medwireNews: Findings from the DESIRES trial suggest that patients with systemic sclerosis (SSc) derive significant improvements in skin sclerosis and lung function from treatment with rituximab.
“Given the paucity of treatment options for patients with systemic sclerosis, the results of our study suggest that rituximab might be an effective and safe treatment option for interstitial lung disease in cutaneous and systemic sclerosis,” say Ayumi Yoshizaki (University of Tokyo Graduate School of Medicine, Japan) and team.
They go as far as to say that “rituximab has the potential to become one of the standard therapies for systemic sclerosis.”
The DESIRES trial included 56 patients with SSc from four Japanese hospitals who had a modified Rodnan skin score (mRSS) of at least 10 and an expected survival of at least 6 months.
Over 24 weeks of follow-up, mRSS decreased by 6.30 points in the 28 patients who were randomly assigned to receive rituximab 375 mg/m2 once a week for 4 weeks. This was a significantly better improvement than the 2.14-point increase in the 26 patients given placebo.
Post-hoc analyses showed an mRSS benefit from rituximab irrespective of patient age or disease duration and whether they had diffuse cutaneous SSc or had received pretreatment with systemic corticosteroids or immunosuppressive drugs.
A greater benefit with rituximab was seen among patients with higher C-reactive protein (CRP) levels, the researchers note, with a mean mRSS reduction of 10.33 points in patients with a CRP of 0.3 mg/dL or above, compared with a 5.66-point reduction in patients with a CRP below 0.3 mg/dL.
Like mRSS, the predicted forced vital capacity (FVC) significantly improved in the rituximab group relative to the placebo group over follow-up, with a respective 0.09% increase versus a 2.87% decrease. There was a similar trend of FVC improvement with rituximab in subgroup analyses of patients with a disease duration of less versus more than 5 years and in those with a baseline predicted FVC of 80% or lower.
On the other hand, there was no significant between-group difference in diffusing capacity for carbon monoxide, with decreases of 1.32% and 3.56% in patients given rituximab and placebo, respectively.
The researchers point out in The Lancet Rheumatology that “the decrease stabilised from 4 weeks onwards in the rituximab group compared with the placebo group.”
In addition to improving skin sclerosis, rituximab also significantly improved systemic sclerosis-associated interstitial lung disease, according to analysis of high resolution computed tomography images. Indeed, a 0.32% reduction in area occupied by interstitial shadows was observed in the rituximab group by week 24 compared with a 2.39% increase in the placebo group.
In an accompanying comment, Michael Hughes (Tameside Hospital, Ashton-under-Lyne, UK) and Dinesh Khanna (University of Michigan, Ann Arbor, USA) say: “The DESIRES trial is timely and informative, providing further evidence to support treatment with rituximab for patients with systemic sclerosis.”
Hughes and Khanna add that “further research is required, including investigation in an international randomised controlled trial, before rituximab can be considered as a standard of care.”
This sentiment was echoed by the study researchers who conclude: “Further studies in other ethnic groups and more severe cases of the disease are needed to confirm the external validity of these results.”
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