 mg at baseline , Weeks 1 , 2 , 3 and 4 then 4-weekly to Week 24 . At Week 24 , PASI90 responders were randomized to secukinumab 300 mg q4w ( n = 644 ) or q6w ( n = 662 ) to Week 52 ; PASI≥75 to < 90 responders were randomized to secukinumab 300 mg q4w ( n = 114 ) or 2-weekly ( q2w ) ( n = 92 ) to Week 52 . Groups were stratified by body weight ( < 90kg , ≥90kg ). Results : PASI90 response was maintained at Week 52 by 85.7 % subjects with q4w dosing vs 74.9 % with q6w dosing ; OR 1.91 ( 95 % CI 1.44 , 2.55 ). The primary endpoint , non-inferiority of q6w vs q4w dosing in PASI90 responders , was not met . In PASI≥75 to < 90 responders , 46.5 % of subjects achieved PASI90 response by Week 52 with q4w dosing . PASI90 response at Week 52 was numerically higher for q2w compared to q4w dosing ( 56.5 % vs . 46.5 %), but this difference did not reach statistical significance ( p = 0.1013 ). This numerical benefit of q2w dosing was even higher in subjects weighing ≥ 90 kg ( n = 49 ; 57.1 % vs . 39.6 %; p = 0.1053 ). No new or unexpected safety signals were observed . Conclusions : Non-inferiority of q6w vs . q4w dosing cannot be claimed in maintaining PASI90 response achieved at Week 24 . Around half of PASI≥75 to < 90 responders at 24 weeks , can achieve PASI90 response with continued q4w dosing . Subjects with higher body weight may benefit from the q2w dosing .
P022 INHIBITION OF ANTI-TNF-ALPHA CYTOKINE IN THE TREATMENT OF PSORIASIS AND THE ANALYSIS OF
INFECTIOUS COMPLICATIONS Tatiana Péčová , Karolína Vorčáková 1 , Marián Grendár 2 , Juraj
Péč 1 1
Department of Dermatovenereology , 2 Biomedical Center Martin , Jessenius Faculty of Medicine in Martin , Comenius University in Bratislava , Slovakia
Introduction : TNF-alpha cytokine plays an important role in the regulation of activation , proliferation , differentiation and apoptosis of the immune cells . It is an important therapeutical target in the treatment of chronic plaque psoriasis . From its other roles , it plays key part in formation and maintenance of granuloma through the increased fagocytic capacity of macrophages and eradication of intracellular pathogens , therefore its inhibitors pose a risk for granulomatous infections and reactivation of latent tuberculosis . Objectives : The main focus was to assess the infectious complications of biologic anti-TNF-alpha treatment of chronic plaque psoriasis with focus on the tuberculosis and reactivation of its latent form . Moreover , the authors tried to establish possible risk factors on the reactivation of latent tuberculosis . Methods : The authors analyzed the group of 190 patients from Middle-European population treated with TNF-alpha inhibitors , as compared to other biologics , for the occurence of infectious complications . Interferon-gamma release assay ( IGRA ) test was performed before the start of the treatment and then every year , in accordance with The Tuberculosis Network European Trials Group ( TBNET ) consensus . Statistical analysis was performed on the results . Results : 3 % of patients had permanently positive IGRA test ( before and after beginning of the treatmet ) and in 28 % of patients treated by TNF inhibitors , conversion of IGRA test appeared with negative test before treatment and positive test after administration of biologics . No active tuberculosis was detected . The average time of IGRA conversion was 3 years after beginning of treatment . The only statistically significant predictor was age , with an increase of age by one year associated with the 5.8 % increase of risk of IGRA conversion . Regarding other infectious complications , the most common infections in patients treated with biologics were respiratory and HPV infections . No severe infection leading to the permanent discontinuation of treatment was observed . Conclusions : Treatment with TNF-alpha inhibitors was associated with statistically significant risk of IGRA test conversion . The only established predictor of risk was age of patient , with no influence of previous or concomittant systemic tretament . However , the limitation was size of group of patients . The most common infections were common respiratory infections and viral HPV infections . References : Andersen P , Munk ME , Polock JM et al . Specific immune-based diagnosis of tuberculosis . Lancet 2000 ; 356:1099-1104 . Bieber J , Kavanaugh A . Tuberculosis and opportunistic infections : relevance to biologic agents . Clin Exp Rheumatol . 2004 ; 22:126-133 . Doherty SD , Van Voorhees A , Lebwohl MG , et al . National Psoriasis Foundation consensus statement on screening for latent tuberculosis infection in patients with psoriasis treated with systemic and biologic agents . J Am Acad Dermatol 2008 ; 59:209-217 . Drago L , Nicola L , Signori V et al . Dynamic QuantiFERON response in psoriasis patients taking long-term biologic therapy . Dermatol Ther 2013 ; 3:73-81 . Hernandez C , Cetner AS , Jordan JE , et al . Tuberculosis in the age of biologic therapy . J Am Acad Dermatol 2008 ; 9:363-380 . Solovič I , Sester M , Gomez-Reino JJ , et al . The risk of tuberculosis related to tumour necrosis factor antagonist therapies : a TBNET consensus statement . Eur Respir J 2010 ; 36:1185-1206 .
P023 TREATMENT USE AND SATISFACTION AMONG PATIENTS WITH PSORIASIS AND PSORIATIC
ARTHRITIS IN SCANDINAVIA Kåre Steinar Tveit 1 , Albert Duvetorp 2 , Mikkel Østergaard 3 , Lone Skov 4 , Kjersti Danielsen 5 , Lars Iversen 6 , Oliver Seifert 7
1
Haukeland University Hospital , Bergen , Norway , 2 Linköping University , Linköping , Sweden ; Skånes Universitetssjukhus , Malmö , Sweden , 3 Copenhagen Center for Arthritis Research , Center for Rheumatology and Spine Diseases , Rigshospitalet , Glostrup , University of Copenhagen , Copenhagen , 4 Herlev and Gentofte Hospital , University of Copenhagen , Copenhagen , Denmark , 5 UiT The Arctic University of Norway , Tromsø , Norway ; University Hospital of North Norway , Tromsø , Norway , 6 Aarhus University Hospital , Aarhus , Denmark , 7 Linköping University , Linköping , Sweden ; Ryhov Hospital , Jönköping , Sweden
Introduction : Patients ’ perspectives on psoriasis ( PsO ) and psoriatic arthritis ( PsA ) treatment are important in establishing better approaches to their care . Objectives : To assess treatment use and satisfaction among patients with PsO / PsA in Scandinavia . Methods : NORPAPP was an on-line survey carried out in Nov / Dec 2015 using YouGov panels in Sweden , Denmark , and Norway . Adults with physician-diagnosed PsO or PsA ( n = 1221 ), answered questions about contact with the healthcare system , and treatment experience and satisfaction . Self-perceived disease severity was dichotomised to severe ( responses of “ quite severe ”, “ very severe ” or “ extremely severe ”) and non-severe (“ not particularly severe ” or “ not severe at all ”). www . medicaljournals . se / acta