ObjectivesTo assess the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy in psoriatic arthritis (PsA) dactylitis.MethodsMulticentre, investigator-initiated, randomised, double-blind, placebo-controlled, parallel-design phase 3b trial in 11 Portuguese rheumatology centres. Patients with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs) were randomly assigned to golimumab or placebo, both in combination with MTX. The primary endpoint was Dactylitis Severity Score (DSS) change from baseline to week 24. Key secondary endpoints included DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score. Analysis was by intention-to-treat for the primary endpoint.ResultsTwenty-one patients received golimumab plus MTX and 23 MTX monotherapy for 24 weeks. One patient from each arm discontinued. Patient inclusion was halted at 50% planned recruitment due to a favourable interim analysis. Median baseline DSS was 6 in both arms. By week 24, patients treated with golimumab plus MTX exhibited significantly greater improvements in DSS relative to MTX monotherapy (median change of 5 vs 2 points, respectively; p=0.026). In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy.ConclusionsThe combination of golimumab and MTX as first-line bDMARD therapy is superior to MTX monotherapy for the treatment of PsA dactylitis.Trial registration numberNCT02065713
Comedication with csDMARDs does not prolong TNFi retention in patients with SpA in clinical practice, suggesting that there is no benefit conferred by the concomitant use of these drugs.
Background: The vasculitides are a group of rare diseases with different manifestations and outcomes. New therapeutic options have led to the need for long-term registries. The Rheumatic Diseases Portuguese Register, Reuma.pt, is a web-based electronic clinical record, created in 2008, which currently includes specific modules for 12 diseases and > 20,000 patients registered from 79 rheumatology centres. On October 2014, a dedicated module for vasculitis was created as part of the European Vasculitis Society collaborative network, enabling prospective collection and central storage of encrypted data from patients with this condition. All Portuguese rheumatology centres were invited to participate. Data regarding demographics, diagnosis, classification criteria, assessment tools, and treatment were collected. We aim to describe the structure of Reuma.pt/vasculitis and characterize the patients registered since its development. Results: A total of 687 patients, with 1945 visits, from 13 centres were registered; mean age was 53.4 ± 19.3 years at last visit and 68.7% were females. The most common diagnoses were Behçet's disease (BD) (42.5%) and giant cell arteritis (GCA) (17.8%). Patients with BD met the International Study Group criteria and the International Criteria for BD in 85.3 and 97.2% of cases, respectively. Within the most common small-and medium-vessel vasculitides registered, median [interquartile range] Birmingham Vasculitis Activity Score (BVAS) at first visit was highest in patients with ANCA-associated vasculitis (AAV) (17.0 [12.0]); there were no differences in the proportion of patients with AAV or polyarteritis nodosa who relapsed (BVAS≥1) or had a major relapse (≥1 major BVAS item) during prospective assessment (p = 1.00, p = 0.479). Biologic treatment was prescribed in 0.8% of patients with GCA, 26.7% of patients with AAV, and 7.6% of patients with BD. There were 34 (4.9%) deaths reported.
BackgroundNailfold capillaroscopy (NCP) is a useful tool for the diagnosis and follow-up of systemic rheumatic diseases and represents one of the best methods to evaluate microvascular abnormalities.ObjectivesTo characterize NCP findings of patients with Systemic Sclerosis (SSc), and understand how NCP associates with the presence of digital ulcers, gastrointestinal involvement, pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD).MethodsNCP findings of adult patients with SSc followed-up in our center were reviewed. Demographic and clinical features were collected. Nonparametric tests were used to determine potential associations between capillaroscopy findings/patterns and the presence of digital ulcers, gastrointestinal involvement, PAH and ILD.ResultsIn total, 52 out of 103 patients with SSc had at least one NCP result available. Forty five were female (86.5%) and seven male (13.5%), the age was 56.6 ±13.2 years and disease duration 10.9 ±10.5 years. Thirty one (59.6%) had limited cutaneous SSc, seven (13.5%) diffuse cutaneous SSc, ten (19,2%) VEDOSS, three (5.8%) overlap syndromes and one (1.9%) SSc sine scleroderma. (table 1). The most frequent NCP findings were hemorrhages (54.7%) megacapillaries (54.7%), and capillary dilatations (52.8%).We found that digital ulcers were significantly associated with the existence of avascular areas (p=0.02), and with neoangiogenesis (p=0.03) in univariate analysis, but were not associated with any capillaroscopy pattern. Looking to interstitial lung disease, there is a trend for association with the presence of avascular areas (p=0.056). Only one patient had PAH confirmed by right heart catheterization. In this case NCP showed giant capillaries, neoangiogenesis and avascular areas. There was also a trend for association between avascular areas and higher values of NT pro BNP (p=0.078). Gastrointestinal involvement was not significantly associated with NCP findings (table 2).Table 1.Distribution of patients according to NCP and disease subtypesDiffuse cutaneousLimited cutaneousOverlap syndromeVEDOSSSine scleroderma(n=7)(n=31)(n=3)(n=10)(n=1)Early pattern n (%)0 (0)9 (29)1 (33)6 (60)0 (0)Active pattern n (%)1 (14.2)5 (16.1)1 (33)2 (20)0 (0)Late pattern n (%)3 (42.9)7 (22.6)0 (0)0 (0)0 (0)Nonspecific n (%)3 (42.9)8 (25.8)1 (33)1 (10)1 (100)Normal NCP n (%)0 (0)2 (6.5)0 (0)1 (11)0 (0)ConclusionsIn our study the presence of avascular areas and neoangiogenesis in NCP was significantly associated with the existence of digital ulcers. Also, ILD and higher values of NT-proBNP were more common in patients who present avascular areas. These results suggest that abnormalities detected in the NCP might help predict organ involvement, although long term follow up and greater numbers of patients are needed in order to confirm the prognostic value of NCP findings.ReferencesMannarino E, Pasqualini L, Fedeli F, Scricciolo V, Innocente S. Nailfold capillaroscopy in the screening and diagnosis of Raynaud's phenomenon. Angiology 1994; 45: 37–42Disclosure of InterestNone d...
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