Journal articles on the topic 'Daniel Brunner'

The majority of scholarship regarding Native Americans and film has focused on the images of Native Americans as constructed by non-Native filmmakers, but how might we better understand the careers of Native people working as actors in studio Hollywood? I propose studying film publicity material to find traces of the labor and negotiations performed by Native actors as they constructed and maintained their personas. Examining both the construction of studio publicity and analyzing the content of publicity regarding Chief Many Treaties (Blackfeet actor William Hazlett), Chief Yowlachie (Yakama actor Daniel Simmons), Chief Big Tree (Seneca actor Isaac Johnny John); and Chief Rolling Cloud (Muscogee [Creek] actor Charles Brunner), I reveal how publicity material can contextualize actors' experiences and suggest ways that these Native performers used their personas to critique and influence their presences onscreen.

Background:Maintenance of clinical response over time has been shown in individual patients (pts) with polyarticular-course juvenile idiopathic arthritis (pJIA) treated with SC abatacept (ABA).1It is unknown whether each individual pt with sustained efficacy also consistently maintains the previously reported shorter-term benefits on patient-reported outcomes (PROs)2,3over time.Objectives:Investigate whether combined efficacy and stringent, optimal PRO responses to ABA treatment are maintained by individual pts with pJIA over time.Methods:In this analysis of the intent-to-treat population, pts in two age cohorts (2–5 and 6–17 yrs) who achieved clinical response to weekly SC ABA (10–<25 kg [50 mg], 25–<50 kg [87.5 mg], ≥50 kg [125 mg]) at Mo 4 (time point of primary pharmacokinetic endpoint4) were followed for 2 yrs. Stringent efficacy outcomes (Juvenile Arthritis Disease Activity Score 27 [JADAS27] minimal disease activity [MDA; ≤3.8] and inactive disease [ID; ≤1] status) were combined with optimal PRO endpoints (childhood [C]HAQ-DI=0, Parental Global Assessment [PaGA] ≤1 and Pain visual analogue scale [VAS] <35). Combined efficacy and PRO responses were analysed at Mos 4, 13 and 21.Results:219 pts entered the study (46 [21.0%] 2–5 yrs; 173 [79.0%] 6–17 yrs); a subgroup of these pts achieved a clinical response at Mo 4 (Table 1). Many pts who achieved JADAS27 MDA or JADAS27 ID combined with optimal PROs at Mo 4 sustained their response at Mo 13, and at both Mo 13 and Mo 21 in the 2–5-yr and 6–17-yr cohorts (Table 1). Across the cohorts, 33–88% of pts maintained a combined JADAS27 MDA with optimal PRO responses through Mo 21. Where estimable, median times to combined efficacy and specific optimal PRO responses were consistent across the cohorts (Table 2; Figs 1, 2).Table 1.Proportion of pts with combined efficacy and optimal PRO responses at Mos 4, 13 and 21EndpointResponders at Mo 4Responders at Mos 4 and 13*Responders at Mos 4, 13 and 21*2–5 yrs (n=46)6–17 yrs (n=173)2–5 yrs6–17 yrs2–5 yrs6–17 yrsJADAS27 MDA and CHAQ-DI=09 (20)34 (20)5/9 (56)25/34 (74)3/9 (33)16/34 (47)JADAS27 MDA and PaGA ≤18 (17)14 (8)8/8 (100)7/14 (50)7/8 (88)5/14 (36)JADAS27 MDA and Pain VAS <35 mm28 (61)70 (41)25/28 (89)58/70 (83)21/28 (75)43/70 (61)JADAS27 ID and CHAQ-DI=07 (15)20 (12)2/7 (29)13/20 (65)1/7 (14)9/20 (45)JADAS27 ID and PaGA ≤16 (13)10 (6)4/6 (67)4/10 (40)4/6 (67)4/10 (40)JADAS27 ID and Pain VAS <35 mm17 (37)31 (18)10/17 (59)22/31 (71)8/17 (47)17/31 (55)Data are n (%) or n/N (%). *% based on n of pts who achieved response at Mo 4 (denominator)Table 2.Kaplan–Meier estimates for median (95% CI) times (mos) to achieving combined efficacy and optimal PRO responsesEndpoint2–5 yrs6–17 yrsJADAS27 MDA and CHAQ-DI=021.5 (6.8, NE)21.5 (13.1, 24.4)JADAS27 MDA and PaGA ≤1NE (15.9, NE)24.6 (24.3, NE)JADAS27 MDA and Pain VAS <35 mm2.8 (1.9, 2.9)3.8 (3.7, 6.6)JADAS27 ID and CHAQ-DI=0NE (18.4, NE)24.4 (18.7, NE)JADAS27 ID and PaGA ≤1NE (21.3, NE)24.6 (24.3, NE)JADAS27 ID and Pain VAS <35 mm3.8 (3.8, 10.3)13.2 (10.3, 15.9)NE=not estimableConclusion:Many individuals with pJIA who achieved stringent efficacy and PRO measures with weekly SC abatacept by Mo 4 sustained them over 2 years. Time to achieve combined efficacy and Pain VAS <35 response was shorter than that for PaGA ≤1 and CHAQ-DI=0.References:[1]Ruperto N, et al.Ann Rheum Dis2019;78:99–100 (abstr OP0056)[2]Brunner H, et al.Arthritis Rheumatol2019;71(suppl 10):abstr 2707[3]Ruperto N, et al.Ann Rheum Dis2017;76:75 (abstr OP0058)[4]Brunner HI, et al.Arthritis Rheumatol2018;70:1144–54Acknowledgments:Katerina Kumpan, PhD, Caudex; funding: Bristol-Myers SquibbDisclosure of Interests: :Hermine Brunner Consultant of: Hoffman-La Roche, Novartis, Pfizer, Sanofi Aventis, Merck Serono, AbbVie, Amgen, Alter, AstraZeneca, Baxalta Biosimilars, Biogen Idec, Boehringer, Bristol-Myers Squibb, Celgene, EMD Serono, Janssen, MedImmune, Novartis, Pfizer, and UCB Biosciences, Speakers bureau: GSK, Roche, and Novartis, Nikolay Tzaribachev: None declared, Ingrid Louw Consultant of: Amgen, Novartis, Pfizer, Roche (advisory boards), Inmaculada Calvo Grant/research support from: Bristol-Myers Squibb, Clementia, GlaxoSmithKline, Hoffman-La Roche, Merck Sharpe & Dohme, Novartis, Pfizer, Sanofi, Speakers bureau: AbbVie, GlaxoSmithKline, Hoffman-La Roche, Novartis, Francisco Zapata: None declared, Gerd Horneff Grant/research support from: AbbVie, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, Bayer, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Ivan Foeldvari Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Chugai, Eli Lilly, Novartis, Pfizer, Daniel Kingsbury: None declared, Maria Gastanaga Grant/research support from: Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, Roche, Carine Wouters Grant/research support from: GlaxoSmithKline, Pfizer, Roche, Johannes Breedt: None declared, Robert Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Marleen Nys Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Margarita Askelson Consultant of: Bristol-Myers Squibb, Joe Zhuo Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Alberto Martini Consultant of: AbbVie, Eli Lily, EMD Serono, Janssen, Novartis, Pfizer, UCB, Daniel J Lovell Consultant of: Abbott (consulting and PI), AbbVie (PI), Amgen (consultant and DSMC Chairperson), AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb (PI), Celgene, Forest Research (DSMB Chairman), GlaxoSmithKline, Hoffman-La Roche, Janssen (co-PI), Novartis (consultant and PI), Pfizer (consultant and PI), Roche (PI), Takeda, UBC (consultant and PI), Wyeth, Employee of: Cincinnati Children’s Hospital Medical Center, Speakers bureau: Wyeth, Nicolino Ruperto Grant/research support from: Bristol-Myers Squibb, Eli Lily, F Hoffmann-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sobi (paid to institution), Consultant of: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda, Speakers bureau: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda

O problema da atenção conjunta tem assumido um lugar importante na psicologia do desenvolvimento e nos estudos da cognição social. Para além dos estudos realizados por Jerome Bruner e Michael Tomasello, Daniel Stern trouxe valiosas contribuições ao tema, baseado em observações sobre a partilha afetiva entre a mãe e o bebê num plano pré-verbal. Neste estudo analisamos algumas destas contribuições, à luz de intercessores ligados à ecologia da atenção, à abordagem da enação e aos estudos da produção de subjetividade. A partir de Daniel Stern, Félix Guattari e Yves Citton, o bebê é descrito como um cartógrafo, na medida em que sua atenção é concentrada e aberta ao plano coletivo de forças e afetos. Articulada com os conceitos de percepção amodal, afetos de vitalidade e sintonia afetiva, a atenção conjunta surge como um modo de conhecer e estar junto com outra pessoa, colocando em evidência a dimensão cognitiva do afeto.

Background:The calcium-binding proteins S100A8/A9 (calprotectin) and S100A12 (extracellular newly identified receptor for advanced glycation end-products binding protein [EN-RAGE]) are involved in multiple signalling pathways to mediate inflammation, can be secreted by activated monocytes/macrophages and exhibit cytokine-like extracellular functions. Circulating levels of these proteins have been associated with disease and clinical responses in systemic juvenile idiopathic arthritis (sJIA), including treatment response.1 Studies suggest that serum S100A8/A9 and S100A12, which are released at inflammation sites, are more specific biomarkers of local inflammation (e.g. in the synovium) than systemic biomarkers such as CRP and ESR.2,3Objectives:To investigate if baseline S100A8/A9 and S100A12 predict clinical response to abatacept treatment in polyarticular JIA (pJIA), and to assess whether changes from baseline in S100A8/A9 or S100A12 can be better prognostic markers for response to abatacept treatment than CRP in pJIA.Methods:Data are from a phase III trial of SC abatacept for the treatment of pJIA (NCT01844518).4 This 24-month, single-arm, open-label, international, multicentre, two-part study included male and female patients with pJIA aged 2–17 years. This analysis examined the correlation between biomarkers (S100A8/A9, S100A12 and high-sensitivity CRP [hsCRP]) and disease activity (measured using Juvenile Arthritis Disease Activity Score [JADAS]) at baseline, baseline biomarker values as predictors of future treatment response (ACR and JADAS endpoints), and the correlation between change from baseline in biomarker values and treatment response at Day 113.Results:Of 219 total patients, 158 (72%) had S100A8/A9 values and 155 (71%) had S100A12 values at baseline. Median S100A8/A9 and S100A12 values were 3295 ng/mL (normal range, 716–3004 ng/mL) and 176 ng/mL (normal range, 32–385 ng/mL), respectively. S100A8/A9, S100A12 and hsCRP (median 0.20 mg/dL; normal ≤0.6 mg/dL) had a low-to-moderate but significant association with disease activity at baseline; coefficients for associations between JADAS71-CRP low disease activity (LDA) and the biomarkers S100A8/A9, S100A12 and hsCRP were 0.23 (p=0.0038), 0.16 (p=0.0448) and 0.26 (p=0.0001), respectively. Baseline S100A8/A9 level above the median was associated with lower odds of ACR100 at Day 113 (p=0.0052). Figure 1 shows the associations of baseline biomarker values with Day 113 ACR and JADAS scores in the overall population. Baseline S100A8/A9 or S100A12 did not significantly influence ACR50 or ACR70 responses at Day 113, but high baseline values were associated with reduced odds of ACR90 (p=0.01), ACR100 (p=0.005), ACR-inactive disease (ID) (p=0.0001), and JADAS71-CRP (LDA) (p=0.02). By Day 477, elevated baseline S100A12 was still significantly associated with lower odds of ACR100 overall (0.467; p=0.0248) but baseline S100A8/A9 was not; at Day 645, neither was significantly associated with ACR100 response. At Day 113, changes from baseline in S100A8/A9 and S100A12 were correlated with ACR100 (coefficients of 0.22 [p=0.0082] and 0.26 [p=0.0015], respectively) and with ACR-ID (0.22 [p=0.0067] and 0.26 [p=0.0014], respectively); change in hsCRP was not significantly correlated with disease response.Conclusion:S100A8/A9 and S100A12 may serve as prognostic biomarkers to predict response to abatacept treatment at Day 113. Changes from baseline S100A8/A9 and S100A12 levels were more highly correlated with efficacy outcomes including ACR100 and ACR-ID at Day 113 compared with hsCRP.References:[1]Aljaberi N, et al. Pediatr Rheumatol Online J 2020;18:7.[2]Hammer H, et al. Arthritis Res Ther 2011;13:R178.[3]Nordal HH, et al. BMC Musculoskelet Disord 2014;15:335.[4]Brunner H, et al. Arthritis Rheumatol 2018;70:1144–1154.Acknowledgements:Professional medical writing and editorial assistance was provided by Rob Coover, MPH, at Caudex and was funded by Bristol Myers Squibb.Disclosure of Interests:Nicolino Ruperto Speakers bureau: NR has received honoraria for consultancies or speaker bureaus (< 10.000 USD each) from the following pharmaceutical companies in the past 3 years: Ablynx, Astrazeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers Squibb, Celgene, Eli Lilly, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Consultant of: NR has received honoraria for consultancies or speaker bureaus (< 10.000 USD each) from the following pharmaceutical companies in the past 3 years: Ablynx, Astrazeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers Squibb, Celgene, Eli Lilly, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Grant/research support from: The IRCCS Istituto Giannina Gaslini (IGG), where NR works as full-time public employee has received contributions (>10.000 USD each) from the following industries in the last 3 years: Bristol Myers Squibb, Eli Lilly, F Hoffmann-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties., Grant Schulert Speakers bureau: Novartis, Consultant of: SOBI, Alyssa Sproles: None declared, Sherry Thornton: None declared, Gabriel Vega Cornejo Speakers bureau: AbbVie, Grant/research support from: Bristol Myers Squibb, Eli Lilly, Janssen, Parexel, Sanofi, Jordi Anton Speakers bureau: AbbVie, Gebro, GlaxoSmithKline, Novartis, Pfizer, Roche, Sobi, Consultant of: AbbVie, Gebro, GlaxoSmithKline, Novartis, Pfizer, Roche, Sobi, Grant/research support from: AbbVie, Amgen, Gebro, GlaxoSmithKline, Lilly, Novartis, Novimmune, Pfizer, Roche, Sanofi, Sobi, Ruben Cuttica Speakers bureau: AbbVie, Bristol Myers Squibb, GlaxoSmithKline, Lilly, Novartis, Pfizer, Roche, UCB, Paid instructor for: AbbVie, Novartis, Pfizer, Roche, Consultant of: AbbVie, Bristol Myers Squibb, GlaxoSmithKline, Lilly, Novartis, Pfizer, Roche, UCB, Michael Henrickson: None declared, Ivan Foeldvari Consultant of: Bristol Myers Squibb, Gilead, Hexal, MEDAC, Novartis, Pfizer, Sanofi, Daniel Kingsbury Consultant of: Pfizer, Margarita Askelson Consultant of: Currently working for Syneos Health providing services to Bristol Myers Squibb, Jinqi Liu Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Sumanta Mukherjee Shareholder of: Bristol Myers Squibb, GlaxoSmithKline, Employee of: Bristol Myers Squibb, GlaxoSmithKline, Robert Wong Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Daniel J Lovell Speakers bureau: Genentech, Wyeth Pharm, Consultant of: Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Hoffman-La Roche, Novartis, Pfizer, Regeneron, Takeda, UBC, Wyeth Pharma, Xoma, Alberto Martini Speakers bureau: AbbVie, Novartis, Consultant of: AbbVie, Eli Lilly, EMD Serono, Idorsia, Janssen, Novartis, Pfizer, Alexei Grom Consultant of: AB2Bio, Novartis, Sobi (NovImmune), Grant/research support from: AB2Bio, Novartis, Sobi (NovImmune), Hermine Brunner Speakers bureau: GlaxoSmithKline, Novartis, Pfizer, Roche, Paid instructor for: Novartis, Pfizer (funds go to CCHMC/employer), Consultant of: Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Roche, UCB (funds go to CCHMC/employer), Grant/research support from: Bristol Myers Squibb, Pfizer (funds go to CCHMC/employer).

Book reviews - Crítica de libros - Crítica de livros (index) Susan Kilby: Peasant Perspectives on the Medieval Landscape: A study of three communities Carlos Tejerizo-García Briony McDonagh: Elite Women and the Agricultural Landscape, 1700-1830 Nicola Verdon Amanda L. Capern, Briony McDonagh and Jennifer Aston (Eds.): Women and the Land 1500-1900 Clare V. J. Griffiths Anne-Lise Head-König, Luigi Lorenzetti, Martin Stuber and Rahel Wunderli (Eds.): Pâturages et forêts collectifs. Économie, participation, durabilité / Kollektive Weiden und Wälder. Ökonomie, Partizipation, Nachhaltigkeit Giulia Beltrametti Stuart G. McCook: Coffee Is Not Forever: A Global History of the Coffee Leaf Rust Albert Folch James Simpson y Juan Carmona: Why Democracy Failed. The Agrarian Origins of the Spanish Civil War Lourenzo Fernández Prieto Bert Theunissen: Beauty or Statistics. Practice and Science in Dutch Livestock Breeding, 1900-2000 Reinaldo Funes Monzote Sylvain Brunier: Le bonheur dans la modernité. Conseillers agricoles et agriculteurs (1945-1985) Daniel Lanero Táboas Francisco García González (Ed.): Vivir en soledad. Viudedad, soltería y abandono en el mundo rural (España y América Latina, siglos XVI-XXI) Joana María Pujadas Mora

Background:Tofacitinib is an oral JAK inhibitor that is being investigated for JIA.Objectives:To assess tofacitinib efficacy and safety in JIA patients (pts).Methods:This was a Phase 3, randomised, double-blind (DB), placebo (PBO)-controlled withdrawal study in pts aged 2−<18 years with polyarticular course JIA (pcJIA), PsA or ERA (NCT02592434). In the 18-week open-label Part 1, pts received weight-based tofacitinib doses (5 mg BID or lower). Pts with ≥JIA ACR30 response at Week (W)18 were randomised 1:1 in the DB Part 2 (W18−44) to continue tofacitinib or switch to PBO. Primary endpoint: disease flare rate by W44. Key secondary endpoints: JIA ACR50/30/70 response rates; change from Part 2 baseline (Δ) in CHAQ-DI at W44. Other efficacy endpoints: time to disease flare in Part 2; JADAS27-CRP in Parts 1 and 2. PsA/ERA pts were excluded from these efficacy analyses. Safety was evaluated in all pts up to W44.Results:225 enrolled pts with pcJIA (n=184), PsA (n=20) or ERA (n=21) received tofacitinib in Part 1. At W18, 173/225 (76.9%) pts entered Part 2 (pcJIA n=142, PsA n=15, ERA n=16). In pcJIA pts, disease flare rate in Part 2 was significantly lower with tofacitinib vs PBO by W44 (p=0.0031; Fig 1a). JIA ACR50/30/70 response rates (Fig 1b) and ΔCHAQ-DI (Fig 1c) at W44, and time to disease flare in Part 2 (Fig 2a), were improved with tofacitinib vs PBO. Tofacitinib reduced JADAS27-CRP in Part 1; this effect was sustained in Part 2 (Fig 2b). Overall, safety was similar with tofacitinib or PBO (Table): 77.3% and 74.1% had adverse events (AEs); 1.1% and 2.4% had serious AEs. In Part 1, 2 pts had herpes zoster (non-serious) and 3 pts had serious infections (SIs). In Part 2, SIs occurred in 1 tofacitinib pt and 1 PBO pt. No pts died.Conclusion:In pcJIA pts, tofacitinib vs PBO resulted in significantly fewer disease flares, and improved time to flare, disease activity and physical functioning. Tofacitinib safety was consistent with that in RA pts.Table.Safety in all ptsPart 1Part 2TofacitinibaN=225TofacitinibaN=88PBO N=85Pts with events, n (%)AEs153 (68.0)68 (77.3)63 (74.1)SAEs7 (3.1)1 (1.1)2 (2.4)Permanent discontinuations due to AEs26 (11.6)16 (18.2)29 (34.1)AEs of special interest Death000 Gastrointestinal perforationb000 Hepatic eventb3 (1.3)00 Herpes zoster (non-serious and serious)2 (0.9)c00 Interstitial lung diseaseb000 Major adverse cardiovascular eventsb000 Malignancy (including non-melanoma skin cancer)b000 Macrophage activation syndromeb000 Opportunistic infectionb000 SI3 (1.3)1 (1.1)d1 (1.2) Thrombotic event (deep vein thrombosis, pulmonary embolismbor arterial thromboembolism)000 Tuberculosisb000a5 mg BID or equivalent weight-based lower dose in pts <40 kgbAdjudicated eventscBoth non-seriousdOne SAE of pilonidal cyst repair was coded to surgical procedures instead of infections, and was inadvertently not identified as an SI. Following adjudication, the SAE did not meet opportunistic infection criteria; it is also included in the table as an SIAE, adverse event; BID, twice daily; PBO, placebo; pts, patients; SAE, serious AE; SI, serious infectionAcknowledgments:Study sponsored by Pfizer Inc. Medical writing support was provided by Sarah Piggott of CMC Connect and funded by Pfizer Inc.Disclosure of Interests:Nicolino Ruperto Grant/research support from: Bristol-Myers Squibb, Eli Lily, F Hoffmann-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sobi (paid to institution), Consultant of: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda, Speakers bureau: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda, Olga Synoverska Speakers bureau: Sanofi, Tracy Ting: None declared, Carlos Abud-Mendoza Speakers bureau: Eli Lilly, Pfizer Inc, Alberto Spindler Speakers bureau: Eli Lilly, Yulia Vyzhga Grant/research support from: Pfizer Inc, Katherine Marzan Grant/research support from: Novartis, Vladimir Keltsev: None declared, Irit Tirosh: None declared, Lisa Imundo: None declared, Rita Jerath: None declared, Daniel Kingsbury: None declared, Betül Sözeri: None declared, Sheetal Vora: None declared, Sampath Prahalad Grant/research support from: Novartis, Elena Zholobova Grant/research support from: Novartis and Pfizer Inc, Speakers bureau: AbbVie, Novartis, Pfizer Inc and Roche, Yonatan Butbul Aviel: None declared, Vyacheslav Chasnyk: None declared, Melissa Lerman Grant/research support from: Amgen, Kabita Nanda Grant/research support from: Abbott, AbbVie, Amgen and Roche, Heinrike Schmeling Grant/research support from: Janssen, Pfizer Inc, Roche and USB Bioscience, Heather Tory: None declared, Yosef Uziel Speakers bureau: Pfizer Inc, Diego O Viola Grant/research support from: Bristol-Myers Squibb, GSK, Janssen and Pfizer Inc, Speakers bureau: AbbVie and Bristol-Myers Squibb, Holly Posner Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Keith Kanik Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Ann Wouters Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Cheng Chang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Richard Zhang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Irina Lazariciu Consultant of: Pfizer Inc, Employee of: IQVIA, Ming-Ann Hsu Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Ricardo Suehiro Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Alberto Martini Consultant of: AbbVie, Eli Lily, EMD Serono, Janssen, Novartis, Pfizer, UCB, Daniel J Lovell Consultant of: Abbott (consulting and PI), AbbVie (PI), Amgen (consultant and DSMC Chairperson), AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb (PI), Celgene, Forest Research (DSMB Chairman), GlaxoSmithKline, Hoffman-La Roche, Janssen (co-PI), Novartis (consultant and PI), Pfizer (consultant and PI), Roche (PI), Takeda, UBC (consultant and PI), Wyeth, Employee of: Cincinnati Children’s Hospital Medical Center, Speakers bureau: Wyeth, Hermine Brunner Consultant of: Hoffman-La Roche, Novartis, Pfizer, Sanofi Aventis, Merck Serono, AbbVie, Amgen, Alter, AstraZeneca, Baxalta Biosimilars, Biogen Idec, Boehringer, Bristol-Myers Squibb, Celgene, EMD Serono, Janssen, MedImmune, Novartis, Pfizer, and UCB Biosciences, Speakers bureau: GSK, Roche, and Novartis

Background:Still’s disease is a systemic auto-inflammatory disease with a pediatric form, sJIA, and an analogous condition in adults, adult-onset Still’s disease (AOSD). The role of interleukin-1 (IL-1) in the pathophysiology of Still’s disease is well established. Canakinumab, a monoclonal antibody against IL-1ß, is approved to treat patients with Still’s disease in Europe (sJIA and AOSD) and the United States (sJIA).Objectives:To study the efficacy of canakinumab in sJIA patients categorized by age, we performed an intention-to-treat analysis of pooled data from 5 clinical trials, as an addition to a previously communicated analysis including 3 of the studies1Methods:The age categories were children (2-<12 years), young adolescents (12-<16 years) and older adolescents and young adults (16-<20 years). We pooled efficacy results from patients with active disease at baseline treated during a 12-week period with canakinumab (4mg/kg every 4 weeks), including the presence of intermittent fever, serum concentrations of C reactive protein (CRP), improvement of sJIA (adapted pediatric ACR 30, 70 and 100 responses) and JIA ACR inactive disease status. Safety was assessed by analysis of reported adverse events (AEs).Results:302 children, 82 young adolescents and 34 older adolescents and young adults were included in the analysis, with a mean disease duration of 922, 1708 and 2615 days, respectively. Prior therapy with other biologics was common, with anakinra used in 33%, 35% and 47% of patients in each group. Disease severity was comparable among groups, with the mean number of active joints ranging from 11.8 to 13.7. Adapted pediatric ACR responses revealed a rapid response to canakinumab, with all groups showing similar rates of responders at most time points (Table 1). In each age group, the proportion of patients with inactive disease progressively increased to Day 57. At all time points after Day 15, the 16-<20 years group presented the highest proportion of patients with inactive disease. Median CRP levels decreased from baseline to reach values in the normal range (<10 mg/L) from Day 29 onwards in the three groups, with improvements more marked in the 16-<20 years group. The safety profile was similar in the three age groups analyzed, with a lower proportion of 16-<20 years old patients experiencing serious AEs (28%) as compared to children (35%) and young adolescents (42%).Table 1.Percentages of patients with Adapted pediatric ACR responses and inactive disease status over time*Time of treatment(Days)2 - <12 yearsa12 - <16 yearsb16-<20 yearscACR301572.781.783.9 (%)2977.584.182.45776.282.988.28565.574.583.3ACR701551.558.364.5 (%)2961.962.270.65765.258.579.48558.661.875.0ACR1001521.625.012.9 (%)2929.530.535.35736.134.138.28534.130.933.3Inactive disease1519.030.019.4 (%)2934.134.147.15739.436.655.98536.743.452.2*Some studies did not include visits at Day 15 and/or 85. For Day 15, 29, 57 and 85 the respective denominators for each age group were:aN = 231, 302, 302, 232;bN = 60, 82, 82, 55;cN = 31, 34, 34, 24.Conclusion:The efficacy and safety profile of canakinumab was consistent in children, adolescents and young adults with sJIA. Since sJIA and AOSD represent pediatric- and adult- onset variants of the Still’s disease continuum, these results further support the therapeutic effect of canakinumab 4 mg/kg every 4 weeks in both children and adults with Still’s disease.References:[1]Feist et al.Clin Exp Rheumatol.2018;36(4):668-75.Disclosure of Interests:Pierre Quartier Consultant of: AbbVie, Chugai-Roche, Lilly, Novartis, Sanofi, Sobi, Speakers bureau: AbbVie, BMS, Chugai-Roche, Novartis, Pfizer, Sobi, Eugen Feist Consultant of: Novartis, Roche, Sobi, Lilly, Pfizer, Abbvie, BMS, MSD, Sanofi, Speakers bureau: Novartis, Roche, Sobi, Lilly, Pfizer, Abbvie, BMS, MSD, Sanofi, Daniel J Lovell Consultant of: Abbott (consulting and PI), AbbVie (PI), Amgen (consultant and DSMC Chairperson), AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb (PI), Celgene, Forest Research (DSMB Chairman), GlaxoSmithKline, Hoffman-La Roche, Janssen (co-PI), Novartis (consultant and PI), Pfizer (consultant and PI), Roche (PI), Takeda, UBC (consultant and PI), Wyeth, Employee of: Cincinnati Children’s Hospital Medical Center, Speakers bureau: Wyeth, Hiroaki Umebayashi: None declared, Nicolino Ruperto Grant/research support from: Bristol-Myers Squibb, Eli Lily, F Hoffmann-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sobi (paid to institution), Consultant of: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda, Speakers bureau: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda, Hermine Brunner Consultant of: Hoffman-La Roche, Novartis, Pfizer, Sanofi Aventis, Merck Serono, AbbVie, Amgen, Alter, AstraZeneca, Baxalta Biosimilars, Biogen Idec, Boehringer, Bristol-Myers Squibb, Celgene, EMD Serono, Janssen, MedImmune, Novartis, Pfizer, and UCB Biosciences, Speakers bureau: GSK, Roche, and Novartis, Cornelia Dunger-Baldauf Employee of: Novartis, Stephanie Noviello Employee of: Novartis, sarah whelan Employee of: Novartis

The development and formation of the cognitive marketing notion are considered in the article. The emergence of cognitive marketing implies the development of a new approach to influencing consumer behavior, namely the formation of consumer consciousness, the creation of a consumption style, which in the future will determine the demand for new products. After the first cognitive revolution, which gave impetus to a more thorough study of these processes, much attention was paid to the study of cognitive psychology, which examines various mental processes, such as sensation and perception, pattern recognition, attention, learning, memory, concept formation, thinking, language, emotions and developmental processes. The essence of cognitive psychology is investigated and works of scientists-psychologists, which explain the essence of the cognitive approach in marketing are analyzed. Scientists who laid the foundations for the development of cognitive psychology are Jean Piaget, Jerome Bruner, Leo Vygotsky, Ulrich Neisser, Robert Solso. Also, the notion of behavioral economics, which combines investigations in the field of psychology and economy, and also generates the basis for cognitive marketing is considered. The article analyzes the works of Leon Festinger, Herbert Simon, Daniel Kahneman and Amos Tversky. All human decisions are almost always based on subjective imagination, depending on values, problem formulation, experience, habits and other personal characteristics. In many cases, people are not inclined to act in accordance with the requirements of neoclassical economics and often show a tendency to a completely irrational behavior. Also, different approaches to the essence of cognitive marketing formulation are analyzed and generalized. Cognitive marketing is an interdisciplinary field that combines cognitive psychology, behavioral economics, classical marketing, which with this synergy allows better understand consumer behavior and expands the tools of research and influence of traditional marketing, to help build effective marketing strategies for product positioning and promotion. Cognitive marketing aims to create new, previously unaware consumer needs for a particular product and creates a new desired style and standard of living, seeked by the consumers of this product.

Background:Enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) are two ILAR categories of juvenile idiopathic arthritis (JIA) and represent paediatric correlates of axial spondyloarthritis (axSpA) and adult psoriatic arthritis (PsA), respectively.1,2 Secukinumab (SEC) has demonstrated efficacy and safety in adult patients (pts) with PsA, ankylosing spondylitis and non-radiographic axSpA.3-5Objectives:Evaluate efficacy and safety of SEC using a flare prevention design in pts with active ERA and JPsA.Methods:This 2-yr study consisted of an open-label (OL) s.c. SEC (75/150 mg in pts <50/ ≥50 kg) at baseline (BL), and at Weeks (Wk) 1, 2, 3, 4, 8 and 12 in treatment-period (TP) 1. Responder pts who achieved at least JIA ACR 30 response at Wk 12 were randomised into the double-blinded TP2 to continue SEC or placebo (PBO) q4w until a disease flare, or up to Wk 100. Pts (aged 2 to <18 yrs) classified as ERA or JPsA according to ILAR criteria of ≥6 months duration with active disease were included. Primary endpoint was time to flare in TP2 and key secondary endpoints were JIA ACR 30/50/70/90/100, inactive disease, JADAS, enthesitis count and safety. Analysis of time to flare in TP2 included proportion of disease flare, Kaplan-Meier (KM) estimate of median time to flare in days, hazard ratio (95% CI) from Cox model, and P-value for the Stratified log-rank test. KM estimates of the probability to disease flare by treatment groups in TP2 were plotted against days. Observed data were used in all analyses. Post-hoc analyses using non-responder imputation (NRI) were performed for JIA ACR 30/50/70/90/100 responses.Results:86/97 (89%) pts were enrolled in the OL period TP1 (mean age, 13.1 yrs; female, 33.7%; ERA, n=52; JPsA, n=34). At BL, mean JADAS-27 score was 15.1 and enthesitis count was 2.6. At the end of TP1, 90.4% (75/83) of pts achieved JIA ACR 30 and 69.9% (58/83) achieved JIA ACR 70. There were 21 and 10 flares in TP2, respectively in PBO and SEC treated pts with a significantly longer time to flare and 72% risk of flare reduction in SEC treatment vs PBO (HR: 0.28; 95% CI: 0.13–0.63; P<0.001) (Figure 1). JIA ACR responses, disease activity and enthesitis count are reported in Table 1. NRI analyses showed that 87.2%, 83.7%, 67.4%, 38.4% and 24.4% of pts achieved JIA ACR 30/50/70/90/100, respectively. Rates of adverse events (AEs; 91.7% vs 92.1%) and serious AEs (14.6% vs 10.5%) in SEC and PBO groups were comparable in the entire TP. No new safety signals were observed.Table 1.Efficacy of secukinumab in Treatment Periods 1 and 2 (Key secondary endpoints)Efficacy Outcomes, %TP1TP2¥SEC (N=83)^SEC (N=37)PBO (N=37)P-valueJIA ACR 3090.489.264.90.014JIA ACR 5086.778.462.20.152JIA ACR 7069.967.643.20.042JIA ACR 9039.851.440.50.431JIA ACR 10025.343.237.80.745Inactive disease#36.147.237.80.500JADAS-27, mean (SD)15.1 (7.2)14.6 (8.1)13.3 (5.8)NAEnthesitis count, mean change from BL (SD)−1.8 (2.3)−2.1 (2.0)−1.9 (1.2)NAP-values: Cochran-Mantel-Haenszel test, adjusted for analysis factors: JIA category (ERA/ JPsA) and MTX use at BL¥The N numbers are values at the end of TP2^Efficacy outcomes (%) in TP1 calculated in patients with evaluable data at Wk 12 (N=83)#Inactive disease: Definition adapted from JIA ACR criteria of Wallace et al., 2011. N=36 for SEC at the end of TP2JADAS, Juvenile Arthritis Disease Activity Score; N, total number of patients in the treatment group; NA, data not availableFigure 1.Time to flare in Treatment Period 2 (Primary Endpoint)Conclusion:In children and adolescents with ERA and JPsA, efficacy of SEC was demonstrated with a significantly longer time to flare vs PBO with sustained improvement of signs and symptoms up to Wk 104 and a favourable safety profile.References:[1]Colbert RA. Nat Rev Rheumatol. 2010;6:477–85.[2]Martini A, et al. J Rheumatol. 2019;46:190–7.[3]McInnes IB, et al. Lancet. 2015;386:1137–46.[4]Baeten D, et al. N Engl J Med. 2015;373:2534–48.[5]Deodhar A, et al. Arthritis Rheumatol. 2021;73:110–20.Disclosure of Interests:Nicolino Ruperto Consultant of: Ablynx, Astrazeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers and Squibb, Celgene, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Grant/research support from: BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi, Speakers bureau: Ablynx, Astrazeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers and Squibb, Celgene, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Ivan Foeldvari Consultant of: Novartis, Speakers bureau: Novartis, Ekaterina Alexeeva Grant/research support from: Novartis, Pfizer, Sanofi, MSD, AMGEN, Eli Lilly, Roche, Speakers bureau: Novartis, Pfizer, Sanofi, MSD, AMGEN, Eli Lilly, Roche, NURAY AKTAY AYAZ: None declared, Inmaculada Calvo Consultant of: Sobi, Novartis, Abbvie, GlaxoSmithKline, Pfizer, Amgen, Clementia, Speakers bureau: Sobi, Novartis, Abbvie, GlaxoSmithKline, Pfizer, Amgen, Clementia, Ozgur KASAPCOPUR: None declared, Vyacheslav Chasnyk: None declared, Markus Hufnagel Grant/research support from: Astellas, F. Hoffmann-La Roche, Novartis, Zbigniew Żuber: None declared, Grant Schulert Consultant of: Sobi, Novartis, Seza Ozen: None declared, Artem Popov: None declared, Athimalaipet Ramanan Speakers bureau: Roche, Sobi, Eli Lilly, UCB, Novartis, Christiaan Scott: None declared, Betül Sözeri: None declared, Elena Zholobova Grant/research support from: Pfizer, Novartis, Speakers bureau: Abbvie, Pfizer, Roche, Novartis, Xuan Zhu Employee of: Novartis, sarah whelan Employee of: Novartis, Shareholder of: Novartis, Luminita Pricop Employee of: Novartis, Shareholder of: Novartis, Angelo Ravelli Consultant of: Abbvie, Bristol-Myers Squibb, Pfizer, Hoffmann-LaRoche, Novartis, Centocor, Angelini Holding, Reckitt Benckiser, Speakers bureau: Abbvie, Bristol-Myers Squibb, Pfizer, Hoffmann-LaRoche, Novartis, Centocor, Angelini Holding, Reckitt Benckiser, Alberto Martini Consultant of: Eli Lilly, EMD Serono, Janssen, Novartis, Pfizer, Abbvie, Speakers bureau: Eli Lilly, EMD Serono, Janssen, Novartis, Pfizer, Abbvie, Daniel J Lovell Consultant of: AstraZeneca, Wyeth, Amgen, Abbott, Pfizer, Hoffmann-La Roche, Novartis, UBC, Takeda, Janssen, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Bristol Myers Squibb, AbbVie, Forest Research, Speakers bureau: AstraZeneca, Wyeth, Amgen, Abbott, Pfizer, Hoffmann-La Roche, Novartis, UBC, Takeda, Janssen, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Bristol Myers Squibb, AbbVie, Forest Research, Hermine Brunner Consultant of: Aurina, AbbVie, Astra Zeneca-Medimmune, Biogen, Boehringer, Bristol-Myers Squibb, Celgene, Eli Lilly, EMD Serono, GlaxoSmithKline, F. Hoffmann-La Roche, Merck, Novartis, R-Pharm, Sanofi, Pfizer, Grant/research support from: Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, F. Hoffmann-La Roche, Janssen, Novartis, and Pfizer, Speakers bureau: Pfizer, Roche and GlaxoSmithKline

Background:Juvenile systemic scleroderma (jSSc) is an orphan disease with a prevalence of 3 per 1 000 000 children. There are limited data regarding the clinical presentation of jSSc. The Juvenile Systemic Scleroderma Inception Cohort (JSSIC) is the largest multinational registry that prospectively collects information about jSSc patients.Objectives:Evaluation of the jSSc patients at the time of inclusion in the JSSIC.Methods:Patients were included in the JSSIC if they fulfilled the adult ACR/EULAR classification criteria for systemic scleroderma, if they presented the first non-Raynaud symptom before 16 years of age and if they were younger than 18 years of age at time of inclusion. Patients’ characteristics at time of inclusion were evaluated.Results:Until 15thof December 2019 hundred fifty patients were included, 83% of them being Caucasian and 80% female. The majority had the diffuse subtype (72%) and 17% of all jSSc had overlap features. The mean age of first presentation of Raynaud´s phenomenon was 9.8 years in the diffuse subtype (djSSc) and 10.7 years in the limited subtype (ljSSc) (p=.197). The mean age at first non-Raynaud’s symptoms was 10.0 years in the djSSc and 11.2 years in the ljSSc (p=0.247). Mean disease duration at time of inclusion was 3.4 years in the djSSc and 2.4 years in the ljSSc group.Significant differences were found between the groups regarding mean modified Rodnan skin score, 18.2 in the djSSc vs 6.2 in the ljSSc (p=0.02); presence of Gottron´s papulae (djSSc 30% vs ljSSc 13%, p=0.43);presence of teleangiectasia (djSSc 42% vs 18% ljSS, p=0.01); history of ulceration (djSSc 42% vs 18% ljSSc,p=0.008); 6 Minute walk test below the 10thpercentile (djSSc 85% vs ljSSc 54%, p=0.044), total pulmonary involvement (djSSc 49% vs ljSSc 31%, p=0.045), cardiac involvement (ljSSc 17% vs djSSc 3%, p=0.002). djSSc patients had significantly worse scores for Physician Global Assessment of disease activity compared to ljSSc patients (VAS 0-100) (40 vs 15) (p=0.001) and for Physician Global Assessment of disease damage (VAS 0-100) (36 vs 17) (p=0.001).There were no statistically significant differences in the other presentations. Pulmonary hypertension occurred in approximately 6% in both groups. No systemic hypertension or renal crisis was reported. ANA positivity was 90% in both groups. Anti-Scl70 was positive in 35% in djSSc and 36% in the ljSSc group. Anticentromere positivity occurred in 3% in the djSSc and 7% in the ljSSc group.Conclusion:In this unique large cohort of jSSc patients there were significant differences between djSSc and ljSSc patients at time of inclusion into the cohort regarding skin, vascular, pulmonary and cardiac involvement. According to the physician global scores the djSSc patients had a significantly more severe disease. Interestingly the antibody profile was similar in both scleroderma phenotypes.Supported by the “Joachim Herz Stiftung”Disclosure of Interests: :Ivan Foeldvari Consultant of: Novartis, Jens Klotsche: None declared, Ozgur Kasapcopur: None declared, Amra Adrovic: None declared, Kathryn Torok: None declared, Maria T. Terreri: None declared, Ana Paula Sakamoto: None declared, Valda Stanevicha: None declared, Flávio R. Sztajnbok: None declared, Jordi Anton Grant/research support from: grants from Pfizer, abbvie, Novartis, Sobi. Gebro, Roche, Novimmune, Sanofi, Lilly, Amgen, Grant/research support from: Pfizer, abbvie, Novartis, Sobi. Gebro, Roche, Novimmune, Sanofi, Lilly, Amgen, Consultant of: Novartis, Sobi, Pfizer, abbvie, Consultant of: Novartis, Sobi, Pfizer, abbvie, Speakers bureau: abbvie, Pfizer, Roche, Novartis, Sobi, Gebro, Speakers bureau: abbvie, Pfizer, Roche, Novartis, Sobi, Gebro, Brian Feldman Consultant of: DSMB for Pfizer, OPTUM and AB2-Bio, Ekaterina Alexeeva Grant/research support from: Roche, Pfizer, Centocor, Novartis, Speakers bureau: Roche, Novartis, Pfizer., Maria Katsikas: None declared, Vanessa Smith Grant/research support from: The affiliated company received grants from Research Foundation - Flanders (FWO), Belgian Fund for Scientific Research in Rheumatic diseases (FWRO), Boehringer Ingelheim Pharma GmbH & Co and Janssen-Cilag NV, Consultant of: Boehringer-Ingelheim Pharma GmbH & Co, Speakers bureau: Actelion Pharmaceuticals Ltd, Boehringer-Ingelheim Pharma GmbH & Co and UCB Biopharma Sprl, edoardo marrani: None declared, Mikhail Kostik: None declared, Natalia Vasquez-Canizares: None declared, Simone Appenzeller: None declared, Mahesh Janarthanan: None declared, Monika Moll: None declared, Dana Nemcova: None declared, Anjali Patwardhan: None declared, Maria Jose Santos Speakers bureau: Novartis and Pfizer, Sujata Sawhney: None declared, Dieneke Schonenberg: None declared, Cristina Battagliotti: None declared, Lillemor Berntson Consultant of: paid by Abbvie as a consultant, Speakers bureau: paid by Abbvie for giving speaches about JIA, Blanca Bica: None declared, Juergen Brunner Grant/research support from: Pfizer, Novartis, Consultant of: Pfizer, Novartis, Abbvie, Roche, BMS, Speakers bureau: Pfizer, Novartis, Abbvie, Roche, BMS, Patricia Costa Reis: None declared, Despina Eleftheriou: None declared, Liora Harel: None declared, Gerd Horneff Grant/research support from: AbbVie, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, Bayer, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Daniela Kaiser: None declared, Dragana Lazarevic: None declared, Kirsten Minden Consultant of: GlaxoSmithKline, Sanofi, Speakers bureau: Roche, Susan Nielsen: None declared, Farzana Nuruzzaman: None declared, Yosef Uziel: None declared, Nicola Helmus: None declared