Effectiveness and Safety of Golimumab in the Treatment of Ankylosing Spondylitis over a 12 Month Period

Denis Choquette¹, Proton Rahman², Maqbool Sheriff³, Wojciech Olszynski⁴, Emmanouil Rampakakis⁵, Eliofotisti Psaradellis⁶, Francois Nantel⁷, Brendan Osborne⁸, Allen J Lehman⁹, Karina Maslova⁹ and Cathy Tkaczyk⁸, ¹Rheumatology Department, Institut de Rhumatologie de Montréal and University of Montreal, Montreal, QC, Canada, ²Medicine, Memorial University, St John's, NF, Canada, ³Nanaimo Regional General Hospital, Nanaimo, BC, Canada, ⁴University of Saskatchewan, Saskatoon, SK, Canada, ⁵JSS Medical Research, St-Laurent, QC, Canada, ⁶JSS Medical Research, Montreal, QC, Canada, ⁷19 Green belt Dr, Janssen Inc., Toronto, ON, Canada, ⁸Medical Affairs, Janssen Inc., Toronto, ON, Canada, ⁹Janssen Inc., Toronto, ON, Canada

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Ankylosing spondylitis (AS), anti-TNF therapy, registry and treatment

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: Although the efficacy and tolerability of golimumab (GLM) in patients with ankylosing spondylitis (AS) has been demonstrated in several controlled clinical trials, it is essential to assess the real-life effectiveness of therapeutic interventions in order to demonstrate true population-based benefits. The aim of this analysis was to describe the real-life effectiveness of GLM in AS patients in a Canadian routine clinical practice setting.

Methods: Biologic Treatment Registry Across Canada (BioTRAC) is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or PsA with infliximab or GLM. Eligible people for this analysis included AS patients treated with GLM enrolled since 2010. Descriptive statistics were produced for clinical outcome measures and patient reported outcomes over 12 months of treatment. Within-group changes were assessed for statistical significance with the paired-samples Student’s t-test. Safety was assessed with the incidence of adverse events (AEs)/100 patient-years.

Results: A total of 206 AS patients were included in this analysis with a mean (SD) age of 45.6 (13.9) years and disease duration since diagnosis of 5.7 (10.2) years, the majority were male (61.2%) and 93.2% were biologic naïve. After six months of treatment, statistically significant (P<0.001) and clinically meaningful improvements were observed for all disease parameters and were sustained over 12 months of treatment (P<0.001). Mean (SD) disease parameters at baseline and 12 months of treatment are shown in Table 1. Clinically important improvement in ASDAS (change ≥1.1) by 6 and 12 months was 46.6% and 40.0%, respectively; major improvement (change ≥2.0) was achieved by 13.8% and 25.0% respectively. The proportion of patients who achieved ASDAS inactive disease (ASDAS <1.3) increased from 2.6% at baseline to 21.2% at 12 months; while very high disease activity (ASDAS >3.5) decreased from 44.4% to 21.2%, respectively. A total of 282 AEs (215.8 events/100 patient-years) were reported by 105 (51.0%) patients and 23 serious AEs (SAEs) (17.6 events/100 patient-years) by 20 (9.7%) patients. The incidence of serious infections and malignancies were 2 (1.5 events/100 patient-years) and 1 (0.8 events/100 patient-years), respectively. There were no deaths reported during the course of the study.

Table 1: Disease Parameters Over 12 Months of GLM Treatment

Parameter Mean (SD) / %	Baseline (n=206)	Month 12 (n=77)	P-Value
AM stiffness: minutes	55.17 (45.29)	24.19 (30.76)	<0.001
HAQ-DI	1.02 (0.60)	0.68 (0.62)	<0.001
Patient Global (PtGA): VAS mm	55.08 (25.96)	32.41 (28.36)	<0.001
Physician Global (MDGA): NRS 0-10	5.32 (2.20)	2.42 (2.40)	<0.001
BASFI	5.10 (2.49)	3.33 (2.80)	<0.001
BASDAI	5.86 (2.13)	3.64 (2.58)	<0.001
ASDAS	3.33 (0.96)	2.46 (1.20)	<0.001
ASDAS Disease Activity (DA) Inactive Disease Moderate DA High DA Very High DA	2.6% 9.3% 43.7% 44.4%	21.2% 23.1% 34.6% 21.2%	<0.001
ASDAS Clinically Important Improvement (Δ≥1.1)	N/A	46.6%	N/A
ASDAS Major Improvement (Δ≥2.0)	N/A	40.0%	N/A

Conclusion: The results of this Canadian longitudinal observational study have shown that GLM is well tolerated and effective in reducing symptom severity and improving disease outcomes in AS patients over a 12 month period.

Disclosure: D. Choquette, Janssen Inc., 5,AbbVie, 5,Amgen, 5,Celgene, 5,BMS, 5,Pfizer Inc, 5; P. Rahman, None; M. Sheriff, Janssen Inc, 5; W. Olszynski, Janssen Inc., 5; E. Rampakakis, JSS, 3; E. Psaradellis, JSS Medical Research, 3; F. Nantel, Janssen Inc., 3; B. Osborne, Janssen Inc., 3; A. J. Lehman, Janssen Inc., 3; K. Maslova, Janssen Inc., 3; C. Tkaczyk, Janssen Inc., 3.

To cite this abstract in AMA style:

Choquette D, Rahman P, Sheriff M, Olszynski W, Rampakakis E, Psaradellis E, Nantel F, Osborne B, Lehman AJ, Maslova K, Tkaczyk C. Effectiveness and Safety of Golimumab in the Treatment of Ankylosing Spondylitis over a 12 Month Period [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/effectiveness-and-safety-of-golimumab-in-the-treatment-of-ankylosing-spondylitis-over-a-12-month-period/. Accessed .

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