ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1528

Secukinumab Provides Rapid and Sustained Pain Relief in Ankylosing Spondylitis Patients with Normal or Elevated Baseline CRP Levels and Correlated with Improvement in Fatigue

Atul A. Deodhar1, Philip G. Conaghan2, Tore K Kvien3, Vibeke Strand4, Lawrence Rasouliyan5, Brian Porter6, Steffen Jugl7 and Kunal Gandhi6, 1Oregon Health & Science University, Portland, OR, 2University of Leeds, Leeds, United Kingdom, 3Diakonhjemmet Hospital, Oslo, Norway, 4Stanford University School of Medicine, Palo Alto, CA, 5RTI Health Solutions, Barcelona, Spain, 6Novartis Pharmaceuticals Corporation, East Hanover, NJ, 7Novartis Pharma AG, Basel, Switzerland

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: , , ,

Session Information

Date: Monday, November 6, 2017

Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Secukinumab has demonstrated sustained efficacy in patients (pts) with active AS.1,2 We investigated improvement in pain and fatigue scores from baseline (BL) through Week (Wk) 104 in AS pts stratified by BL CRP status and prior use of TNF inhibitor (TNFi) therapy from the MEASURE 2 trial.

Methods: The MEASURE 2 study design has been reported previously.1 This post-hoc analysis assessed the mean change from BL in total spinal and nocturnal pain scores (by visual analog scale) using mixed-effect model repeated measure analysis through Wk 16 (least squares mean change) and observed data from Wk 20‒104 (mean change). The results are reported for the overall population, pts stratified by BL CRP level (normal [<5 mg/L] or elevated [≥5 mg/L]), and by prior use of TNFi (TNFi-naïve vs TNFi-inadequate responder/intolerant [TNFi-IR]) for the approved secukinumab 150 mg subcutaneous dose. The proportion of pts reporting clinically meaningful improvements (≥20% mean change from BL) in spinal pain scores was also assessed. The correlations between pain (spinal or nocturnal) and functional assessment of chronic illness therapy‒fatigue (FACIT‒Fatigue) score and response (improvement ≥4 points) were also evaluated.

Results: In the overall population (N = 219), secukinumab 150 mg-treated pts (n = 72) reported rapid reductions across pain scores by Wk 1, which were sustained or further improved through Wk 104: mean change (secukinumab vs placebo [PBO]) in spinal pain: Wk 1 (−10.6 vs −3.6, P <0.05), Wk 16 (−29.0 vs −11.4, P <0.0001), and Wk 104 (secukinumab: −36.4); mean change in nocturnal pain: Wk 1 (−12.7 vs −1.7, P <0.001), Wk 16 (−30.3 vs −10.1, P <0.0001), and Wk 104 (secukinumab: −38.6). Furthermore, 63% of pts on secukinumab reported clinically meaningful improvements vs PBO in spinal pain as early as Wk 3 (36%, P <0.01), increasing to 78% at Wk 104. Secukinumab improved pain scores to a similar extent, irrespective of BL CRP status (Table). At Wk 16, moderate correlations were observed between spinal or nocturnal pain and fatigue (FACIT‒Fatigue score: −0.49/−0.48 [P <0.05 for both correlations]; FACIT‒Fatigue response: −0.48/−0.51 [P <0.05 for both correlations]). Improvements in pain scores and correlations between pain and fatigue showed similar trends among TNFi-naïve and TNFi-IR pts, with a greater magnitude of improvement observed in the TNFi-naïve group (Table).

Conclusion: Secukinumab provides rapid and sustained pain relief through 104 wks of therapy in AS pts with normal or elevated BL CRP levels and in TNFi-naïve and TNFi-IR pts. Pain relief showed a positive correlation with improvement in fatigue.

References: 1. Baeten D, et al. N Engl J Med. 2015;373:2534‒48; 2. Marzo-Ortega H, et al. Arthritis Care Res (Hoboken). 2017;doi: 10.1002/acr.23233.

Table. Summary of Results

By Baseline CRP

Normal Baseline CRP (<5 mg/L)

Elevated Baseline CRP (≥5 mg/L)

Pain scores

Week

Secukinumab 150 mg (N = 27)

PBO

(N = 26)

P-value

Secukinumab 150 mg (N = 45)

PBO

(N = 48)

P-value

Spinal Pain

16

−34.6

−16.6

0.016

−26.7

−7.8

0.0001

104

−31.2

–

–

−40.2

–

–

Nocturnal Pain

16

−30.2

−10.0

0.0081

−31.6

−9.3

<0.0001

104

−28.6

–

–

−41.1

–

–

By TNFi Status

TNFi-Naïve

TNFi-IR

Pain scores

Week

Secukinumab 150 mg (N = 44)

PBO

(N = 45)

P-value

Secukinumab 150 mg (N = 28)

PBO

(N = 29)

P-value

Spinal pain

16

−33.2

−13.2

<0.0001

−22.5

−9.4

0.0564

104¥

−37.7

–

–

−33.7

–

–

Nocturnal pain

16

−35.4

−14.9

<0.0001

−22.8

−4.0

0.0043

104¥

−40.5

–

–

−34.8

–

–

Correlation coefficient€

Week

FACIT‒Fatigue score

FACIT‒Fatigue response£

FACIT‒Fatigue score

FACIT‒Fatigue response£

Spinal pain‡

16

−0.51

−0.45

−0.42

−0.49

104

−0.59

−0.68

−0.55

−0.68

Nocturnal pain‡

16

−0.55

−0.59

−0.31

−0.34

104

−0.50

−0.56

−0.51

−0.61

P-values and LS mean change at Week 16 from MMRM analysis and mean change at Week 104 from observed data; ¥n = 39 (150 mg) for TNFi-naïve and n = 20 (150 mg) for TNFi-IR; N, number of patients randomized; €Pearson correlation coefficients calculated for FACIT‒Fatigue score and polyserial correlation coefficients calculated for FACIT‒Fatigue response; £FACIT‒Fatigue response dichotomized (using observed data), as 1 if FACIT‒Fatigue score improvement ≥4 points, otherwise 0; ‡P <0.05 for all values, P-value calculated from the Chi-Square likelihood ratio test; FACIT‒Fatigue, Functional Assessment of Chronic Illness Therapy‒Fatigue; LS, least squares; MMRM, mixed-effect model repeated measure; PBO, placebo

Disclosure: A. A. Deodhar, AbbVie Inc., Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer Inc., UCB, 2,Eli Lilly, Janssen, Novartis, Pfizer, UCB, 5; P. G. Conaghan, AbbVie, BMS, Eli Lilly, Novartis, Pfizer, Roche, 5,AbbVie, BMS, Eli Lilly, Novartis, Pfizer, Roche, 8; T. K. Kvien, AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, UCB, 5,AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, UCB, 8; V. Strand, AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Celltrion, CORRONA, EMD Serono, Genentech/Roche, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, UCB, 5; L. Rasouliyan, Novartis Pharmaceutical Corporation, 5,RTI Health Solutions, 3; B. Porter, Novartis Pharmaceutical Corporation, 1,Novartis Pharmaceutical Corporation, 3; S. Jugl, Novartis Pharma AG, 1,Novartis Pharma AG, 3; K. Gandhi, Novartis Pharmaceutical Corporation, 1,Novartis Pharmaceutical Corporation, 3.

To cite this abstract in AMA style:

Deodhar AA, Conaghan PG, Kvien TK, Strand V, Rasouliyan L, Porter B, Jugl S, Gandhi K. Secukinumab Provides Rapid and Sustained Pain Relief in Ankylosing Spondylitis Patients with Normal or Elevated Baseline CRP Levels and Correlated with Improvement in Fatigue [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/secukinumab-provides-rapid-and-sustained-pain-relief-in-ankylosing-spondylitis-patients-with-normal-or-elevated-baseline-crp-levels-and-correlated-with-improvement-in-fatigue/. Accessed .

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