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Abstract Number: 1730

Disease Progression Among Non-Achievers of Minimal Disease Activity in Psa Patients Treated with Infliximab or Golimumab

Dalton Sholter1, Proton Rahman2, Maqbool Sheriff3, Michel Zummer4, Suneil Kapur5, Philip Baer6, Michael Starr7, John Kelsall8, Emmanouil Rampakakis9, Eliofotisti Psaradellis10, Brendan Osborne11, Karina Maslova12, Cathy Tkaczyk11, Francois Nantel13 and Allen J Lehman12, 1University of Alberta, Edmonton, AB, Canada, 2Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, 3Nanaimo Regional General Hospital, Nanaimo, BC, Canada, 4Rheumatology, Ch Maisonneuve-Rosemont, Montreal, QC, Canada, 5University of Ottawa, 139 Greenbank Rd, Suite 203, ON, Canada, 6Independent Rheumatology Practice, Scarborough, ON, Canada, 7Rheumatology, Mcgill University, Pointe-Claire,, QC, Canada, 8Rheumatology, University of British Columbia, Vancouver, BC, Canada, 9JSS Medical Research, St-Laurent, QC, Canada, 10JSS Medical Research, Montreal, QC, Canada, 11Medical Affairs, Janssen Inc., Toronto, ON, Canada, 12Janssen Inc., Toronto, ON, Canada, 1319 Green belt Dr, Janssen Inc., Toronto, ON, Canada

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Biologics, Clinical Response, infliximab, psoriatic arthritis and registry

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Session Information

Date: Monday, November 14, 2016

Session Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster II: Psoriatic Arthritis

Session Type: ACR Poster Session B

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

Background/Purpose : Early achievement of minimal disease activity (MDA) is recommended as a valid treat-to-target approach in psoriatic arthritis (PsA). The purpose of the current analysis was to evaluate disease progression in PsA patients among non-achievers of MDA treated with anti-TNF agents under Canadian routine practice.  

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 (IFX) or Golimumab (GLM), or with ustekinumab (UST) for PsA. Eligible people for this analysis included PsA patients treated with IFX who were enrolled since 2005 or with GLM enrolled since 2010 or with UST enrolled since 2014 and with available MDA information at 6 and 12 months of treatment. MDA was defined as the fulfillment of ≥5 of the following criteria: TJC28≤1, SJC28≤1, PASI≤1 or BSA≤3, Pain (VAS)≤15mm, PtGA (VAS)≤20mm, HAQ ≤0.5, tender entheseal points ≤1. Pairwise comparisons in disease parameters were assessed with the non-parametric Wilcoxon test. Variables associated with improved DAS28 and MDA achievement were examined using general linear models and logistic regression, respectively, wherein variables showing a statistical trend (P<0.150) in univariate analysis were considered in multivariate analysis to identify predictors.

Results: A total of 106 patients (55.2% male and 88.7% bio-naïve) were included with a mean (SD) age and disease duration of 49.6 (11.4) and 5.6 (6.9) years, respectively. The proportion of patients who achieved MDA at 6 months was 49.1% (n=52) while 50.9% (n=54) did not achieve MDA. Among patients with MDA at 6 months, 75.0% had sustained MDA at 12 months and among the non-achievers, 14.8% achieved MDA at 12 months of treatment. Disease parameters over time among the non-MDA achievers at 6 months are described in Table 1; overall, no statistical changes were observed between 6 months and 12 months. Multivariate logistic regression analysis showed that lower baseline HAQ (OR=0.459, P=0.071) and MDA achievement at 6 months were associated with higher odds (OR=12.604; P<0.001) of MDA achievement at 12 months of treatment. Multivariate general linear models showed that MDA achievement at 6 months (B=-0.770, P=0.042) and being bio-naïve (B=-2.296, P=0.001) were significant predictors of DAS28 improvement at 12 months of treatment.

Conclusion: The results of the current analysis have shown that achievement of MDA at 6 months is critical for MDA achievement/maintenance at 12 months highlighting the importance of intensive treatment early on. Furthermore, these results highlight the importance of treatment optimization in cases where MDA is not achieved.     Table 1: Disease Parameters for MDA Non-Achievers at 6 Months of Treatment

Disease Parameter, mean (SD)

Visit

P-Value

12 mos vs 6 mos

 

Baseline

Month 6

Month 12

SJC28

5.57 (5.02)

1.83 (2.63)

2.52 (3.89)

0.243

TJC28

8.92 (6.91)

4.93 (6.11)

4.50 (5.35)

0.968

Pain, mm VAS

55.24 (23.55)

45.30 (19.87)

42.43 (26.71)

0.385

PtGA, mm VAS

59.00 (23.62)

44.61 (22.15)

41.74 (25.49)

0.533

HAQ-DI

1.29 (0.57)

1.15 (0.52)

1.19 (0.56)

0.135

PASI

3.02 (4.43)

1.24 (2.48)

1.27 (1.86)

0.242

Enthesitis Count

1.96 (3.55)

1.67 (3.55)

1.76 (3.11)

0.436

DAS28

4.71 (1.38)

3.62 (1.18)

3.58 (1.40)

0.780

   


Disclosure: D. Sholter, Janssen Pharmaceutica Product, L.P., 5; P. Rahman, Janssen Inc., 5; M. Sheriff, Janssen Pharmaceutica Product, L.P., 5; M. Zummer, Janssen Pharmaceutica Product, L.P., 5; S. Kapur, Janssen Pharmaceutica Product, L.P., 5; P. Baer, Janssen Inc., 5; M. Starr, Janssen Inc., 5; J. Kelsall, Janssen Inc., 5; E. Rampakakis, employee of JSS Medical Research, 3; E. Psaradellis, employee of JSS Medical Research, 3; B. Osborne, Employee of Janssen Inc., 3; K. Maslova, Employee of Janssen Inc., 3; C. Tkaczyk, Employee of Janssen Inc., 3; F. Nantel, Employee of Janssen Inc., 3; A. J. Lehman, Employee of Janssen Inc., 3.

To cite this abstract in AMA style:

Sholter D, Rahman P, Sheriff M, Zummer M, Kapur S, Baer P, Starr M, Kelsall J, Rampakakis E, Psaradellis E, Osborne B, Maslova K, Tkaczyk C, Nantel F, Lehman AJ. Disease Progression Among Non-Achievers of Minimal Disease Activity in Psa Patients Treated with Infliximab or Golimumab [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/disease-progression-among-non-achievers-of-minimal-disease-activity-in-psa-patients-treated-with-infliximab-or-golimumab/. Accessed February 25, 2021.
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