Predictive value of laser speckle contrast analysis in systemic sclerosis. A systematic review and pilot study.

OBJECTIVES: To assess whether tools to functionally examine the microcirculation, such as laser speckle contrast analysis (LASCA), are predictive of ischaemic digital trophic lesions ([i]DTL) in patients with systemic sclerosis (SSc). METHODS: First, a systematic review (according to PRISMA) was conducted to identify studies describing a link between LASCA and SSc-related (i)DTL. In the additional pilot study, consecutive SSc patients underwent clinical and LASCA examinations (to assess the peripheral blood perfusion [PBP] of both hands) at enrolment. For one year, a monthly telephone survey was conducted to investigate (i)DTL occurrence. Logistic regression and ROC analysis were performed. RESULTS: None of the three manuscripts retained through the systematic review examined the predictive value of LASCA for future (i)DTL. In our pilot study, 7/106 (6.6%) SSc patients developed at least one iDTL during follow-up, with PBP not found to be predictive (OR = 0.995, p = .418; ROC-AUC = 0.597). Post hoc, when only patients not taking vasodilators were analysed (n = 57), all three who developed iDTL had an average PBP ≤ 70 PU, while only 9/54 (16.7%) patients without iDTL occurrence had such values. CONCLUSION: A predictive role of LASCA for (i)DTL has not yet been described in the literature and could also not be attested by our additional pilot study, due to a lower-than-expected iDTL incidence in our day-to-day SSc population in which patients were allowed to continue their vasodilator medication. However, the promising observations in the subgroup of vasodilator-naïve patients encourage further investigation of this potential added value of LASCA.

Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis.

OBJECTIVES: Following results in open-label studies of rituximab in patients with systemic sclerosis, a Belgian three-centre initiative was launched to explore safety and efficacy of rituximab in early, diffuse cutaneous systemic sclerosis (dcSSc). METHODS: Open-label study of 17 patients with early dcSSc, treated with two courses of rituximab, at month 0 and 6. Clinical examination, lung function testing, echocardiography, disease activity score (DAS) and functional status were performed at baseline and over 24 months of follow-up. RESULTS: Modified Rodnan skin score (MRSS) changed significantly over time, with a mean of 25.5 (standard deviation [SD] 6.0) at baseline to 12.6 (SD 5.1) at month 24 (Mixed Model Analysis [MMA] p < 0.0001), which is a decrease of 51% at month 24 vs. baseline. DAS showed significant decrease over the total study period, with a score of 4.1 (SD 1.7) at baseline to 1.5 (SD 1.8) at month 24 (MMA p < 0.0001). Additionally, this was significant at all time points vs. baseline, both for MRSS and DAS. Internal organ status remained clinically stable throughout the study period. No statistically significant differences compared to baseline were found at the follow-up time points. Seven serious adverse events took place, all except for one, considered unrelated to study medication. CONCLUSIONS: This is the first multicentre Belgian collaboration investigating potential efficacy of rituximab in early dcSSc. Rituximab appears to be safe and tolerable and it may have beneficial effects on skin involvement, on overall disease activity and on stabilization of internal organ status in early dcSSc.