scholarly journals Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

Author(s):  
Ilkka Rauma ◽  
Tiina Mustonen ◽  
Juha Matti Seppä ◽  
Maritta Ukkonen ◽  
Marianne Männikkö ◽  
...  

Abstract Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1–3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

2014 ◽  
Vol 86 (1) ◽  
pp. 15 ◽  
Author(s):  
Ali Abdel Raheem ◽  
Hassan El-Tatawy ◽  
Ahmed Eissa ◽  
Abdel Hamid Elbahnasy ◽  
Mohamed Elbendary

Objectives: Penile fracture with concomitant complete urethral disruption is an uncommon urologic disorder. Data about the treatment and outcome measurements of this condition are scarce in the literature. The aim of the present study is to evaluate the long term urinary and sexual functions of patients with penile fracture associated with complete urethral injury after immediate surgical reconstruction. Patients and methods: Twelve patients met our inclusion criteria and were included in this retrospective case series study; however, one was lost during follow-up. Patient's medical records were reviewed and all patients were interviewed for clinical evaluation. Urinary function was assessed by history, uroflometry and retrograde urethrography, while, sexual function was assessed by questionnaire (Sexual Health Inventory for Men) and penile Doppler for patients with erectile dysfunction. Results: Patients’ mean age was 32.3 ± 7.5 years (range 21-43) and the mean follow-up period was 72.6 ± 45.4 months (range 14-187). Vigorous sexual intercourse was the main cause in 91% of our patients. No serious long term complications was found. Only 1 patient (9%) suffered from anterior urethral stricture, 1 patient (9%) complained of weak erection, 3 patients (27%) had a palpable fibrosis and 2 patients (18%) reported a slight penile curvature during erection. Ninety one percent of all our patients maintained their normal urinary and sexual functions. Conclusion: On the long term follow-up, most of the patients maintained their normal erectile and voiding functions with no harmful long-term complications. We advocate immediate surgical intervention and reconstruction of both corpora cavernous and urethra as a first line treatment for those patients.


2012 ◽  
Vol 16 (3) ◽  
pp. 212-217 ◽  
Author(s):  
Nicolas Aubut ◽  
Jimmy Alain ◽  
Joël Claveau

Background: Intralesional methotrexate (IL-MTX) is an effective treatment for keratoacanthoma. Objective: We sought to determine the response rates and adverse events in KA treated with intralesional methotrexate. Methods: All cases of KA treated with intralesional methotrexate at our institutions from 2001 to 2009 were systematically reviewed. Results: Forty-six cases of KA treated with IL-MTX were identified. A complete resolution was achieved in 74% of patients, requiring an average of 1.8 injection sessions, for a mean total dose of 10 mg. Adverse events did not occur. Limitations: The follow-up period was short, and there was no histologic confirmation of the initial diagnosis. Conclusion: IL-MTX is an effective and well-tolerated alternative to surgery for the treatment of KA.


2020 ◽  
pp. 112070002090183
Author(s):  
Josko Jelicic ◽  
Antea Buterin ◽  
Goran Vrgoc ◽  
Zeljko Butorac ◽  
Anton Tudor ◽  
...  

Background: The modern indications for Chiari pelvic osteotomy (CPO) have narrowed and the number of such operations performed has diminished markedly. So far published long-term experience with CPO indicate the fact that in selected patients satisfactory functional results can be achieved. The aim of this study was to investigate the parameters which influence CPO survival and its conversion into total hip arthroplasty (THA). Methods: This is a single-centre retrospective case-series study. In the period from 1976 to 2012, it included 172 CPO in 158 patients. Of those, in 43 patients (48 hips) the follow-up was discontinued, leaving 115 patients (124 hips) for final analyses. The median age at the time of the surgery was 34 years, and the mean duration of the follow-up was 19 years. Results: In 115 patients (124 CPO) included in the study, a total of 51 THA was performed in 49 patients. The median period between CPO and THA was 14 years. Conclusion: Supporting our results, we suggest that CPO should still be indicated in a selected group of younger patients even with advanced stage of hip osteoarthritis who prefer a joint-conserving procedure and consent to a predicted less optimal outcome.


2018 ◽  
Vol 10 ◽  
pp. 175883401775163 ◽  
Author(s):  
John Shen ◽  
Jason Chang ◽  
Melody Mendenhall ◽  
Grace Cherry ◽  
Jonathan W. Goldman ◽  
...  

Background: The anti-programmed cell death-1 (PD-1) and anti-programmed cell death ligand-1 (PD-L1) immunotherapies have shown exceptional activity in many cancers. However, these immunotherapies can also result in diverse adverse cutaneous eruptions that need to be better characterized for ongoing management. The objective was to provide clinical and histopathologic descriptions of the variety of cutaneous adverse events seen in patients who received anti-PD-1/PD-L1 treatment and discuss their management. Methods: Patients with advanced cancers in clinical trials at University of California Los Angeles (UCLA), receiving anti-PD-1/PD-L1 treatment between 2012 and 2016 who developed cutaneous eruptions and were evaluated in the dermatology clinic were included in this retrospective case series study. A total of 16 patients were included in this study; of these, five were treated with pembrolizumab alone, two with avelumab alone, eight with nivolumab plus ipilimumab and one with nivolumab plus T-Vec. Of these 16 patients, eight had received systemic chemotherapy, six had received radiotherapy, and one had received trememlimumab prior to the immunotherapies described in this study. Results: Cutaneous eruptions occurred at variable times, from week 1 to 88, with a median of 11.5 weeks; the morphologies included lichenoid, bullous, psoriasiform, macular, morbiliform appearances, and alopecia which were confirmed histopathologically in several of the cases. All cutaneous immune-related adverse events were either grade 1 or 2. Ten patients were treated with topical corticosteroids, and one also received NBUVB. Four patients eventually required systemic steroids. Three required discontinuation of their anti-PD-1/PD-L1 therapy secondary to the cutaneous eruptions. Conclusions: There are several different types of adverse cutaneous morphologies that may be seen with administration of PD-1 and PD-L1 inhibitors. Identifying the patterns of eruption may assist in prompt treatment. Most eruptions could be managed with topical corticosteroids and without discontinuation of the systemic treatment.


2007 ◽  
Vol 13 (8) ◽  
pp. 975-980 ◽  
Author(s):  
E. Cocco ◽  
P. Marchi ◽  
C. Sardu ◽  
P. Russo ◽  
A. Paolillo ◽  
...  

We investigated the clinical and MRI effects of mitoxantrone (MITOX) administered to 45 patients during the first five years of highly active relapsing-remitting multiple sclerosis. Differences occurring between the end of treatment and follow-up (clinical mean: 3.6 years; brain MR: 1.8 years) with respect to baseline variables (EDSS, annualized relapse rate, active T2 lesions, new T1 lesions and number of Gd-enhancing lesions) were analysed using parametric and non-parametric tests. One patient developed leukemia four months after the end of the treatment; no other serious adverse events occurred during treatment and the follow-up period. A clinically relevant reduction in the annualized relapse rate ( P < 0.0001 at end of treatment and P < 0.0001 at follow-up) and improvement in the EDSS ( P < 0.0001 at end of treatment and P = 0.0005 at follow-up) was found. At the end of treatment, 53% of patients experienced no increase in active T2 lesions, while 73% showed no increase in the number of new T1 lesions. At follow-up, 41 out of 45 (91%) patients showed a stable MRI pattern and were active-scan free. Despite potential serious adverse events, MITOX may be considered an option in selected patients with very active early MS. Multiple Sclerosis 2007; 13: 975—980. http://msj.sagepub.com


2021 ◽  
Vol 11 (10) ◽  
pp. 1341
Author(s):  
Marco Allinovi ◽  
Angelo Bellinvia ◽  
Francesco Pesce ◽  
Sabrina Milan Manani ◽  
Lorenzo Razzolini ◽  
...  

(1) Background: Complement system activation has been proposed as one of the different factors that contribute to Multiple Sclerosis (MS) pathogenesis. In this study, we aimed to describe the potential effects of eculizumab, an anticomplement therapy, on MS disease activity in a cohort of relapsing–remitting (RR) MS patients who discontinued IFN-β therapy due to IFN-β-related thrombotic microangiopathy (TMA) onset. (2) Methods: In this retrospective observational multicentric study, we searched for all patients with MS treated by eculizumab with a survey of several nephrological and neurological centers (over 45 centers). (3) Results: Nine patients were included. The mean follow-up time under eculizumab was 3.72 ± 2.58 years. There were no significant differences in disease activity (EDSS, relapses, new T2, and/or Gd-enhancing lesions at MRI) considering the two years before and after eculizumab therapy. No adverse events potentially related to eculizumab therapy were reported during follow-up. (4) Conclusions: In this preliminary study, we described a good safety profile for eculizumab therapy in MS. However, the available data are not sufficient to make firm conclusions about the possible efficacy of eculizumab as a disease-modifying therapy for MS patients.


PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0256878
Author(s):  
Shumpei Obata ◽  
Taku Imamura ◽  
Masashi Kakinoki ◽  
Takahide Yanagi ◽  
Yoshihiro Maruo ◽  
...  

Purpose To evaluate systemic adverse events after screening for retinopathy of prematurity (ROP) performed with mydriatic. Methods This was a retrospective case series study. Medical records of consecutive patients who underwent screening for ROP with 0.5% phenylephrine and 0.5% tropicamide eyedrops were retrospectively reviewed. The score of abdominal distention (0–5), volume of milk sucked and volume of stool, along with systemic details (pulse and respiration rates, blood pressure and number of periods of apnea) were collected at 1 week and 1 day before ROP examination, and at 1 day after examination. Results were compared between the days before and after examination. Correlation between body weight at the time of examination and the score of abdominal distention was examined. The numbers of infants with abdominal and/or systemic adverse events were compared between pre- and post-examination periods. Results Eighty-six infants met the inclusion criteria. The score of abdominal distention increased from 2.0 at 1 day before examination to 2.3 at 1 day after examination (p = 0.005), and the number of infants who had worsened abdominal distension increased after examination (p = 0.01). Infants with lower body weight had a higher score of abdominal distention (p < 0.0001, r = −0.57). The number of infants with reduced milk consumption increased after examination (p = 0.0001), as did the number of infants with decreased pulse rate (p = 0.0008). Conclusions Screening for ROP with mydriatic may have adverse effects on systemic conditions. Infants should be carefully monitored after ROP screening with mydriatic.


2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Yingru Chen ◽  
Yigong Fang ◽  
Jinsheng Yang ◽  
Fei Wang ◽  
Yingying Wang ◽  
...  

To investigate the effect of acupuncture on women with premature ovarian failure (POF), prospective consecutive case series study was applied. 31 women with POF were included; all patients were treated with acupuncture once every other day, three times a week for three months. Acupoints, GV 20, GV 24, GB 13, CV 3, CV 4, BL 23, BL 32, ST 25, ST 28, ST 29, ST 36, SP 6, KI 3, and LR 3, were selected. Serums FSH, E2, and LH level, Self-Rating Anxiety Scale (SAS), and Kupperman score were measured at baseline and at the end of treatment; the menstrual cycle was recorded during one-month follow-up. Compared with baseline, patients’ serums FSH and LH were decreased, E2was increased, and SAS score and Kupperman score were decreased. Four patients resumed menstrual cycle after treatment and two resumed during follow-up. No serious adverse events were found in all patients. The results indicate that acupuncture may decrease serums FSH and LH level, raise serum E2level, relieve anxiety, reduce mental stress, and improve the menopausal symptoms.


PEDIATRICS ◽  
1995 ◽  
Vol 95 (3) ◽  
pp. 345-349
Author(s):  
Robert L. Davis ◽  
Michael Hughes ◽  
K. Dean Gubler ◽  
Patti L. Waller ◽  
Frederick P. Rivara

Objective. Recent evidence suggests that patients with a normal cranial CT scan after head injury can be safely discharged home from the emergency department. However, supporting data from previous studies has relied on incomplete patient follow-up. We utilized a statewide comprehensive hospital abstract reporting system (CHARS) to assess whether children with normal CT scans after head injury subsequently developed intracranial sequelae in the month following their initial injury. Design. Retrospective case-series study, with comprehensive statewide follow-up for 1 month. Setting. The emergency department of a Level 1 Trauma Center in Seattle, Washington. Participants. All children (n = 400) with head injury, Glasgow Coma Score of 13 to 15, and initial normal CT scan seen over a 4.5-year time period. All were matched against CHARS to evaluate admissions within 30 days after emergency department disposition. For readmissions, International Classification of Diseases (9th revision) discharge and procedure information was collected. All children were also matched against the state death files. Results. Four children were readmitted for neurologic reasons within 1 month following injury. One child on coumadin for heart disease developed a symptomatic subdural hematoma 5 days after head injury, requiring neurosurgical drainage. One child developed a symptomatic hemorrhagic contusion 3 days after injury, requiring observation only. Two children were readmitted 1 day after injury for concussive symptoms; both were discharged home after observation only. There were no deaths among the study population. Conclusions. Among children with a normal cranial CT scan after mild head injury, delayed intracranial sequelae requiring intervention are extremely uncommon. In otherwise stable patients, a normal cranial CT scan can identify patients to be safely discharged from the emergency department, and would be more cost-effective than 1 to 2 days of hospital observation.


Author(s):  
Ahmed Mourad ◽  
Hussein Jaffal ◽  
Ismaeel El-Hakim ◽  
Hamdy El-Hakim

Abstract Background Inferior turbinoplasty (IT) and adenoidectomy (Ad) are frequently resorted to in children with chronic rhinitis (CR) refractory to medical therapy. The aim of this study is to document the long-term improvement in quality of life (QOL) in children with CR following endoscopic IT with or without Ad. Methods A retrospective case series study was conducted. We searched a prospectively kept surgical database for children ≤18 years old who had CR who underwent endoscopic IT with or without Ad between 2009 and 2016 at a tertiary care children’s center. Patients with sinonasal pathologies other than CR, had craniofacial syndromes or dysmorphism and had other sinonasal procedures or trauma were excluded. Collected data included demographics, secondary diagnoses, duration of follow-up, and complications of procedures. The Glasgow Children’s Benefit Inventory (GCBI) was administered by phone to assess QOL improvement. Results One hundred sixty-five eligible subjects were identified. Eighty-nine subjects met the inclusion criteria. Data was collected for the 60 subjects that were reached. Forty-two patients had IT only while 18 had IT and Ad. The mean age was 10.7 ± 2.7 years, with 31 males and 29 females. The median duration of follow-up (25th, 75th percentile) was 38.1 months (24.6, 55.8). The median GCBI score (25th, 75th percentile) was 22.9 (6.3, 39.6) revealing an overall positive benefit in all domains. There was only one complication. Conclusions This study validates prior findings regarding improvement of QOL and safety of IT with or without Ad for children with CR and indicates it is maintained in the long term.


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