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Randomized Controlled Trial
. 2018 Jun 7;20(1):113.
doi: 10.1186/s13075-018-1610-3.

Secukinumab provides rapid and sustained pain relief in psoriatic arthritis over 2 years: results from the FUTURE 2 study

Iain B McInnes  1 , Philip J Mease  2 , Georg Schett  3 , Bruce Kirkham  4 , Vibeke Strand  5 , Nicole Williams  6 , Todd Fox  7 , Luminita Pricop  8 , Steffen M Jugl  7 , Kunal K Gandhi  8 ; FUTURE 2 Study Group
Affiliations
Randomized Controlled Trial

Secukinumab provides rapid and sustained pain relief in psoriatic arthritis over 2 years: results from the FUTURE 2 study

Iain B McInnes et al. Arthritis Res Ther. .

Abstract

Background: Pain is one of the most important domains affecting health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA). Secukinumab has demonstrated rapid and sustained improvements in signs and symptoms, including HRQoL, among patients with active PsA. This analysis evaluates the effect of secukinumab on patient-reported pain in PsA through 104 weeks of treatment.

Methods: Pain was assessed through week 104 using clinically relevant measures, including change from baseline in a pain visual analog scale (VAS) and Short Form-36 (SF-36) bodily domain scores; proportion of patients reporting improvements equal to or better than minimum clinically meaningful differences in the pain VAS and SF-36 bodily pain domain scores; and proportion of patients with no, moderate, or extreme pain/discomfort measured by the EuroQoL 5-Dimension 3-Level Questionnaire (EQ-5D-3 L) pain item scores. Correlations of pain measures were analyzed using Pearson's correlation coefficient. Pre-specified analyses of TNF-naïve patients and patients who stopped TNF-inhibitors (TNFis) due to inadequate responses or safety/tolerability (TNF-IR patients) were performed using "as-observed data."

Results: Mean improvements from baseline in pain VAS scores were greater with secukinumab versus placebo by week 3 (- 16.9; P < 0.0001 with secukinumab 300 mg and - 12.6; P < 0.05 with secukinumab 150 mg) and sustained through week 104. SF-36 bodily pain domain scores were significantly greater with 300 mg secukinumab and secukinumab 150 mg versus placebo by week 4 (16.2 and 16.3, respectively; P < 0.0001 for both), and these changes were maintained through week 104. With both secukinumab 300 mg and secukinumab 150 mg, improvements equal to or better than the minimum clinically meaningful differences in pain VAS and SF-36 bodily pain were significant versus placebo at week 3 and week 4, respectively. At week 4, 15%, 9%, and 5% of patients receiving secukinumab 300 mg, secukinumab 150 mg, and placebo, respectively, reported "no pain/discomfort" measured by EQ-5D-3 L; these proportions increased to week 104 with both secukinumab doses. Similarly, improvements in pain measures were significant in both TNF-naïve and TNF-IR patients.

Conclusion: Secukinumab provided rapid and sustained pain relief in PsA over 2 years of treatment. Improvements in pain were reported regardless of prior exposure to TNFis.

Trial registration: ClinicalTrials.gov, NCT01752634 . Registered on 19 December 2012.

Keywords: Pain relief; Psoriatic arthritis; Secukinumab.

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Conflict of interest statement

Ethics approval and consent to participate

This study was conducted in accordance with the principles of the Declaration of Helsinki, and all centers received approval from independent ethics committees or institutional review boards.

Competing interests

IB McInnes received research grants, consultation fees, or speaker honoraria from AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB. PJ Mease received research grants, consultation fees, or speaker honoraria from AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Eli Lilly, Merck, Novartis, Pfizer, and UCB. G Schett received speaker fees from Abbvie, BMS, Celgene, Chugai, Eli Lilly, Janssen, Novartis, Roche, and UCB. B Kirkham received research support from AbbVie, Novartis, Roche; served as a consultant and speaker for Abbott, BMS, Chugai, MSD, Novartis, Pfizer, Roche, UCB; and participated in speakers bureaus for Abbott, BMS, Chugai, MSD, Novartis, Pfizer, Roche, UCB. V Strand is a founding member of the executive of Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 36 companies; a member of the American College of Rheumatology’s Clinical Trials Task Force and Chair of the American College of Rheumatology/OMERACT Imaging Subcommittee. Dr. Strand also has served as a consultant and member of advisory boards for AbbVie, Alder, Amgen Corporation, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celltrion, Genentech/Roche, GlaxoSmithKline, Janssen, Eli Lily, Novartis, Pfizer, Regeneron, Sandoz, Sanofi, and UCB. N Williams is a consultant for Novartis through employment at RTI Health Solutions and is an employee of RTI Health Solutions. T Fox, L Pricop, SM Jugl, and KK Gandhi are employees of Novartis and own Novartis stock.

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Figures

Fig. 1
Fig. 1
Proportion of patients with ≥ 20% improvement in pain visual analog scale (VAS) score through week 104 (a) and proportion of patients with ≥ 20% improvement in pain VAS response (b) Data are presented as LS mean change using MMRM from weeks 1-24, and observed data are presented from weeks 28-104 (shaded area); P values are calculated from a MMRM analysis (a). Observed data are presented; P values are calculated from Fisher’s exact test (b) 1Number of patients originally randomized to each treatment group. *P < 0.0001; †P < 0.001; ‡P < 0.05 §P < 0.01 versus placebo LS, least squares; MMRM, mixed-effect model for repeated measures; PBO, placebo; s.c., subcutaneous; SEC, secukinumab
Fig. 2
Fig. 2
Change from baseline in the Short Form-36 (SF-36) bodily pain score through week 104 (a) and proportion of patients with improvement ≥ 5 in the SF-36 bodily pain domain score (b) Data are presented as LS mean change using MMRM from weeks 1-24, and observed data are presented from weeks 52-104 (shaded area); P values are calculated from a MMRM analysis (a). Observed data are presented; P values are calculated from Fisher’s exact test (b) 1Number of patients originally randomized to each treatment group. *P < 0.0001; †P < 0.001; ‡P < 0.05 versus placebo. LS, least squares; MMRM, mixed-effect model for repeated measures; PBO, placebo; s.c., subcutaneous; SEC, secukinumab
Fig. 3
Fig. 3
Proportion of patients with no pain or discomfort in the EuroQoL 5-Dimension (EQ-5D-3 L) domain through week 104 Observed data are presented. Data are presented only for evaluable patients at each time point s.c., subcutaneous
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