SAT0564 EFFICACY OF ETANERCEPT OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RA, AXSPA, PSA OR PSO: FINAL RESULTS OF A GERMAN NON-INTERVENTIONAL, PROSPECTIVE, MULTI-CENTER STUDY (ADEQUATE)
Authors: Eugen Feist, Xenofon Baraliakos, Frank Behrens, Diamant Thaçi, Thilo Klopsch, Anja Plenske, Lisa Kristina Blindzellner, Thomas Meng, Peter Andreas Löschmann
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> For patients with chronic autoimmune diseases such as rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) or plaque psoriasis (Pso), the treat-to-target concept requires attaining remission or at least low disease activity and is defined by the corresponding guidelines. The achievement of these targets affects radiological progression and functional measures. If treat-to-target has not been achieved after 3 months, current treatment could either be continued with an expected increased response over time or could be switched to another treatment option. <h3>Objectives</h3> The primary goal of this non-interventional study was to determine the proportion of patients achieving the treat-to-target criteria with Etanercept at month 3, 6 and 12 in a real-life setting. Secondly, the proportion of patients achieving the treat-to-target criteria at month 6, even if it has not yet been fully attained until month 3, was determined. <h3>Methods</h3> Into this German non-interventional, prospective, multi-center cohort study, adult patients with confirmed diagnosis of RA, axSpA, PsA or Pso without prior Etanercept treatment were included. Planned recruitment number was 2,100 patients: 1,200 RA patients, and 300 patients each with axSpA, PsA or Pso. Criteria for remission and minimal clinical efficacy were defined according to recommendations of the respective treatment guidelines and the study protocol. The analyses were based on the number of patients completing the respective study period (3, 6 and 12 months). <h3>Results</h3> Overall, 1,465 patients were included (treated set), i.e. 901 females (61.5%) and 564 males (38.5%); patients' mean ± SD age was 54.9 ± 14.5 years. Patients' median disease duration ranged across the rheumatic indications from 3.4 years in PsA to 5.5 years in RA, and was markedly longer in Pso (median: 15.3 years). At week 12, the proportion of patients reached remission was 24.4% in RA, 19.0% in axSpA, 38.3% in PsA and 7.1% in Pso. Further increases were seen up to week 24 in RA (30.6%), PsA (50.7%) and Pso (18.6%), while axSpA rates remained similar (18.4%). In all indications, these proportions continued to increase from week 24 up to week 52 (RA: 37.3%, axSpA: 23.4%, PsA: 54.0%, Pso: 31.8%). Considering low disease activity as target, the proportion of patients achieving that goal at week 12, were 39.4% patients for RA, 38.6% for axSpA, 50.0% for PsA and 34.3% for Pso, while further increases were noted up to week 24 in all indications (RA: 45.2%, axSpA: 45.4%, PsA: 60.3%, Pso: 50.8%). During the observational period, a total of 702 patients (47.9%) experienced at least one treatment emergent Adverse Event (TEAE). However, serious drug-related AEs were only reported in 41 patients (2.8%). <h3>Conclusion</h3> A considerable proportion of patients attained the target of remission or low disease activity at week 12 under daily routine practice conditions, proving a reliable positive therapeutic effect of Etanercept in a real life setting. These percentages further increased up to week 24 except for axSpA patients. With regard to the safety profile of Etanercept, the incidence numbers and types of AEs were in an expected range and in-line with documented safety profile according to the SmPC. <h3>Acknowledgement</h3> The study was funded by Pfizer Pharma GmbH. <h3>Disclosure of Interests</h3> Eugen Feist Grant/research support from: Pfizer, Roche, Novartis, BMS, Sanofi, Lilly, Consultant for: Pfizer, Roche, Novartis, BMS, Abbvie, Celgene, Sanofi, MSD, Lilly, Speakers bureau: Pfizer, Roche, Novartis, BMS, Abbvie, Celgene, Sanofi, Lilly, Xenofon Baraliakos Grant/research support from: AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Chugai, Janssen, MSD, Novartis, Pfizer Inc, Roche and UCB, Grant/research support from: AbbVie, Pfizer, Merck Sharp &amp; Dohme, UCB Pharma, Novartis, Consultant for: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen Biologics, Novartis, Pfizer, UCB Pharma, Galapagos, Speakers bureau: AbbVie, Chugai, Janssen, Novartis, Pfizer, UCB Pharma, Frank Behrens Grant/research support from: Pfizer, Janssen, Novartis, Roche, Consultant for: Abbvie, Pfizer, Roche, Chugai, UCB, BMS, Celgene, MSD, Novartis, Biotest, Janssen, Genzyme, Lilly, Sanofi, Sandoz, Boehringer, Speakers bureau: Abbvie, Pfizer, Roche, Chugai, UCB, BMS, MSD, Celgene, Novartis, Biotest, Janssen, Genzyme, Lilly, sanofi, Sandoz, Boehringer, Diamant Thaçi Grant/research support from: AbbVie, Almirall, Amgen, Bio Skin, Biogen-Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Chugai, Dermira, Dignity, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen Cilag, Leo Pharma, Novartis, Pfizer, Regeneron, Roche, Sandoz-Hexal, Sanofi, and UCB, Consultant for: AbbVie, Almirall, Bristol-Myers Squibb, Celgene, Dignity, Galapagos, Leo Pharma, Lilly, Novartis, Pfizer, and UCB; honoraria: AbbVie, Almirall, Amgen, Bio Skin, Celgene, Dignity, Janssen, Leo Pharma, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche-Posay, Sandoz-Hexal, Sanofi, and USB; advisory board: AbbVie, Bio Skin, Bristol-Myers Squibb, Celgene, Dignity, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen Cilag, Leo Pharma, Morphosis, Novartis, Pfizer, Sandoz, Sanofi, and UCB, Thilo Klopsch Shareholder of: Abbie, Amgen, Astrazeneca, Clinuvel Pharmaceutical, Fresenius, Morphosys, Evotec, Johnson &amp; Johnson, Anja Plenske Employee of: Pfizer Pharma GmbH, Lisa Kristina Blindzellner Employee of: Pfizer Pharma GmbH, Thomas Meng Shareholder of: Pfizer Pharma GmbH, Employee of: Pfizer Pharma GmbH, Peter Andreas Löschmann Shareholder of: Pfizer Pharma GmbH, Employee of: Pfizer Pharma GmbH, Speakers bureau: Pfizer Pharma GmbH