Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study

2008 ◽  
Vol 69 (01) ◽  
pp. 193-197 ◽  
Author(s):  
V Smith ◽  
J T Van Praet ◽  
B Vandooren ◽  
B Van der Cruyssen ◽  
J-M Naeyaert ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Short Form ◽  
Health Assessment ◽  
Histopathological Study ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Study ◽  
Skin Sclerosis ◽  
Potential Efficacy ◽  
Diffuse Cutaneous Systemic Sclerosis

Objectives:The safety and potential efficacy of rituximab was examined in diffuse cutaneous systemic sclerosis (dc-SSc).Methods:A 24 week open-label study in which eight patients with dc-SSc received an infusion of 1000 mg rituximab administered at baseline and day 15, together with 100 mg methylprednisolone at each infusion. Assessment included CD19+ peripheral blood lymphocyte number, skin sclerosis score, indices of internal organ functioning, the health assessment questionnaire disability index, the 36-item Short Form health survey and histopathological evaluation of the skin.Results:Ritixumab induced effective B-cell depletion in all patients (<5 CD19+ cells/μl blood). There was a significant change in skin score at week 24 (p<0.001). Also, significant improvements were measured in the dermal hyalinised collagen content (p = 0.014) and dermal myofibroblast numbers (p = 0.011). Two serious adverse events occurred, which were thought to be unrelated to the rituximab treatment.Conclusions:Rituximab appears to be well tolerated and may have potential efficacy for skin disease in dc-SSc.This study is registered with ClinicalTrials.gov, number NCT00379431.

Two-year Results of an Open Pilot Study of a 2-treatment Course with Rituximab in Patients with Early Systemic Sclerosis with Diffuse Skin Involvement

2012 ◽  
Vol 40 (1) ◽  
pp. 52-57 ◽  
Author(s):  
VANESSA SMITH ◽  
YVES PIETTE ◽  
JENS T. VAN PRAET ◽  
SASKIA DECUMAN ◽  
ELLEN DESCHEPPER ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Activity Score ◽  
Open Label ◽  
Serious Adverse Events ◽  
Skin Score ◽  
Potential Efficacy ◽  
Clinically Significant ◽  
Clinical Measurements

Objective.To study safety and potential efficacy of a 2-treatment course (month 0/6) with rituximab (RTX) in early diffuse systemic sclerosis (dcSSc).Methods.Two years’ followup (open-label study) was done of 8 patients with early dcSSc. Patients received an infusion of 1000 mg RTX 2 times at months 0 and 6, with 100 mg methylprednisolone. Clinical measurements, Disease Activity Score, functional status, and CD19+ peripheral blood count were performed at months 0, 3, 6, 12, 15, 18, and 24 and histopathological evaluation of the skin at months 0, 3, 12, and 24.Results.There was a clinically significant change in skin score, with a mean Modified Rodnan skin score of 24.8 at baseline (SD 3.4) and 13.6 at Month 24 [SD 5.6; mixed models analyses (MMA) p < 0.0001] and a significant decrease in Disease Activity Score (DAS), with a median of 4.5 at baseline (range 1.5–7.5) and 0.5 at Month 24 (range 0.0–5.5; MMA p < 0.0001). Indices of internal organ involvement remained stable throughout the study. RTX induced effective B cell depletion at baseline and Month 6 (< 5 CD19+ cells/μl blood). The blindly assessed hyalinized collagen score changed significantly over time (MMA p = 0.009), with a mean of 69.3 at baseline (SD 22.8) and 33.1 at 24 months (SD 27.0). Five serious adverse events were considered unrelated to the RTX treatment.Conclusion.A 2-treatment course (months 0/6) with RTX appears to be well tolerated and may have potential efficacy for skin disease and stabilization of internal organ status in early dcSSc. Clinical Trials Registration NCT00379431.

scholarly journals Comment on: A prospective open-label study of mycophenolate mofetil for the treatment of diffuse systemic sclerosis: reply

Rheumatology ◽  
2010 ◽  
Vol 49 (8) ◽  
pp. 1608-1608
Author(s):  
C. T. Derk ◽  
E. Grace ◽  
M. Shenin ◽  
M. Naik ◽  
S. Schulz ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Systemic Sclerosis ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Diffuse Systemic Sclerosis

Safety and tolerability of bosentan for digital ulcers in Japanese patients with systemic sclerosis: Prospective, multicenter, open-label study

2016 ◽  
Vol 44 (1) ◽  
pp. 13-17 ◽  
Author(s):  
Yasuhito Hamaguchi ◽  
Takayuki Sumida ◽  
Yasushi Kawaguchi ◽  
Hironobu Ihn ◽  
Sumiaki Tanaka ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Japanese Patients ◽  
Digital Ulcers ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Health Assessment Questionnaire-Disability Index (HAQ-DI) use in modelling disease progression in diffuse cutaneous systemic sclerosis: an analysis from the EUSTAR database

2020 ◽  
Author(s):  
Yannick Allanore ◽  
Sylvie Bozzi ◽  
Augustin Terlinden ◽  
Doerte Huscher ◽  
Caroline Amand ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Disease Progression ◽  
Health Assessment Questionnaire ◽  
Multivariable Analysis ◽  
Health Assessment ◽  
Organ Involvement ◽  
Risk Of Death ◽  
Diffuse Cutaneous Systemic Sclerosis ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Abstract Background: Patients with diffuse cutaneous systemic sclerosis (dcSSc) have a poor prognosis. The importance of monitoring subjective measures of functioning and disability, such as the Health Assessment Questionnaire-Disability Index (HAQ-DI), is important as dcSSc is rated by patients as worse than diabetes or hemodialysis for quality of life impairment. This European Scleroderma Trials and Research (EUSTAR) database analysis was undertaken to examine the importance of impaired functionality in dcSSc prognosis. The primary objectives were to identify predictors of death and HAQ-DI score progression over 1 year. HAQ-DI score, major advanced organ involvement, and death rate were also used to develop a comprehensive model to predict lifetime dcSSc progression. Methods: This was an observational, longitudinal study in patients with dcSSc registered in EUSTAR. Death and HAQ-DI scores were, respectively, analyzed by Cox regression and linear regression analyses in relation to baseline covariates. A microsimulation Markov model was developed to estimate/predict natural progression of dcSSc over a patient’s lifetime.Results: The analysis included dcSSc patients with (N = 690) and without (N = 4132) HAQ-DI score assessments from the EUSTAR database. Baseline HAQ-DI score, corticosteroid treatment and major advanced organ involvement were predictive of death on multivariable analysis; a 1-point increase in baseline HAQ-DI score multiplied the risk of death by 2.7 (p < 0.001) and multiple advanced major organ involvement multiplied the risk of death by 2.8 (p < 0.05). Multivariable analysis showed that baseline modified Rodnan Skin Score (mRSS) and baseline HAQ-DI score were associated with HAQ-DI score progression at 1 year (p < 0.05), but there was no association between baseline organ involvement and HAQ-DI score progression at 1 year. HAQ-DI score, major advanced organ involvement, and death were successfully used to model long-term disease progression in dcSSc.Conclusions: HAQ-DI score and major advanced organ involvement were comparable predictors of mortality risk in dcSSc. Baseline mRSS and baseline HAQ-DI score were predictive of HAQ-DI score progression at 1 year, indicating a correlation between these endpoints in monitoring disease progression. It is hoped that this EUSTAR analysis may change physician perception about the importance of the HAQ-DI score in dcSSc.

scholarly journals AN OPEN-LABEL MULTICENTER OBSERVATIONAL STUDY OF THE EFFICACY, TOLERABILITY, AND SAFETY OF THE NONSTEROIDAL ANTI-INFLAMMATORY DRUG AMTOLMETIN GUACIL IN PATIENTS WITH KNEE OSTEOARTHRITIS AND DYSPEPSIA

2017 ◽  
Vol 54 (6) ◽  
pp. 654-659 ◽  
Author(s):  
E. S. Tsvetkova ◽  
L. N. Denisov ◽  
A. N. Otteva ◽  
A. L. Dubikov ◽  
S. P. Yakupova ◽  
...  
Keyword(s):  
Observational Study ◽  
Knee Osteoarthritis ◽  
Analgesic Effect ◽  
Varicose Veins ◽  
Health Assessment ◽  
Open Label ◽  
Serious Adverse Events ◽  
Multicenter Observational Study ◽  
Knee Oa ◽  
Anti Inflammatory

Objective: to investigate the efficacy and tolerability of amtolmetin guacil (AMG; Niselat®, Dr. Reddy's Laboratories Ltd, India) versus previous therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with knee osteoarthritis (OA) and signs of dyspepsia.Subjects and methods. The open-label observational study included 220 patients aged 30–65 years who suffered from knee OA and intense pain during NSAID intake and had symptoms of dyspepsia in the absence of contraindications to the use of AMG. Among the comorbidities that generally occurred in 68% of the patients, there was a preponderance of hypertension (42%), lower extremity varicose veins (6.4%), and diabetes mellitus (6%). Treatment efficacy was evaluated using three domains of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), by also taking into account pain intensity and general health assessment on the visual analogue scale. A Severity of Dyspepsia Assessment (SODA) scale was used to rate dyspepsia.Results and discussion. AMG had a marked analgesic effect confirmed by 40% or more pain reduction that occurred in 72.5% of the patients. The high analgesic effect of AMG was confirmed by a statistically significant (p <0.001) reduction in the WOMAC index (pain and stiffness) and by an increase in functional activity. There was a significant decrease in painless and painful signs of dyspepsia, as well as positive changes in the measures “overall assessment of dyspepsia severity” (p < 0.001) and “satisfaction with treatment”. Overall assessment of AMG tolerability was only positive: excellent (33%), good (56%), and satisfactory (11%). There were no serious adverse events (AE). AE were graded as moderate and mild in 8 and 82% of cases, respectively. AE were recorded in 7.7% of the patients. Conclusion. The findings suggest that AMG offers good prospects for knee OA treatment.

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