Background/Purpose: Treatment effectiveness in patients with axial spondylarthritis (axSpA) is evaluated by a combination of objective markers of disease activity and patient reported outcomes (PROs), e.g. pain, physical function, fatigue and global scores. Development in PROs over time in patients, who initiate treatment with their 1^st, 2^nd or 3^rd Tumour Necrosis Factor inhibitor (TNFi) in routine practice is limited. Hence, the aim of this study was to investigate PROs at baseline, 6 and 12 months in axSpA patients who initiate their 1^st, 2^nd or 3^rd TNFi in clinical practice: their distribution, changes from baseline and heterogeneity across registries.

Methods: Pooled data on axSpA patients from 14 European registries participating in the EuroSpA Research Collaboration were analysed (1). Patients were included if they had been followed in the registry from initiation of the 1^st TNFi. PROs included scores for pain, disease activity (global and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)), physical function (Bath Ankylosing Spondylitis Functional Index (BASFI)) and fatigue, all captured with Visual Analogue Scales 0-100 mm (VAS). The distribution of PROs at 6, 12 and 24 months after TNFi start and the changes from baseline to 6, 12 and 24 months were investigated with descriptive statistics. PRO remission rates were defined as the proportion of patients achieving a state of pain score ≤20 mm, global score 20 mm, BASDAI ≤20 mm, BASFI ≤20 mm and fatigue score ≤20 mm. Crude and LUNDEX-adjusted (2) PRO remission rates were assessed for the pooled cohort and the individual countries.

Results: Of the 25,988 axSpA patients, who initiated 1^st TNFi, 8,294 patients switched to a 2^nd TNFi, while 2,842 patients subsequently switched to a 3^rd TNFi. Baseline characteristics of the study cohort are shown in Table 1. The 6, 12 and 24 month PRO status and changes in PROs for 1^st, 2^nd and 3^rd TNFi in the pooled cohort are summarized in Table 2. For the 1^st, 2^nd and 3^rd TNFi, median PROs after 6 months ranged from 20mm to 30mm, 27mm to 40mm and 35mm to 50mm, respectively. Similarly, median decreases in PROs from baseline to 6 months ranged from 18 to 30mm, 8 to 18mm and 8 to 18mm for the 1^st, 2^nd and 3^rd TNFi. In the overall cohort 6 month LUNDEX-adjusted PRO remission rates varied from 33% to 41%, 23% to 33% and 17% to 24% for the 1^st, 2^nd and 3^rd TNFi, respectively (Table 2). In the individual registries, LUNDEX-adjusted 6 months PRO remission rates for the 1^st TNFi ranged from 32% to 51%, 24% to 50%, 28% to 48%, 32% to 51% and 21% to 47% for pain, global, BASDAI, BASFI and fatigue scores, respectively.

Conclusion: Overall, one-third of patients in a very large observational cohort achieved a state of PRO remission after 6 months of treatment with their first TNFi with considerable variation in PRO remission rates between registries.

As expected, improvements in PROs and PRO remission rates were lower in those who received a 2^nd or 3^rd TNFi, reflecting confounding by indication (i.e. selection of non-responders and more severe cases).

References:

(1) Brahe et al. Arthritis Rheumatol, 2018; 70(suppl 10)

(2) Kristensen et al. Arthritis Rheumatol, 2006, 54(2), p:600-6

Acknowledgements: Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration.

20190603_EuroSpA_study2.2_Table1

20190603_EuroSpA_study2.2_table2

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/patient-reported-outcomes-over-time-in-25988-axial-spondyloarthritis-patients-initiating-treatment-with-1st-2nd-or-3rd-tnf-inhibitor-in-clinical-practice-is-pro-remission-achieved-results/