Long-term data on efficacy and safety of adalimumab in Behçet's disease.

INTRODUCTION: Behçet's disease (BD) is a systemic, inflammatory disorder affecting multiple organ systems, frequently treated with TNF-α blocking agents, as infliximab and adalimumab. Insights about long-term use of adalimumab are lacking. Therefore, we conducted a study into the long-term efficacy and safety of adalimumab in BD. METHODS: A retrospective cohort study from patients with BD treated with adalimumab in the Erasmus Medical Center was performed. Patients included were at least 18 years of age, diagnosed according to ISG criteria, and uninterruptedly used adalimumab for at least 36 months. RESULTS: In a population of 39 BD patients using adalimumab, 29 patients persisted treatment >36 months (range 37-206 months). Indications for treatment were uveitis (n = 15) 51.7%, mucocutaneous involvement (n = 9) 31%, arthritis (n = 2) 6.9%, intestinal disease (n = 3) 10.3%. Overall, adalimumab decreased the occurrence of flares from 0.64 to 0.17 flares per year and BCVA improved subsequently. Also, a steady decline in BDCAF is reported over the course of at least 5 years. Subsequently, 79% was able to reduce their use of immunosuppressive agents aside from adalimumab. Adverse effects were reported in, (n = 15) 51.7% of which (n = 13) 86.6% were infectious complications. Two of those required inpatient hospital care. CONCLUSION: Our study illustrates durable long-term efficacy of adalimumab treatment in patients with BD. In our patient cohort long-term adalimumab treatment is safe, with a low incidence of serious adverse events.

Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study.

Background: Since the late '90s, infliximab (Remicade®) is being used successfully to treat patients with several non-infectious immune mediated inflammatory diseases (IMIDs). In recent years, infliximab biosimilars, including Remsima® were introduced in clinical practice. Aim: To investigate the interchangeability of Remicade® (originator infliximab) and its biosimilar Remsima® in patients with rare immune-mediated inflammatory diseases (IMIDs). Methods: This two-phased prospective open label observational study was designed to monitor the transition from Remicade® to Remsima® in patients with rare IMIDs. All included patients were followed during the first 2 years. The primary endpoint was the demonstration of non-difference in quality of life and therapeutic efficacy, as measured by parameters including a safety monitoring program, physicians perception of disease activity (PPDA) and patient self-reported outcomes (PSROs). Secondary outcomes included routine blood analysis, pre-infusion serum drug concentration values and anti-drug antibody formation. Results: Forty eight patients treated with Remicade® were switched to Remsima® in June-July 2016 and subsequently monitored during the first 2 years. The group consisted of patients with sarcoidosis (n = 17), Behçet's disease (n = 12), non-infectious uveitis (n = 11), and other diagnoses (n = 8). There were no significant differences in PPDA, PSROs, clinical and laboratory assessments and pre-infusion serum drug concentrations between the groups. De novo anti-drug antibodies were observed in two patients. Seven patients with sarcoidosis and five with another diagnosis developed a significant disease relapse (n = 7) or adverse events (n = 5) within 2 years; 10 of these patients discontinued Remsima® treatment, one withdrew from the study and one received additional corticosteroid therapy. Conclusions: We observed no significant differences in PSROs, PPDA and laboratory parameters after treatment was switched from Remicade® to Remsima®. However, disease relapse or serious events were observed in 12 out of 48 patients when treatment was switched from Remicade® to Remsima®. The choice to switch anti-TNF alpha biologics in patients with rare IMIDs, particularly in sarcoidosis, requires well-considered decision-making and accurate monitoring due to a possibly higher incidence of disease worsening.

Uveitis-like syndrome and iris transillumination after the use of oral moxifloxacin.

OBJECTIVE: To report a newly recognized adverse effect of oral moxifloxacin. DESIGN: Observational case reports. PARTICIPANTS: Five patients who used oral moxifloxacin therapy. MAIN OUTCOME MEASURES: In five patients, a uveitis-like episode followed oral moxifloxacin therapy, afterwards they experienced photophobia. At slitlamp investigation, the patients showed almost complete iris transillumination, not restricted to one sector, and persistent mydriasis of the pupil, with no reaction to light and no near reflex. Follow-up of 3 years in one of the patients showed no change of symptoms. Only in one patient, with a history of anterior uveitis, an anterior chamber tap was positive for herpes simplex genome. Only after the use of moxifloxacin did she experience continuous photophobia. CONCLUSIONS: Iris transillumination and sphincter paralysis is a newly recognized adverse effect of oral moxifloxacin therapy.