AB0786 HIGH TREATMENT SATISFACTION OF THERAPY WITH USTEKINUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS DUE TO EARLY AND LONG-TERM TREATMENT RESPONSE AND HIGH TOLERABILITY – RESULTS OF THE NON-INTERVENTIONAL STUDY SUSTAIN. (June 2019)

• Record Type: Journal Article
• Authors: Wendler, Joerg; Wagener, Peter; Hamann, Frank; Damann, Nils; Movshovich, Evgenia; Behrens, Frank
• Is Part Of: Annals of the rheumatic diseases. Volume 78(2019)Supplement 2
• Page Start: 1862
• Page End: 1863
• Publication Date: 2019-06
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2019-eular.4655
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: SUSTAIN is a prospective, multi-center non-interventional study in Germany. Objectives: The objectives are to observe long term efficacy and safety, quality of life and further patient reported outcomes in patients with active psoriatic arthritis (PsA) under treatment with ustekinumab in routine clinical care. Methods: In this study nearly 400 patients were planned to be included at 75 centers for 160 weeks with documentation intervals at week 0 and 4 and then every 12 weeks. The treatment with ustekinumab is according to the label. Besides demographic data, the following data will be documented: Number of swollen and tender joints, tender entheses, amount of skin psoriasis (BSA and PASI), patient reported outcome concerning disease activity of PsA and pain, Health assessment Questionnaire (HAQ), quality of life (SF-12), sleep quality (VAS), satisfaction with therapy of patient and physician, safety (adverse events/serious adverse events), pharmacoeconomic aspects, number of patients with "Minimal Disease activity" (MDA), number of patients with MDA at week 28 und 52. For the present interim analysis baseline data of 336 patients and results of the documented visits up to week 112 were analyzed. Results: For the present analysis 336 patients (57% women) at 75 centers were observed. The number of documented patients was 310 at week 4, 318 at week 16, 278 at week 28, 160 at week 76 and 108 at week 112. At time of inclusion into the study, patients had arthritis at small (73.2%) and/or large (52.4%) joints, spinal involvement (17%) and enthesitis (13.1%). For 30.1% of patients, the medical history revealed structural bone damage and 2.1% had uveitis present at time of inclusion. Mean age was 54 years (22-85), mean BMI 30 kg/m² (19-52). The mean ustekinumab dose was 0.7 mg/kg body weight (0.2-1.3). 54.5% of the patients had as prior medication at least one TNF inhibitor and 44% used MTX as concomitant medication. The data extension of the present interim analysis demonstrated relevant improvements with high treatment satisfaction and good safety and tolerability after 4 weeks and up to 112 weeks. The data show the maintenance of these treatment results up to week 112, i.e. reduction in the number of tender joints from a mean of 10.0 (CI 95% 8.6/11.3) at baseline to 1.8 (1.1/2.5) at week 112. The number of swollen joints improved from 4.1 (3.4/4.9) at baseline to 0.7 (0.3/1.0) at week 112. In the same period, skin symptoms (PASI) declined from 8.4 to 1.0 and pain assessment (VAS) declined from 56.0 to 34.3. Of the 96 patients who completed the week 112, 30.2% reached MDA at week 28 and 29.2% reached MDA at week 52. Efficacy of the therapy with ustekinumab was assessed as "very good" or "good" by 91.1% of the treating physicians and by 89.9% of the patients at week 112. Until data cut off point (45 months after study start), 105 SAEs have been documented, of which only 14 were related to ustekinumab as assessed by physician of treatment center. 3.9% of patients discontinued treatment with ustekinumab (N=121), mainly due to an adverse event. Safety of therapy with ustekinumab was assessed as "very good" or "good" by 100% of the treating physicians and by 100% of the patients at week 112. Conclusion: The present interim analysis of the prospective non-interventional study SUSTAIN confirmed relevant improvements with high treatment satisfaction and good safety in patients with active psoriatic arthritis treated with ustekinumab after 4 weeks and demonstrated that these effects were maintained at least up to 112 weeks in routine care. Disclosure of interests: Joerg Wendler Consultant for: Roche Pharma aG, abbVie, Jannssen Cilag, Novartis, Speakers bureau: Roche Pharma aG, abbVie, Jannssen Cilag, Novartis, Peter Wagener: None declared, Frank Hamann: None declared, Nils Damann: None declared, Evgenia Movshovich: None declared, Frank Behrens Grant/research support from: abbVie, Pfizer, Roche, Chugai, Prophylix, Bioline, Novartis, Consultant for: abbVie, Pfizer, Roche, Chugai, UCB, Bristol-Myers Squibb, Celgene, MSD, Novartis, Biotest, Janssen, Genzyme, Eli Lilly, Speakers bureau: ad board: abbVie, Pfizer, Roche, Chugai, UCB, Bristol-Myers Squibb, Celgene, Novartis, Biotest, Janssen, Genzyme, Eli Lilly