P255 Secukinumab provides sustained improvement in nail psoriasis and inhibition of radiographic progression in PsA patients with nail phenotype: 52-week results from a Phase 3 study
Authors: Kirkham Bruce , Nash Peter , Mease Philip J , Balsa Alejandro C , Singhal Atul , Quebe-Fehling Erhard , Pricop Luminita , Gaillez Corine 
Published: April 2020

Background

Nail psoriasis (PsO) affects up to 80% of patients with psoriatic arthritis (PsA) and is associated with significant pain, psychosocial disability and decreased physical function and quality of life (QoL). Secukinumab demonstrated efficacy for patients with nail PsO in TRANSFIGURE, and improvements in the signs and symptoms and low radiographic progression in patients with PsA in FUTURE 5 (NCT02404350). We report the efficacy of secukinumab on nail PsO and other disease facets, including radiographic progression, in the nail subset from FUTURE 5 through 52 weeks.

Methods

Patients (N = 996) with active PsA were randomised to subcutaneous secukinumab 300 mg loading dosage (LD), 150 mg LD, 150 mg no LD or placebo. All groups received secukinumab or placebo at baseline, Weeks 1, 2, 3 and 4, and every 4 weeks thereafter. Efficacy assessments through Week 52 included mNAPSI, radiographic progression (mTSS), ACR, PASI, HAQ-DI, SF-36 physical component summary, PsAQoL, and dactylitis and enthesitis resolution. Analyses through Week 16 used non-responder imputation for binary and mixed-effect model repeated measures for continuous variables. Data beyond Week 16 are presented as observed.

Results

663/996 (66.6%) of PsA patients had concomitant nail PsO at baseline. Baseline characteristics were balanced between groups. The total mean mNAPSI score at baseline was 16.4. Secukinumab 300 and 150 mg LD, improved nail PsO vs placebo at Weeks 8, 12 and 16 (all P &lt; 0.0001, except secukinumab 150 mg LD vs placebo at Week 8 [p = 0.0002]), with further improvements through Week 52. Mean change from baseline in mTSS score at Weeks 24 and 52 are shown in the Table. Proportions of patients with no radiographic progression (change from baseline in mTSS≤0.5) with secukinumab at 52 weeks were 94.0% (300 mg LD), 83.5% (150 mg LD) and 88.4% (150 mg no LD). ACR20/50 and PASI 90 responses, dactylitis and enthesitis resolution, physical function and QoL also improved with secukinumab vs placebo at Week 16, with sustained improvements through 52 weeks.

Conclusion

Secukinumab provided sustained improvements in nail disease, signs and symptoms of PsA, physical function and QoL, along with low radiographic progression, through 52 weeks in PsA patients with moderate-to-severe nail PsO.

Disclosures

B. Kirkham: Consultancies; Gilead, AbbVie, Janssen, Lilly, Novartis, Roche. Honoraria; Gilead, AbbVie, Janssen, Lilly, Novartis, Roche. Grants/research support; Gilead, AbbVie, Janssen, Lilly, Novartis, Roche. P. Nash: Honoraria; Novartis, AbbVie, Roche, Pfizer, Bristol-Myers Squibb, Janssen, Celgene. Grants/research support; Novartis, AbbVie, Roche, Pfizer, Bristol-Myers Squibb, Janssen, Celgene. P.J. Mease: Consultancies; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Galapagos, Gilead, Genentech, GlaxoSmithKline, Janssen, Leo, Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, INC pharma, UCB. Member of speakers’ bureau; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen, Leo, Lilly, Merck, Novartis, Pfizer, UCB. Grants/research support; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen, Leo, Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, INC pharma, UCB. A.C. Balsa: Consultancies; Pfizer, AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion, UCB. Honoraria; Pfizer, AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion, UCB. Grants/research support; Pfizer, AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion, UCB. A. Singhal: Member of speakers’ bureau; AbbVie. Grants/research support; AbbVie, Gilead, Sanofi, Regeneron, Amgen, Roche, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Pfizer, UCB, AstraZeneca, MedImmune, FujiFilm, Nichi-Iko, Mallinckrodt. E. Quebe-Fehling: Shareholder/stock ownership; Novartis. Other; Employee of: Novartis. L. Pricop: Shareholder/stock ownership; Novartis. Other; Employee of: Novartis. C. Gaillez: Shareholder/stock ownership; Novartis, Bristol-Myers Squibb. Other; Employee of: Novartis.