Secukinumab Provides Sustained Reduction in Fatigue in Patients with Active Psoriatic Arthritis Through 3 Years: Long-term Data from the FUTURE 1 and FUTURE 2 Studies. British Society for Rheumatology (BSR), Liverpool, May 2018.British Society for Rheumatology (2018)
Background: Fatigue is common in patients with psoriatic arthritis (PsA) and negatively impacts social functioning and quality of life. We assessed the long-term effects of secukinumab on fatigue in TNF inhibitor (TNFi)-naïve PsA patients and those with inadequate response or intolerance to TNFi therapy (TNFi-IR).
Methods: 606 and 397 participants were randomised to secukinumab or placebo in FUTURE 1 (10 mg/kg i.v. followed by 150 or 75 mg S.C.) and FUTURE 2 (300, 150 or 75 mg S.C.), respectively. Fatigue was assessed at baseline and weeks 4, 8, 12, 16, 24, 52, 104 and 156 (FUTURE 1 only) using FACIT-Fatigue (higher score=less fatigue). Fatigue response was defined as increase in FACIT-Fatigue score of ≥ 4 from baseline (corresponding to the minimal clinically important difference). Correlations between baseline characteristics and improvements in fatigue were investigated using a logistical regression model. Only data for approved doses of secukinumab are shown.
Results: FACIT-Fatigue was 27.8-28.9 and 26.6-29.2 at baseline across groups in FUTURE 1 and 2, respectively. Observed improvements in fatigue with all doses of secukinumab vs. placebo at Weeks 4-24 were sustained through 156 weeks in FUTURE 1 and 104 weeks in FUTURE 2 in both the overall population and subgroups stratified by prior TNFi exposure (Table 1). The numerically higher responses with secukinumab 150 vs. 300 mg in the observed analysis resulted from a higher discontinuation rate due to lack of efficacy with the lower dose, thus inflating the response rate. In the overall population, the least-squares mean change (±standard error) from baseline in FACIT-Fatigue was significantly greater with secukinumab vs. placebo at week 16 in both FUTURE 1 (7.25±0.72 vs. 4.07±0.76; p = 0.002) and FUTURE 2 (300 mg: 5.89±0.92 vs. 1.86±0.93, p = 0.002; 150 mg: 7.40±0.90 vs. 1.86±0.93, p < 0.0001); improvements were sustained throughout the entire follow up in both studies (FUTURE 1 week 156: 6.14±0.77; FUTURE 2 Week 104: 300 mg 7.29±1.04, 150 mg 7.02±1.06). Improvements were numerically larger in TNFi-naïve patients than in TNFi-IR patients.
Conclusion: Secukinumab-treated PsA patients achieved rapid, sustained, and clinically meaningful improvements in fatigue for up to 156 weeks, with higher responses in TNFi-naïve patients.
Disclosures: H.C. has received honoraria, speaker fees and educational grants from UCB, and has received grants/research support from Novartis. H.C. has received travel support from Abbvie and Janssen for attending conferences. L.G. has received honoraria from Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer and UCB and has received grants/research support from Pfizer and UCB. T.K.K. has received consultancies from AbbVie, Biogen, BMS, Celltrion, Eli Lilly, Janssen, Merck-Serono, MSD, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Samsung, Sandoz and UCB. P.G.C. has received consultancies from Abbvie, Lilly, Novartis, Pfizer and Roche, and has received speaker fees from Abbvie and BMS. M.Ø. ahs received consultancies from Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Merck, Novartis, Orion, Pfizer, Regeneron, Roche and UCB and has received grants/research support from Abbvie, Celgene, Centocor, Merck and Novartis. D.G. has received consultancies from Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, and honoraria from Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB. D.G. has received grants/research support from Abbvie, Amgen, Celgene, Eli Lilly, Novartis, Pfizer and UCB. P.M. has received consultancies from AbbVie, Amgen, Bristol Myers Squibb, Celegene, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, UCB and Zynerba, and has received speaker fees from Lilly, Sun and Zynerba. P.M. has received grants/research support from AbbVie, Amgen, Bristol Myers Squibb, Celegene, Genentech, Janssen, Novartis, Pfizer and UCB. L.R. is an employee of RTI Health Solutions, a company that receives funding from Novartis to provide biostatistical services. L.P., C.G. and S.J. are Novartis employees and have stocks/shares in the company.
Publication DateApril, 2018
Citation InformationHector Chinoy, Laure Gossec, Tore K Kvien, Philip G. Conaghan, et al.. "Secukinumab Provides Sustained Reduction in Fatigue in Patients with Active Psoriatic Arthritis Through 3 Years: Long-term Data from the FUTURE 1 and FUTURE 2 Studies. British Society for Rheumatology (BSR), Liverpool, May 2018." British Society for Rheumatology (2018)
Available at: http://works.bepress.com/philip-mease/109/