ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2498

Rheumatologists Use Different Cut-Offs for Disease Activity in Real Life – the Experience with Golimumab in Ankylosing Spondylitis- Subanalysis from a Non-Interventional German Study

Jürgen Braun1, Xenofon Baraliakos2, Uta Kiltz1, Klaus Krüger3, Gerd R. Burmester4, Siegfried Wassenberg5 and Matthias H. Thomas6, 1Rheumazentrum Ruhrgebiet, Herne, Germany, 2Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, 3Praxiszentrum St. Bonifatius München, München, Germany, 4Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany, 5Rheumazentrum Ratingen, Ratingen, Germany, 6Medical Affairs, MSD Sharp & Dohme GmbH, Bünde, Germany

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords:

Session Information

Date: Tuesday, November 7, 2017

Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster III: Outcomes, Outcome Measures, and Comorbidities

Session Type: ACR Poster Session C

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

Background/Purpose:

International recommendations for the management of axial spondyloarthritis including ankylosing spondylitis (AS) suggest a BASDAI level of disease activity of ≥4 to indicate treatment with biologics. Other cut-offs have rarely been studied so far.
Therefore, we were interested to learn about the level of disease activity used in daily routine to start anti-TNF therapy.

Methods:

In a posthoc subanalysis of the non-interventional, prospective, study GO-NICE that has been performed in a real life setting in Germany we used data from biologic naïve patients with established AS to study the initial BASDAI values before the start of therapy with Golimumab 50mg SC once monthly. Established standardized outcome measures were used.

Results:

Out of a total of 543 AS-patients (pts.) documented in 126 German centers, 244 biologic-naïve pts. were eligible. A total of 134 pts. (54.9%) completed the 24 month observational period. The majority of pts. (70.5%), had a BASDAI ≥4 (group (gr.).1), while 14.3% had a BASDAI of ≥2.8 – <4 (gr.2) and 15.1% even had a BASDAI <2.8 (gr.3, Table). The patient demographics did not differ much between these 3 groups, the proportion of males was numerically somewhat lower in gr.1. The proportion of pts. with an elevated CRP was highest in gr.2 at BL. The BASDAI in gr.1,2 and 3 was initially 5.9±1.3, 3.4±0.4 and 2.0±0.8, dropped significantly to 2.2*±2.0, 1.9*±1.2 and 1.0±1.2 within 3 months (*p<0.0001 vs. BL), and decreased significantly (p<0.005) to 2.2±1.7, 1.9±1.7 and 1.4±1.0 at month 24, respectively (fig.).The BASDAI 50% improvement was 68.8%, 44.8%, and 45.2% at month 3, and increased to 84.9%, 61.9%, and 55.0% at month 24, respectively.

Demographics and baseline characteristics

BASDAI
≥4; n=172

BASDAI
2.8 – <4; n=35

BASDAI
<2.8; n=37

total AS patients;
n = 244

Mean age [years] ± SD
(range)

41.9±12.5
(18-72)

44.7±11.6
(20-69)

39.1±12.5
(23-69)

41.9±12.4
(18-72)

Proportion males n (%)

117 (68.0%)

29 (82.9%)

27 (73.0%)

173 (70.9%)

Mean time since first diagnosis [years] ± SD (range)

8.8±9.5
(0-49.2)

10.1±10.2
(0.1-37.9)

8.7±9.0
(0.2-36.5)

9.0±9.5
(0.0-49.2)

Mean C-reactive protein (CRP) [mg/l] ± SD (range)

18.4±52.8 (0.3-660.0)

27.7±74.1 (0.3-426.0)

18.3±17.8 (1.0-60.6)

19.7±52.7 (0.3-660.0)

Outside normal range?
yes, no,
missing, n (%)

75 (45.2%)

91 (54.8%)

6

21 (65.6%)

11 (34.4%)

3

18 (51.4%)

17 (48.6%)

2

114 (48.9%)

119 (51.1%)

11

Conclusion: The most interesting observation of this real life study and posthoc analysis is certainly that almost a third of the pts. were included in the study who did not reach the recommended BASDAI cut-off of ≥4. Furthermore the data show that the patients with a BASDAI 2.8 < 4 seem to have significant benefit of antiTNF treatment, while this was not really the case with in pts. with a BASDAI <2.8. This finding should lead to a reevaluation of the established BASDAI cut-off of ≥ 4. Future studies should also evaluate the performance of an ASDAS cut-off. It seems likely that especially pts. with elevated CRP levels and a BASDAI < 4 will benefit from this new strategy. We think that in light of the rather weak correlation of pain and ‘objective’ parameters of inflammation such as CRP and MRI the here reported observation does make some sense.
Regarding the treatment with Golimumab no new safety signals were detected.

Disclosure: J. Braun, AbbVie (Abbott), Amgen, Biogen, Boehringer Ingelheim, BMS, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Epirus, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, 5; X. Baraliakos, AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Pfizer, Roche, MSD and UCB, 5; U. Kiltz, AbbVie, Chugai, Janssen, MSD, Novartis, Pfizer, Roche and UCB, 5; K. Krüger, AbbVie, BMS, Celgene, Janssen Biologics, MSD, Pfizer, Roche and Sanofi-Aventis, 5; G. R. Burmester, AbbVie, BMS, MSD, Pfizer, Roche, and UCB, 5; S. Wassenberg, AbbVie, Chugai, Janssen Biologics, MSD, Novartis, Pfizer, Roche, and UCB, 5; M. H. Thomas, MSD Sharp Dohme GmbH Germany, 3.

To cite this abstract in AMA style:

Braun J, Baraliakos X, Kiltz U, Krüger K, Burmester GR, Wassenberg S, Thomas MH. Rheumatologists Use Different Cut-Offs for Disease Activity in Real Life – the Experience with Golimumab in Ankylosing Spondylitis- Subanalysis from a Non-Interventional German Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/rheumatologists-use-different-cut-offs-for-disease-activity-in-real-life-the-experience-with-golimumab-in-ankylosing-spondylitis-subanalysis-from-a-non-interventional-german-study/. Accessed .

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/rheumatologists-use-different-cut-offs-for-disease-activity-in-real-life-the-experience-with-golimumab-in-ankylosing-spondylitis-subanalysis-from-a-non-interventional-german-study/