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PurposeThis multicenter, randomized, crossover study compared preference, ease of use, acceptability, satisfaction, and safety of repeated subcutaneous (SC) self-administrations with prefilled pens and prefilled syringes delivering methotrexate (MTX), in patients with rheumatoid arthritis (RA).Patients and methodsThe study (ClinicalTrials.gov number NCT01793259) enrolled 120 patients requiring initiation or intensification of MTX therapy for RA. Patients were randomized to receive the test drug, a prefilled pen (Metex® PEN/Metoject® PEN), or the reference drug, a prefilled syringe (Metex®/Metoject®), at doses of 15, 17.5, or 20 mg MTX SC once a week for 3 weeks. This was followed by receipt of the reference drug (prefilled syringe) or the test drug (prefilled pen) in a crossover design, with each patient serving as his/her own control. Questionnaires regarding patient preference, the Self-Injection Assessment Questionnaire (SIAQ), and diaries regarding local tolerability were used to document outcomes.ResultsOverall patient preference for the MTX prefilled pen was 75% (P<0.0001). In a six-item questionnaire, 73% to 76% of the patients preferred the prefilled pen in relation to use, acceptability, and satisfaction, and 67% of the patients confirmed that it did not take much effort to overcome SC self-injection with the pen. The SIAQ showed no clinical differences, in any domain scores, between both devices. Overall patient attitude towards self-injection at baseline was positive, as was patient experience with both devices during the study. As well, 92% of physicians and study nurses indicated that they would recommend the MTX prefilled pen to patients for future MTX treatment. The formulations were generally well tolerated.ConclusionSC self-injection of MTX with a prefilled pen was generally preferred, by patients with RA, over a prefilled syringe with regard to use, acceptability, and satisfaction. This is supported by the strong appreciation of their attending study nurses and physicians, for its convenience.

Tocilizumab administered in a real-life setting showed clinically meaningful improvements and a safety profile that was consistent with data reported from pre-approval Phase III studies.

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This observational study assessed functional ability in patients treated with modified-release prednisone under conditions of normal clinical practice. Patients treated with modified-release prednisone were observed over 9 months. The primary outcome measure was the change from baseline total score using the Questionnaire on Activity Status (QAS); total QAS score ranges from 0 (severely impaired) to 100 (completely unimpaired). Other measures included Visual Analogue Scale (VAS) from 0 to 10 (where 10 = full daily performance) and Health Assessment Questionnaire Disability Index (HAQ-DI). There were no restrictions on dose of modified-release prednisone or use of concomitant therapy. A total of 1,733 patients were included in the study, with valid observations at baseline and study end for 1,185 patients (thereof 74 % female, median age 59 years, median disease duration 5 years). Mean total QAS score improved significantly after 9 months of treatment with modified-release prednisone from 54.3 to 70.2 (p < 0.001). There were also significant (p < 0.001) improvements in all three QAS dimensions (occupational performance: 66.6-78.9; household duties: 55.6-70.9; leisure activities: 51.6-69.4), daily performance (mean VAS 5.1-7.0; p < 0.001) and mean HAQ-DI score (1.35-1.00; p < 0.001). Dose of modified-release prednisone was significantly reduced (from 5.0 to 4.4 mg/day, p < 0.001) and fewer patients required biological rheumatoid arthritis (RA) treatments, analgesia and gastroprotectants. Functional ability in patients with RA improved significantly from baseline after 9 months of treatment with modified-release prednisone. This observational study, conducted under daily-practice conditions, confirms the beneficial effects of modified-release prednisone shown previously in randomised controlled trials.

ObjectivesSUSTAIN 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.MethodsIn 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.ResultsOverall, 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.ConclusionsThe 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 InterestJ. 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

Background Tocilizumab (TCZ) is an interleukin-6-receptor inhibitor for treatment of patients (pts) with rheumatoid arthritis (RA), which was approved in the EU in JAN 2009. Objectives To evaluate the effectiveness, safety, and utilization of TCZ in a usual care setting in Germany. Methods ROUTINE is a prospective, non-interventional study with 174 study sites (specialized rheumatologists or hospital units) across Germany. Included pts were to be treated according to the Summary of Product Characteristics (SmPC); the individual observation period was 52 weeks. Main study objectives were to assess the physicians’ adherence to SmPC when treating their pts, occurrence of infections and other adverse events (AEs), and post-baseline changes in disease activity up to Week 52. All statistical analyses were purely descriptive. Additional subgroup analyses considered prior RA treatment (conventional DMARDs [cDMARDs] vs. TNF inhibitors [TNFi]) and the use of other concomitant RA drugs in addition to TCZ (TCZ combination therapy vs. monotherapy). Results A total of 850 pts (mean age: 56±13 years; 75% women) were analyzed. Mean disease duration was 10.3±8.6 years. Most pts (79%) had previously received TNFi, while 21% were previously treated only with cDMARDs. The most common previous RA treatments (>50% of pts) were the cDMARDs MTX (79%) and leflunomide (LEF, 68%), and the TNFi adalimumab (53%) and etanercept (50%). Mean number of previous DMARDs (both cDMARDs and TNFi) was 4.0±2.1. Mean treatment duration on study was 329±133 days (median: 377 days). TCZ was generally dosed as recommended (ie, 8.0 mg/kg body weight). At baseline 60.5% of pts received TCZ in combination with other RA drugs (incl. steroids), while 39.5% were treated with TCZ as monotherapy. During the entire course of the study TCZ was mostly combined with MTX (77%), followed by LEF (20%), prednisolone (7%), sulfasalazine (6%), hydroxychloroquine (3%), and prednisone (2%; percentages based on 555 pts with combination treatment at any time). Mean steroids (prednisolone equivalent) decreased from 8.9±9.6 mg/day at baseline to 6.1±6.5 mg/day at Week 52. Mean baseline DAS28 was 5.5±1.3 and decreased to 2.6±1.6 at Week 52 (observed data). At Week 52, “good” EULAR response was achieved in 62.3%, LDAS in 44.4%, and DAS remission in 55.1% of pts (percentages based on pts. with observation). 300 pts (35.3%) discontinued the study prematurely; most common reasons (>5%) were lack of effectiveness (10.5%), intolerability (7.3%), missing data (6.1%), and pt’s request (5.6%). Any acute infections and severe acute infections during the study period occurred in 314 and 60 pts (37.6% and 7.2%, respectively; N=836). Most of the infections were related to upper respiratory infections and usually completely resolved; 2 cases of tuberculosis were reported. Generally, incidence and pattern of AEs did not show new or unexpected findings. Conclusions TCZ administered in usual care demonstrated clinically meaningful effectiveness, which was consistent with the efficacy results o...

Background The ICHIBAN study collects routine clinical data to evaluate the effectiveness and safety of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in real world practice over a period of 2 years. Methods The start of this prospective, non-interventional study was in February 2010. The target recruitment is 4000 patients. Clinical data of RA patients, their therapies, therapeutic responses, patient reported outcomes and adverse events are collected in the process of normal practice using an online database with structured web forms. Results As of 1st December 2012, baseline data for 1895 patients were available. In 490 of these patients the observation period was at least 76 weeks under TCZ treatment, or treatment was interrupted or changed (analysis was performed according to LOCF method). The total TCZ exposure was 2299.8 patient years. 74.9% of the 1895 patients were female, the mean age was 56.3 years. Mean duration of RA was 10.0 years and baseline DAS28 was 5.1. 72.0% of the patients had concomitant diseases. 69.8% were pre-treated with TNF-alpha inhibitors, 28.0% exclusively with synthetic DMARDs. At baseline 40.1% of TCZ-treated patients did not receive any additional DMARD, while 46.0% were treated in combination with MTX. At W76, 34.0% of the patients (n=149/438) achieved DAS28 remission (<2.6). A moderate or good EULAR response was seen in 29.1% or 56.9% of the patients, respectively. The mean tender joint count (TJC) decreased from 9.6 to 3.5, the mean swollen joint count from 6.9 to 2.1. Mean ESR decreased from 35.5 to 10.6 mm/1h and CRP from 3.5 to 0.6 mg/dl. Data on patient reported outcomes (PRO) at week 76 are shown in Tab. 1. In 12.0% of the initially TCZ-treated patients (n=59/490) treatment was changed during the observational period. 1916 adverse events were reported (in 751/1895 patients; 83.3/100 patient years). 404 of these events were infections (17.6/100 patient years). 370 serious adverse events were reported (in 222 patients; 16.1/100 patient years), 219 of which (59.2%) were judged at least “unlikely” in relation to TCZ. Conclusions In daily practice TCZ treatment of patients with moderate to severe RA demonstrates good efficacy also in monotherapy and confirms the known safety profile. The first 490 patients having completed the observational period of at least one and a half years show clear improvements in all recorded RA parameters, as well as further improvements compared to the results after the first year of treatment. Disclosure of Interest C. Specker Grant/research support from: Has received honoraria from Chugai for advising in study design and conduction and fees for talks, in summary less than €10.000/year, J. Kaufmann: None Declared, H. Kellner: None Declared, M. Bohl-Bühler: None Declared, H. Schwenke: None Declared, M. Vollmer: None Declared, A. Kapelle: None Declared, S. Zinke: None Declared, M. Hofmann: None Declared, P. Hellmann: None Declared, G. Fliedner Grant/research support from: Has received honoraria from Chugai for advising in study de...