ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2146

Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis in Anti-TNF-Naive Patients and Those Previously Exposed to Anti-TNF Therapy: 52-Week Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with Subcutaneous Dosing

Arthur Kavanaugh1, Iain B. McInnes2, Philip J. Mease3, Stephan Hall4, Hector Chinoy5, Alan J Kivitz6, Manmath Patekar7, Zailong Wang8 and Shephard Mpofu9, 1University of California, San Diego School of Medicine, LaJolla, CA, 2Immunology, Infection and Inflammation, University of Glasgow, Glasgow, United Kingdom, 3Rheumatology Research, Swedish Medical Center, Seattle, WA, 4Monash University, Melbourne, Australia, 5University of Manchester, Manchester, United Kingdom, 6Altoona Center for Clinical Research, Duncansville, PA, 7Novartis Healthcare Pvt. Ltd., Hyderabad, India, 8Novartis Pharmaceuticals Corporation, East Hanover, NJ, 9Novartis Pharma AG, Basel, Switzerland

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: ,

Session Information

Date: Monday, November 9, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment:Treatment of PsA and SpA

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: There remains an unmet need for additional treatment options for patients (pts) with psoriatic arthritis (PsA) who have had an inadequate response to or intolerance of anti-tumor necrosis factor (anti-TNF) therapy. Secukinumab, a human anti–IL-17A monoclonal antibody, demonstrated significant efficacy in the randomized, double-blind, placebo (PBO)-controlled phase 3 FUTURE 2 study (NCT01752634).1Here, we present the 52-week (wk) efficacy and safety of secukinumab by anti-TNF history in pts enrolled in this study.

Methods: Pts were randomized to receive subcutaneous (s.c.) secukinumab 300 mg, 150 mg, or 75 mg, or placebo (PBO) at baseline, Wks 1, 2, 3, and 4, and then every 4 wks (q4wk) from Wk 8. At Wk 16, PBO-treated pts were re-randomized to receive secukinumab 300 mg or 150 mg s.c. q4wk from Wk 16 or 24, depending upon clinical response. Randomization was stratified by anti-TNF history: anti‒TNF-naïve, or inadequate response/intolerance to not more than 3 anti-TNF agents (anti‒TNF-IR). The primary endpoint was ACR20 response at Wk 24. Secondary endpoints were PASI 75/90, DAS28-CRP, SF-36 PCS, HAQ-DI, ACR 50, dactylitis, and enthesitis. ACR70 was an exploratory endpoint. Analyses used non-responder imputation (binary variables) and mixed-effect model repeated measures (continuous variables) through Wk 52. Analysis of primary and secondary endpoints stratified by anti-TNF history was pre-specified.

Results: Of the 397 pts enrolled in FUTURE 2, 65% were anti‒TNF-naïve and 35% were anti‒TNF-IR. At Wk 24, ACR 20/50/70 and PASI 75/90 responses were higher with secukinumab versus PBO in both anti‒TNF-naïve and anti‒TNF-IR pts (Table). Improvements with secukinumab  versus PBO at Wk 24 were also observed for other secondary endpoints in both anti‒TNF-naïve and anti‒TNF-IR pts. Response rates were generally higher amongst anti‒TNF-naïve pts versus anti‒TNF-IR pts. The greatest improvements in the anti‒TNF-IR group were generally observed with secukinumab 300 mg. Clinical responses to secukinumab were sustained or continued to improve through 52 wks of therapy in both anti‒TNF-naïve and anti‒TNF-IR pts (Table).

Conclusion: Secukinumab provided sustained improvements in the signs and symptoms of PsA in both anti‒TNF-naïve and anti‒TNF-IR pts.

Reference: 1. Mclnnes IB, et al. ACR/ARHP Annual Meeting, Boston, MA, USA. November 14-19, 2014. Oral Presentation L1.

Table: Efficacy of secukinumab at Wks 24 and 52

 

Responders (%)

 

FUTURE 2

PBO

Secukinumab

300 mg

150 mg

75 mg

Anti‒TNF-IRa

ACR20/50/70

 

N=

33

37

34

35

Wk 24

45.5§/27.3‡/15.2‡

29.7/18.9/10.8

14.7/5.9/5.9

14.3/8.6/0.0

Wk 52

 54.5/27.3/18.2

37.8/21.6/13.5

35.3/17.6/8.8

–

PASI 75/90b

 

N=

11

22

17

12

Wk 24

63.6‡/36.4

36.4/22.7

23.5/11.8

8.3/8.3

Wk 52

63.6/45.5

50.0/40.9

41.2/23.5

–

Anti‒TNF-naïve

ACR20/50/70

 

N=

67

63

65

63

Wk 24

58.2*/38.8*/22.4†

63.5*/44.4*/27.0*

36.9§/24.6§/6.2

15.9/6.3/1.6

Wk 52

68.7/52.2/26.9

79.4/49.2/23.8

58.5/36.9/20.0

–

PASI 75/90b

 

N=

30

36

33

31

Wk 24

63.3†/53.3†

55.6§/38.9§

30.3/12.1

19.4/9.7

Wk 52

76.7/60.0

61.1/44.4

51.5/24.2

–

aPts who had previously used up to 3 anti-TNF agents and had experienced an inadequate response or stopped treatment due to safety or tolerability reasons

bPts who had psoriasis affecting ≥3% body surface area at baseline

Missing values were imputed as non-response (non-responder imputation)

*P<0.0001; †P<0.001; §P<0.01; ‡P<0.05 versus PBO

ACR, American College of Rheumatology response criteria; N, number of pts randomized; PASI, psoriasis area-and-severity index; PBO, placebo

Disclosure: A. Kavanaugh, Novartis Pharmaceutical Corporation, 5; I. B. McInnes, Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, 5,Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, 2,Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, 9; P. J. Mease, Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, 2,Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, 5,Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, 9; S. Hall, None; H. Chinoy, Novartis, Janssen, Pfizer, UCB, Abbvie, Celgene, Servier, Roche, MSD, and aTyr, 5,Novartis, Janssen, Pfizer, UCB, Abbvie, Celgene, Servier, Roche, MSD, and aTyr, 2; A. J. Kivitz, Novartis Pharmaceutical Corporation, 5; M. Patekar, Novartis Pharmaceutical Corporation, 3; Z. Wang, Novartis Pharmaceutical Corporation, 3; S. Mpofu, Novartis Pharmaceutical Corporation, 3,Novartis Pharmaceutical Corporation, 1.

To cite this abstract in AMA style:

Kavanaugh A, McInnes IB, Mease PJ, Hall S, Chinoy H, Kivitz AJ, Patekar M, Wang Z, Mpofu S. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis in Anti-TNF-Naive Patients and Those Previously Exposed to Anti-TNF Therapy: 52-Week Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with Subcutaneous Dosing [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/secukinumab-provides-sustained-improvements-in-the-signs-and-symptoms-of-active-psoriatic-arthritis-in-anti-tnf-naive-patients-and-those-previously-exposed-to-anti-tnf-therapy-52-week-results-from-a/. Accessed .

« Back to 2015 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/secukinumab-provides-sustained-improvements-in-the-signs-and-symptoms-of-active-psoriatic-arthritis-in-anti-tnf-naive-patients-and-those-previously-exposed-to-anti-tnf-therapy-52-week-results-from-a/