Objectives SUSTAIN is a prospective, multi-center non-interventional study in Germany to observe long term efficacy and safety, quality of life and further patient reported outcomes in patients with active psoriatic arthritis under treatment with Ustekinumab in routine clinical care.
Methods In this study treatment with Ustekinumab is according to the label (Stelara®). It is planned to observe 400 patients at 75 centers for 160 weeks with documentation intervals at week 0 and 4 and then every 12 weeks. Besides demographic data, the following data will be documented: Amount of swollen and tender joints, tender entheses, skin symptoms (BSA and PASI), patient reported outcome concerning disease activity and pain, Health Assessment Questionnaire (HAQ), quality of life (SF-12), sleep quality (VAS), satisfaction with therapy of patient and physician, safety (adverse events [AE]/serious adverse events [SAE]), pharmacoeconomic aspects, number of patients with “Minimal Disease Activity” (MDA), number of patients with MDA at week 28 und 52.
Results Overall, there have been 189 patients (56% women) at 59 centers documented after 11 months. At week 4 154 patients and at week 16 112 patients. At baseline, the patients had a mean age of 56 years (29–85), body weight 87 kg (50–147), BMI 30 (19–47), showed arthritis at small (68.8%) and/or big (51.3%) joints, skeletal involvement (19%), enthesitis (13.2%). The number of tender joints improved from a mean of 8,6 (CI 95% 7.1/10.2) to 4.7 (3.1/6.3) at week 16, number of swollen joints from 3,4 (2,6/4,2) to 1,4 (0.9/1.9). The patient reported global disease activity (0–100) decreased from 55.1 to 38.6 at week 16. Further improvements were documented for enthesitis, PSA, BSA, PASI, and pain. Efficacy of the therapy with Ustekinumab after 16 weeks was assessed as “very good” by 32.3% and as “good” by 44.8% of the treating physicians and by 34% and 40.2%, respectively, of the patients. In total, 60 adverse events were reported, of which four were serious. All in all safety of therapy with Ustekinumab after 16 weeks was assessed as “very good” by 51% and as “good” by 43.8% of the treating physicians, and by 55% and 37%, respectively, of the patients.
Conclusions The non-interventional study SUSTAIN showed relevant improvements with elevated therapy satisfaction and good safety in patients with active psoriatic arthritis after 16 weeks under real world condition.
Disclosure of Interest J. Wendler Consultant for: Janssen-Cilag GmbH, Speakers bureau: Janssen-Cilag GmbH, I. Schwarze: None declared, H. Schwenke: None declared, J. Behrens Employee of: Janssen-Cilag GmbH, T. Gruppe Employee of: Janssen-Cilag GmbH, F. Behrens Consultant for: Janssen-Cilag GmbH, Speakers bureau: Janssen-Cilag GmbH