FRI0457\u2005SECUKINUMAB PROVIDES SIGNIFICANT AND SUSTAINED IMPROVEMENT IN NAIL PSORIASIS AND SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS IN PATIENTS WITH NAIL PHENOTYPE: 52-WEEK RESULTS FROM THE PHASE III FUTURE 5 STUDY

Abstract

Background Nail psoriasis (PsO) is present in up to 80% in psoriatic arthritis (PsA) patients (pts) and associated with significant pain, psychosocial disability, decreased physical function and quality of life (QoL).1 Nail PsO is considered as one of the six core PsA domains by GRAPPA2 and is a predictor of severe disease with joint involvement and structural damage. Secukinumab (SEC) has demonstrated efficacy for pts with nail PsO in the TRANSFIGURE study3 and significant improvement in signs and symptoms of PsA in the FUTURE 5 study4 Objectives To evaluate the efficacy of SEC on nail PsO and other facets of disease in the nail subset from the FUTURE 5 study through 52 weeks (wks). Methods Pts (N=996) with active PsA, were randomised to subcutaneous SEC 300 mg loading dosage (LD; 300 mg), 150 mg LD (150 mg), 150 mg no LD or placebo (PBO). All groups received SEC or PBO at baseline (BL), Wks 1, 2, 3, and 4, and then every 4 wks. Efficacy assessments through Wk 52 included mNAPSI, ACR, PASI, HAQ-DI, SF-36 PCS, PsAQoL and resolution of dactylitis and enthesitis. Analyses through Wk 16 used non-responder imputation (NRI) for binary and mixed-effect model repeated measure (MMRM) for continuous variables. Observed data are presented from Wk 20-52. Results A total of 663/996 (66.6%) PsA pts had concomitant nail PsO at BL. Demographics and BL disease characteristics were balanced between treatment groups in the nail subset, which were comparable with overall population. The total mean mNAPSI score at BL was 16.4. SEC 300 and 150 mg doses improved nail PsO vs. placebo (PBO) at Wk 8, 12 and 16 (P < 0.0001), with further improvements through Wk 52 (Figure). ACR20/50 and PASI 90 responses, resolution of dactylitis and enthesitis, physical function and QoL were also improved with SEC vs. PBO at Wk 16 with sustained improvements through 52 wks (Table). Conclusion Secukinumab provided sustained improvements in nail disease, signs and symptoms of PsA, physical function and QoL through 52 wks in pts with PsA and moderate to severe nail PsO. References [1] Baran R. Dermatology2010;221(Suppl1):1-5. [2] Coates LC, et al. Arthritis Rheumatol. 2016;68:1060-71. [3] Reich K, et al. Br J Dermatol. 2018. Doi: 10.1111/bjd.17351. [4] Mease PJ, et al. Ann Rheum Dis. 2018;77:890-7.Table Summary of results SEC PBO N=231 Variable Wk 300 mg N=144 150 mg N=135 150 mg no LD N=153 ACR201 16 66.7* 60.0* 61.4* 29.0 52 81.2 (133) 73.7 (118) 77.9 (136) - ACR501 16 43.1* 40.7* 32.0* 9.1 52 54.1 (133) 45.8 (118) 50.7 (136) - PASI 901,2 16 52.0* 36.8* 31.0* 7.6 52 62.3 (69) 50.7 (75) 49.3 (75) - HAQ-DI3 16 -0.6* -0.5* -0.5* -0.2 52 -0.6 (132) -0.6 (117) -0.6 (136) - SF-36 PCS3 16 7.82* 6.90* 6.00* 2.29 52 8.0 (134) 6.71 (123) 7.93 (137) - PsAQoL3 16 -3.6* -3.6* -3.0† -1.1 52 -3.9 (134) -4.2 (122) -3.8 (137) - Resolution of enthesitis,%4 16 58.2† 56.8† 47.2‡ 34.3 52 81.5 (92) 68.7 (80) 70.7 (82) - Resolution of dactylitis,%4 16 63.8† 52.6‡ 59.2† 32.4 52 78.8 (52) 79.6 (49) 80.3 (66) - *P<0.0001; † P<0.001; $ P<0.01; ‡ P<0.05 vs. PBO. NRI data for binary and MMRM data for continuous variables presented at Wk 16. Observed data presented at Wk 52. 1% responders (n); 2Data from pts with BL psoriasis ≥3% BSA: N=75 [300 mg]; 87 [150 mg], 84 [150 mg no LD] and 118 [PBO]; 3Mean change from baseline (n); 4Data from pts with enthesitis/dactylitis at BL: N=98/58 [300 mg]; 88/57 [150 mg], 89/76 [150 mg no LD] and 140/102 [PBO]; N, number of pts with nail PsO in each group; n, number of evaluable pts at Wk 52 Disclosure of Interests Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant for: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Philip J Mease Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Consultant for: AbbVie, Amgen, BMS, Galapagos, Gilead Sciences, Inc., Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer and UCB, Bruce Kirkham Grant/research support from: Abbvie, Janssen, Lilly, Novartis, Roche, UCB, Consultant for: Abbvie, Janssen, Lilly, Novartis, Roche, UCB, Speakers bureau: Abbvie, Janssen, Lilly, Novartis, Roche, UCB, Alejandro Balsa Grant/research support from: Abbvie, Pfizer, Novartis, BMS, Nordic, Sanofi, Consultant for: Abbvie, Pfizer, Novartis, BMS, Nordic, Sanofi, Sandoz, Lilly, Paid instructor for: Pfizer, Speakers bureau: Pfizer, Novartis, UCB, Nordic, Sanofi, Sandoz, Lilly, Atul Singhal Grant/research support from: AbbVie, Gilead, Sanofi, Regeneron, Amgen, Roche, BMS, Janssen, Lilly, Novartis, Pfizer, UCB, Astra Zeneca, MedImmune, FujiFilm, Nichi-Iko, Mallinckrodt, Speakers bureau: AbbVie, Erhard Quebe-Fehling Shareholder of: Novartis, Employee of: Novartis, Luminita Pricop Shareholder of: Novartis, Employee of: Novartis, Corine Gaillez Shareholder of: Novartis, BMS, Employee of: Novartis