scholarly journals Impaired Kidney Function Associated with Increased Risk of Side Effects in Patients with Small Vessel Vasculitis Treated with Rituximab as an Induction Therapy

2021 ◽  
Vol 10 (4) ◽  
pp. 786
Author(s):  
Aleksandra Rymarz ◽  
Anna Matyjek ◽  
Magdalena Sułek-Jakóbczyk ◽  
Magdalena Mosakowska ◽  
Stanisław Niemczyk

Rituximab (RTX), a monoclonal antibody against the CD20 molecule, is used as an induction therapy in the treatment of small vessel vasculitis (SVV). The aim of the study was to evaluate the efficacy and safety of RTX induction therapy for refractory SVV. A retrospective analysis of 20 patients treated with RTX for active SVV (BVAS/WG ≥ 3) was performed to assess the remission rate and the drug-related severe adverse events 6 months after therapy. The mean age of the studied population was 49 ± 13 years (50% female), 90% of which were PR3-ANCA positive. Complete remission was achieved in 85% of patients, and partial remission was achieved in a further 10% within 6 months after RTX infusions. The remission rate was not influenced by kidney function. Adverse events such as infections (25%), a late onset of neutropenia (10%) and severe hypogammaglobulinemia (5%) were noted. The patients who developed adverse events were older (42 ± 11 vs. 57 ± 12 years; p = 0.014) and had a higher serum creatinine level (1.3 mg/dL vs. 3.35 mg/dL; p = 0.044). Patients with a glomerular filtration rate (eGFR) lower than 30 mL/min/1.73 m2 had a nine-fold higher risk of side effects (OR 9.0, 95%CI: 1.14–71.0). In conclusion, RTX was highly effective as an induction therapy in patients with SVV. Advanced kidney failure with an eGFR lower than 30 mL/min/1.73 m2 was one of the risk factors for the occurrence of side effects.

Processes ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 1081
Author(s):  
Ming-Yang Lee ◽  
Mei-Yi Lin ◽  
Yu-Ju Chang ◽  
Yu-Ting Tseng ◽  
I-An Huang ◽  
...  

(1) Background: The epidermal growth factor inhibitors (EGFRIs)/tyrosine kinase inhibitors (TKIs) are effective for cancer target therapy, but acneiform rashes or so-called inflammatory papulopustular exanthemas are common (50% to 90%). The conventional therapy for EGFRIs/TKIs-induced skin toxicity is steroids and antibacterial drugs, but it is still ineffective for some patients, and EGFRIs/TKIs dose reduction/interruption may be needed. In this study, a modified Chinese herbal medicine, Huang-Lian-Jie-Du decoction cream with Yin-Cold (YC) medicine characteristic, was investigated for the effect on patients suffering EGFRIs/TKIs-induced skin toxicity. (2) Methods: The modified Huang-Lian-Jie-Du (mHLJD) decoction cream was made from 10 herbal medicines, including 4 major medicines (Huanglian, Huangqin, Huangbo, and Zhizi) in traditional HLJD decoction. Patients with EGFRIs/TKIs-induced skin toxicity were enrolled. Patients were excluded if they also used other cream for skin toxicity. Skin conditions were monitored by follow up every 2 weeks. The patients’ characteristics, the skin toxicities, treatment response, and adverse events were recorded and analyzed until skin problems resolved or the study ended. (3) Results: The mHLJD decoction cream and its sub-packages were stored at 4 °C before use. Thirty-four patients who had grade 1–3 skin toxicities after receiving EGFRIs/TKIs were enrolled. Seven patients withdrew or were excluded. Finally, data from 27 patients were analyzed. The mean grade of rash acneiform was significantly decreased from 2.19 (ranged 1 to 3) to 0.88 (ranged 0 to 2) after mHLJD decoction cream treatment for 4 weeks and to 0.55 (ranged 0 to 2) after mHLJD decoction cream treatment for 8 weeks. Additionally, the mean grade of dry skin was also significantly decreased from 1.57 (ranged 1 to 2) to 0.71 (ranged 0 to 1) after mHLJD decoction cream treatment for 4 weeks. The changes of skin toxicity were significant, with no obvious adverse events. (4) Conclusions: In summary, the mHLJD decoction cream provides benefits for alleviation of EGFRIs/TKIs-induced skin rash acneiform and dry skin. Additionally, no obvious side effects were found in patients using mHLJD decoction cream.


2016 ◽  
Vol 3 (2) ◽  
pp. 3-9
Author(s):  
Buddhi Prasad Paudyal ◽  
Anjana Education Rajbhandari

 Introductions: Vasculitides can cause significant morbidity and mortality if not treated on time. There is lack of data locally. This study aims to define the pattern, clinical characteristics, and outcome of vasculitides.Methods: This was a cross sectional study between January 2011 and December 2015 at Patan Hospital, Patan Academy of Health Sciences, Lalitpur, Nepal. The medical records of patients diagnosed with vasculitides in adults rheumatology service of the hospital were reviewed.Results: Ninety six patients were diagnosed with vasculitides during the study period. The mean age was 42.2 years. Sixty nine (71.8%) patient had small vessel, 20 (20.8%) large vessel and five (5.2%) had variable vessel vasculitides. Seventy five patients (78.1%) had primary and 21 (21.8%) secondary vasculitides. Cutaneous leucocytoclasticangitis was seen in 27 (28.1%), Takayasu arteritis in 17 (17.7), Henoch-Schonlein purpura in 11 (11.4%) and Rheumatoid arthritis associated vasculitis in nine patients. Purpura was present in all 96 (100%). The overall mortality was 9 (9.3%).Conclusions: Primary vasculitides were more common than secondary forms. Small vessel vasculitis was the most common. Cutaneous symptoms were predominant features. The mortality was attributed to active disease, sepsis, and complications of the primary disease. Journal of Patan Academy of Health  Sciences. 2016 Dec;3(2):3-9


Rheumatology ◽  
2019 ◽  
Vol 59 (4) ◽  
pp. 718-726 ◽  
Author(s):  
Dina Omar ◽  
Yu Chen ◽  
Ye Cong ◽  
Lingli Dong

Abstract Objective To assess the safety and efficacy of glucocorticoids (GCs), immunosuppressive agents (IM) and rituximab (RTX), alone or in combination, for the treatment of IgG4-RD. Methods Relevant articles published were searched in the databases with relevant key words. Network meta-analysis was conducted, with various outcomes including relapse rate, remission rate and adverse events. Data were calculated with odds ratio (ORs) and 95% CI. P-score was used to rank the treatments. Results A total of 15 studies involving 1169 patients were included. Network meta-analysis indicated that RTX maintenance therapy had the lowest relapse rate of all treatments (OR = 0.10, 95% CI [0.01, 1.63]), whereas GCs + IM was associated with a lower relapse rate compared with GCs alone (OR = 0.39, 95% CI [0.20, 0.80]). Further, patients treated with GCs + IM had a higher remission rate than those given GCs (OR= 3.36, 95% CI [1.44, 7.83]), IM (OR= 55.31, 95% CI [13.73, 222.73]) monotherapies or RTX induction therapy only (OR= 7.38, 95% CI [1.56, 34.94]). The rate of adverse events was comparable among the different treatment groups. Conclusion Treatment of IgG4-RD patients with GCs and IM was associated with higher remission rates and lower relapse rates, as well as comparable safety profiles compared with GC, IM and RTX induction therapy. RTX maintenance therapy had a larger reduction in the relapse rate compared with GC and IM. The current evidence should be carefully scrutinized as the included studies were observational in design. Larger randomized controlled trials are needed to confirm.


2021 ◽  
Vol 9 ◽  
Author(s):  
Thanan Supasiri ◽  
Nuntida Salakshna ◽  
Krit Pongpirul

Background: Acupuncture shows benefits for patients with melasma, although no optimal number of sessions have been determined.Methods: The prospective observational study was conducted in melasma patients who were treated with acupuncture procedures two times a week and were evaluated after the 5th and the 10th sessions of acupuncture, with a 1-week follow-up after the last session. Participants Groups A and B received five and 10 acupuncture sessions, respectively. Melasma was assessed by using the melanin index (MI), melasma area and severity index (MASI), patient-reported improvement scores, and acupuncture-related adverse events.Results: Out of 113 participants, 67 received five sessions of acupuncture treatment while 39 received 10 sessions. At 1 week after five sessions of acupuncture in Group A, the mean MI decreased by 28.7 (95% CI −38.5 to −18.8, p < 0.001), whereas the median MASI decreased by 3.4 (95% CI −6.9 to −1.2, p < 0.001) points. At 1 week after ten sessions of acupuncture in Group B, the mean MI decreased by 31.3 (95% CI −45 to −17.6, p < 0.001), whereas the median MASI decreased by 5.4 (95%CI −9.9 to −3, p < 0.001) points. The first five sessions of acupuncture had a higher incremental effect than the last five sessions, although there was no statistically significant difference. Twenty-nine participants reported minor side effects. Group B had a risk ratio (RR) of having adverse events 1.8 times (95% CI 1.0–3.4, p = 0.05) compared with Group A.Conclusion: Short acupuncture regimens of 5–10 sessions in melasma seem to be effective and practical with minor side effects.


2020 ◽  
Vol 7 (1) ◽  
pp. e000411
Author(s):  
Romy Kallas ◽  
Daniel Goldman ◽  
Michelle A Petri

ObjectivesWe determined the temporal association between clinical and serological disease manifestations and development of cutaneous small vessel vasculitis in a large prospective multiethnic cohort.MethodsPatients with SLE diagnosed according to the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria or the revised classification criteria as defined by the American College of Rheumatology (ACR) were enrolled in the Hopkins Lupus Cohort. Cutaneous small vessel vasculitis was determined as a component of the Systemic Lupus Erythematosus Disease Activity Index. SLE-associated cutaneous small vessel vasculitis lesions were reported clinically. They presented as punctate lesions, palpable purpura, tender erythematous plaques or macules with or without necrosis. No histopathological diagnosis was pursued to confirm the diagnosis of vasculitis or to differentiate it from other causes of digital lesions in patients with SLE. Disease manifestations that preceded the first occurrence of cutaneous small vessel vasculitis lesions were analysed using Kaplan-Meier. Cox regression analysis was used to assess the relationship between baseline clinical and immunological manifestations and the development of cutaneous small vessel vasculitis. We adjusted for gender, race and age at SLE diagnosis.ResultsA total of 2580 patients were studied: 52.4% were Caucasian and 39.4% were African-American. The mean age of the cohort was 45.5±14.5 years. The mean years of cohort follow-up was 7.9±7.6. Cutaneous small vessel vasculitis was observed in 449 (17.3%). The mean time to cutaneous vasculitis after SLE diagnosis was 4.78 years (95% CI 3.96 to 5.60). At least 159 (35%) patients had recurrences of cutaneous vasculitis lesions. Discoid rash, Raynaud’s phenomenon, myositis, anaemia, Coombs’ positivity, leucopenia, anti-Smith and anti-RNP (Ribonucleoprotein) were significantly associated with the development of cutaneous vasculitis. The SLICC/ACR Damage Index score was higher in patients with cutaneous vasculitis compared with those without cutaneous vasculitis.ConclusionsCutaneous vasculitis is frequent (17.3%) and often recurrent (35%). African-Americans are at higher risk of developing cutaneous small vessel vasculitis than Caucasians. Clinical presentations such as myositis and haematological manifestations are predictors of cutaneous vasculitis development. The presence of cutaneous vasculitis is associated with increased organ damage.


2021 ◽  
Vol 12 ◽  
pp. 204209862198913
Author(s):  
Ryan Pelletier ◽  
Kelvin Ng ◽  
Wajd Alkabbani ◽  
Youssef Labib ◽  
Nicolas Mourad ◽  
...  

Background: Multiple published quantitative systematic reviews have reported on adverse events associated with the use of sodium glucose co-transporter 2 (SGLT-2) inhibitors in patients with type 2 diabetes mellitus. Aims: To summarize and appraise the quality of evidence from quantitative systematic reviews assessing adverse events of SGLT-2 inhibitors. Methods: We searched PubMed, EMBASE and the Cochrane Library for quantitative systematic reviews assessing SGLT-2 inhibitor safety. Two reviewers extracted data and assessed methodological quality using the Assessment of Multiple Systematic Reviews 2 (AMSTAR 2) tool. Main outcomes included pooled and single study point estimaates (in the absence of pooled estimates) with corresponding 95% confidence intervals (CIs) of SGLT-2 inhibitors versus placebo or active comparators for genitourinary infections, volume depletion, acute kidney injury, bone fractures, diabetic ketoacidosis, lower limb amputations, cancers, and other notable adverse events. Results: Out of 1289 citations screened, 47 reviews assessed SGLT-2 inhibitor safety, of which 35 were of low quality. Canagliflozin, dapagliflozin and empagliflozin were consistently associated with an increased risk of genital tract infections versus placebo (point estimates ranged from 2.5 to 9.8) and other antihyperglycemic agents (point estimates ranged from 2.7 to 12.0). Canagliflozin and dapagliflozin were associated with an increased risk of diabetic ketoacidosis. Canagliflozin was the only agent associated with an increased amputation risk; however, this was driven by results from a single trial program. Dapagliflozin was the only agent that exhibited a statistically significant increased risk of urinary tract infections. Empagliflozin was associated with a statistically significant increased risk of bladder cancer; however, this finding was susceptible to detection bias. None of the agents were associated with a statistically significant increased risk of acute kidney injury, or bone fractures compared to placebo or mixed (active or placebo) comparators. Upper 95% CI limits do not rule out clinically meaningful outcomes. Conclusion: The majority of quantitative systematic reviews reporting on adverse events of SGLT-2 inhibitors were of low methodological quality. Despite almost 50 quantitative systematic reviews published on the safety of SGLT-2 inhibitors, clinicians are still left uncertain of the risks of important adverse effects. Plain Language Summary SGLT-2 iInhibitor side effects: overview of reviews Many published systematic reviews have reported on side effects associated with the use of sodium glucose co-transporter 2 (SGLT-2) inhibitors in patients with type 2 diabetes. We aimed to summarize and appraise the quality of evidence from quantitative systematic reviews assessing side effects of SGLT-2 inhibitors. Using the Assessment of Multiple Systematic Reviews 2 (AMSTAR 2) tool, two authors extracted data and assessed the methods of included reviews. Main outcomes included reported pooled and single study point estimates for several SGLT-2 inhibitor side effects such as genital infections, bone fractures, lower limb amputations, increased blood acidity, among others. Of the reviews included in our study, 35 of the 47 reviews assessed were of low quality. Canagliflozin and dapagliflozin were associated with an increased risk of blood acidity in a 2020 review. Canagliflozin was the only agent associated with an increased amputation risk; however, this was driven by results from a single trial program. Dapagliflozin was the only agent that exhibited a significantly increased risk of urinary tract infections. Empagliflozin was associated with an increased risk of bladder cancer; however, this finding was susceptible to bias. None of the agents were associated with an increased risk of kidney injury or bone fractures.


2021 ◽  
Author(s):  
Thanan Supasiri ◽  
Krit Pongpirul

AbstractBackgroundMelasma is a common skin pigmentation disorder. Acupuncture shows benefits for patients with melasma, although no standardized method or optimal number of sessions have been determined.ObjectiveTo comparatively assess clinical outcomes of melasma between five vs ten standard acupuncture sessions.MethodsWe performed a prospective observational cohort study in all melasma patients at the Acupuncture Clinic, King Chulalongkorn Memorial Hospital, Bangkok, Thailand. All patients were treated with standard acupuncture procedure twice a week and were evaluated after the fifth and the tenth sessions of acupuncture, with a follow-up one week after the last session. Participants were divided into two treatment groups: Groups A and B received five and ten acupuncture sessions respectively. Melasma outcomes were assessed by using the Melanin Index (MI), Melasma Area and Severity Index (MASI), patient-reported improvement scores and acupuncture-related adverse events.ResultsOf 113 participants, 67 received five sessions of acupuncture treatment while 39 received ten sessions. 7 participants did not finish treatment. After five sessions of acupuncture in Group A, the mean MI decreased by 28.7 (95%CI -38.5 to -18.8), whereas the median MASI decreased by 3.4 (−6.9, -1.2) points. After ten sessions of acupuncture in Group B, the mean MI decreased by 31.3 (95%CI -45.0 to -17.6), whereas the median MASI decreased by 5.4 (−9.9, - 3.0) points. The first five sessions of acupuncture had a higher effect on the change in magnitude than the last five sessions, although there was no statistically significant difference. However, ten-session of acupuncture, had not reached the peak benefit on melasma yet. Further studies should be done with a higher number of sessions to determine the optimal rounds of treatment. Twenty-nine participants reported minor side effects, mostly consisting of persistent pain and small hematoma. Group B had RR of having adverse events 1.8 times (95% CI 1.0-3.4) compared to group A.ConclusionAcupuncture has a potential dose-response effect on clinical and patient-reported melasma outcomes with minor side effects.


2019 ◽  
Vol 7 (2) ◽  
pp. 232596711882545 ◽  
Author(s):  
Avinesh Agarwalla ◽  
Anirudh K. Gowd ◽  
Joseph N. Liu ◽  
Grant H. Garcia ◽  
Daniel D. Bohl ◽  
...  

Background: A longer operative time has been previously recognized as a risk factor for short-term complications after various orthopaedic procedures; however, it has yet to be investigated as an independent risk factor for postoperative complications after anterior cruciate ligament (ACL) reconstruction. Purpose: To identify whether a longer operative time in ACL reconstruction is an independent risk factor for the development of postoperative complications, hospital readmissions, or an extended length of stay within 30 days of the index procedure. Study Design: Descriptive epidemiology study. Methods: Patients undergoing ACL reconstruction between 2005 and 2016 were identified using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. Cases with concomitant procedures were excluded from the analysis. We evaluated the association between operative time and preoperative variables such as patient age, sex, body mass index, comorbidities, and procedure. Correlations between adverse events and operative time, while controlling for the above preoperative variables, were calculated using multivariate Poisson regression with robust error variance. Results: A total of 14,159 procedures were included in this investigation. The mean patient age was 32.6 ± 10.8 years, the mean body mass index was 27.7 ± 6.5 kg/m2, and the mean operative time was 89.7 ± 28.6 minutes. Patients who were between the ages of 18 and 30 years (mean operative time, 95.1 ± 27.8 minutes; relative risk [RR], 17.7; P < .001), male (mean operative time, 91.9 ± 28.3 minutes; RR, 4.7; P < .001), and nondiabetic (mean operative time, 89.8 ± 28.6 minutes; RR, 7.1; P = .011) were associated with a longer operative duration. The overall complication rate was 1.1%. After adjusting for demographic characteristics and procedures, 15-minute incremental increases in operative duration were associated with an increased risk of deep vein thrombosis (RR, 1.12; P = .042), surgical site infections (RR, 1.21; P = .001), and sepsis (RR, 1.66; P < .001) as well as increased readmission rates (RR, 1.23; P = .001) and an extended length of stay (RR, 1.18; P = .008). Conclusion: While the overall adverse risk rate after ACL reconstruction remains low, marginal increases in operative time are associated with an increased risk of adverse events such as deep vein thrombosis, surgical site infections, sepsis, an extended length of stay, and readmissions. Thus, the operating physician and surgical staff should make all efforts to coordinate and prepare for each case to maximize surgical efficiency.


2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Sophie A. Hamilton ◽  
Wisdom P. Nakanga ◽  
Josephine E. Prynn ◽  
Amelia C. Crampin ◽  
Daniela Fecht ◽  
...  

Abstract Background An epidemic of chronic kidney disease of unknown cause (CKDu) is occurring in rural communities in tropical regions of low-and middle-income countries in South America and India. Little information is available from Southern African countries which have similar climatic and occupational characteristics to CKDu-endemic countries. We investigated whether CKDu is prevalent in Malawi and identified its potential risk factors in this setting. Methods We conducted a cross-sectional study from January–August 2018 collecting bio samples and anthropometric data in two Malawian populations. The sample comprised adults > 18 years (n = 821) without diabetes, hypertension, and proteinuria. Estimates of glomerular filtration rate (eGFR) were calculated using the CKD-EPI equation. Linear and logistic regression models were applied with potential risk factors, to estimate risk of reduced eGFR. Results The mean eGFR was 117.1 ± 16.0 ml/min per 1.73m2 and the mean participant age was 33.5 ± 12.7 years. The prevalence of eGFR< 60 was 0.2% (95% confidence interval (95% CI) 0.1, 0.9); the prevalence of eGFR< 90 was 5% (95% CI =3.2, 6.3). We observed a higher prevalence in the rural population (5% (3.6, 7.8)), versus urban (3% (1.4, 6.7)). Age and BMI were associated with reduced eGFR< 90 [Odds ratio (OR) (95%CI) =3.59 (2.58, 5.21) per ten-year increment]; [OR (95%CI) =2.01 (1.27, 3.43) per 5 kg/m2 increment] respectively. No increased risk of eGFR < 90 was observed for rural participants [OR (95%CI) =1.75 (0.50, 6.30)]. Conclusions Reduced kidney function consistent with the definition of CKDu is not common in the areas of Malawi sampled, compared to that observed in other tropical or sub-tropical countries in Central America and South Asia. Reduced eGFR< 90 was related to age, BMI, and was more common in rural areas. These findings are important as they contradict some current hypothesis that CKDu is endemic across tropical and sub-tropical countries. This study has enabled standardized comparisons of impaired kidney function between and within tropical/subtropical regions of the world and will help form the basis for further etiological research, surveillance strategies, and the implementation and evaluation of interventions.


2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
I. W. M. van Uden ◽  
A. G. W. van Norden ◽  
K. F. de Laat ◽  
L. J. B. van Oudheusden ◽  
R. A. R. Gons ◽  
...  

Introduction. Late onset depressive symptoms (LODSs) frequently occur in elderly with cerebral small vessel disease (SVD). SVD cannot fully explain LODS; a contributing factor could be amygdala volume. We investigated the relation between amygdala volume and LODS, independent of SVD in 503 participants with symptomatic cerebral SVD.Methods. Patients underwent FLAIR and T1 scanning. Depressive symptoms were assessed with structured questionnaires; amygdala and WML were manually segmented. The relation between amygdala volume and LODS/EODS was investigated and adjusted for age, sex, intracranial volume, and SVD.Results. Patients with LODS had a significantly lower left amygdala volume than those without (P=0.02), independent of SVD. Each decrease of total amygdala volume (by mL) was related to an increased risk of LODS (OR=1.77; 95% CI 1.02–3.08;P=0.04).Conclusion. Lower left amygdala volume is associated with LODS, independent of SVD. This may suggest differential mechanisms, in which individuals with a small amygdala might be vulnerable to develop LODS.


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