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Abstract Number: 2847

Predictors of Therapeutic Response in Ankylosing Spondylitis Patients Initiating Therapy with Adalimumab in a German Non-Interventional Study 

Michaela Koehm1,2, Frank Behrens1,3, Eva C. Scharbatke4, Marc Schmalzing5, Holger Gnann6, Gerd Greger7, Bianca Wittig8, Hans Peter Tony9 and Harald Burkhardt3,10, 1Clinical Research, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main, Germany, 2Rheumatology, Goethe-University Frankfurt, Frankfurt/Main, Germany, 3Rheumatology, Goethe-University Frankfurt, Frankfurt, Germany, 4Rheumatology/Immunology, University of Würzburg, Würzburg, Germany, 5Rheumatology/Immunology, University Würzburg, Würzburg, Germany, 6Abteilung Biostatistik, GKM Gesellschaft für Therapieforschung mbH, München, Germany, 7AbbVie Deutschland GmbH & Co.KG, Wiesbaden, Germany, 8Abbott GmbH & Co KG, Wiesbaden, Germany, 9Rheumatology / Clinical Immunology, University Hospital Würzburg, Würzburg, Germany, 10Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main, Germany

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: adalimumab and ankylosing spondylitis (AS)

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Session Information

Date: Tuesday, November 10, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy

Session Type: ACR Poster Session C

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

Background/Purpose:

Ankylosing spondylitis (AS) is associated with a significant burden of illness and has limited treatment options. The identification of predictors of response to anti-tumor necrosis factor (TNF) therapy may help clinicians select therapy and address patient expectations. 

Methods:

We analyzed data from a large German multicenter, prospective, observational study of patients with active AS who initiated adalimumab (ADA) therapy during routine clinical care. Multiple regression models were used to evaluate significant predictors of improvement at month 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI). For both indices, higher scores indicate greater disease activity/impairment. 

Results:

Patients in the full analysis set (N = 3756) had a mean age of 43.0 ± 12.2 years and a mean disease duration of 14.2 ± 10.9 years. During ADA therapy, mean BASDAI scores improved from 5.5 ± 1.9 at baseline to 3.1 ± 2.1 at month 12 and BASFI scores improved from 4.9 ± 2.4 at baseline to 3.2 ± 2.4 at month 12 in evaluable patients remaining on therapy. Although both HLAB27 status and baseline erythrocyte sedimentation rate (ESR) were positive predictors of therapeutic response for BASDAI and BASFI (Table), the strongest positive predictors were not shared between these two indices (dactylitis and baseline BASDAI for BASDAI, baseline BASFI and employment for BASFI). In contrast, most of the negative predictors of response were shared between the BASDAI and BASFI, including the two strongest predictors, mental disorder/depression and a greater number of previous biologics. 

Conclusion:

AS patients showed marked improvement in BASDAI and BASFI during 12 months of treatment with ADA in routine clinical practice. Positive predictors of response to ADA therapy differ between BASDAI and BASFI in AS patients, but negative predictors are generally shared. 


Disclosure: M. Koehm, Pfizer Inc, 2,MSD; Pfizer, 5,Janssen Pharmaceutica Product, L.P., 8; F. Behrens, AbbVie Deutschland GmbH & Co KG; Chugai; Pfizer; Roche, 5,Pfizer Inc, 8; E. C. Scharbatke, AbbVie Deutschland GmbH Co.KG; Baxter; Chugai; Roche, 5,Chugai, 8; M. Schmalzing, AbbVie Deutschland GmbH Co.KG; Actelion; Chugai; Pfizer; Roche; UCB, 5; H. Gnann, Abi Deutschland GmbH Ko.KG, 5; G. Greger, AbbVie Deutschland GmbH + Co.KG, 3; B. Wittig, AbbVie Deutschland GmbH + Co.KG, 3; H. P. Tony, None; H. Burkhardt, AbbVie Deutschland; Pfizer; BMS; UCB; Chugai, 5,Pfizer Inc, 2.

To cite this abstract in AMA style:

Koehm M, Behrens F, Scharbatke EC, Schmalzing M, Gnann H, Greger G, Wittig B, Tony HP, Burkhardt H. Predictors of Therapeutic Response in Ankylosing Spondylitis Patients Initiating Therapy with Adalimumab in a German Non-Interventional Study  [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/predictors-of-therapeutic-response-in-ankylosing-spondylitis-patients-initiating-therapy-with-adalimumab-in-a-german-non-interventional-study/. Accessed .
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