To assess the efficacy and safety of Golimumab in patients with refractory uveitis to other anti-TNFα drugs.
Methods
Study of patients from a single center with refractory uveitis to previous standard synthetic immunosuppressive drugs and at least 1 anti-TNFα drug. Golimumab was given at the standard dose of 50 mg/sc/month.
Results
A total of 25 patients (39 affected eyes) (19 men/6 women); mean age, 32.5±8.9 years (range 11-47); fulfilled the above-mentioned criteria. In 14 cases uveitis was bilateral and in 11 cases it was unilateral. The underlying diseases were spondylarthritis (n=7), psoriatic arthropathy (n=4), juvenile idiopathic arthritis (n=4), sarcoidosis (n=3), Behçet disease (n=2), uveitis associated with HLA-B27 and ulcerative colitis (n=1), pars planitis (n=1) and Vogt-Koyanagi-Harada (n=1). Besides oral steroids and before Golimumab onset they had received: intraocular corticosteroids (n=10), methylprednisolone i.v. boluses (n=6), methotrexate (n=20), cyclosporine A (n=6), azathioprine (n=6), adalimumab (n=17), infliximab (n=14), abatacept (n=2) and certolizumab (n=1). Golimumab was started because inefficacy (n=23) and/or toxicity (n=2) to other biologics. Golimumab was used as monotherapy (n=9) or in combination with methotrexate (n=9), azathioprine (n=3), leflunomide (n=2) and mycophenolate (n=2). There was a rapid (from 1st week) and maintained (1st year) improvement of visual acuity, anterior chamber inflammation, vitritis and OCT. The mean OCT improved from 319.9±77.9 μm (baseline) to 270.2±54.8 μm (1st month) (p<0.01) and to 244.3±43.2 μm (1st year) (p=0.02). After a mean follow-up of 13.3±8.3 (range 2-30) months the most important side-effects observed were local erythema in injection area (n=1) and herpes zoster (n=1).
Conclusions
Golimumab seems an effective and safe treatment for those patients with uveitis even refractory to other anti-TNFα drugs.
Acknowledgements
This study was supported by a grant from “Fondo de Investigaciones Sanitarias” PI12/00193 (Spain). This work was also partially supported by RETICS Programs, RD08/0075 (RIER) and RD12/0009/0013 from “Instituto de Salud Carlos III” (ISCIII) (Spain).
Disease registries are a very useful tool to clarify and analyze in clinical practice differences between patients regarding epidemiology, prognostic, therapeutic efficacy, quality of life and socio-economic characteristics.
Objectives
To evaluate the main differences at the beginning of the current biological therapy between the prevalent and incident patients included in REGISPONSERBIO.
Methods
REGISPONSERBIO is a Spanish multicenter (17), prospective registry (3 year-follow-up, with clinical controls every six months) of patients with axial SpA (ASAS criteria) under biological treatment. All patients included should be under biologic treatment and have a minimum data set necessary to achieve the main objectives planed for the registry. The inclusion period extended between September 2013 and December 2014. The registry included two groups of patients: a) prevalent cases (patients receiving biological treatment prior to baseline visit) b) incident cases (patients who started biological therapy at the inclusion in the registry). In all patients the following data was collected at baseline: age, disease and treatment duration, gender, HLA B27, Body Mass Index (BMI), BASDAI, BASFI, CRP, ESR, metrological data, ASQoL, WAPAI, extra-articular manifestations, comorbidities, radiological study, biological treatment at the time of inclusion in the registry and concomitant treatments. For this study, characteristics between prevalent and incident cases were compared using t-Student and chi-square tests. Results are shown as mean (standard deviation) or relative frequencies.
Results
This registry included 258 patients, 174 out of 258 (67%) were prevalent cases. The group of prevalent patients showed higher disease evolution: 15 (11) vs 8 (11) years (p<0.001), higher proportion of males: 144 (83%) vs 57 (69%) (p=0.01), less proportion of non radiographic axial spondylarthritis: 6 (3%) vs 12 (14%) (p=0.001) and higher proportion of HLA-B27 positive 145 (84%) vs 57 (69%) although this latter result did not reach statistical significance (p=0.06).
Conclusions
The observed data suggest that the profile of patients starting biological therapy seems to be changing in the last years.
Methotrexate-induced nephrogenic diabetes insipidus: first case report SIR, Methotrexate (MTX) has become the dominant second-line agent in the treatment of patients with