Abstract
Background/Aims
SERENA is an ongoing, non-interventional study involving ∼400 European sites with an observation period of ≤ 5 years to evaluate retention, effectiveness, safety/tolerability and quality of life with secukinumab (SEC) in patients with moderate-to-severe plaque psoriasis, active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS) in the real world. We present effectiveness and safety data through 1 year in the 577 PsA and 507 AS patients enrolled, of which 533 PsA and 461 AS patients comprised the target study population (fulfilling all eligibility criteria).
Methods
Patients (aged ≥18 years) with active PsA or AS who were treated for at least 16 weeks with SEC were enrolled. Effectiveness assessments included 78 tender joint count/76 swollen joint count, PGA, total pain (VAS, 0-100 mm), presence of enthesitis/dactylitis and PASI75/90/100 in patients with PsA, and BASDAI, PtGA, C-reactive protein, ASDAS and total spinal pain in patients with AS.
Results
Mean disease duration from diagnosis to enrolment was 8.6 and 9.8 years for PsA and AS patients. Patients received SEC for a mean duration of 1 year prior to enrolment (range: 0.90-1.00). In total, 64.7% (N = 533) of PsA and 60.7% (N = 461) of AS patients received other biologic drugs prior to SEC treatment, with 59.7% and 52.7% of PsA and AS patients receiving at least two different biologic drugs. Most patients pre-treated with biologics discontinued biologic treatment due to lack of efficacy (88.0% PsA; 86.8% AS). Retention rates for SEC after 1 year were 85.9% and 86.5% in PsA and AS patients. Responses across all effectiveness assessments in both cohorts were maintained or improved after 1 year of observation (Table 1). No new or unexpected safety signals were reported. P186 Table 1:Effectiveness outcomes in patients with PsA or AS at enrolment and Year 1Characteristic, mean±SD (M), unless otherwise specifiedPsA (N = 533)PsA (N = 533)AS (N = 461)AS (N = 461)EnrolmentYear 1EnrolmentYear 1Total pain (VAS 0-100 mm)31.80±24.28a (432)30.77±24.57a (322)34.68±24.23b (350)34.16±24.49b (228)Presence of tender or swollen joint, n/M (%)280/520 (53.8%)158/373 (42.4%)--Tender joint count, mean [min-max] (m)6.5 [0-68] (203)6.8 [0-78] (140)--Swollen joint count, mean [min-max] (m)3.3 [0-38] (203)2.8 [0-23] (140)--Presence of dactylitis, n/M (%)33/516 (6.4%)13/370 (3.5%)--Enthesitis index0.4±1.0c (276)c0.3±0.9c (243)c0.7±1.70d (246)0.6±1.7d (170)HAQ-DI0.83±0.70 (398)0.83±0.72 (268)--BASDAI--3.20±2.28 (436)3.24±2.36 (270)ASDAS-CRP--2.25±0.94 (229)2.27±0.97 (173)hsCRP, mg/L--8.53±13.42 (285)8.10±14.72 (218)PtGA (NRS) (VAS 0-10 cm)--4.18±2.32 (366)4.07±2.37 (246)aTotal pain;bTotal back pain;cLeeds enthesitis index;dMaastricht Ankylosing Spondylitis Enthesitis Score. AS, ankylosing spondylitis; ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score-C-reactive protein; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; HAQ-DI, Health Assessment Questionnaire Disability Index; hsCRP, high sensitivity C-reactive protein; m, number of patients with detailed assessments of tender or swollen joints; M, number of patients with evaluation; n, number of patients with a positive response; N, number of patients in the study population; NRS, numeric rating scale; PsA, psoriatic arthritis; PtGA, Patient’s Global Assessment; SD, standard deviation; VAS, visual analogue scale.
Conclusion
Patients in SERENA had long-standing disease with more than half previously treated with biologics, most of whom had discontinued treatment due to lack of efficacy. SEC showed sustained effectiveness, a high retention rate and favourable safety profile in PsA and AS patients in the real world over 1 year of observation. Incomplete data due to lack of rigorous monitoring (an intrinsic weakness of observational studies) must be considered when interpreting real-world findings.
Disclosure
K. Gaffney: Grants/research support; Research grants, consultancy fees and/or speaker fees from AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB. N. Gullick: Grants/research support; Research support, consultancy fees and/or speakers fees from AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB. U. Kiltz: Grants/research support; Research grants, support and/or consultancy fees from AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche and UCB. P. Sfikakis: Grants/research support; Research grants, support and consultancy fees from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis and Pfizer. A. Theodoridou: Honoraria; Consultancy fees from UCB, Amgen, Novartis. J. Brandt-Jürgens: Honoraria; Consultancy fees and speaker honoraria from AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen and Medac. E. Lespessailles: Honoraria; Received speaker and consultant fees from Amgen, Expanscience, Lilly and MSD, and research grants from AbbVie, Amgen, Lilly, MSD and UCB. C. Perella: Other; Novartis employee. E. Pournara: Shareholder/stock ownership; Novartis shareholder. Other; Novartis employee. B. Schulz: Other; Novartis employee. J. Veit: Other; Novartis employee.
163 A multi-centre retrospective study to describe the real world effectiveness of golimumab for treating ankylosing spondylitis (AS) in UK clinical practice