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LB0006 (2019)
SUBCUTANEOUS SECUKINUMAB 300MG AND 150MG PROVIDES SUSTAINED INHIBITION OF RADIOGRAPHIC PROGRESSION IN PSORIATIC ARTHRITIS OVER 2 YEARS: RESULTS FROM THE PHASE 3 FUTURE-5 TRIAL
Philip J. Mease1, Robert B. M. Landewé2, Proton Rahman3, Hasan Tahir4, Atul Singhal5, Elke Boettcher6, Sandra Navarra7, Aimee Readie8, Shephard Mpofu9, Eumorphia Maria Delicha9, Luminita Pricop8, Désirée van der Heijde10
1Swedish Medical Centre and University of Washington, Seattle, United States of America
2University of Amsterdam and Atrium Medical Centre, Amsterdam, Netherlands
3Memorial University, Newfoundland and Labrador, Canada
4Whipps Cross Hospital, London, United Kingdom
5Southwest Rheumatology, Dallas, United States of America
6Rheumazentrum Favoriten, Vienna, Austria
7University of Santo Tomas Hospital, Manila, Philippines
8Novartis Pharmaceuticals Corp., East Hanover, United States of America
9Novartis Pharma AG, Basel, Switzerland
10Leiden University Medical Centre, Leiden, Netherlands

Background: Secukinumab (SEC) provided sustained clinical efficacy, and inhibition of radiographic progression over 52 Weeks (Wks) in patients (pts) with psoriatic arthritis (PsA) in the FUTURE 5 study 1 .


Objectives: To report the effect of SEC on radiographic progression at Wk 104 (2 years) in PsA pts in the FUTURE 5 study.


Methods: Adults (N=996) with active PsA, stratified by prior anti-TNF therapy (naïve and inadequate response/intolerance [IR]) were randomised 2:2:2:3 to subcutaneous SEC 300mg with loading dose (LD; 300mg), 150mg LD (150mg), 150mg no LD, or placebo at baseline (BL), Wks 1, 2, 3, 4, and every 4 wks thereafter. Pts could have SEC dose escalated from 150 to 300 mg starting from Wk 52, based on physicians' judgement. Data are shown for pts originally randomised to SEC; 150mg groups include pts who had dose escalated to 300mg. Concomitant MTX (≤25 mg/week) was allowed. Radiographic progression (mean change in van der Heijde-modified total Sharp score [vdH-mTSS] and its components: erosion and joint space narrowing [JSN] scores, was based on hand/wrist/foot X-rays obtained at BL and Wk 104, and assessed by two blinded readers (plus an adjudicator if required). Other efficacy endpoints included ACR20/50, PASI90 and resolution of dactylitis and enthesitis.


Results: Overall, 84.7% (300mg), 82.3% (150mg) and 75.2% (150mg no LD) pts completed 2 years of treatment. A total of 86 (39%) and 92 (41%) pts had their dose escalated to 300mg in the 150mg and 150mg no LD groups, respectively. Inhibition of radiographic progression was sustained with SEC through 2 years (Table 1). Proportions of pts with no radiographic progression (change from BL in mTSS ≤0.5) with SEC were 89.5% (300 mg), 82.3% (150 mg), and 81.1% (150 mg no LD) at 2 years; corresponding proportion of pts for change from BL in mTSS ≤0.0 were: 81.2%, 69.1% and 73.4%, respectively. Clinical responses were also sustained through 2 years (Table 1).


Conclusion: Subcutaneous secukinumab provided sustained inhibition of radiographic progression and sustained clinical responses through 2 years of treatment in pts with active PsA.


REFERENCE:

[1] Mease PJ et al. Arthritis Rheumatol 2018;70(suppl 10).


Disclosure of Interests: Philip J Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, Inc., and UCB., Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, Inc., and UCB., Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Leo, Merck, Novartis, Pfizer and UCB.., Robert B.M. Landewé: None declared, Proton Rahman Grant/research support from: Investigator for Janssen Research & Development, LLC and Novartis, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly,Novartis, and UCB, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, and Novartis, Hasan Tahir Grant/research support from: Novartis, Eli-Lilly, Speakers bureau: AbbVie, Janssen, Eli Lilly, and Novartis, Atul Singhal Grant/research support from: AAbbVie, Gilead, Sanofi, Regeneron, Amgen, Roche, BMS, Janssen, Lilly, Novartis, Pfizer, UCB, Astra Zeneca, MedImmune, FujiFilm, Nichi-Iko, Mallinckrodt, Speakers bureau: AbbVie, Elke Boettcher Consultant for: Amgen, Roche, Eli Lilly, Pfizer, MSD, Novartis, Speakers bureau: Amgen, Roche, Eli Lilly, Pfizer, MSD, Novartis, Sandra Navarra Speakers bureau: Astellas, Johnson & Johnson, Novartis, Pfizer, Aimee Readie Shareholder of: Novartis, Employee of: Novartis, Shephard Mpofu Shareholder of: Novartis, Employee of: Novartis, Eumorphia Maria Delicha Consultant for: Novartis, Luminita Pricop Shareholder of: Novartis, Employee of: Novartis, Désirée van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, Union Chimique Belge

DOI: 10.1136/annrheumdis-2019-eular.8808


Citation: Ann Rheum Dis, volume 78, supplement 2, year 2019, page A262
Session: Late breaking abstract session (Scientific Abstracts)