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5 th World Psoriasis & Psoriatic Arthritis Conference 2018
( Table ). Radiographic progression ( mTSS ) was significantly inhibited at Wk24 in all SEC arms vs PBO ( Table ). A greater proportion of pts had no radiographic progression ( change from BL in mTSS ≤ 0.5 ) with SEC vs PBO : 88 % ( 300mg ), 79 % ( 150mg ), 83 % ( 150mg without LD ), and 73 % ( PBO ). Results for other secondary endpoints are shown in Table . No unexpected safety signals were reported . Conclusions : Subcutaneous SEC 300 mg with LD and 150 mg with and without LD provided rapid and clinically significant improvements in the signs and symptoms of PsA and inhibited radiographic progression . Safety profile was consistent with that previously reported . Reference :
1 . Mease PJ , et al . Arthritis Rheumatol . 2017 ; 69 ( suppl 10 ). Table
Wk 16 data ( a ) ACR20 ( b ) mTSS ( c ) PASI 75 / 90 ( b , d ) HAQ-DI ( c ) Enthesitis resolution ( b , e ) Dactylitis resolution ( b , e ) DLQI ( c , d ) mNAPSI ( c , f )
300 mg 62.6 *** 0.08 * 70 ***/ 53.6 *** – 0.6 *** 55.7 ** 65.9 *** – 8.5 *** – 9.2 ***
150 mg 55.5 *** 0.17^ 60 ***/ 36.8 *** – 0.4 *** 54.6 ** 57.5 ** – 7.4 *** – 9.3 ***
150 mg without LD 59.5 *** – 0.09 * 58.1 ***/ 31.6 *** – 0.5 *** 41.9 56.3 – 7.0 *** – 7.7 ***
PBO 27.4 0.5 12.3 / 9.3 – 0.2 35.4 32.3 – 2.4 – 2.5
*** P < 0.0001 ; ** P < 0.001 ; * P < 0.01 ; ^P < 0.05 un-adjusted P-values vs PBO . ( a ) Wk24 data for mTSS ; ( b )% responders ; ( c ) mean change from BL ; ( d ) Data from pts with BL psoriasis ≥3 % body surface area ; ( e ) Data from pts with dactylitis or enthesitis at BL ; ( f ) Data from pts with nail psoriasis at BL
P037 INCIDENCE OF INFLAMMATORY BOWEL DISEASE IN PATIENTS TREATED WITH SECUKINUMAB : POOLED ANALYSIS OF 21 RANDOMISED CONTROLLED PHASE 3 / 4 CLINICAL TRIALS OF PSORIASIS , PSORIATIC
ARTHRITIS , AND ANKYLOSING SPONDYLITIS Stefan Schreiber 1 , Jean-Frederic Colombel 2 , Brian G Feagan 3 , Kristian Reich 4 , Atul Deodhar 5 , Iain B McInnes 6 , Brian Porter 7 , Ayan Das Gupta 8 , Luminita Pricop 7 , Todd Fox 9
1
Department of Internal Medicine , University Hospital Schleswig-Holstein , Kiel , Germany , 2 Division of Gastroenterology , Icahn School of Medicine at Mount Sinai , New York , USA , 3 Robarts Clinical Trials Inc ., Department of Epidemiology and Biostatistics , Department of Medicine , Division of Gastroenterology , University of Western Ontario , London , Ontario , Canada ,
4
Dermatologikum Hamburg and Georg-August-University , Göttingen , Germany , 5 Oregon Health & Science University , Portland , OR , USA , 6 Institute of Infection Immunity and Inflammation , University of Glasgow , Glasgow , UK , 7 Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA ,
8
Novartis Healthcare Pvt . Ltd ., Hyderabad , India , 9 Novartis Pharma AG , Basel , Switzerland
Introduction : Inflammatory bowel disease ( IBD ) including Crohn ’ s disease ( CD ) and ulcerative colitis ( UC ) are common comorbidities associated with psoriasis , psoriatic arthritis ( PsA ), and ankylosing spondylitis ( AS ). Compared with the general population , epidemiological studies have shown that patients ( pts ) with psoriasis or PsA are at a 2 – 4-fold increased risk of developing CD and a 2 – 3-fold increased risk of developing UC . 1 – 5 Additionally , in pts with AS , there is a 3 – 5-fold increased risk of IBD compared with the general population . 6 Secukinumab is a fully human monoclonal antibody that neutralizes interleukin-17A and is approved for the treatment of psoriasis , PsA , and AS . Objectives : To evaluate the incidence of IBD , CD , and UC in pts with psoriasis , PsA , or AS who received IL-17A-inhibition with secukinumab from 21 phase 3 / 4 clinical trials of secukinumab for psoriasis , PsA , or AS . Methods : This analysis evaluated pooled data from fourteen phase 3 and one phase 4 psoriasis trials , three phase 3 PsA trials , and three phase 3 AS trials . Pts with a history of IBD , but not active ongoing IBD , were eligible for enrollment in these trials . Data from all pts that received at least one dose of secukinumab were included in this analysis . IBD reporting includes cases of CD , UC , and IBD not otherwise specified ( NOS ).
Results : A total of 7355 pts receiving secukinumab were assessed for the presence of IBD : 5181 with psoriasis , 1380 with PsA , and 794 with AS . Over the entire treatment period , the mean total exposure to secukinumab was 10,416.9 patient-years ( pt-yrs ) in pts with psoriasis , 3866.9 pt-yrs in pts with PsA , and 1943.1 pt-yrs in pts with AS . The exposure-adjusted incidence rate ( EAIR ) per 100 pt-yrs ( 95 % confidence interval ) of CD , UC , and IBD NOS in secukinumab-treated pts were 0.05 [ 0.02 , 0.11 ], 0.13 [ 0.07 , 0.23 ], and 0.01 [ 0.00 , 0.05 ], respectively in the psoriasis studies ; 0.08 [ 0.02 , 0.23 ], 0.08 [ 0.02 , 0.23 ], and 0.05 [ 0.01 , 0.19 ], respectively in the PsA studies ; and 0.4 [ 0.2 , 0.8 ], 0.2 [ 0.1 , 0.5 ], and 0.1 [ 0.0 , 0.3 ], respectively in the AS studies . Additionally , the incidence of IBD , CD , and UC did not increase over time . Conclusion : Pooled data from 21 studies indicated that the observed exposure- adjusted incidence rates of IBD , CD , and UC with secukinumab were low and did not increase over time in pts with moderate to severe plaque psoriasis , PsA , or AS . References : 1 . Augustin M , et al . Acta Derm Venereol . 2010 ; 90 ( 2 ): 147-51 2 . Cohen AD , et al . J Eur Acad Dermatol Venereol 2009 ; 23:561-5 . 3 . Egeberg A , et al . Br J Dermatol . 2016 ; 175 ( 3 ): 487-92 . 4 . Li WQ , et al . Ann Rheum Dis . 2013 ; 72 ( 7 ): 1200-5 . 4 . Makredes M , et al . J Am Acad Dermatol . 2009 ; 61 ( 3 ): 405-10 . 5 . Stolwijk C , et al . Ann Rheum Dis . 2015 ; 74 ( 7 ): 1373-8 ; 6 . Stolwijk C , et al . Ann Rheum Dis . 2015 ; 74 ( 7 ): 1373-8 .
P038 ANALYSIS OF THE POSITION OF THE FUMARIC ACID ESTERS IN CURRENT EUROPEAN PSORIASIS GUIDELINES Cecilia Dietrich 1 , Adria Gual 2 , Laura Padulles 2
1
Dermatologikum Hamburg , Germany , 2 Almirall S . A ., Barcelona , Spain
Introduction : Since 1994 a combination of fumaric acid esters ( FAEs ) ( dimethylfumarate [ DMF ] plus three salts of monoethylfumarate [ MEF ]) has been approved in Germany for moderateto-severe psoriasis , however is not widely licensed elsewhere . While a new formulation of DMF has been recently approved by the European Commission ( June 2017 ) as monotherapy for adults with moderate-to-severe psoriasis , only UK ( NICE ) guidelines mention DMF to date .[ 1 ] Method : Current treatment guidelines for plaque psoriasis in several European countries are reviewed to determine if these guidelines include therapy with FAEs and how these may guide the use of DMF monotherapy in the future . Results : FAE status varies across Europe . Current European guidelines recommend FAEs for the initial and long-term treatment of psoriasis . These guidelines ( based on consensus / expert opinion ) also recommend a gradual increase in dose .[ 2 ] Country-specific guidelines vary in their individual recommendations . German guidelines endorse FAEs as 1st-line treatment for moderate-tosevere psoriasis , based on BSA > 10 % or a PASI score of > 10 , and recommend clinical assessments after 16 – 24 weeks of treatment .[ 3 ] UK guidelines approve FAEs only as a 2nd-line option for severe plaque psoriasis ( PASI ≥10 or DLQI≥ 10 ),[ 1 ] whilst in the Netherlands FAEs are indicated only for initial treatment of moderate-to-severe disease .[ 4 ] Swiss guidelines also recommend the use of FAEs for moderate-to-severe psoriasis , but only in patients who are unresponsive to topical therapy .[ 5 ] In Sweden , FAEs can be considered as a 2nd-line treatment option .[ 6 ] Other country-specific guidelines are less clear . While Spanish guidelines discuss FAEs as a slower-acting therapy requiring treatment goals to be set at week 16 , no specific guidance on the use of FAEs is given .[ 7 ] Likewise , while Italian guidelines mention FAEs , they are not included in treatment recommendations as they are currently not licensed in Italy .[ 8 ] In contrast , there is no mention of FAEs in guidelines in Denmark , Portugal and Norway . Conclusion : European guidelines recommend FAEs for both the www . medicaljournals . se / acta