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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