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FRI0494 Secukinumab provides rapid and sustained pain relief in psoriatic arthritis: 2-year results from the future 2 study
  1. IB McInnes1,
  2. PJ Mease2,
  3. G Schett3,
  4. B Kirkham4,
  5. V Strand5,
  6. N Williams6,
  7. T Fox7,
  8. L Pricop8,
  9. S Jugl7,
  10. KK Gandhi8,
  11. on behalf of the FUTURE 2 study group
  1. 1University of Glasgow, Glasgow, United Kingdom
  2. 2Swedish Medical Center and University of Washington, Seattle, United States
  3. 3University of Erlangen-Nuremberg, Erlangen, Germany
  4. 4Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom
  5. 5Stanford University School of Medicine, Palo Alto
  6. 6RTI Health Solutions, Durham, United States
  7. 7Novartis Pharma AG, Basel, Switzerland
  8. 8Novartis Pharmaceuticals Corp., East Hanover, United States

Abstract

Background Pain remains a major clinical challenge in the treatment of psoriatic arthritis (PsA). Secukinumab (SEC) has demonstrated significant efficacy in PsA patients (pts), across a range of quality of life related outcome measures.1,2

Objectives This post-hoc analysis evaluated change in pain scores from baseline (BL) to Week (Wk) 104 in PsA pts receiving SEC in the FUTURE 2 study.

Methods FUTURE 2 study design has been reported.2 Mean change from BL in pain VAS and SF-36 bodily pain domain scores were evaluated using mixed-effect model for repeated measures (MMRM) through Wk 16 and as observed through Wk 104. Proportion of pts reporting improvements ≥clinically meaningful differences in pain VAS (mean change from BL ≥20%) was assessed. Results are reported for SEC 300 and 150mg in overall population and stratified by prior use of TNF inhibitor (TNFi; TNFi-naïve vs. inadequate responder/intolerant [TNFi-IR]). EQ–5D-3L pain item scores (no-, moderate- or extreme-pain/discomfort) were assessed as proportions.

Results Mean changes from BL in pain VAS were greater with SEC vs. placebo (PBO) by Wk 3 (least squares mean [LSM]: -16.9, -12.6 with SEC 300 and 150mg, respectively vs. -5.75 with PBO; P<0.05), and Wk 16 (LSM: -24.0 and -23.0 for SEC 300 and 150mg, respectively vs. -8.41 with PBO; P<0.05). Mean changes were sustained through Wk 104 (-26.1 and -25.9 with SEC 300 and 150mg, respectively). In both SEC groups, >50% pts reported improvements of ≥20% by Wk 3 and this increased through Wk 104. Similarly, SF-36 bodily pain domain scores improved from BL by Wk 4 and 16 with SEC vs. PBO, exceeding minimum clinically important differences of 5.0 (Wk 4: LSM: 16.2 and 16.3 for SEC 300 and 150mg, respectively vs. 5.9 with PBO; P<0.05 and Wk 16: LSM: 21.1 and 22.0 for SEC 300 and 150mg, respectively vs. 6.9 with PBO; P<0.05). Improvements in pain were consistent in TNFi-naïve and TNFi-IR pts; and of greater magnitude in the naïve subgroup (table). Based on the EQ–5D-3L pain/discomfort item, 99% pts reported moderate to extreme pain or discomfort at BL. At Wk 4, the proportion of pts with no pain or discomfort was greater for the SEC 300mg (15%) and 150mg (10%) vs. PBO (5%) and increased through Wk 104 to 28% and 16% with SEC 300 and 150mg, respectively.

Table 1.

Summary of results by TNFi status at baseline

Conclusions SEC provides rapid and sustained pain relief through 104 wks in pts with PsA as assessed by multiple clinically relevant patient-reported measures of pain. Improvements were reported by pts regardless of their prior TNFi therapy status.

References

  1. Strand V, et al. Ann Rheum Dis 2017;76:203–7.

  2. McInnes IB, et al. Lancet 2015;386:1137–46.

References

Disclosure of Interest I. McInnes Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, P. Mease Grant/research support from: Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, Consultant for: Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, Speakers bureau: Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB, G. Schett: None declared, B. Kirkham Grant/research support from: AbbVie, Eli Lilly, Novartis, Roche and UCB, Consultant for: Abbott, Eli Lilly and Novartis, Speakers bureau: Abbott, Janssen, Novartis and Pfizer, V. Strand Consultant for: AbbVie, Amgen, BMS, Celgene, Celltrion, Corrona, Genentech/Roche, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi and UCB, N. Williams Consultant for: Novartis through employment at RTI, Employee of: RTI Health Solutions, T. Fox Shareholder of: Novartis, Employee of: Novartis, L. Pricop Shareholder of: Novartis, Employee of: Novartis, S. Jugl Shareholder of: Novartis, Employee of: Novartis, K. Gandhi Shareholder of: Novartis, Employee of: Novartis

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