Over the past years, introduction of biologics for treatment of psoriatic arthritis (PsA) has improved the treatment responses in all clinical domains. However, little is known regarding the characteristics of patients who discontinue/switch biologics in non-clinical trial setting.
Objectives
To characterize PsA patients who discontinue/switch the index biologic and evaluate the reasons for discontinuation in the Corrona PsA/Spondyloarthritis (SpA) registry, a large US national cohort of patients with PsA/SpA.
Methods
PsA patients enrolled in the registry between 3/2013 and 7/2015, with a biologic at baseline (registry enrollment) and at least 2 follow-up visits were included. Two cohorts were identified: patients who discontinued/switched the index biologic (group 1) and those who stayed on the index biologic by the 2nd follow-up visit approximately 15 months after the enrollment (group 2). Descriptive analyses on patient demographics, clinical outcomes (eg. clinical disease activity index (CDAI), dactylitis, enthesitis), patient reported outcomes (eg. pain, fatigue, work productivity and activity impairment (WPAI)) and treatment at time of enrollment were examined. Chi-square tests and t-tests were used for continuous and categorical variables respectively to evaluate differences.
Results
Of the 251 PsA patients meeting the inclusion criteria, 26% (n=65) discontinued/switched the index biologic and 74% (n=186) stayed on the index biologic by the 2nd follow-up visit. A significantly greater percent of females discontinued/switched the index biologic (56% vs 41%, p<0.05). However both cohorts were similar in age (mean: 55 yrs vs 53 yrs), and disease duration (12 vs 12 yrs.). Group 1 patients reported significantly higher scores for pain (mean: 42 vs 27) and fatigue (mean: 48 vs 33) compared to Group 2 (p<.0001). Almost one-third of patients in Group 1 reported greater overall work impairment (mean: 30% vs 15%, p<0.01) compared to Group 2. Patients in Group 1 were most likely to have higher disease activity (mean CDAI: 13 vs 9, p<0.0001) and enthesitis (26% vs 15%, p<0.05) vs. group 2. Overall a majority of patients had a history of prior biologic use (97%), with about 55% on current monotherapy. The major reason for discontinuing the index biologic was lack of efficacy (60%), followed by other reasons (16%) and side effects (12%).
Conclusions
About a quarter of patients discontinued their index biologic over an average of 15 months follow up period. Those patients were more likely to have higher disease activity (CDAI) and poorer patient reported outcomes (pain, fatigue, WPAI) at enrollment. The most common reason for switching was lack of efficacy.
Acknowledgement
The design, study conduct, and financial support for this analysis was provided by Novartis. Corrona LLC: In the last two years, AbbVie, Amgen, BMS, Crescendo, Genentech, Horizon Pharma USA, Janssen, Eli Lilly, Novartis, Pfizer, and UCB have supported Corrona LLC through contracted subscriptions.
Disclosure of Interest
P. Mease Grant/research support from: Celgene, Novartis, Abbvie, Amgen, BMS, Janssen, Lilly, Pfizer, UCB, Consultant for: Celgene, Corrona, Merck, Novartis, Abbvie, Amgen, BMS, Crescendo, Genentech, Janssen, Lilly, Merck, Pfizer, UCB;, Speakers bureau: Abbvie, Amgen, BMS, Crescendo, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, C. Karki Employee of: Corrona, LLC, M. Liu Employee of: Corrona, LLC, A. Kavanugh Grant/research support from: Amgen Abbvie Janssen Pfizer Novartis, C. Ritchlin Grant/research support from: Amgen, Janssen, and UCB, Consultant for: Abbvie, Amgen, Janssen, Regeneron, and UCB, D. Huynh Speakers bureau: AbbVie, BMS, R. Pandurengan Employee of: Corrona, LLC, V. Herrera Employee of: Novartis Pharmaceuticals Corporation, J. Palmer Employee of: Novartis Pharmaceuticals Corporation, J. Greenberg Shareholder of: Corrona, LLC, Consultant for: AstraZeneca, Celgene, Genentech, Janssen, Novartis and Pfizer, Employee of: Corrona, LLC
Only a few european studies have shown that most of the clinical features and assessments of axial spondyloarthritis (ax-SpA) are similar in patients with/without radiographic changes1. However, some differences might be observed which might be prognostic factors of more severe disease.
Objectives
To describe the demographic, clinical, patient reported outcomes (PROs) and treatment characteristics of ax-SpA population in the Corrona registry, a large national cohort of psoriatic arthritis (PsA)/SpA patients in the US.
Methods
The study included ax-SpA patients enrolled in the registry between 3/2013–7/2015. Ax-SpA population was further stratified into two cohorts: ankylosing spondylitis (AS) and non-radiographic Axial SpA (nr-axSpA) based on the NY modified criteria for AS (1984) and ASAS criteria for ax-SpA without sacroiliac radiographic changes respectively. Descriptive analyses on patient characteristics (demographics, clinical, patient reported outcomes and treatment) were evaluated at enrollment into the registry. Chi-square and t-tests were used for continuous and categorical variables respectively to evaluate the differences.
Results
Of the 407 patients identified with ax-SpA, 310 were diagnosed with AS and 97 with nr-axSpA. Patients with AS were slightly older (mean: 49yrs vs 44 yrs) and mostly males (65% vs 57%) compared to patients with nr-axSpA respectively. Both cohorts had similar functional disability measured by health assessment questionnaire, HAQ (mean: 0.6 vs 0.6), quality of life measured by EQ-5D (mean: 0.7 vs 0.7) and mean percentage of overall activity impairment measured by WPAI (26.8% vs 31.6%). About 7.6% of AS patients had fibromyalgia compared to 9.7% of nr-axSpA (p-value: 0.5). While clinical features (BASDAI, BASFI, ASDAS) did not differ between the AS and nr-axSpA patients, signs of inflammation measured by acute phase reactants were significantly higher in patients with AS compared to nr-axSpA (mean ESR: 14.4 vs 8.9 respectively, p<0.05) (figure 1), which are consistent with other national cohorts (1). In addition, patients with nr-axSpA were more likely to have enthesitis (47.4% vs. 29.0%) and dactylitis (12.4% vs. 9.0%) respectively. Although there were some differences in the history of biologic use (65% and 74% resp.), current biologic use (61.3% and 63.9%) and use of prednisone (5.5% and 6.2%) was similar in both groups.
Conclusions
This is the first characterization of axial SpA patients from the US Corrona registry with stratification into ankylosing spondylitis and non-radiographic axial SpA. Patients with nr-axSpA were younger and more likely to be female compared to patients with AS. Both groups had similar clinical characteristics, quality of life, disability and work impairment.
References
Rudwaleit et al.2009. Arthritis and Rheumatism, Vol. 60, No. 3, March 2009, pp 717–727
Acknowledgement
The design, study conduct, and financial support for this analysis was provided by Novartis. Corrona LLC: In the last two years, AbbVie, Amgen, BMS, Crescendo, Genentech, Horizon Pharma USA, Janssen, Eli Lilly, Novartis, Pfizer, and UCB have supported Corrona LLC through contracted subscriptions.
Disclosure of Interest
P. Mease Grant/research support from: Celgene, Novartis, Abbvie, Amgen, BMS, Janssen, Lilly, Pfizer, UCB;, Consultant for: Celgene, Corrona, Merck, Novartis, Abbvie, Amgen, BMS, Crescendo, Genentech, Janssen, Lilly, Merck, Pfizer, UCB;, Speakers bureau: Abbvie, Amgen, BMS, Crescendo, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, C. Karki Employee of: Corrona, LLC, J. Palmer Employee of: Novartis Pharmaceuticals Corporation, M. Liu Employee of: Corrona, LLC, R. Pandurengan Employee of: Corrona, LLC, V. Herrera Employee of: Novartis Pharmaceuticals Corporation, J. Greenberg Shareholder of: Corrona, LLC, Consultant for: AstraZeneca, Celgene, Genentech, Janssen, Novartis and Pfizer, Employee of: Corrona, LLC
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