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THU0311 (2018)
Impact of secukinumab treatment on psoriatic arthritis patients with or without enthesitis at baseline: pooled data from two phase 3 studies (FUTURE 2 AND FUTURE 3)
J.K. Wallman1, G. Schett2, I.B. McInnes3, E. Quebe-Fehling4, L. Rasouliyan5, L. Pricop6, A.E. Fasth7, C. Gaillez4, on behalf of the FUTURE 2 and FUTURE 3 study groups
1Lund University, Lund, Sweden
2University of Erlangen-Nuremberg, Erlangen, Germany
3University of Glasgow, Glasgow, UK
4Novartis Pharma AG, Basel, Switzerland
5RTI Health Solutions, Barcelona, Spain
6Novartis Pharmaceuticals Corporation, East Hanover, USA
7Novartis Sverige AB, Täby, Sweden

 

Background: Enthesitis is a common phenotypic manifestation of psoriatic arthritis (PsA) affecting approximately 70% of patients (pts) and may be associated with worse outcomes.1 Secukinumab (SEC), a fully human monoclonal antibody that selectively neutralises IL-17A, provided significant and sustained improvement in the signs and symptoms of active PsA, with sustained resolution of enthesitis in Phase 3 studies.2,3

Objectives: To report the impact of SEC treatment on efficacy outcome measures in active PsA pts with or without baseline (BL) enthesitis (defined by Leeds Enthesitis Index) using pooled data from the FUTURE 2 (NCT01752634) and FUTURE 3 (NCT01989468) studies over 2 years.

Methods: SEC and placebo (PBO) were administered weekly during the first 4 weeks (wks) followed by subcutaneous maintenance dosing every 4 wks thereafter (PBO until Wk 16/24). The results are reported only for SEC 300 and 150 mg (approved doses). Efficacy outcomes (ACR20/50/70, PASI 90, HAQ-DI, SF-36 PCS and DAS28-CRP) were analysed post-hoc in pts with enthesitis at BL (BLE; n=466) or without enthesitis at BL (No BLE; n=246). Observed data are presented for binary variables and least-square (LS) means from analysis of covariance for continuous variables.

Results: A total of 65% of pts had BLE. BL demographics were balanced between the BLE and No BLE groups except for a higher proportion of females and numerically higher tender joint count, disability (HAQ-DI) and lower physical function (SF-36 PCS) in BLE pts than No BLE pts. At Wk 16, improvements in ACR and PASI responses, HAQ-DI, SF-36 PCS and DAS28-CRP were similar in both groups treated with SEC 300 mg, but were lower (except for PASI) in BLE pts treated with SEC 150 mg (table 1). Improvements in these outcomes followed a similar trend to Wk 104 in SEC-treated pts (table 1).

Abstract THU0311 – Table 1 Summary of Results with Secukinumab

Wk

BLE

No BLE

300 mg

150 mg

PBO

300 mg

150 mg

PBO

ACR20a,b

16

53.5

46.5

19.6

53.7

64.6

18.1

104

56.8

52.4

-

62.6

62.9

-

ACR50a,b

16

31.3

21.4

6.7

35.8

35.4

5.6

104

44.7

24.8

-

47.3

34.3

-

ACR70a,b

16

16.0

8.2

1.8

21.1

16.5

1.4

104

26.5

15.2

-

34.1

21.4

-

PASI 90a,c

16

50.0

36.6

7.9

42.1

37.0

6.7

104

67.9

59.7

-

73.5

44.4

-

HAQ-DId

16

−0.5

−0.3

−0.2

−0.5

−0.5

−0.2

104

−0.5

−0.4

-

−0.5

−0.6

-

SF-36 PCSd

16

6.4

3.7

2.5

6.5

7.4

2.6

104

7.4

4.3

-

6.6

6.9

-

DAS28-CRPd

16

−1.5

−1.05

−0.5

−1.35

−1.6

−0.5

104

−1.7

−1.6

-

−2.0

−1.9

-
aResponse,%; bAt Wk 16/104, n=144/132 (SEC 300), 159/145 (SEC 150) and 163 (PBO) with enthesitis and n=95/91 (SEC 300), 79/70 (SEC 150) and 72 (PBO) without enthesitis at BL; cAt Wk 16/104, n=66/56 (SEC 300), 82/62 (SEC 150) and 63 (PBO) with enthesitis and n=38/34 (SEC 300), 46/36 (SEC 150) and 30 (PBO) without enthesitis at BL (psoriasis subset); dLS mean

Conclusions: Although pts with BLE had more severe BL clinical characteristics than pts with No BLE, SEC showed higher efficacy than PBO at Wk 16 and sustained efficacy over 104 wks in both groups with greater magnitude of improvement in pts treated with SEC 300 mg than 150 mg.

References:

  1. Schett G, et al. Nat Rev Rheumatol 2017;13:731–41.
  2. Mease PJ, et al. N Engl J Med 2015;373:1329–39.
  3. McInnes IB, et al. Lancet 2015;386:1137–46.

Disclosure of Interest: J. Wallman Consultant for: AbbVie, Celgene, Lilly, Novartis, UCB, G. Schett Grant/research support from: BMS, Celgene, GSK, Lilly, Novartis, Consultant for: AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, UCB, Speakers bureau: AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, I. McInnes Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, E. Quebe-Fehling Shareholder of: Novartis, Employee of: Novartis, L. Rasouliyan Consultant for: Novartis, Employee of: RTI Health Solutions, L. Pricop Shareholder of: Novartis, Employee of: Novartis, A. Fasth Shareholder of: Novartis, Employee of: Novartis, C. Gaillez Shareholder of: Novartis, Employee of: Novartis

DOI: 10.1136/annrheumdis-2018-eular.2024


Citation: Ann Rheum Dis, volume 77, supplement Suppl, year 2018, page A373
Session: Psoriatic arthritis