21st belgian congress on · pdf filewe are very pleased to welcome you to the 21st belgian...

21st Belgian Congresson Rheumatology

27 - 29 September 2017Belfry, Bruges

Scientific OrganiserValérie Badot

Local Organising CommitteePhilippe CarronMieke Devinck

Yves Piette

www.rheumacongress.be

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WIFI codeBCR17_ Bruges

Table of Contents

Organisation ...........................................................................................................................4

22nd Belgian Congress on Rheumathology - BCR 2018 ............................................4

Welcome Address ................................................................................................................ 5

Scientific Programme Wednesday, 27 September ...................................................... 6

Scientific Programme Thursday, 28 September .......................................................... 9

Scientific Programme Friday, 29 September ............................................................... 12

Meeting for Health Professionals in Rheumatology ................................................... 14

Registration ........................................................................................................................... 16

General Information ............................................................................................................ 17

Major Sponsors & Exhibitors ............................................................................................ 18


Scientific Organiser Valérie [email protected]

Local Organising CommitteePhilippe CarronUZ Gent AZ Alma - Campus SijseleDe Pintelaan 185 Gentse Steenweg 1329000 Gent 8340 Sijsele - [email protected]

Mieke DevinckAZ Sint-LucasSint-Lucaslaan 298310 [email protected]

Yves PietteAZ Sint-Jan UZ GentRuddershove 10 De Pintelaan 1858000 Brugge 9000 [email protected]

Upcoming Congress 22nd Belgian Congress on Rheumatology - BCR 2018 Spa, September 26 - 28, 2018

Congress SecretariatMedicongress ServicesNoorwegenstraat 49B-9940 Evergem, BelgiumPhone: +32 (0)9 218 85 81Fax: +32 (0)9 344 40 [email protected]

Welcome Address

Dear colleagues and friends,

We are very pleased to welcome you to the 21st Belgian Congress on Rheumatology, taking place in Bruges on 27-29 September 2017.

The congress takes place at the impressive Belfry, located on the market square. Situated in the very heart of the city, this medieval bell tower with its carillon of 47 melodious bells is the unique setting for this 21st edition of our annual Congress.

The scientific programme has been coordinated by Valérie Badot, who has put together a varied and interesting programme with state-of-the-art keynote lectures and oral communications. Furthermore, a poster tour, 4 workshops for early risers and 10 Updates in Therapeutics are scheduled. The ‘Thieves Market’ is also scheduled again this year.

We do hope you will enjoy the Congress and the hospitable city of Bruges!

Yours sincerely,

Philippe CarronMieke DevinckYves Piette

Local Organising Committee


Wednesday, September 27

Young Investigator Meeting Meeting Room (2nd floor) Chairs: Kristof Thevissen (AZ Alma & ZOL Genk), Muriel Stubbe (OLV Aalst) and Silvia Monteagudo (KUL)

10.00 The paracaspase MALT1 plays a central role in the pathogenesis of rheumatoid arthritis Elisabeth Gilis, Jens Staal, Rudi Beyaert, Dirk Elewaut

10.15 RORγt inhibition selectively targets pathogenic subsets of human iNKT and γδ-T cells enriched in spondyloarthritis while preserving tissue protective IL-22 responses Koen Venken, Mark E. Labadia, Peggy Jacques, Tine Decruy, Julie Coudenys, Kathleen Hoyt, Sofie Van Gassen, Joseph Wahle, Gaëlle Varkas, Heleen Cypers, Philippe Carron, Serge Van Calenbergh, Filip Van Den Bosch, Yvan Saeys, Gerald Nabozny, Dirk Elewaut

10.30 Inclusion of anti-DFS70 Ab identification in the diagnostic algorithm of ANA: One year of experience Mathieu Cauchie, Muriel Stubbe, Stefanie Van den Bremt, Bert Vander Cruyssen, Xavier Bossuyt, Lieve Van Hoovels

10.45 DOT1L inhibition reduces the pro-fibrotic effects of TGFβ in primary human dermal fibroblasts on gene expression level and it increases their viability Nathalie Berghen, Ellen De Langhe, Rik Lories

11.00 Repositioning suramin as a cartilage-protective drug Laura-An Guns, Silvia Monteagudo, Maryna Kvasnytsia, Greet Kerckhofs, Jennifer Vandooren, Ghislain Opdenakker, Rik J. Lories, Frédéric Cailotto

11.15 A phage display screen for novel theranostic autoantibodies in rheumatoid arthritis Patrick Vandormael, Dana Quaden, Patrick Verschueren, Veerle Somers

11.30 SMOC2, a secreted calcium-binding protein affects chondrogenic differentiation of precursor cells and cartilage homeostasis via modulation of the Wnt signaling Tine Peeters, Rik Lories, Frédéric Cailotto

11.45 Gut-derived TNF as risk factor for the development of sacroiliac inflammation Karlijn Debusschere, Heleen Cypers, Peggy Jacques, Filip Van den Bosch, D. Souza, M. Brown, Gerald Nabozny, Dirk Elewaut


12.00 Welcome Lunch

12.30 Opening Ceremony Auditorium Bernard Lauwerys, UCL, Valérie Badot, ULB & Catherine Bailleux, KBVR-SRBR

SESSION 1 Auditorium Chairs: Frédéric Houssiau (UCL) and Rik Joos (ZNA & UGent) 12.50 Vesalius Lecture Management of antiphospholipid syndrome Munther Kamashta, London, UK

13.35 Abstract Presentations

Glucocorticoid withdrawal in an inception cohort of lupus nephritis patients Séverine Wautier, Farah Tamirou, Séverine Nieuwland-Husson, Frédéric A. Houssiau

Syndecan-1 loss at the surface of renal tubular cells amplifies inflammation-induced tubular damage and renal function impairment in lupus nephritis Cristina Pamfil, Pauline Montigny, C. Galant, Aurélie De Groof, Frédéric A. Houssiau, Bernard R. Lauwerys

Evaluation of the detection of myositis-specific antibodies by lineblot as a tool for characterization of a prospective multicenter cohort Carolien Bonroy, Yves Piette, Joke Dehoorne, Jan De Bleecker, Maxime De Sloovere, Liesbet Van Praet, An-Sofie Vander Mijnsbrugge, Peggy Jacques, Stien Vandendriessche, Matthieu Versaevel, Filip De Keyser, Vanessa Smith

14.05 FWRO/FRSR Award Ceremony Chairs: Xavier Janssens (Gent) and René Westhovens (KUL)

14.30 Update in Therapeutics – Organised with an educational grant from Roche Outcome of JIA in the biological era Joke Dehoorne, UGent

15.00 Coffee Break


Thursday, September 28

07.15 Workshop 1 Room Groeninghe 1, Casselbergh Hands-on ultrasound imaging of the wrist Philippe Carron (UGent & AZ Alma), Anne Durnez (UCL & AZ Jan Portaels Vilvoorde), Maria-José Fernandez (Centre Medicis & UZ Antwerpen), Jan Lenaerts (KUL & Reuma-Instituut Hasselt), Laurent Méric de Bellefon (UCL, CNDG & CHU Saint-Pierre Brussels), Maria S. Stoenoiu (UCL) On behalf of the Belgian Young Rheumatologists group (BYRc)

Over the past few years, important progress has been made in the field of ultrasound, allowing it to become a very powerful tool in daily rheumatology practice. Accordingly, ultrasound has now been introduced in the core curriculum of rheumatology training in most EU countries. The scope of this workshop is to improve practical skills in ultrasoundimaging of the wrist.

07.15 Workshop 2 Room Groeninghe 2, Casselbergh PASI and psoriatic score use in rheumatology Laure Tant (ULB) and Farida Benhadou (ULB)

SESSION 4 Auditorium Chairs: Ellen De Langhe (KUL) and Marie Vanthuyne (UCL & GHDC)


The low-dose intravenous cyclophosphamide Euro-Lupus regimen does not impact the ovarian reserve of lupus patients, as measured by serum anti-Mullerian hormone levels Farah Tamirou, Séverine Nieuwland-Husson, Damien Gruson, Frédéric Debiève, Bernard R. Lauwerys, Frédéric A. Houssiau

Autoantibodies to two novel peptides in seronegative and early rheumatoid arthritis Liesbeth De Winter, Wendy Hansen, Hanna W. van Steenbergen, Piet Geusens, Jan Lenaerts, Klaartje Somers, Piet Stinissen, Annette H. M. van der Helm-van Mil, Veerle Somers

Sustained effectiveness after remission induction with methotrexate and step-down glucocorticoids (COBRA Slim) in patients with early rheumatoid arthritis following a treat-to-target strategy: 2 year data from the CareRA study Veerle Stouten, Johan Joly, Diederik De Cock., Sofia Pazmino, Kristien Van der Elst, René Westhovens, Patrick Verschueren


SESSION 2 Auditorium Chairs: Isabelle Peene (AZ Sint-Jan & UGent) and Valérie Badot (ULB) 15.30 Clinical assessment of patients with idiopathic inflammatory myopathies Ingrid Lundberg, Stockholm, Sweden

16.00 Hot topics in lupus nephritis: so many exciting advances Farah Tamirou, UCL

16.30 Update in Therapeutics – Organised with an educational grant from Celgene Dactylitis: A medical challenge in spondyloarthropathies Filip Van den Bosch, UGent

17.00 Update in Therapeutics – Organised with an educational grant from Sanofi-Genzyme Is there a best second biologic in RA? Jacques-Eric Gottenberg, Strasbourg, France

17.30 Walking Dinner

SESSION 3 - Ethics & Economy Auditorium Chairs: Philippe Carron (UGent & AZ Alma), Mieke Devinck (AZ Sint-Lucas) and Yves Piette (AZ Sint-Jan & UGent) 19.00 Burn-out for dummies Arnout Van den Bossche

19.45 Patients before paperwork: Panel discussion Moderator: Marleen Finoulst (Editor-in-chief Bodytalk; Coordinator website www.gezondheidenwetenschap.be) Panelists: Jo De Cock (RIZIV-INAMI), Philiep Berkein (Bond Moyson), Guido Herman (Federal Ombudsman), Mitchell Silva (ReumaNet), Filip Van Den Bosch (Rheumatologist)

22.00 End of Day 1

The Workshops take place at Hotel Casselbergh, Hoogstraat 8 (350 m from the Belfry)


Thursday, September 28 Auditorium09.00 Optimal management of patients with systemic sclerosis Vanessa Smith, UGent

09.50 Coffee Break

SESSION 5 Auditorium Chairs: Patrick Durez (UCL) and Ilse Hoffman (GZA) 10.30 Belgian Rheumatology in Review Peggy Jacques (UGent) and Jan Lenaerts (KUL & Reuma-Instituut Hasselt)

11.00 Update in Therapeutics – Organised with an educational grant from Janssen-Cilag Treatment strategies in early RA Patrick Verschueren, KUL

11.30 Update in Therapeutics – Organised with an educational grant from Novartis Novel therapies in SpA Rik Lories, KUL

12.00 Lunch

13.00 Poster Tour

14.00 General Assembly

SESSION 6 Auditorium Chairs: Christian Von Frenckel (ULG) and Marco Hirsch (ZithaKlinik Luxembourg) 14.30 Autoinflammatory disorders: From gene to therapy Carine Wouters, KUL

15.10 Update in Therapeutics – Organised with an educational grant from Pfizer Restoring immune homeostasis in RA Bernard Combe, Montpellier, France

15.40 Coffee Break

Thursday, September 28

SESSION 7 Auditorium Chairs: Patrick Verschueren (KUL) and Pierre De Marneffe (CHR Huy)


Disease activity evolution in the CareRA cohort: A detailed component analysis Sofia Pazmino, René Westhovens, Johan Joly, Veerle Stouten, Kristien Van der Elst, Patrick Verschueren

Non OMERACT -expert Rheumatologists sonographers and inter- ultrasound machine reliability of the OMERACT Ultrasound Scoring in Rheumatoid arthritis in a clinical-based setting: A Belgian study Jean-Philippe Hauzeur, Marie-Joëlle Kaiser, Jacques Bentin, Jean-Pierre Brasseur , Béatrice André, Philippe Carron, Etienne Deflandre, Elena Dragan, Cécile Mbena, Catherine Naveau, Clio Ribbens, Charline Rinkin, Ruth Wittoek for the Belgian Group of Ultrasonography in Rheumatology, SRBR, Maria-Antonietta d’Agostino, Viviane De Maertelaer

Ultrasound lesions underlying dactylitis are associated with patient- reported outcomes Adrien Nzeusseu Toukap, T. Kirchgesner, P. Navarro Guerra, F. Lecouvet, Anne Durnez, Maria S. Stoenoiu

16.45 Update in Therapeutics – Organised with an educational grant from AbbVie Use of biological therapies during pregnancy Catherine Nelson-Piercy, London, UK

17.15 Official opening of the first virtual symposium on rheumatology in Belgium Gerd Jacobs (President of ReumaNet)

17.25 End of Day 2


Friday, September 29

07.15 Workshop 3 Room Groeninghe 1, Casselbergh Joint and soft tissue injections Yves Piette (AZ Sint-Jan & UGent) and Laurent Méric de Bellefon (UCL, CNDG & CHU Saint-Pierre Brussels)

Workshop 4 Room Groeninghe 2, Casselbergh Autoantibodies for dummies Isabelle Peene (AZ Sint-Jan & UGent)

SESSION 8 Auditorium Chairs: Anne Durnez (UCL & AZ Jan Portaels) and Valérie Gangji (ULB) 08.30 Osteoporosis: New recommendations on fracture prevention Piet Geusens, Genk, UHasselt & Maastricht, The Netherlands


High drug-free remission in early peripheral spondyloarthritis after induction therapy with golimumab Philippe Carron, Gaëlle Varkas, Heleen Cypers, Liesbet Van Praet, Dirk Elewaut, Filip Van den Bosch and on behalf of the CRESPA-investigators Effect of mechanical stress on magnetic resonance imaging of the sacroiliac joints: The Assessment of military Recruits by Magnetic resonance Imaging (ARMI) study Gaëlle Varkas, Manouk de Hooge, Thomas Renson, Sophie De Mits, Philippe Carron, Peggy Jacques, Muriel Moris, G. Souverijns, Lennart Jans , Dirk Elewaut, Filip Van den Bosch

Needle arthroscopy of the knee: complication rate, short term articular effects, and rate of tissue contamination Kristel Van Landuyt, Patrick Verschueren

09.40 Bone and Joint Lecture Mesenchymal stem cell therapy in rheumatology Christian Jorgensen, Montpellier, France

10.30 Update in Therapeutics – Organised with an educational grant from MSD Treatment persistence from both patient and physician perspectives Thao Pham, Marseille, France

11.00 Coffee Break

Friday, September 29

SESSION 9 Auditorium Chairs: Dirk Elewaut (UGent) and Bernard Lauwerys (UCL) 11.30 Thieves Market

An infected abdominal aortic aneurysm presenting as a septic arthritis Steven Van Offel, Elke Geens, Michiel Schils, Ruth Wittoek, Kurt De Vlam, Rik Joos

Severe panniculitis and polyarthritis in an old man Marc Plier, Alexandros Rapitis, Maria Stoenoiu, Adrien Nzeusseu, Frédéric Houssiau, Patrick Durez

Paraneoplastic acral vascular syndrome: Presentation of 2 cases Inge Vanassche, Filip De Keyser, Dirk Elewaut, Saskia Decuman, Filip Van den Bosch, Herman Mielants, Vanessa Smith

12.00 Update in Therapeutics – Organised with an educational grant from BMS Immune checkpoints and rheumatic diseases: What can cancer immuno- therapy teach us Timothy R.D.J. Radstake, Utrecht, The Netherlands

12.30 Update in Therapeutics – Organised with an educational grant from Eli Lilly The unmet need in RA management Ernest Choy, Cardiff, UK

13.00 Closure of the Congress

13.10 Farewell Lunch

14.00 KBVR-SRBR Board Meeting

The Workshops take place at Hotel Casselbergh, Hoogstraat 8 (350 m from the Belfry)


Thursday, September 28 Meeting Room (2nd floor)

Meeting for Health Professionals in RheumatologyOrganised by the Belgian Health Professionals in Rheumatology (BHPR) vzw/asbl

Chairpersons: Kristien Van der Elst (KU Leuven) and Pauline Hoellinger (University Hospital Saint-Luc)

08.15 Registration*

08.50 Welcome to the Health Professionals in Rheumatology Meeting Kristien Van der Elst, Rheumatology Nurse; PhD-student; Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven

Pauline Hoellinger, Occupational therapist; Rheumatology and Orthopedics, University Hospital Saint-Luc; ISEI, Haute Ecole Léonard de Vince, Brussels

09.00 Patient-led projects in rheumatology: An update from ReumaNet vzw Gerd Jacobs, Chair ReumaNet vzw

What’s hot in Rheumatology? Part I 09.20 Illness perceptions in systemic diseases: A summary Seher Arat, Rheumatology Nurse, PhD-student; Skeletal Biology and Engineering Research Center, KU Leuven

09.35 Co-design of a mobile application for patients with axial spondyloarthritis Jonas Geuens, Engineer, PhD-student; Electrical Engineering (ESAT) TC, Group-T, KU Leuven

09.50 The power of food supplements in rheumatology: Evidence-based nutritional advice in clinical practice Sofie De Clercq, Dietician, Fly-Over center, Ghent

10.15 Coffee Break

10.45 How to implement evidence-based practice for health professionals in rheumatology Thanny Bries, Rheumatology Nurse, REUMA instituut, Hasselt

Pharmacological therapies11.00 Biologicals versus Biosimilars: A survey among patients and rheumatologists Eline van Overbeeke, PhD researcher; Clinical Pharmacology and Pharmacotherapy, KU Leuven

Thursday, September 28 Meeting Room (2nd floor)

Meeting for Health Professionals in RheumatologyOrganised by the Belgian Health Professionals in Rheumatology (BHPR) vzw/asbl

Chairpersons: Kristien Van der Elst (KU Leuven) and Pauline Hoellinger (University Hospital Saint-Luc)

11.15 Panel discussion (moderator: Eline van Overbeeke) René Westhovens, Rheumatologist, Chair covenant biosimilars, RIZIV

Karlien Claes, Nurse specialist, Ghent university hospital,

Wouter De Bock, Rheumatologist, GZA hospitals

Ilse De Keyser, Coordinator Patient Organization ReumaNet

Liese Barbier, Pharmacist, Researcher, KU Leuven

Tineke Van Hooland, Representative pharmaceutical industry, External Affairs Director, Abbvie

11.45 Lunch Break and Networking

13.15 General Assembly Belgian Health Professionals in Rheumatology vzw/asbl (welcome - and a must do - to all)

• Projects from BeHPR vzw: e-learning in rheumatology• New board election• Discussion on working groups

Workshop14.00 The importance of mental resilience and a healthy palliative palet on both sides during treatment Michael Portzky, Clinical Psychologist, author of all Dutch validated and normated resilience scales, Psychiatric Center Ghent-Sleidinge

15.00 Coffee Break

What’s hot in Rheumatology? Part II15.20 Message from the lab: Interpretation of laboratory parameters for clinicians Ellen De Langhe, Rheumatologist, Professor; Division of rheumatology, University Hospitals Leuven, Skeletal Biology and Engineering Research Center, KU Leuven

15.55 Closing discussion and future congress Kristien Van der Elst, Pauline Hoellinger and new chair BeHPR vzw

*Registration includes coffee breaks and lunch.


Registration

Registration Fees LATE As of 1 SeptemberMembers KBVR-SRBR € 250,00 Non Members € 350,00 Trainees in Rheumatology* € 75,00 Other Trainees* € 100,00 Researchers non-MD* € 75,00 Emeriti € 75,00

Workshops** Free

* Registration as a trainee or researcher non-MD will only be accepted if accompanied by a copy of your student card or a certificate of your director (proof to be uploaded during the registration process). Without proof the non-member fee will be charged.

** Participation in the workshops is free of charge and is limited to 30 participants.

The registration fee for participants includes• Participation in all scientific sessions• Participation in the hands-on workshops (separate registration required,

limited to 30 participants)• Participation in the ‘Updates in Therapeutics’ organised by the Industry• Congress bag with the Programme and Abstracts and congress related

documents• Access to the exhibition• Lunches and coffee breaks

CancellationsParticipants canceling their registration before 1 September 2017, will receive a full refund, less € 50,00 administration costs. There will be no refunds for cancellations received after this date. Cancellations must be confirmed in writing to the Organising Secretariat. All refunds will be processed after the Congress.

General Information

Venue Belfry BrugesMarkt 78000 Brugge

The Workshops take place at Hotel Casselbergh, Hoogstraat 8, Brugge (350 m from the Belfry).

Where to park A large - and cheap - car park for about 1,500 cars is available at the railway station, which is located at a 20 minutes’ walking distance from the Belfry.Other car parks in the city centre:Het Zand, Het Zand 17: 7 minutes walking distance from the BelfryParking Alfa, Predikherenrei 4a: 9 minutes walking distance from the BelfryParking Pandreitje, Park 2: 5 minutes walking distance from the Belfry (this is a smaller parking and often full) Poster Presentations The poster dimensions are: • max width: 90 cm • max height: 120-150 cm (= PORTRAIT position) Installation: • Wednesday, September 27 between 12.00 and 20.00 hrs or• Thursday, September 28 between 08.00 and 10.30 hrs Removal: • Friday, September 29 between 12.30 and 13.00 hrs

Tape and scissors will be available at the registration desk.

Accreditation A request for accreditation has been submitted to the RIZIV/INAMI. A certificate of attendance will be sent by email after the Congress.Please make sure to sign the attendance list each day at the KBVR-SRBR booth.

Exhibition A medical exhibition will be held on the occasion of the Congress. Access is free for registered participants. The exhibition is not accessible for non-MDs.

Liability Neither the organisers nor Medicongress accept liability for damages and/or losses of any kind which may be incurred by Congress participants during the Congress. Participants are advised to take out insurance against loss, accidents or damage which could be incurred during the Congress.


Major SponsorsThe Organising Committee of the 21st Belgian Congress on Rheumatology would like to thank

Major Sponsors

AbbVie

Bristol-Myers Squibb

Celgene

Eli Lilly

Janssen-Cilag

MSD

Novartis

Pfizer

Roche

Sanofi-Genzyme

Exhibitors

Analogic Benelux

Amgen

GE Healthcare

Grünenthal

Mundipharma

Sandoz

Swedish Orphan Biovitrum (SOBI)

Takeda Belgium

Tilman

TRB Chemedica

UCB Pharma

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See full leaflet for how to report adverse reactions. Name: Cosentyx 150 mg solution for injection in pre-filled syringe / Cosentyx 150 mg solution for injection in pre-filled pen Composition: Each pre-filled syringe contains 150 mg secukinumab* in 1 ml / Each pre-filled pen contains 150 mg secukinumab* in 1 ml. * Secukinumab is a recombinant fully human monoclonal antibody selective for interleukin-17A. Secukinumab is of the IgG1/κ-class produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see full leaflet. Pharmaceutical form: Solution for injection in pre-filled syringe (injection). The solution is clear and colourless to slightly yellow / Solution for injection in pre-filled pen (SensoReady pen). The solution is clear and colourless to slightly yellow. Therapeutic indications: Plaque psoriasis: Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis: Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Ankylosing spondylitis: Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Posology: Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated. Plaque psoriasis: The recommended dose is 300 mg of secukinumab by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. Each 300 mg dose is given as two subcutaneous injections of 150 mg. Psoriatic arthritis: For patients with concomitant moderate to severe plaque psoriasis or who are anti-TNFα inadequate responders (IR), the recommended dose is 300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. Each 300 mg dose is given as two subcutaneous injections of 150 mg. For other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. Ankylosing spondylitis: The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. For all of the above indications, available data suggest that a clinical response is usually achieved within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response by 16 weeks of treatment. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special populations: Elderly patients (aged 65 years and over): No dose adjustment is required. Renal impairment / hepatic impairment: Cosentyx has not been studied in these patient populations. No dose recommendations can be made. Paedriatic population: The safety and efficacy of Cosentyx in children below the age of 18 years have not yet been established. No data are available. Contraindications: Severe hypersensitivity reactions to the active substance or to any of the excipients. Clinically important, active infection (e.g. active tuberculosis). Undesirable effects: Summary of the safety profile: see full leaflet. List of adverse reactions: ADRs from psoriasis, psoriatic arthritis and ankylosing spondylitis clinical studies as well as from post-marketing experience (Table 1) are listed by MedDRA system organ class. Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).List of adverse reactions in clinical studies1) and post-marketing experience: Infections and infestations: Very common: Upper respiratory tract infections; Common: Oral herpes; Uncommon: Oral candidiasis; Uncommon: Tinea pedis; Uncommon: Otitis externa. Not known: Mucosal and cutaneous candidiasis (including oesophageal candidiasis). Blood and lymphatic system disorders: Uncommon: Neutropenia. Immune system disorder: Rare: Anaphylactic reactions. Eye disorders: Uncommon: Conjunctivitis. Respiratory, thoracic and mediastinal disorders: Common: Rhinorrhoea. Gastrointestinal disorders: Common: Diarrhoea. Skin and subcutaneous tissue disorders: Uncommon: Urticaria. 1)Placebo-controlled clinical studies (phase III) in plaque psoriasis, PsA and AS patients exposed to 300 mg, 150 mg or placebo up to 12 weeks (psoriasis) or 16 weeks (PsA and AS) treatment duration. Description of selected adverse reactions: see full leaflet. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. Mode of delivery: Medicinal product subject to medical prescription. Marketing authorisation holder and numbers: Novartis Europharm Limited, Frimley Business Park, Camberley GU16 7SR, United Kingdom; EU/1/14/980/001- EU/1/14/980/007 Date of revision of the text: 22.03.2017

P.P. Co-payment*Cosentyx® 2x150 mg € 1.119,38 € 11,90 Cosentyx® 1x150 mg € 564,20 € 11,90

The first and only IL-17A

inhibitor with a central role

in psoriatic arthritis

(PsA) and in

ankylosing

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(AS)1

* ordinary insured persons (preferentially insured persons € 7,90)1. Cosentyx® SmPC

BE1703617539 - 31/03/2017

Novartis_Cosentyx_PUB_A5_SpA.indd 3 1/09/2017 9:34:39

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