Objective. Complex regional pain syndrome type I (CRPS-I) is a severely disabling pain syndrome for which no definite treatment has been established. The aim of this multi-centre, randomized, double-blind placebo-controlled trial was to test the efficacy of the amino-bisphosphonate neridronate in patients with CRP-I. Methods. Eighty-two patients with CRP-I at either hand or foot were randomly assigned to i.v. infusion of 100 mg neridronate given four times over 10 days or placebo. After 50 days the former placebo patients were given open label the same regimen of neridronate. Results. Within the first 20 days, visual analogue scale (VAS) score decreased significantly more in the neridronate group. In the following 20 days, VAS remained unchanged in the placebo group and further decreased in the active group by 46.5 mm (95% CI −52.5, −40.5) vs 22.6 mm (95% CI −28.8, −16.3) for placebo group (P < 0.0001). Significant improvements vs placebo were observed also for a number of other indices of pain and quality of life. During the open-extension phase in the formerly placebo group the results of treatment were superimposable on those seen during the blind phase in the active group. A year later none of the patients was referring symptoms linked to CRPS-I. Conclusion. In patients with acute CRPS-I, four i.v. infusions of neridronate 100 mg are associated with clinically relevant and persistent benefits. These results provide conclusive evidence that the use of bisphosphonates, at appropriate doses, is the treatment of choice for CRPS-I. Trial registration: EU Clinical Trials Register, https://www.clinicaltrialsregister.eu/, 2007-003372-18.
Background Vitamin D could have important immunomodulatory effects in psoriasis. Objectives To measure 25-hydroxyvitamin D [25(OH)D], parathyroid hormone (PTH) and calcium serum levels in patients with psoriasis and the associations with some relevant clinical features. Methods A cross-sectional study was conducted over 1 year including 145 patients with chronic plaque psoriasis, 112 patients with rheumatoid arthritis (RA) and 141 healthy controls. 25(OH)D, PTH and calcium serum levels were measured in a centralized laboratory. Demography, comorbidities, disease severity and exposure time to sunlight (which was derived by questionnaire) were collected. Results The prevalence of vitamin D deficiency [25(OH)D levels < 20 ng mL−1] in patients with psoriasis was 57·8% vs. 37·5% in patients with RA and 29·7% in healthy controls (P <0·001). In winter, the prevalence of vitamin D deficiency rose to 80·9% in patients with psoriasis, to 41·3% in those with RA and to 30·3% in healthy controls (P <0·001). Patients with psoriasis or psoriatic arthritis did not differ in 25(OH)D serum levels nor in the prevalence of vitamin D deficiency. In the logistic regression analysis, vitamin D deficiency was associated with psoriasis independently of age, sex, body mass index, calcium, PTH levels and season of blood sampling. A limitation is that the study design does not allow a causal or temporal relationship between vitamin D deficiency and psoriasis to be established. Conclusions Vitamin D deficiency may be common in patients with psoriasis, especially in winter.
Objective Non-specific musculoskeletal pain is common in subjects destined to develop psoriatic arthritis (PsA). We evaluated psoriatic patients with arthralgia (PsOAr) compared with psoriasis alone (PsO) and healthy controls (HCs) using ultrasonography (US) to investigate the anatomical basis for joint symptoms in PsOAr and the link between these imaging findings and subsequent PsA transition. Methods A cross-sectional prevalence analysis of clinical and US abnormalities (including inflammatory and structural lesions) in PsOAr (n=61), PsO (n=57) and HCs (n=57) was performed, with subsequent prospective follow-up for PsA development. Results Tenosynovitis was the only significant sonographic feature that differed between PsOAr and PsO (29.5% vs 5.3%, p<0.001), although synovitis and enthesitis were numerically more frequent in PsOAr. Five patients in PsOAr and one in PsO group developed PsA, with an incidence rate of 109.2/1000 person-years in PsOAr vs 13.4/1000 person-years in PsO (p=0.03). Visual Analogue Scale pain, Health Assessment Questionnaire, joint tenderness and US active enthesitis were baseline variables associated with PsA development. Conclusion Tenosynovitis was associated with arthralgia in subjects with psoriasis. Baseline US evidence of enthesitis was associated with clinical PsA development in the longitudinal analysis. These findings are relevant for enriching for subjects at risk of imminent PsA development.
1 May 2014 in Immunology and Allergy Clinics of North America