ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 713

Clinical and Imaging Efficacy of Etanercept in Early Non-Radiographic Axial Spondyloarthritis: 104-Week Treatment Results

Maxime Dougados1, Désirée van der Heijde2, Joachim Sieper3, Juergen Braun4, Gustavo Citera5, Filip van Den Bosch6,7, Ronald Pedersen8, Randi Bonin9, Heather Jones10, Lisa Marshall10, Sameer Kotak11, Isabelle Logeart12, Bonnie Vlahos13, Jack F Bukowski9 and Walter Maksymowych14, 1Rheumatology Department, Hôpital Cochin, Paris, France, 2Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 3Medical Department I, Rheumatology, Charité Universitätesmedizin Berlin, Berlin, Germany, 4Rheumazentrum Ruhrgebiet, Herne, Germany, 5Rheumatology, Consultorios Reumatológicos Pampa, Buenos Aires, Argentina, 6Department of Rheumatology, Ghent University Hospital, Ghent, Belgium, 7Rheumatology, Ghent University Hospital, Ghent, Belgium, 8Department of Biostatistics, Pfizer, Collegeville, PA, 9Clinical Affairs, Pfizer, Collegeville, PA, 10Inflammation Global Medical Affairs, Pfizer, Collegeville, PA, 11Global Health and Value, Pfizer, New York, NY, 12Medical Affairs, Pfizer, France, Paris, France, 13GIPB - Clinical Sciences, Pfizer, Collegeville, PA, 14Department of Medicine, University of Alberta, Edmonton, AB, Canada

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , , ,

Session Information

Date: Sunday, November 8, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster I: Clinical Aspects and Assessments

Session Type: ACR Poster Session A

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

Background/Purpose: In the multiphase, randomized, placebo (PBO)-controlled EMBARK study (ClinicalTrials.gov identifier: NCT01258738), clinical signs/symptoms and MRI-measured inflammation were evaluated in patients with early, active non-radiographic axial spondyloarthritis (nr-axSpA) after 12 wks of double-blind (DB) treatment with etanercept (ETN)1and 92 wks of open-label (OL) ETN.

Methods: Patients who satisfied Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, and who were unresponsive to ≥2 NSAIDs received DB ETN 50 mg/wk or PBO for 12 wks, followed by OL ETN 50 mg/wk (ETN/ETN or PBO/ETN) to wk 104. All patients continued background NSAIDs. Pre-specified analyses of conventional clinical assessments included ASAS, ASDAS (high sensitivity CRP [hs CRP]), BASDAI, and BASFI; the Spondyloarthritis Research Consortium of Canada (SPARCC) scoring method was used for MRI assessment of SI joint and spine inflammation. Post hoc analysis of sustained ASDAS remission (ASDAS <1.3 for ≥24 continuous wks over 104 wks; no missing data) was also conducted. Binary and continuous endpoints were analyzed in all patients with wk-12 efficacy data who continued into the OL period, received ≥1 ETN dose in OL period, and were included in the modified intent-to-treat (mITT) population in the DB period using non-responder imputation (NRI) and last observation carried forward (LOCF) approaches, respectively. A Cochran-Mantel-Haenszel chi-square test and ANCOVA were used for between-group comparisons of binary and continuous endpoints, respectively, at wk 12.

Results: Of 215 randomized patients (DB-phase mITT population), 205 entered and 169 completed the OL phase (ETN/ETN, n=100/n=83; PBO/ETN, n=105/n=86). At the end of the DB phase (wk 12), 33% and 15% of patients in the ETN and PBO groups achieved ASAS40 (P<0.01, between groups); at the end of the OL phase (wk 104), 49% and 51% of patients in the ETN/ETN and PBO/ETN groups achieved this endpoint (table). By wk 104, 51% (51/100) and 58% (61/105) of ETN/ETN- and PBO/ETN-treated patients achieved sustained ASDAS remission. Significantly greater mean reductions from wk 0 to wk 12 in SPARCC SI joint and spinal scores were seen in patients receiving ETN vs PBO (–3.8 vs –0.8, P<0.001; –2.1 vs –1.2, P<0.05); between wk 0 and wk 104, these scores decreased by –5.4 and –3.5 (SI joint) and –1.9 and –0.8(spinal) in patients receiving ETN/ETN and PBO/ETN. From wk 0 to wk 104, 8% and 7% of patients in the ETN/ETN and PBO/ETN groups had serious adverse events; no new safety signals were seen.

Table. Effects of ETN in patients with nr-axSpA in the EMBARK study*

Endpoint

DB phase (wk 12)

OL phase (wk 104)

ETN

PBO

ETN/ETN

PBO/ETN

% Patients Achieving Endpoints (n/N)

ASAS40

33.3† (35/105)

14.8 (16/108)

49.0 (49/100)

51.4 (54/105)

ASAS20

52.4‡ (55/105)

36.1 (39/108)

61.0 (61/100)

65.7 (69/105)

ASDAS inactive disease (<1.3)

40.0# (42/105)

17.4 (19/109)

48.0 (48/100)

59.1 (62/105)

BASDAI50

43.8† (46/105)

23.9 (26/109)

57.0 (57/100)

62.9 (66/105)

Mean (SD) at wk 0/

Mean (SE) D from wk 0 to wk 12

Mean (SE) D from wk 0 to wk 104

ASDAS-hsCRP

3.0 (0.9) /

–1.1# (0.1)

3.0 (1.0) /

–0.5 (0.1)

–1.6 (0.1)

–1.7 (0.1)

BASDAI

6.0 (1.8) /

–2.0‡ (0.3)

6.0 (1.9) /

–1.3 (0.3)

–3.4 (0.2)

–3.9 (0.2)

BASFI

4.2 (2.5) /

–1.4‡ (0.2)

3.9 (2.5) /

–0.8 (0.2)

–2.4 (0.2)

–2.4 (0.2)

SPARCC SI joint score

8.0 (9.7) /

–3.8# (0.7)

7.7 (10.1)/

–0.8 (0.6)

–5.4 (1.0)

–3.5 (0.8)

SPARCC spinal score

4.7 (7.1) /

–2.1‡ (0.5)

3.5 (5.6) /

–1.2 (0.5)

–1.9 (0.8)

–0.8 (0.4)

*In all patients with wk-12 efficacy data who continued into the OL period, received ≥1 ETN dose in OL period, and were included in the DB mITT population. Binary endpoints at wk 12, LOCF; at wk 104, NRI. Continuous endpoints at wks 12 and 104, LOCF.

†P<0.01; ‡P<0.05; #P<0.001, between-group comparisons.

Conclusion: Patients with early, active nr-axSpA and an inadequate response to NSAIDs demonstrated improvement in clinical and imaging outcomes that was sustained through 104 wks of etanercept treatment.

Reference: 1. Dougados M, et al. Arthritis Rheum. 2014:66:2091-102.

Disclosure: M. Dougados, Pfizer Inc, 5,UCB, 5,AbbVie, 5,Merck Pharmaceuticals, 5; D. van der Heijde, AbbVie, 5,Amgen, 5,Astellas, 5,AstraZeneca, 5,BMS, 5,Celgene, 5,Daiichi Pharmaceutical Corporation, 5,Eli Lilly and Company, 5,Galapagos, 5,Merck Pharmaceuticals, 5,Novartis Pharmaceutical Corporation, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,Sanofi-Aventis Pharmaceutical, 5,UCB, 5; J. Sieper, Abbott, Merck, Pfizer, UCB Pharma, Novartis, Eli Lilly, Janssen, 5,Abbott, Merck, Pfizer, UCB Pharma, Novartis, Eli Lilly, Janssen, 8; J. Braun, Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 2,Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 5; G. Citera, Bristol-Myers Squibb, 1,Pfizer Inc, 1,AbbVie, 1; F. van Den Bosch, None; R. Pedersen, Pfizer Inc, 1,Pfizer Inc, 3; R. Bonin, Pfizer Inc, 1,Pfizer Inc, 3; H. Jones, Pfizer, Inc, 3,Pfizer, Inc, 1; L. Marshall, Pfizer Inc, 1,Pfizer Inc, 3; S. Kotak, Pfizer Inc, 1,Pfizer Inc, 3; I. Logeart, Pfizer Inc, 3; B. Vlahos, Pfizer Inc, 1,Pfizer Inc, 3; J. F. Bukowski, Pfizer Inc, 3; W. Maksymowych, Abbvie, Amgen, Boehringer Ingelheim, Eli Llilly and Company, Janssen Pharmaceutica Product, L.P., Pfizer, UCB, 5,Abbvie, 2.

To cite this abstract in AMA style:

Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, van Den Bosch F, Pedersen R, Bonin R, Jones H, Marshall L, Kotak S, Logeart I, Vlahos B, Bukowski JF, Maksymowych W. Clinical and Imaging Efficacy of Etanercept in Early Non-Radiographic Axial Spondyloarthritis: 104-Week Treatment Results [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/clinical-and-imaging-efficacy-of-etanercept-in-early-non-radiographic-axial-spondyloarthritis-104-week-treatment-results/. Accessed .

« Back to 2015 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/clinical-and-imaging-efficacy-of-etanercept-in-early-non-radiographic-axial-spondyloarthritis-104-week-treatment-results/