Faculty Bibliography

OBJECTIVES/OBJECTIVE:To assess adherence to published guidelines for the treatment of Behçet's syndrome (BS) in two geographic areas. METHODS:We extracted guideline statements from the 2008 EULAR recommendations. Adherence to these statements was evaluated retrospectively in both New York (USA) and Amsterdam (The Netherlands), by reviewing records from patients fulfilling the ISG criteria. We analysed data per statement and event, and divided data according to the year in which an event occurred. We compared events prior to 2009 to those after publication of the EULAR recommendations (2009 and later). RESULTS:474 patients were evaluated, 24 of whom were from Amsterdam. Treatment adherence varied substantially across various Behçet's manifestations, ranging from 21% vs. 31% in posterior uveitis, 50% vs. 25% in arterial disease, 29% vs. 29% in arthritis and 38% vs. 55% in erythema nodosum to 65% vs. 67% in deep venous thrombosis (DVT), before and after publication of the guidelines respectively. Topical treatment of mucocutaneous disease was only 2% vs. 8%, whereas adherence in neuro-Behçet was ≥ 94% and 100% in gastrointestinal disease. CONCLUSIONS:Adherence to treatment guidelines varies substantially by Behçet's manifestation. Lack of adherence in manifestations such as eye disease and arthritis suggests that current recommendations are not sufficient or other concurrent manifestations require more aggressive treatment. The extensive use of anti-TNF agents might indicate a shift towards more aggressive treatment. Thus, our results suggest the 2008 guidelines were not in line with treatment in clinical practice over the past years and the recent revision of the recommendations was indeed needed.

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group has been working toward developing a data-driven core set of outcome measures for use in clinical trials of Behcet's syndrome [Behcet disease (BD)]. This paper summarizes the group's work through OMERACT 2016, discussions during the meeting, and the future research agenda. METHODS: Qualitative patient interviews were conducted among 20 patients with BD who have different types of organ involvement. A 3-round Delphi among BD experts and patients was initiated to identify domains, subdomains, and outcomes to be assessed in clinical trials of BD. The results of these studies were discussed during OMERACT 2016 and next steps were planned. RESULTS: Patients' perspectives and priorities were identified through qualitative interviews that identified candidate domains and subdomains for inclusion in the Delphi and characterized some shortcomings of the currently used patient-reported outcomes in BD. The first round of the Delphi was completed and several domains or subdomains were endorsed by the experts and/or the patients. Because many more items were endorsed than would be feasible to assess during a clinical trial, rating and ranking of items by physicians and patients was planned as a next critical step. The challenges of assessing specific organ system involvement was also discussed. CONCLUSION: The OMERACT Behcet Syndrome Working Group research program will identify core domains for assessment in BD with the goal of developing a core set of outcome measures for use in all trials of BD with the option to incorporate additional outcomes for specific organ involvement.

BACKGROUND: Biosimilar infliximab (CT-P13) was first approved in Europe in 2013.
OBJECTIVE(S): This study compared treatment patterns of Turkish patients (pts) with a diagnosis of rheumatoid arthritis (RA) who initiated originator IFX (IFX) and either continued IFX or switched to CT-P13.
METHOD(S): Adult pts with >= 1 RA diagnosis code and IFX claim were identified in a national Turkish healthcare database. Eligible pts initiated and continued IFX (Continuer cohort; CC) or initiated IFX and switched to CT-P13 (Switch cohort; SC) during study period (Dec 1, 2010-Jun 1, 2016). The index date was defined as the CT-P13 switch date for SC or a random IFX date during the period of CT-P13 availability for CC. Cohorts were matched on age, sex, and number of IFX prescriptions during baseline. Discontinuation was defined as a switch to another biologic or no index biologic for >= 120 days without censoring. Patient demographics, discontinuation and switching were summarized with descriptive statistics.
RESULT(S): A total of 697 pts initiating IFX were studied; 87% (N = 605) continued on IFX throughout the study period; 13% (N = 92) switched to CT-P13. Mean duration of IFX therapy during the baseline period was 422 days (CC) and 438 days (SC). Average duration of postindex follow-up was 16 months (CC) and 15 months (SC). During the combined baseline and post-index periods, median time on any IFX therapy was 1,080 days (CC) and 540 days (SC). Discontinuation post-index occurred in 19% (CC) and 87% (SC); mean time from index to IFX discontinuation/censoring was 276 days (CC) while the mean time from index to CT-P13 discontinuation/censoring was 132 days. Switching from IFX to CT-P13 occurred in 13% all IFX initiators (i.e., 100% of SC) on the index date; an additional 10% of the CC cohort switched to a non-IFX anti-TNF post-index. The majority of SC (82%) switched from CT-P13 post-index and 88% of those re-initiated IFX. Regional variation in switching was noted. Switching from IFX to CT-P13 occurred most frequently in Central Anatolia (26% of 697 IFX initiators). Switching from CT-P13 occurred in > 75% of SC patients in all regions except for Aegean (44% switched from CT-P13 to another biologic, predominantly IFX).
CONCLUSION(S): In Turkey, RA patients maintained on IFX had greater treatment persistence than those who initiated IFX and switched to CT-P13. High rates of CT-P13 discontinuation favored IFX re-initiation. Reasons for discontinuation are unknown, however regional differences in practice patterns were observed

BACKGROUND: Comorbidities may contribute to disease activity and treatment response in rheumatoid arthritis (RA) patients. We defined a somatization comorbidity phenotype (SCP) and examined its influence on response to certolizumab pegol (CZP) using data from the PREDICT trial. METHODS: Patients in PREDICT were randomized to the patient-reported Routine Assessment of Patient Index Data 3 (RAPID3) or physician-based Clinical Disease Activity Index (CDAI) for treatment response assessment. Post-hoc analyses identified patients with the SCP, which included diagnosis of depression, fibromyalgia/myalgias, and/or use of medications indicated for treatment of depression, anxiety, or neuropathic pain. The effect of the SCP on RAPID3 or CDAI response at week 12 and low disease activity (LDA; Disease Activity Score in 28 joints based on erythrocyte sedimentation rate