Background Secukinumab has been shown to significantly improve symptoms of psoriatic arthritis (PsA)1 and ankylosing spondylitis (AS)2 in numerous phase III studies. Still, as randomized, controlled, clinical trials often limit their patients to a very strict and selected group, further data on real world evidence is necessary to assess efficacy in a broader patient group.
Objectives To evaluate baseline characteristics regarding demographics, disease activity and comorbidities in patients with active PsA or AS in daily practice treated with secukinumab in Germany.
Methods AQUILA, a non-interventional, multi-center, 52-week study enrolling 2000 patients with active PsA or AS. Patients are documented as treated in clinical practice. Here, we will report the baseline characteristics of a subgroup of 347 patients who have been enrolled in the study. At baseline patient's health status, selected comorbidities and disease history was assessed using routine parameters (among others: CRP, joint count, BASDAI). Furthermore, overall disease activity and quality of life has been documented using ASAS-HI (AS) and PsAID-12 item (PsA).
Results 108 AS- and 239 PsA-patients were included, majority of AS patients were male, in PsA the majority was female. Previous bDMARD exposure was high in both groups, percentage of NSAID and cDMARD exposure varied (Tab). For PsA patients elevated CRP (Tab) and a high number of tender (8.4) and swollen joints (4.4) was reported. Assessed comorbidities included coronary heart disease (9.7%), stroke (2.5%), heart failure (2.9%) and depression (13.4%). Effect of PsA on patient's life at baseline was reported via PsAID-12 item with a mean score of 5.0 (±2.2). AS patients enrolled in this trial had a high disease activity with a mean BASDAI of 5.5 (±2.0) and elevated CRP (Table). Considered comorbidities were coronary heart disease (4.6%), stroke (0%), heart failure (0.9%) and depression (12%). Patient's impairments due to AS were assessed at baseline with the ASAS-HI, reporting a mean score of 8.1 (±3.6).
Conclusions The baseline characteristics of the population are comparable with other studies in the phase III program of secukinumab1,2. Major difference is represented by the high number of biological-experienced patients and comorbidities. Potential differences between these real world results and previously obtained phase III results will have to be discussed to assess their impact on patients.
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Disclosure of Interest U. Kiltz Grant/research support from: AbbVie, Chugai, MSD, Novartis, Pfizer, Roche, UCB, Consultant for: AbbVie, Chugai, MSD, Novartis, Pfizer, Roche, UCB, C. Legeler: None declared, M. Maier-Peuschel Employee of: Novartis, J. Veit Employee of: Novartis, C. Mann Employee of: Novartis, H.-P. Tony Grant/research support from: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, Consultant for: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi