scholarly journals P186 Secukinumab effectiveness and safety in patients with active psoriatic arthritis or ankylosing spondylitis: interim analysis of an observational study in the real-world setting

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Karl Gaffney ◽  
Nicola Gullick ◽  
Uta Kiltz ◽  
Petros Sfikakis ◽  
Athina Theodoridou ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Real World ◽  
C Reactive Protein ◽  
Research Support ◽  
Research Grants ◽  
The Real ◽  
Reactive Protein ◽  
Number Of Patients ◽  
Support Research

Abstract Background/Aims  SERENA is an ongoing, non-interventional study involving ∼400 European sites with an observation period of ≤ 5 years to evaluate retention, effectiveness, safety/tolerability and quality of life with secukinumab (SEC) in patients with moderate-to-severe plaque psoriasis, active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS) in the real world. We present effectiveness and safety data through 1 year in the 577 PsA and 507 AS patients enrolled, of which 533 PsA and 461 AS patients comprised the target study population (fulfilling all eligibility criteria). Methods  Patients (aged ≥18 years) with active PsA or AS who were treated for at least 16 weeks with SEC were enrolled. Effectiveness assessments included 78 tender joint count/76 swollen joint count, PGA, total pain (VAS, 0-100 mm), presence of enthesitis/dactylitis and PASI75/90/100 in patients with PsA, and BASDAI, PtGA, C-reactive protein, ASDAS and total spinal pain in patients with AS. Results  Mean disease duration from diagnosis to enrolment was 8.6 and 9.8 years for PsA and AS patients. Patients received SEC for a mean duration of 1 year prior to enrolment (range: 0.90-1.00). In total, 64.7% (N = 533) of PsA and 60.7% (N = 461) of AS patients received other biologic drugs prior to SEC treatment, with 59.7% and 52.7% of PsA and AS patients receiving at least two different biologic drugs. Most patients pre-treated with biologics discontinued biologic treatment due to lack of efficacy (88.0% PsA; 86.8% AS). Retention rates for SEC after 1 year were 85.9% and 86.5% in PsA and AS patients. Responses across all effectiveness assessments in both cohorts were maintained or improved after 1 year of observation (Table 1). No new or unexpected safety signals were reported. P186 Table 1:Effectiveness outcomes in patients with PsA or AS at enrolment and Year 1Characteristic, mean±SD (M), unless otherwise specifiedPsA (N = 533)PsA (N = 533)AS (N = 461)AS (N = 461)EnrolmentYear 1EnrolmentYear 1Total pain (VAS 0-100 mm)31.80±24.28a (432)30.77±24.57a (322)34.68±24.23b (350)34.16±24.49b (228)Presence of tender or swollen joint, n/M (%)280/520 (53.8%)158/373 (42.4%)--Tender joint count, mean [min-max] (m)6.5 [0-68] (203)6.8 [0-78] (140)--Swollen joint count, mean [min-max] (m)3.3 [0-38] (203)2.8 [0-23] (140)--Presence of dactylitis, n/M (%)33/516 (6.4%)13/370 (3.5%)--Enthesitis index0.4±1.0c (276)c0.3±0.9c (243)c0.7±1.70d (246)0.6±1.7d (170)HAQ-DI0.83±0.70 (398)0.83±0.72 (268)--BASDAI--3.20±2.28 (436)3.24±2.36 (270)ASDAS-CRP--2.25±0.94 (229)2.27±0.97 (173)hsCRP, mg/L--8.53±13.42 (285)8.10±14.72 (218)PtGA (NRS) (VAS 0-10 cm)--4.18±2.32 (366)4.07±2.37 (246)aTotal pain;bTotal back pain;cLeeds enthesitis index;dMaastricht Ankylosing Spondylitis Enthesitis Score. AS, ankylosing spondylitis; ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score-C-reactive protein; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; HAQ-DI, Health Assessment Questionnaire Disability Index; hsCRP, high sensitivity C-reactive protein; m, number of patients with detailed assessments of tender or swollen joints; M, number of patients with evaluation; n, number of patients with a positive response; N, number of patients in the study population; NRS, numeric rating scale; PsA, psoriatic arthritis; PtGA, Patient’s Global Assessment; SD, standard deviation; VAS, visual analogue scale. Conclusion  Patients in SERENA had long-standing disease with more than half previously treated with biologics, most of whom had discontinued treatment due to lack of efficacy. SEC showed sustained effectiveness, a high retention rate and favourable safety profile in PsA and AS patients in the real world over 1 year of observation. Incomplete data due to lack of rigorous monitoring (an intrinsic weakness of observational studies) must be considered when interpreting real-world findings. Disclosure  K. Gaffney: Grants/research support; Research grants, consultancy fees and/or speaker fees from AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB. N. Gullick: Grants/research support; Research support, consultancy fees and/or speakers fees from AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB. U. Kiltz: Grants/research support; Research grants, support and/or consultancy fees from AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche and UCB. P. Sfikakis: Grants/research support; Research grants, support and consultancy fees from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis and Pfizer. A. Theodoridou: Honoraria; Consultancy fees from UCB, Amgen, Novartis. J. Brandt-Jürgens: Honoraria; Consultancy fees and speaker honoraria from AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen and Medac. E. Lespessailles: Honoraria; Received speaker and consultant fees from Amgen, Expanscience, Lilly and MSD, and research grants from AbbVie, Amgen, Lilly, MSD and UCB. C. Perella: Other; Novartis employee. E. Pournara: Shareholder/stock ownership; Novartis shareholder. Other; Novartis employee. B. Schulz: Other; Novartis employee. J. Veit: Other; Novartis employee.

scholarly journals P191 Secukinumab demonstrates a consistent safety profile in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis over long term: updated pooled safety analyses

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Iain B McInnes ◽  
Xenofon Baraliakos ◽  
Atul Deodhar ◽  
Alice B Gottlieb ◽  
Mark Lebwohl ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Safety Data ◽  
Cardiac Events ◽  
Research Support ◽  
Phase 3 ◽  
Research Grants ◽  
Adverse Cardiac Events ◽  
Post Marketing

Abstract Background/Aims  Pooled safety data have been reported with secukinumab in patients with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and psoriasis (PsO). Here we report longterm safety data for secukinumab in patients with PsA, AS or PsO up to 5 years. Methods  The integrated clinical trial safety dataset included data pooled from 28 randomised controlled clinical trials of secukinumab 300, 150 or 75 mg in PsO (11 Phase 3 and 8 Phase 4 trials), PsA (5 Phase 3 trials) and AS (4 Phase 3 trials), along with post-marketing safety surveillance data starting 26 December 2014, with a cut-off date of 25 December 2018. Adverse events were reported as exposure-adjusted incident rates (EAIRs) per 100 patient-years. Analyses included all patients who received ≥1 dose of secukinumab. Results  A total of 12,637 patients (8,819, 2,678 and 1,140 patients with PsO, PsA and AS, with an exposure of 15,063.1, 5,984.6 and 3,527.2 patient-years, respectively) were included. The most frequent adverse event was upper respiratory tract infection and the EAIR per 100 patient-years for inflammatory bowel disease (IBD), malignancies and major adverse cardiac events (MACE) remained low. The EAIR per 100 patient-years for adverse events of special interest are reported in Table 1. The cumulative post-marketing exposure to secukinumab was estimated to be ∼285,811 patient-years across the approved indications. Post-marketing safety data showed cumulative reporting rates of 1.4, 0.3, 0.2 and 0.2 patienttreatment years for serious infections, malignancy, total IBD and MACE, respectively. Conclusion  Secukinumab was well tolerated in this long-term analysis of patients with PsO, PsA and AS across clinical trials and post-marketing surveillance, with a safety profile consistent with previous reports (Deodhar, 2019). P191 Table 1:Selected adverse events of interest with secukinumab across pooled clinical trialsVariablePsOPsAASSEC N = 8,819SEC N = 2,678SEC N = 1,140Exposure (days),mean (SD)623.9 (567.7)816.2 (580.7)1130.1 (583.0)Death, n (%)14 (0.2)11 (0.4)9 (0.8)Selected adverse events of interest, EAIR (95% CI)Serious infectionsa1.4 (1.2-1.6)1.8 (1.5-2.2)1.2 (0.9-1.6)Candida infectionsb2.9 (2.7-3.2)1.5 (1.2-1.9)0.7 (0.5-1.1)IBDc0.01 (0.0-0.05)0.03 (0.0-0.1)0.03 (0.0-0.2)Crohns diseasec0.1 (0.05-0.2)0.1 (0.04-0.2)0.4 (0.24-0.7)Ulcerative colitisc0.1 (0.08-0.2)0.1 (0.04-0.2)0.2 (0.1-0.5)MACEd0.4 (0.3-0.5)0.4 (0.3-0.6)0.7 (0.4-1.0)Uveitisc0.01 (0.0-0.05)0.1 (0.04-0.2)1.2 (0.9-1.7)Malignancye0.9 (0.7-1.0)1.0 (0.77-1.3)0.5 (0.3-0.8)aRates for system organ class;bRates for high level term;cRates for preferred term (PT; IBD for unspecified IBD);dRates for Novartis MedDRA Query term;eRates for standardised MedDRA Query term - ‘malignancies and unspecified tumour’. AS, ankylosing spondylitis; CI, confidence interval; EAIR, exposure-adjusted incidence rate per 100 patient-years; IBD, inflammatory bowel disease; MACE, major adverse cardiac events; MedDRA, Medical Dictionary for Regulatory Activities; N, number of patients in the analysis; PsA, psoriatic arthritis; PsO, psoriasis; PT, preferred term; SD, standard deviation; SEC, secukinumab. Disclosure  I. McInnes: Other; I.M. has received research grants, consultation fees or speaker honoraria from AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB. X. Baraliakos: Consultancies; X.B. is a consultant for AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen. Member of speakers’ bureau; X.B. is a member of the speakers' bureau for AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen. Grants/research support; X.B. has received grant/research support from AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen. A. Deodhar: Other; A.D. has received honoraria for consulting or speaking for, or has received research grants from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb (BMS), Eli Lilly, GlaxoSmithKline (GSK), Janssen, Novartis, Pfizer and UCB. A. Gottlieb: Other; A.G. has received research grants, consultation fees or speaker honoraria for lectures from Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB. M. Lebwohl: Consultancies; M.L. is a consultant for Allergan, Almirall, Arcutis, Inc., Avotres Therapeutics, BirchBioMed Inc., Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Theravance and Verrica. Grants/research support; M.B. receives receives research funds from AbbVie, Amgen, Arcutis, AstraZeneca, Boehringer Ingelheim, Celgene, Clinuvel, Eli Lilly, Incyte, Janssen Research & Development, LLC, Kadmon Corp., LLC, LEO Pharma, Medimmune, Novartis, Ortho Dermatologics, Pfizer, Sciderm, UCB, Inc. and ViDac. S. Schreiber: Consultancies; S.S. has received consultation fees from AbbVie, Arena, BMS, Biogen, Celltrion, Celgene, IMAB, Gilead, MSD, Mylan, Pfizer, Fresenius, Janssen, Takeda, Theravance, Provention Bio, Protagonist, and Dr Falk Pharma. K. Marfo: Other; K.M. is an employee of Novartis with Novartis stock. W. Bao: Other; W.B. is an employee of Novartis with Novartis stock. H. Richards: Other; H.B.R. is an employee of Novartis with Novartis stock. L. Pricop: Other; L.P. is an employee of Novartis with Novartis stock. A. Shete: Other; A.S. is an employee of Novartis with Novartis stock. J. Safi: Other; J.S. is an employee of Novartis with Novartis stock. P. Mease: Consultancies; P.M. is a consultant for AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB. Member of speakers’ bureau; P.M. is a member of the speakers' bureau for AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB. Grants/research support; P.M. has received grant/research support from AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB.

scholarly journals AB0817 DOES SMOKING AFFECT SECUKINUMAB TREATMENT OUTCOMES AND SAFETY IN PATIENTS WITH PSORIATIC ARTHRITIS? - REAL WORLD DATA FROM THE GERMAN AQUILA STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1711.1-1711
Author(s):  
E. Riechers ◽  
U. Kiltz ◽  
J. Brandt-Juergens ◽  
P. Kästner ◽  
D. Peterlik ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Interim Analysis ◽  
Smoking Status ◽  
Depressive Mood ◽  
Research Support ◽  
Real World Data ◽  
World Data ◽  
Number Of Patients

Background:Several studies have shown a negative association between smoking status and psoriatic arthritis (PsA) clinical outcomes.1,2The German non-interventional study AQUILA provides real-world data on the influence of smoking on therapeutic effectiveness and safety issues under secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin-17A.Objectives:The aim of this interim analysis is to describe selected baseline (BL) demographics, to evaluate SEC effectiveness on disease activity and depressive mood and to report the safety profile depending on smoking status of PsA patients.Methods:AQUILA is an ongoing, multi-center study including up to 2700 patients with active PsA or ankylosing spondylitis. Patients were observed from BL up to week (w) 52. Real-world data was assessed prospectively and analyzed as observed. In addition to the assessment of C-reactive protein (CRP), data was collected on patient´s disease activity (tender/swollen joint counts, TJC/SJC), skin disease activity (Psoriasis Area and Severity Index, PASI) and depressive mood (Beck´s Depression Inventory version II, BDI-II). For calculation of the proportion of patients who experienced (serious) adverse events ((S)AEs), all PsA patients were included who received at least one dose of SEC irrespective of further documentation of any study visit. This interim analysis focuses on subgroups non-smoker (NS) and smoker (S).Results:At BL, 641 PsA patients were included: 49.8% (n=319) non-smokers (NS) and 24.3% (n=156) smokers (S). 17.5% (n=112) were ex-smoker and 8.4% (n=54) of unknown smoking status. In both, NS and S, the proportion of women was higher (58.0% in NS and 67.3% in S). NS were slightly older than S (mean age: 53.8/49.7 years). There were no significant differences between NS and S in mean CRP within the 52 weeks (Fig. 1A). Both TJC and SJC improved over time and were similar between NS and S (Fig. 1B). Although mean absolute PASI value was worse in S at BL, a similar temporal improvement was seen in both groups (NS: 7.0 at BL to 1.0 at w52; S: 9.2 at BL to 1.0 at w52). BDI-II scores decreased in both groups with overall higher values in S (NS: 10.9 at BL to 9.1 at w52; S: 12.8 at BL and 10.8 at w52). Regarding the occurrence of AEs and SAEs with or without suspected relationship to SEC, NS had percentagewise less events than S (Table 1). In addition, percentage of PsA patients who discontinued SEC treatment due to an AE was lower for NS compared to S.Table 1.Overview of AEs (and SAEs) under SEC treatment depending on smoking status in PsA patientsNumber of patients withNS (N=333), n (%)S (N=161),n (%)P valueAE233 (70.0)118 (73.3)0.11AE with suspected relationship to SEC129 (38.7)72 (44.7)0.10SAE74 (22.2)45 (28.0)0.06SAE with suspected relationship to SEC29 (8.7)18 (11.2)0.37Figure 1.Disease activity in PsA patients treated with SEC depending on the smoking status**CRP data/ACR joint counts were documented not for all PsA patients at BL and subsequent visits.Conclusion:In a real-world setting, SEC improved disease activity and depressive mood of PsA patients with no obvious differences between NS and S. Overall, this interim analysis shows that SEC is an effective and reliable treatment, irrespective of the PsA patients’ smoking status. Further progress of the AQUILA study as well as long-term data from other real-world observational studies with SEC, such as SERENA, will reveal whether this trend will continue.References:[1]Hojgaard P et al, Ann Rheum Dis 2015; 74:2130-6; 2. Eder L et al, Arthritis Care Res 2011 Aug; 63:1091-7Disclosure of Interests:Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens: None declared, Peter Kästner Consultant of: Chugai, Novartis, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

scholarly journals SAT0432 EFFECT OF SEX ON DISEASE CHARACTERISTICS AND DISEASE IMPACT IN PATIENTS WITH PSORIATIC ARTHRITIS (PsA): INSIGHTS FROM THE REAL-WORLD, OBSERVATIONAL MULTINATIONAL PsABio COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1171.1-1173
Author(s):  
M. T. Nurmohamed ◽  
I. Van der Horst-Bruinsma ◽  
A. W. Van Kuijk ◽  
S. Siebert ◽  
P. Bergmans ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Physical Functioning ◽  
Real World ◽  
Comprehensive Treatment ◽  
Diagnosis Delay ◽  
Health State ◽  
Research Support ◽  
Disease Characteristics ◽  
Disease Impact

Background:Female sex has been associated with more severe disease and poorer treatment outcomes in PsA. These observations are often based on small populations or national cohorts/registries.Objectives:To investigate the effects of sex on disease characteristics and disease impact in PsA, using data of 929 consecutive patients (pts) from PsABio.Methods:PsABio is a real-world, non-interventional European study in PsA pts treated with UST or TNFi based on their rheumatologist’s choice. Observed male and female baseline (BL) data were described and compared using 95% CI.Results:Women in PsABio (n=512 [55%]) were numerically older than men (mean [SD]: 50.5 [12.7] / 48.7 [12.3] years, respectively). Women were more obese (BMI >30), % (95% CI): F: 35 (30, 39), M: 24 (20, 29), men more overweight (BMI >25–30): F: 31 (27, 36), M:51 (46, 57). Age at diagnosis, delay from first symptom to diagnosis, and disease duration were similar for both sexes.Women entered PsABio more often on 3rd line treatment, whereas men started on 1st-line biologic treatment more often (F/M 1st line 47%/55%; 2nd line 34%/33%; 3rd line 20%/12%). Numerically, concomitant MTX was given more often to women vs men (32% vs 27%). At BL, 60% of women and 64% of men were on NSAIDs; 7.9% and 2.5% on antidepressant drugs. Women had significantly more comorbidities, with numerically more cardiovascular disease and anxiety/depression, and 3 times more IBD.Women had significantly higher 68 tender joint counts (TJC): 13.0 vs 10.4, while 66 swollen joint counts were not significantly different: 5.8 vs 5.5. Axial or combined axial-peripheral disease was similarly frequent, in 29% of women and 26% of men (Figs. 1, 2).Clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) was higher in women (31.8 vs 27.3); pt-reported levels of pain, global disease activity (VAS scales) and higher TJC contributed to this. While enthesitis prevalence (based on Leeds Enthesitis Index) was comparable, men had significantly more frequent dactylitis, nail disease and worse skin psoriasis. At BL, 3.4% of women vs 7.1% of men, were in MDA.Regarding physical functioning (HAQ-DI), impact of disease (PSAID-12) and quality of life (EQ5D-3L health state), women with PsA starting a biologic (b)DMARD, expressed significantly greater negative impact and more limitations due to their disease (Fig. 2).Conclusion:In routine care, women with PsA starting a bDMARD presented with worse outcomes over a range of assessments compared with men (higher pt-reported pain and disease activity, TJC, and worse physical functioning and QoL), while men had worse dactylitis and psoriasis. Follow-up analysis will report whether the effects of biologic therapy are different in both sexes. The increased prevalence of associated features related to pain and impact on functioning and QoL may indicate the need for a more comprehensive treatment approach for women to avoid unnecessary and premature bDMARD stop or switch.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Arno WR van Kuijk Grant/research support from: Janssen, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Wim Noel Employee of: Janssen Pharmaceuticals NV, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

scholarly journals POS1012 HOW IMPORTANT WOULD BE THE IMPACT OF SPONDYLOARTHRITIS ON MILITARY POPULATION’S WORKING LIFE?

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 774.2-774
Author(s):  
T. Mehmli ◽  
R. Dhahri ◽  
M. Slouma ◽  
E. Hannech ◽  
B. Louzir ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Activity Index ◽  
Productivity Loss ◽  
Young Patients ◽  
Work Productivity ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Military Patients ◽  
The Impact

Background:Spondyloarthritis is a group of chronic inflammatory diseases involving axial and peripheral joints. It mainly affects young patients typically of working age. Therefore, its impact on work outcomes may be considerable particularly in military patients.Objectives:The aim of this study was to evaluate the impact of spondyloarthritis on work ability and productivity in military patients, and to assess relationship between work productivity loss and disease activity.Methods:Thirty Three patients diagnosed with spondyloarthritis in the militay hospital of Tunis were included in the study. Age, gender and C-reactive protein were recorded. Data related to duration of the disease, Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were also recorded. Employed patients completed Work Productivity and Activity Impairment (WPAI) questionnaire witch assesses four subscales: presenteism, absenteism, overall work impairemend and daily activity impairement in the 7 past days.Results:Among the thirty three patients, 63 % were men and 37% were women. The average age was 43,7 ± 13,5. The average duration of disease was 8,5 ± 7,75 years. Mean C-Reactive protein was 27,5 ± 39,3. Mean ASDAS and BASDAI were 3,12 ± 1,39 and 4,26 ± 1,78 respectively. 22 patients (66%) had an active disease and 11 (33%)were in remission. 48,4% of patients were using NSAIDs, 48,4% were under DMARDs and 42% were under biologics (12 patients using TNF-alpha blockers and 2 patients were given IL-17 inhibitors). Among this patients, 27 were employed. Three patients (11%) had a total work disability and were retired from work and two have been outplaced.Employed patients worked an average of 35,6 ± 10,3 hours per week and missed an average of 3,48 ± 6,49 hours per week. The mean rates of absenteeism, presenteeism and work productivity loss were 8,8 ± 16,9 %, 48,4 ± 19,9 % and 48,6 ± 19,7 %.There was a statistically significant correlation between BASDAI and work missed hours (p<0,05, r=0,48), absenteeism (p<0,05, r=0,48), presenteeism (p<0,01, r=0,669), work impairement (p<0,01, r=0,669), activity impairement (p<0,05, r=0,475) and work productivity loss (p<0,05, r=0,475), as well as between ASDAS CRP and presenteeism (p<0,05, r= 0,593), work impairement (p<0,05, r=0,593), activity impairement(p<0,05, r=0,460) and work productivity loss (p<0,05, r=0,460). No relation was found between WPAI indexes and C-reactive protein.Conclusion:This study demonstrates that spondyloarthritis has a major impact on military patients’ work productivity with a significant correlation between WAPI indexes and disease activity scores (ASDAS CRP and BASDAI). No relation was found with C-reactive protein.Disclosure of Interests:None declared.

scholarly journals POS0241 VALIDATION OF THE ANKYLOSING SPONDYLITIS DISEASE ACTIVITY SCORE WITH A QUICK QUANTITATIVE C-REACTIVE PROTEIN ASSAY (ASDAS-QCRP) IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS (AXSPA): A PROSPECTIVE, NATIONAL, MULTICENTER STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 342.1-342
Author(s):  
F. Proft ◽  
J. Schally ◽  
H. C. Brandt ◽  
J. Brandt-Juergens ◽  
G. R. Burmester ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
High Disease Activity ◽  
Activity Score ◽  
Inactive Disease ◽  
Treat To Target ◽  
C Reactive Protein ◽  
Low Disease Activity ◽  
Reactive Protein

Background:According to international recommendations, the Ankylosing Spondylitis Disease Activity Score (ASDAS) is the preferred score for assessing disease activity in axial spondyloarthritis (axSpA) [1]. However, routine determination of C-reactive protein (CRP) to calculate ASDAS values takes hours to days. This limits the use of ASDAS in clinical routine and clinical trials and hinders the implementation of treat-to-target approaches in axSpA. Whereas quick quantitative CRP (qCRP) tests allow CRP assessment within a few minutes. In a pilot project the performance of qCRP-based ASDAS assessment (ASDAS-qCRP) was already investigated in a single center study of 50 newly diagnosed, bDMARD-naïve axSpA patients with promising results [2].Objectives:To validate the ASDAS-qCRP in a prospective, multicenter study of axSpA patients in a typical axSpA cohort with an appropriate sample size.Methods:The study was conducted in five centers in Germany. Consecutive adult (≥ 18 years) axSpA patients were included. In addition to a rheumatological assessment, including patient reported outcomes (PROs), routine CRP and erythrocyte sedimentation rate (ESR) were measured in the local labs. Additionally, a qCRP testing with the „QuikRead go instrument“ (Aidian Oy, Finland) was performed at the study center (measurement range 0.5 - 200 mg/l for hematocrit concentrations of 40 – 45%). Statistical analysis included descriptive statistics, cross tabulation and weighted Cohen´s kappa comparing disease activity categories, Bland-Altman plots and intraclass correlation coefficient (ICC) for ASDAS-CRP and ASDAS-qCRP.Results:In this study 251 axSpA patients were included between January and September 2020 (mean age: 38.4 years; mean disease duration: 6.2 years, 159 patients (63.3%) were male, 211 (84.1%) HLA-B27 positive and 195 (77.7%) were classified as radiographic axSpA). 143 patients (57.0%) were treated with bDMARDs. CRP and qCRP showed mean values of 2.12 and 2.17 mg/l, respectively. With the ASDAS-qCRP, 242 patients (96.4%) were assigned to the same disease activity category as compared to the ASDAS based on the conventional lab CRP measurement (Table 1). Weighted Cohen´s kappa was 0.966 (95%CI: 0.943; 0.988). ICC for ASDAS-CRP- and ASDAS-qCRP-values was 0.997 (95%CI: 0.994; 0.999). The agreement of ASDAS-qCRP and ASDAS-CRP is shown in a Bland-Altman plot (Figure 1).Table 1.Disease activity categories by ASDAS-qCRP vs. ASDAS-CRPASDAS-qCRP (n = 251)Inactive Disease(< 1.3)Low Disease Activity (1.3 - < 2.1)High Disease Activity (2.1 - 3.5)Very high Disease Activity (> 3.5)ASDAS-CRPInactive Disease(< 1.3)56 (22.3%)2 (0.8%)Low Disease Activity (1.3 - < 2.1)62 (24.7%)7 (2.8%)High Disease Activity (2.1 - 3.5)97 (38.6%)Very high Disease Activity (> 3.5)27 (10.8%)The fields highlighted in red indicate that disease activity categories do not match.ASDAS = Ankylosing Spondylitis Disease Activity Score, CRP = C-reactive protein, qCRP = quick quantitative CRPConclusion:The ASDAS-qCRP and ASDAS-CRP showed an almost perfect agreement on the assignment to disease activity categories (96%) with the important advantage of time. With ASDAS-qCRP, rheumatologists could base their clinical decision-making on a disease activity measurement by using a composite score immediately. ASDAS-qCRP, therefore, can be integrated in clinical routine and clinical trials in the future and may facilitate implementation of the treat-to-target concept in axial SpA.References:[1]Smolen JS, et al. Ann Rheum Dis. 2018 Jan; 77(1):3-17.[2]Proft F, et al. Joint Bone Spine. 2019 Jul 29.Figure 1.Bland-Altman plot for ASDAS-qCRP and ASDAS-CRPAcknowledgements:The authors would like to deeply thank Braun T, Doerwald C, Deter N, Höppner C, Lackinger J, Lorenz C, Lunkwitz K, Mandt B, Sron S and Zernicke J for their practical support and coordinating the study.Funding statement: The AQUA study was supported by an unrestricted research grant from Novartis. Testing kits were provided free of charge from Aidian Oy, Finland.Disclosure of Interests:None declared

scholarly journals P189 Comparison of secukinumab versus adalimumab efficacy on skin outcomes in psoriatic arthritis: 52-week results from the EXCEED study

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Alice Gottlieb ◽  
Frank Behrens ◽  
Peter Nash ◽  
Joseph F Merola ◽  
Pascale Pellet ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Missing Data ◽  
Multiple Imputation ◽  
Plaque Psoriasis ◽  
Stock Ownership ◽  
Research Support ◽  
Acr20 Response ◽  
Number Of Patients ◽  
Pasi Score ◽  
To Receive

Abstract Background/Aims  Psoriatic arthritis (PsA) is a heterogeneous disease comprising musculoskeletal and dermatological manifestations, especially plaque psoriasis. Secukinumab, an interleukin17A inhibitor, provided significantly greater PASI75/100 responses in two head-to-head trials versus etanercept or ustekinumab, a tumour necrosis factor inhibitor (TNFi), in patients with moderate-to-severe plaque psoriasis. The EXCEED study (NCT02745080) investigated whether secukinumab was superior to adalimumab, another TNFi, as monotherapy in biologic-naive active PsA patients with active plaque psoriasis (defined as having ≥1 psoriatic plaque of ≥ 2 cm diameter, nail changes consistent with psoriasis or documented history of plaque psoriasis). Here we report the pre-specified skin outcomes from the EXCEED study in the subset of patients with ≥3% body surface area (BSA) affected with psoriasis at baseline. Methods  In this head-to-head, Phase 3b, randomised, double-blind, active-controlled, multicentre, parallel-group trial, patients were randomised to receive subcutaneous secukinumab 300 mg at baseline and Weeks 1-4, followed by dosing every 4 weeks until Week 48, or subcutaneous adalimumab 40 mg at baseline followed by the same dosing every 2 weeks until Week 50. The primary endpoint was superiority of secukinumab versus adalimumab on ACR20 response at Week 52. Pre-specified outcomes included the proportion of patients achieving a combined ACR50 and PASI100 response, PASI100 response, and absolute PASI score ≤3. Missing data were handled using multiple imputation. Results  Overall, 853 patients were randomised to receive secukinumab (n = 426) or adalimumab (n = 427). At baseline, 215 and 202 patients had at least 3% BSA affected with psoriasis in the secukinumab and adalimumab groups, respectively. At Week 52, more patients achieved simultaneous improvement in ACR50 and PASI100 response with secukinumab versus adalimumab (30.7% versus 19.2%, respectively; P = 0.0087). Greater efficacy was demonstrated for secukinumab versus adalimumab for PASI100 responses and for the proportion of patients achieving absolute PASI score ≤3 (Table 1). Conclusion  In this pre-specified analysis, secukinumab provided higher responses compared with adalimumab in achievement of combined improvement in joint and skin disease (combined ACR50 and PASI100 response) and in skin-specific endpoints (PASI100 and absolute PASI score ≤3) at Week 52. P189 Table 1:Skin-specific outcomes at Week 52Endpoints, % responseSEC 300 mg (N = 215)ADA 40 mg (N = 202)P value (unadjusted)PASI10046300.0007Combined ACR50 and PASI10031190.0087Absolute PASI score ≤379650.0015P value vs ADA; unadjusted P values are presented. Multiple imputation was used for handling missing data. ADA, adalimumab; ACR, American College of Rheumatology; N, number of patients in the psoriasis subset; PASI, Psoriasis Area and Severity Index; SEC, secukinumab. Disclosure  A. Gottlieb: Grants/research support; A.G. has received research support, consultation fees or speaker honoraria from Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB. F. Behrens: Consultancies; F.B. is a consultant for Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer Ingelheim, Janssen, MSD, Celgene, Roche and Chugai. Grants/research support; F.B. has received grant/research support from Pfizer, Janssen, Chugai, Celgene, Lilly and Roche. P. Nash: Consultancies; P.N. is a consultant for AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc., Roche, Sanofi and UCB. Member of speakers’ bureau; for AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc., Roche, Sanofi and UCB. Grants/research support; P.N. has received research support from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi and UCB. J. Merola: Consultancies; J.F.M. is a consultant for Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB Pharma, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and LEO Pharma. P. Pellet: Corporate appointments; P.P. is an employee of Novartis. Shareholder/stock ownership; P.P. is a shareholder of Novartis. L. Pricop: Corporate appointments; L.P. is an employee of Novartis. Shareholder/stock ownership; L.P. is a shareholder of Novartis. I. McInnes: Consultancies; I.M. is a consultant for AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, Novartis, Pfizer and UCB. Grants/research support; I.M. has received grant/research support from Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen and UCB.

scholarly journals AB0649 REAL WORLD EFFICACY OF SECUKINUMAB: A SINGLE CENTRE EXPERIENCE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1619-1620
Author(s):  
G. Kasavkar ◽  
T. Blake ◽  
N. Gullick
Keyword(s):  
Clinical Trial ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Real World ◽  
Certolizumab Pegol ◽  
Tender Joint Count ◽  
Inadequate Response ◽  
Technology Appraisal ◽  
New Onset

Background:Secukinumab was approved by NICE for patients with active Ankylosing Spondylitis and Psoriatic Arthritis in 2017. Clinical trial data suggests secukinumab is a useful treatment option in both conditions, but often real world experience differs greatly from clinical trial results. In addition, patients with more refractory disease are often excluded from clinical trials.Objectives:To assess the response to secukinumab in patients with seronegative spondyloarthropathy receiving treatment at University Hospital Coventry and WarwickshireMethods:Patients starting secukinumab at UHCW were identified from the Blueteq funding database. Medical notes were reviewed retrospectively to assess response rates using BASDAI responses in Ankylosing spondylitis and PsARC responses in PsA. Patients who had previously had inadequate response to TNF inhibitors (PsA only) and severe psoriasis received 300mg secukinumab monthly; the remainder were prescribed 150mg monthly.Results:146 patients commenced secukinumab between June 2017 and January 2020 and had outcome data recorded. 73 patients (50%) had received previous biologic agents prior to secukinumab exposure. Patients with Ankylosing spondylitis had high BASDAI (6.8±1.4) and spinal pain (7.5±1.4). 48 patients had an initial response to treatment as per outcome measures done before and after Secukinumab inception. Secukinumab was effective in 89 patients (94%), and 87 (91%) continued treatment.In psoriatic arthritis, despite high levels of activity at baseline (mean tender joint count 10±8; swollen joint count 6±3) and 65% prior biologic exposure; high rates of response were seen. The majority of patients have continued treatment. Secukinumab was well tolerated in both patient groups with low rates of discontinuation due to adverse events (8 patients, 5%). Adverse events included recurrent infection (3), rash (1), mouth ulcers (1), vertigo (1), new onset cancer (1) and new onset Crohn’s (1) although rates were low overall. Patients with pre-existing uveitis did not develop exacerbations but low numbers of patients with prior uveitis were treated.PsA (n=51)AS (n=95)Age in years, mean (SD)53 (13)49(12)Male sex, n (%)21 (41)62 (65)Disease duration in years, mean (SD)8 (8)10.9 (9.2)Previous biologic exposure, n (%)30 (65)43 (48)Number of prior biologics, median (range)1 (1-4)1 (1-4)Responder, n (%)37 (72)*89 (93)Discontinuation, n(%)12 (24)8 (8.5)Adverse events62Lack of efficacy64Other02*Response could not be assessed in 3/51 PsA patients due to insufficient clinical data; these patients have been recorded as non respondersConclusion:Secukinumab demonstrates high levels of efficacy even in a cohort of patients with longstanding PSA and AS with high rates of inadequate responses to other biologics.Secukinumab is well tolerated with low rates of discontinuation due to adverse events.References:Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs Technology appraisal guidance [TA445]Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors Technology appraisal guidance [TA407]Disclosure of Interests:None declared

scholarly journals SAT0398 PERSISTENCE OF USTEKINUMAB (UST) OR TNF INHIBITOR (TNFI) TREATMENT IN PSORIATIC ARTHRITIS (PsA): INSIGHTS FROM THE LARGE, PROSPECTIVE, MULTINATIONAL, REAL-WORLD PsABio COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1149-1150
Author(s):  
L. Gossec ◽  
S. Siebert ◽  
P. Bergmans ◽  
K. De Vlam ◽  
E. Gremese ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Real World ◽  
Treatment Effect ◽  
Cox Model ◽  
Tnf Inhibitor ◽  
Skin Involvement ◽  
Research Support ◽  
Treatment Persistence ◽  
Kaplan Meier ◽  
Significant Difference

Background:Several biologic DMARDs (bDMARDs) exist for PsA, TNFi and UST being the earliest on European markets. When bDMARDs are insufficiently effective, later-line bDMARDs typically have shorter persistence. Treatment persistence reflects a mix of effectiveness and adverse events (AEs), and persistence data are limited in PsA.Objectives:Comparative analysis of 1-year persistence of UST and TNFi within the prospective PsABio cohort.Methods:PsABio is an observational, multinational study of PsA patients (pts) treated with 1st to 3rd line UST or TNFi at their rheumatologist’s discretion.1Treatment persistence (up to 15 months of follow-up) was defined as time between start of first bDMARD treatment in PsABio, and either stop or switch to another bDMARD, or withdrawal.Persistence of UST and TNFi is shown by Kaplan-Meier curves and compared using Cox regression analysis, with propensity score (PS) to adjust for baseline imbalanced demographic and disease-related covariates (age, sex, bDMARD line, BMI, Clinical Disease Activity index for PSoriatic Arthritis [cDAPSA], 12-item PsA Impact of Disease [PsAID-12], Fibromyalgia Rapid Screening Tool [FiRST] score, co-treatments with MTX, NSAIDs, glucocorticoids, cardiovascular/metabolic comorbidities, dactylitis, enthesitis and body surface area [BSA]). Factors including concomitant MTX use and skin involvement: <3%, 3–10% and >10%, were added to the Cox model to investigate their impact on the PS-adjusted treatment effect.Results:Of 438 and 455 pts who started UST and TNF, respectively, 121 (28%) and 134 (29%) stopped or switched treatment before Month 15, with differences (as expected) according to treatment line (Fig. 1a, b). Reasons for stop/switch were related to safety/AEs in 12% (UST) and 28% (TNFi), and effectiveness (joints, nails or skin) in 77% (UST) and 69% (TNFi) of pts.The observed mean time on drug was 397 days for UST and 385 days for TNFi pts (1st line 410/397 days, 2nd 390/382 days, 3rd 381/338 days). Fig. 1b shows similar persistence for all drugs and treatment lines, except for lower persistence in TNFi 3rd line vs 1st/2nd. In PS-adjusted Cox analysis, no statistically significant difference between UST and TNFi persistence was seen; hazard ratio (HR; 95% CI) for stop/switch bDMARD (UST vs TNFi) was 0.82 (0.60, 1.13). In the model, bDMARD monotherapy (without MTX) and extensive skin involvement (BSA >10%), showed significantly better persistence for UST (HR 0.61 [0.42, 0.90] and 0.41 [0.19, 0.89] respectively; unadjusted Kaplan-Meier graphs shown in Fig. 1c, d). MTX co-therapy and low BSA did not affect the PS-adjusted treatment effect. Other factors added to the PS-adjusted Cox model did not show significant effects.Conclusion:In this real-world PsA cohort undergoing bDMARD treatment, persistence was generally comparable for UST and TNFi, but some clinical situations led to better drug persistence with UST compared to TNFi – particularly monotherapy, more extensive skin involvement, and in 3rd-line treatment. Our data emphasise the importance of skin involvement for pts with PsA.References:[1]Gossec L, et al.Ann Rheum Dis. 2018;77(suppl 2):Abstract AB0928Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Wim Noel Employee of: Janssen Pharmaceuticals NV, Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi

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