scholarly journals Digital ulcers in systemic sclerosis: their epidemiology, clinical characteristics, and associated clinical and economic burden

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Kathleen Morrisroe ◽  
Wendy Stevens ◽  
Joanne Sahhar ◽  
Gene-Siew Ngian ◽  
Nava Ferdowsi ◽  
...  

Abstract Background To determine the frequency and clinical characteristics of systemic sclerosis-related digital ulcers, and associated direct health care costs, quality of life, and survival. Methods Digital ulcers (DUs) were defined as an area with a visually discernible depth and a loss of continuity of epithelial coverage. DU severity was calculated based on the physician reported highest number of new DUs at clinical review (mild = 1–5 DUs, moderate 6–10 DUs, severe > 10 DUs). Healthcare use was captured through data linkage, wherein SSc clinical data captured prospectively in a dedicated clinical database were linked with health services databases to capture hospital admissions, emergency department (ED) presentations and ambulatory care (MBS) utilization and cost for the period 2008–2015. Healthcare cost determinants were estimated using logistic regression. Results Among 1085 SSc patients, 48.6% experienced a DU over a mean follow-up of 5.2 ± 2.5 years. Those who developed DUs were more likely to have diffuse disease subtype (34.9% vs 18.2%, p < 0.001), anti-Scl-70 antibody (18.9% vs 9.3%, p < 0.001), and a younger age at SSc onset (43.6 ± 13.9 vs 48.8 ± 14.0 years, p < 0.001) in addition to reduced health-related quality of life (HRQoL) measured by the SF-36 but without a significant impact on survival. SSc patients with a history of a DU utilized significantly more healthcare resources per annum than those without a DU, including hospitalizations, ED presentation, and ambulatory care services. Total healthcare services, excluding medications, were associated with an annual excess cost per DU patient of AUD$12,474 (8574-25,677), p < 0.001, driven by hospital admission and ED presentation costs. Conclusion DUs place a large burden on the patient and healthcare system through reduced HRQoL and increased healthcare resource utilization and associated cost.

Author(s):  
G Boudreau ◽  
WJ Becker ◽  
C Graboski ◽  
M Ong-Lam ◽  
I Finkelstein ◽  
...  

Background: We assessed long-term health-related quality of life (HRQoL) and functioning in adults receiving onabotulinumtoxinA for CM. Methods: Interim analysis of multicentre, prospective, observational study in adults naïve to botulinum toxin (NCT02502123). Mean change from baseline in Migraine-Specific Quality of Life (MSQ) score (primary); healthcare resource utilization (HRU) and work productivity (secondary) assessed in patients receiving 4 of 7 onabotulinumtoxinA treatments (Tx4; ~10 months). Results: Across treatments (baseline, n=196, post-Tx2, n=173, post-Tx4, n=137), the mean (SD) between-session interval and onabotulinumtoxinA dose was 13.1 weeks and 170.4 (17.2) U, respectively. MSQ scores increased significantly (P&lt;0.0001) (baseline to post-Tx4; all role function domains). Patient percentages declined from baseline to post-Tx2 and post-Tx4 for emergency room visits (17.3%; 9.3%; 6.6%), hospital admissions (3.6%; 2.9%; 1.5%), and headache-related diagnostic testing (35.9%; 15.9%; 8.1%). The percentages of patients employed at baseline (73.5%) and post-Tx4 (72.3%) were similar. Hours worked increased slightly from baseline to post-Tx4 (28.0 [SD=15.4]; 29.4 [SD=16.0]). Headache-related missed work hours decreased (5.9 [SD=9.5]; 2.5 [SD=5.9]). Patients reported less headache-related impact on work productivity from baseline to post-Tx4 (5.4 [SD=2.1] vs 3.9 [SD=2.6]) and ability to perform daily activities (6.1 [SD=2.1] vs 4.2 [SD=2.8]). Conclusions: OnabotulinumtoxinA for CM improved HRQoL and work productivity and reduced HRU.


2021 ◽  
Author(s):  
Martin Iglesias ◽  
Iván Torre-Villalvazo ◽  
Patricia Butrón-Gandarillas ◽  
Tatiana S. Rodríguez-Reyna ◽  
Erik A. Torre-Anaya ◽  
...  

ABSTRACTBackgroundIn the hand, the Systemic Sclerosis (SS) is characteristically evidenced by Raynaud’s phenomenon (RP) and fibrosis of the skin, tendons, ligaments, and joints as well as digital ulcers with prolonged healing. Current medical treatment not always cure these complications. Local adipose-derived stromal vascular fraction (ADSVF) administration into the hands has been proposed as an emerging treatment for these complications, due to its proangiogenic, antifibrotic, and immunoregulatory activities. The objective of this controlled trial was to evaluate the safety and clinical effects of fat micrografts plus ADSVF administration into the hands of patients with SS.MethodsThis was an open-label, monocentric, randomized controlled study. Twenty patients diagnosed with SS were enrolled and assigned to the experimental or control group. Fat micrografts plus the ADSVF were injected into the right hand of experimental group patients. The control group continued to receive only medical treatment. Demographic, serologic data and disease severity were recorded. Digital oximetry, pain, Raynaud phenomenon (RP), digital ulcer healing (DUH), mobility, thumb opposition, vascular density of the nail bed, skin affection of the hand, Serologic antibodies, hand function, and quality of life scores were evaluated in both groups. The mean follow-up period was 168 days.The differences between before and after the intervention were analyzed with the Wilcoxon range test, and the differences between the control and experimental groups at 0 days and 168 days were analyzed with the Mann–Whitney U test.ResultsAdverse events were not observed in both groups. There were no changes in disease severity, serologic antibodies, nailfold capillaroscopy patterns, mobility, and hand function in both groups. There were significant improvements in pain, DUH and quality of life scores in the experimental group. RP improved significantly in both groups. However, on statistically comparing the results at 168 days between the groups, significant improvements were only observed in pain levels (p = 0.02) and DUH (p=0.003).ConclusionsThe injection of ADSVF plus fat micrografts is a reproducible, and safe technique. Pain and digital ulcers in the hands of patients with SS can be treated with this treatment.Trial RegistrationRetrospectively registered in ClinicalTrials.gov with identifier NCT04387825


2021 ◽  
Author(s):  
Martin Iglesias ◽  
Ivan Torre-Villalvazo ◽  
Patricia Butrón-Gandarillas ◽  
Tatiana S Rodríguez-Reyna ◽  
Erik A Torre-Anaya ◽  
...  

Abstract Background. In the hand, the Systemic Sclerosis (SS) is characteristically evidenced by Raynaud's phenomenon (RP) and fibrosis of the skin, tendons, ligaments, and joints as well as digital ulcers with prolonged healing. Current medical treatment not always cure these complications. Local adipose-derived stromal vascular fraction (ADSVF) administration into the hands has been proposed as an emerging treatment for these complications, due to its proangiogenic, antifibrotic, and immunoregulatory activities. The objective of this controlled trial was to evaluate the safety and clinical effects of fat micrografts plus ADSVF administration into the hands of patients with SS.Methods. This was an open-label, monocentric, randomized controlled study. Twenty patients diagnosed with SS were enrolled and assigned to the experimental or control group. Fat micrografts plus the ADSVF were injected into the right hand of experimental group patients. The control group continued to receive only medical treatment. Demographic, serologic data and disease severity were recorded. Digital oximetry, pain, Raynaud phenomenon (RP), digital ulcer healing (DUH), mobility, thumb opposition, vascular density of the nail bed, skin affection of the hand, Serologic antibodies, hand function, and quality of life scores were evaluated in both groups. The mean follow-up period was 168 days. The differences between before and after the intervention were analyzed with the Wilcoxon range test, and the differences between the control and experimental groups at 0 days and 168 days were analyzed with the Mann–Whitney U test.Results. Adverse events were not observed in both groups. There were no changes in disease severity, serologic antibodies, nailfold capillaroscopy patterns, mobility, and hand function in both groups. There were significant improvements in pain, DUH and quality of life scores in the experimental group. RP improved significantly in both groups. However, on statistically comparing the results at 168 days between the groups, significant improvements were only observed in pain levels (p = 0.02) and DUH (p=0.003).Conclusions. The injection of ADSVF plus fat micrografts is a reproducible, and safe technique. Pain and digital ulcers in the hands of patients with SS can be treated with this treatment. Trial Registration: Retrospectively registered in ClinicalTrials.gov with identifier NCT04387825


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1596.2-1596
Author(s):  
S. Pavlov-Dolijanovic ◽  
V. Koletic ◽  
N. Vujasinovic Stupar ◽  
N. Damjanov

Background:Many treatments have been tried in therapy systemic sclerosis (SSc) patients but use of hyperbaric oxygen therapy (HBOT) is very limited.Objectives:To assess the effects of HBOT to quality of life and state of microcirculation in SSc patients.Methods:18 female patients aged 29-68 years (mean 57 years) with limited SSc and digital or leg ulcers were included in this work. The HBOT protocol comprised 20 sessions 5 day/weekly, 60 min, 100% oxygen at 2.2 ATA. The treated patients were evaluated at baseline and after 20 HBOT sessions. Evaluation consisted of physical examination, capillaroscopy, pulmonary function tests, biochemical analyses, socio-demographic and clinimetric questionnaires: Systemic Sclerosis Questionnaire (SySQ) and Health Assessment Disaability index Questionnaire (HAQ-DI).Results:Mean value [before: after, mean (range)] for SySQ [15.5 (4-48) vs 9.0 (3-31)], HAQ-DI [0.60 (0-2.88) vs 0.35 (0 -1.75)], erythrocyte sedimentation rate [21 (4-42) vs 12 (3-27)], forced vital capacity (96.61±14.44% vs 115.94±16.69%), diffusing lung capacity of carbon monoxide (73.61±6.63% vs 87.33±9.30%) significantly improved after HBOT sessions (p<0.001). There was no significant changes in the total number of capillaries (325 vs 338, p=0.235), mean number of enlarged capillaries (21 vs 27, p=0.182), giant capillaries (14 vs 14, p=0.235) and ramified/bushy capillaries (14 vs 13, p=0.178) before and after HOBT. All patients had digital ulcers, and 5 patients had bilateral lesions (digital and leg ulcers). Mean size of ulceration before HBOT was 12x11mm, and after therapy was 4x4mm (p<0.001). Three patients had digital gangrene. Amputation was not require for any.Conclusion:Our data confirm the efficacy of HBOT in treating SSc patients. Further studies are required to evaluate the protocol and to understand the durattion of the clinical effect.References:[1]Mirasoglu B, Bagli BS, Aktas S. Hyperbaric oxygen therapy for chronic ulcers in systemic sclerosis - case series. Int J Dermatol. 2017;56(6):636-640.[2]Gerodimos C, Stefanidou S, Kotsiou M, et al. Hyperbaric oxygen treatment of intractable ulcers in a systemic sclerosis patient.Aristotle Un Med J. 2013;(40)3:19-22.[3]Wallace DJ, Silverman S, Goldstein J, Hughes D. Use of hyperbaric oxygen in rheumatic diseases: case report and critical analysis. Lupus. 1995;4(3):172-5.Disclosure of Interests:Slavica Pavlov-Dolijanovic: None declared, Vesna Koletic: None declared, Nada Vujasinovic Stupar: None declared, Nemanja Damjanov Grant/research support from: from AbbVie, Pfizer, and Roche, Consultant of: AbbVie, Gedeon Richter, Merck, Novartis, Pfizer, and Roche, Speakers bureau: AbbVie, Gedeon Richter, Merck, Novartis, Pfizer, and Roche


2009 ◽  
Vol 69 (01) ◽  
pp. 214-217 ◽  
Author(s):  
L Mouthon ◽  
C Mestre-Stanislas ◽  
A Bérezné ◽  
F Rannou ◽  
P Guilpain ◽  
...  

Objective:To assess the impact of digital ulcers (DUs) on disability and health-related quality of life (HRQoL) in systemic sclerosis (SSc).Methods:Two hundred and thirteen patients with SSc were evaluated at four annual meetings of a patient society between 2004 and 2007 (n = 177) or during hospital stay (n = 36). HRQoL was assessed by the SF-36, global disability by the health assessment questionnaire (HAQ), hand disability by the Cochin Hand Function Scale (CHFS) and global hand and wrist mobility by the Kapandji index.Results:Sixty-seven patients (31.4%) had at least one DU at the time of evaluation. Patients with DUs showed significantly more pitting scars (p<0.001) and calcinosis (p<0.0001) than others. Patients with DU had significantly greater HAQ (mean (SD) 1.218 (0.723) vs 0.930 (0.717), p = 0.008), CHFS (mean (SD) 27.38 (20.68) vs 16.73 (18.19), p<0.0001) and aesthetic prejudice (mean (SD) 6.1 (2.2) vs 3.9 (2.5), p<0.0001) scores than others. Hand and wrist mobility were significantly diminished in patients with DU (mean (SD) Kapandji score 75.3 (22.8) vs 81.7 (19.2), p<0.0001). The presence of a DU did not significantly alter the physical component but influenced the mental component (mean (SD) 43.38 (12.53) vs 39.58 (9.54), p = 0.026) of the SF36.Conclusion:Patients with SSc with DUs have reduced wrist and hand mobility, increased global and hand disabilities and decreased mental component of HRQoL.


2020 ◽  
Vol 48 (12) ◽  
pp. 030006052097987
Author(s):  
Umesh Jayarajah ◽  
Thisaru Widyarathne ◽  
Metthananda Nawarathne ◽  
Sivananthan Raguvaran ◽  
Nishanthan Subramaniam ◽  
...  

Objective We aimed to describe the clinical characteristics of chronic pancreatitis (CP) and patient quality of life (QOL) in a resource-limited setting. Methods We performed a cross-sectional study including patients with clinical and radiological features of CP. We collected clinical data and assessed QOL using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire. Results We included 103 patients (median age 44 years, 84 men). Median age at symptom onset was 36 (4–78) years. Around 70% of patients had diabetes mellitus and 62.1% had consumed alcohol; 36 (35%) were current smokers. The mean overall global QOL score was 68.7. Most patients (91.3%) sought treatment from multiple centers. Nineteen (18.5%) had pancreatic stone disease, 38 (36.9%) had persistent abdominal pain (median severity 7.8/10, 59 (57.3%) had steatorrhea, and 56 (54.4%) had jaundice. Poor QOL was significantly associated with weight loss, loss of appetite, and intractable pain. No correlation with age, sex, or alcohol consumption was noted. Conclusion A considerable proportion of patients with CP had troublesome symptoms. Intractable pain, loss of appetite, and weight loss were significantly associated with poor QOL. Further assessment is needed of patients’ psychosocial well-being and its association with QOL.


2020 ◽  
Vol 7 (1) ◽  
pp. e000598
Author(s):  
Michael T Durheim ◽  
Anna-Maria Hoffmann-Vold ◽  
Tomas M Eagan ◽  
Arnt-Ove Hovden ◽  
May Brit Lund ◽  
...  

IntroductionIdiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD) are fibrotic ILDs with divergent disease populations. Little is known about health-related quality of life (HRQL) in SSc-ILD relative to IPF.MethodsWe used the Kings Brief Interstitial Lung Disease Questionnaire (K-BILD) to compare HRQL in a cross-sectional study of 57 patients with IPF and 29 patients with SSc-ILD. Analysis of covariance was used to adjust for age, gender and lung function.ResultsThe unadjusted mean K-BILD score was 63.1 (95% CI 57.1 to 69.1) among patients with SSc-ILD, as compared with 54.7 (51.8–57.5) among those with IPF (p=0.005). However, this difference in HRQL was attenuated after adjustment for age, gender and lung function. In a multivariable model, only forced vital capacity was associated with K-BILD scores. K-BILD scores were correlated with both forced vital capacity and with other relevant HRQL measures, regardless of ILD diagnosis.DiscussionPatients with SSc-ILD may have better ILD-specific quality of life than patients with IPF, but this difference appears to be driven primarily by better lung function. These results underscore the impact of lung function on HRQL in fibrotic ILD and the utility of K-BILD to assess HRQL in SSc-ILD.


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