Two-Years Survival of Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis and Predictors Thereof in Real-Life Settings

Leonardo Santo¹, Angelo Semeraro², Carmelo Zuccaro³, Maria Grazia Anelli⁴, Romano Bucci⁵, Antonio Marsico⁶, Laura Quarta⁷, Giorgio Carlino⁸, Francesco Paolo Cantatore⁹, Annamaria Gaudio¹⁰, Fabio Cacciapaglia¹¹, Oriana Casilli¹², Paola Chiara Francesca Falappone¹³ and Florenzo Iannone¹⁴, ¹DSS4 Barletta, ASL BT Andria - Rheumatology Service, Barletta, Italy, ²Unità Operativa di Reumatologia ASL Taranto, Taranto, Italy, ³U.O.of Geriatrics, Outpatient clinic of Rheumatology, Brindisi, Italy, ⁴DIM, Rheumatology Unit, Bari, Italy, ⁵A.O.U., Rheumatology Hospital Unit, Foggia, Italy, ⁶Outpatient clinic of Rheumatology, Taranto,, Italy, ⁷Department of Rheumatology, "V.Fazzi" Hospital, San Cesario di Lecce, Italy, ⁸ASL LE - DSS Casarano and Gallipoli, Rheumatology Service, Gallipoli, Italy, ⁹Department of Rheumatology, University of Foggia,, Foggia, Italy, ¹⁰Department of Rheumatology, University of Foggia, Foggia, Italy, ¹¹Internal Medicine Unit and Outpatient clinic of Rheumatology, “N. Melli” Hospital, San Pietro Vernotico (BR), Italy, ¹²Department of Rheumatology, "Vito Fazzi" Hospital, San Cesario di Lecce, Italy, ¹³Internal Medicine Unit - Outpatient clinic of Rheumatology,, "S. Camillo de' Lellis" Hospital, Mesagne (BR), Italy, ¹⁴Interdisciplinary Department of Medicine (DIM), Rheumatology Unit, University of Bari, Bari, Italy

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Biologic agents, Psoriatic arthritis, rheumatoid arthritis (RA) and spondylarthritis

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:

It has previously been shown that the survival of anti-TNF drugs was lower in Rheumatoid arthritis (RA) than in other chronic arthritis¹. The objective of this study was to investigate the drug retention of Golimumab (GOL) and its effectiveness in patients affected with axial Spondyloarthritis (AxSpA), Psoriatic arthritis (PsA) and RA. Furthermore, the impact of possible baseline predictors was also evaluated.

Methods:

This is a multicenter prospective observational study of unselected patients with AxSpA, PsA and RA starting GOL because of their active disease despite prior treatment with conventional disease modifying drugs (DMARDs) or biological DMARDs (bDMARDs) in the settings of standard care from 11 rheumatologic centres of Apulia (Southern Italy). The primary endpoint was GOL drug retention at 2 years. A secondary endpoint was clinical outcomes based on DAS28 and BASDAI reduction. Time to discontinuation was defined as the time between drug initiation and last administration plus one dispensation interval. Kaplan-Meier curve analysis was used to assess drug retention, and a Cox proportional regression model, adjusting for potential confounders, including prior bDMARD exposure, patient demographics and disease characteristics, for the analysis of predictors.

Results: To date, 357 patients (PsA 154, AR 80, AxSpA 123) have been enrolled, 151 (42.3%) were “biologic-naïve”. Disease duration was 6.7 ±6 yrs for PsA, 8.1 ±7 for RA, and 7.0 ±6 for AxSpA, respectively. At 2 years (Fig.1), the crude survival rate was 74.8% (21.1 ± 0.5 months) for AxSpa, 67.5% (20.2 ± 0.8 months) for RA and 63.6% (18.8 ± 0.6 months) for PsA, being the difference not statistically significant. Analysis of predictors showed that female gender strongly correlated with GOL discontinuation (hazard ratio (HR) (95% CI): 3.82, (1.54-9.51)), while the lack of extra-articular manifestations was a negative predictor (HR (95% CI): 0.21, (0.49-0.91) for AxSpA patients. No predictors of drug survival for RA and PsA were found. Additionally, GOL was effective in all patients with a significant reduction of DAS28 and BASDAI at 12 and 24 months compared to baseline (Table 1).

Conclusion:

Unlike previous studies on TNF inhibitors, GOL seems to have similar drug survival in different chronic arthritides regardless of prior bDMARD treatment. Female AxSpA patients with extra-articular manifestations have higher hazard to discontinue the therapy .

REFERENCES:

1. Carmona L. et al. Arthritis Res Ther 2006; 8:3, R72

Disclosure: L. Santo, None; A. Semeraro, None; C. Zuccaro, None; M. G. Anelli, None; R. Bucci, None; A. Marsico, None; L. Quarta, None; G. Carlino, None; F. P. Cantatore, None; A. Gaudio, None; F. Cacciapaglia, None; O. Casilli, None; P. C. F. Falappone, None; F. Iannone, None.

To cite this abstract in AMA style:

Santo L, Semeraro A, Zuccaro C, Anelli MG, Bucci R, Marsico A, Quarta L, Carlino G, Cantatore FP, Gaudio A, Cacciapaglia F, Casilli O, Falappone PCF, Iannone F. Two-Years Survival of Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis and Predictors Thereof in Real-Life Settings [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/two-years-survival-of-golimumab-in-patients-with-rheumatoid-arthritis-psoriatic-arthritis-and-axial-spondyloarthritis-and-predictors-thereof-in-real-life-settings/. Accessed .

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