ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 537

No Effect of Baseline Serum CRP Levels on Clinical Efficacy Parameters in Rheumatoid Arthritis Patients Treated with Filgotinib: Post Hoc Analysis from Two Phase 2B Studies

Arthur Kavanaugh1, Annegret Van der Aa2, Corinne Jamoul2, Chantal Tasset2, Pille Harrison2 and René Westhovens3, 1Medicine, University of California, San Diego, La Jolla, CA, 2Galapagos NV, Mechelen, Belgium, 3Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: C-reactive protein (CRP), Janus kinase (JAK) and rheumatoid arthritis (RA)

  • Tweet
  • Email
  • Print
Session Information

Date: Sunday, November 5, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster I: Comorbidities and Adverse Events; Efficacy and Safety of Small Molecules

Session Type: ACR Poster Session A

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

Background/Purpose:

Filgotinib (GLPG0634, GS-6034) is an oral, selective JAK1 inhibitor that has demonstrated safety and efficacy data in two 24-week placebo-controlled phase 2B studies as add-on to methotrexate and as monotherapy in active rheumatoid arthritis (RA) patients with inadequate response to MTX (MTX-IR)1,2.

The objective was to evaluate the effect of baseline serum CRP levels on clinical efficacy after 12 weeks of treatment, as assessed by the ACR and DAS28(CRP) subcomponents in MTX-IR RA patients treated with filgotinib.

Methods:

Patients were randomized in a double-blind manner to placebo (PBO) or one of 3 daily doses of filgotinib (50mg, 100mg or 200mg) for 24 weeks. In the DARWIN 1 study, filgotinib on MTX background was evaluated as once (QD) or twice daily treatment. In the DARWIN 2 study once-daily filgotinib was assessed as monotherapy. The inclusion criterion for CRP was amended during the studies and was decreased from 13.5 mg/L to 6.3 mg/L. This post-hoc analysis included patients treated with the selected Phase 3 filgotinib doses, 100mg and 200mg QD, and PBO. Efficacy outcomes were analyzed by baseline CRP level (low: ≤9 mg/L and high: >9 mg/L, with 9mg/L as ULN).

Results:

Baseline disease activity was high and balanced across the different treatment groups. Comparable baseline values were shown between both CRP subgroups, except for the mean CRP levels (Table 1).

In both low and high CRP subgroups, patients on filgotinib at 100mg or 200mg QD for 12 weeks showed efficacy over PBO, as measured by change from baseline in different subcomponents of the ACR/DAS28(CRP) composite score (TJC68, SJC66, Pt pain, Pt GDA, Inv GDA, HAQ-DI and CRP) (Table 1). In both studies, there was no clear pattern suggesting that baseline CRP level had a consistent effect on filgotinib efficacy.

Conclusion:

This post-hoc analysis of two Phase 2B studies in MTX-IR RA patients suggests that filgotinib treatment once daily at 100mg and 200mg both on the background of MTX and as monotherapy was consistently associated with improved clinical outcomes compared to placebo at Week 12, regardless of baseline CRP levels, as measured by ACR and DAS28(CRP) subcomponents.

Table 1. Mean baseline and change from baseline (SE) values in key efficacy parameters at Week 12 by CRP subgroup

 

 

DARWIN 1

DARWIN 2

 

PBO

 

filgotinib 100mg QD

filgotinib 200mg QD

PBO

filgotinib

100mg QD

filgotinib 200mg QD

Low CRP subgroup (≤9 mg/L) 

N

33

25

15

11

20

20

TJC68

23.45

-9.42 (2.68)

21.94

-12.17 (2.04)

26.60

-14.87 (2.82)

21.64

-3.55 (3.59)

27.13

-14.68 (2.90)

23.70

-16.63 (2.71)

SJC66

15.52

-8.82 (1.62)

14.30

-10.09 (1.57)

17.00

-12.07 (2.53)

14.18

-5.09 (3.11)

19.50

-10.75 (2.04)

13.21

-9.51 (1.30)

Pt pain

64.94

-19.24 (6.41)

61.24

-30.12 (5.77)

69.67

-27.27 (6.25)

72.64

-11.27 (7.63)

73.15

-36.05 (6.76)

66.05

-32.30 (8.50)

Pt GDA

62.88

-17.82 (5.92)

66.96

-36.16 (5.74)

72.60

-35.33 (7.88)

74.09

-13.36 (7.68)

71.85

-38.20 (5.74)

67.80

-30.25 (7.35)

Inv GDA

65.27

-29.24 (5.84)

65.84

-38.88 (4.85)

67.00

-41.40 (5.53)

76.18

-33.36 (9.51)

74.25

-50.50 (4.73)

68.55

-49.75 (4.86)

HAQ-DI

1.47

-0.21 (0.121)

1.51

-0.76 (0.133)

1.91

-0.64 (0.100)

1.93

-0.12 (0.163)

1.75

-0.74 (0.172)

1.72

-0.74 (0.158)

CRP

5.57

+5.97 (2.53)

5.57

+0.14 (1.96)

4.29

+0.04 (1.69)

4.44

+1.56 (1.49)

5.20

-0.09 (0.99)

4.41

+0.89 (1.31)

High CRP subgroup (>9 mg/L)

N

53

60

71

61

50

49

TJC68

25.94

-8.98 (1.44)

26.73

-14.86 (1.68)

29.32

-18.22 (1.49)

25.87

-6.21 (1.62)

27.22

-15.29 (1.82)

27.28

-17.73 (1.79)

SJC66

16.51

-6.87 (1.03)

17.15

-9.67 (1.22)

17.43

-10.80 (1.03)

16.30

-3.89 (1.34)

18.31

-11.65 (1.48)

16.77

-10.87 (1.27)

Pt pain

66.11

-15.49 (3.53)

67.14

-26.19 (3.72)

66.42

-32.24 (3.29)

71.38

-13.70  (3.41)

72.42

-29.66 (4.02)

69.00

-30.86 (3.82)

Pt GDA

65.00

-15.98 (3.39)

67.83

-26.18 (3.84)

67.87

-33.94 (3.46)

70.59

-11.21 (3.19)

71.30

-26.78 (4.03)

69.33

-27.43 (3.57)

Inv GDA

67.25

-25.77 (3.65)

66.65

-31.33 (3.10)

65.54

-37.25 (2.62)

69.33

-21.87 (3.29)

71.14

-39.02 (3.15)

67.33

-38.38 (3.30)

HAQ-DI

1.83

-0.49 (0.080)

1.78

-0.61 (0.087)

1.73

-0.78 (0.076)

1.77

-0.25 (0.074)

1.82

-0.65 (0.081)

1.82

-0.74 (0.086)

CRP

22.89

+0.61 (3.22)

32.44

-19.28 (3.60)

31.91

-20.90 (3.88)

40.82

-10.56 (5.01)

33.70

-17.12 (6.19)

30.82

-21.27 (3.33)

 

References

1Westhovens R, et al. Ann Rheum Dis 2017;76:998-1008; 2Kavanaugh A, et al.Ann Rheum Dis 2017;76:1009-1019.

 



Disclosure: A. Kavanaugh, AbbVie, 5,Amgen, 5,Celgene, 5,Novartis Pharmaceutical Corporation, 5,Janssen Pharmaceutica Product, L.P., 5,Eli Lilly and Company, 5,Pfizer Inc, 5,UCB, 5,Galapagos NV, 5; A. Van der Aa, Galapagos NV, 1,Galapagos NV, 3; C. Jamoul, Galapagos NV, 3; C. Tasset, Galapagos NV, 1,Galapagos NV, 3; P. Harrison, Galapagos NV, 1,Galapagos NV, 3; R. Westhovens, Bristol-Myers Squibb, 2,Roche Pharmaceuticals, 2,CellTrion, 5,Galapagos NV, 5.

To cite this abstract in AMA style:

Kavanaugh A, Van der Aa A, Jamoul C, Tasset C, Harrison P, Westhovens R. No Effect of Baseline Serum CRP Levels on Clinical Efficacy Parameters in Rheumatoid Arthritis Patients Treated with Filgotinib: Post Hoc Analysis from Two Phase 2B Studies [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/no-effect-of-baseline-serum-crp-levels-on-clinical-efficacy-parameters-in-rheumatoid-arthritis-patients-treated-with-filgotinib-post-hoc-analysis-from-two-phase-2b-studies/. Accessed .
  • Tweet
  • Email
  • Print

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/no-effect-of-baseline-serum-crp-levels-on-clinical-efficacy-parameters-in-rheumatoid-arthritis-patients-treated-with-filgotinib-post-hoc-analysis-from-two-phase-2b-studies/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology