scholarly journals Efficacy and Safety Profile of Intra-Articular Administration of Jointex® in Patients Suffering from Symptomatic Hip Osteoarthritis: An Open, Prospective Study with a 12-Month Follow-up

2011 ◽  
Vol 9 (3) ◽  
pp. 269-276 ◽  
Author(s):  
A. Migliore ◽  
U. Massafra ◽  
E. Bizzi ◽  
F. Vacca ◽  
L.S. Martin-Martin ◽  
...  
Keyword(s):  
Prospective Study ◽  
Safety Profile ◽  
Hip Osteoarthritis ◽  
Efficacy And Safety ◽  
Open Prospective Study

scholarly journals Duration of the efficacy of omalizumab after treatment discontinuation in ‘real life’ severe asthma

Thorax ◽  
2017 ◽  
Vol 73 (8) ◽  
pp. 782-784 ◽  
Author(s):  
Maria del Carmen Vennera ◽  
Carlos Sabadell ◽  
Cesar Picado
Keyword(s):  
Prospective Study ◽  
Asthma Control ◽  
Severe Asthma ◽  
Asthma Exacerbation ◽  
Real Life ◽  
First Year ◽  
Severe Asthma Exacerbation ◽  
Optimal Duration ◽  
Open Prospective Study

Efficacy of omalizumab in severe asthma is well documented; however, the optimal duration of the treatment remains unclear. In an open prospective study, we sought to assess the persistence of response in subjects withdrawing from omalizumab treatment. We evaluated 49 patients who voluntarily accepted to discontinue omalizumab treatment after 6 years of therapy. Asthma relapse was defined as any severe asthma exacerbation associated with loss of asthma control. Twelve patients relapsed in the first year of follow-up, and 7 within 13 and 48 months. These results suggest that the effects of 6 years of omalizumab may persist after discontinuation of therapy in 60% of patients for at least 4 years.

Efficacy and Safety of Clinical Use of Etanercept for the Treatment of Moderate-to-Severe Psoriasis in Spain: Results of a Multicentric Prospective Study at 12 Months Follow-Up

Dermatology ◽  
2012 ◽  
Vol 225 (3) ◽  
pp. 220-230 ◽  
Author(s):  
Lluís Puig ◽  
Francisco Miguel Camacho Martínez ◽  
Enrique Gimeno Carpio ◽  
Angel López-Ávila ◽  
Carmen García-Calvo
Keyword(s):  
Prospective Study ◽  
Severe Psoriasis ◽  
Clinical Use ◽  
Efficacy And Safety

Results of open prospective study of clinical assessment of efficacy and safety of Nifuratel during exacerbations of recurrent cystitis

2021 ◽  
pp. 20-24
Author(s):  
Z. V. Moskvina ◽  
M. S. Evdokimov ◽  
L. G. Spivak
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Prospective Study ◽  
Clinical Assessment ◽  
Lower Urinary Tract ◽  
Efficacy And Safety ◽  
Lower Urinary Tract Infection ◽  
Open Prospective Study ◽  
Recurrent Cystitis ◽  
Lower Urinary

The article presents the results of an open prospective study of the clinical assessment of the efficacy and safety of the use of nifuratel during exacerbations of recurrent cystitis. The aim of the program was to assess the change in the duration of the relapse-free course of recurrent cystitis and the effectiveness of the course treatment with Nifuratel-SZ in the treatment of recurrent cystitis. During a non-interventional program, Nifuratel-SZ has been shown to be an effective and well-tolerated drug for the treatment of recurrent uncomplicated lower urinary tract infection.

Stable Migration Pattern of an Ultra-Short Anatomical Uncemented Hip Stem: A Prospective Study with 2 Years Radiostereometric Analysis Follow-Up

2017 ◽  
Vol 27 (3) ◽  
pp. 259-266 ◽  
Author(s):  
Ahmed Nageeb Mahmoud ◽  
Uldis Kesteris ◽  
Gunnar Flivik
Keyword(s):  
Prospective Study ◽  
Hip Arthroplasty ◽  
Hip Osteoarthritis ◽  
Substantial Improvement ◽  
Migration Pattern ◽  
Implant Design ◽  
Radiostereometric Analysis ◽  
Early Results ◽  
Early Migration

Introduction Shorter, anatomically shaped and proximally loading stems have been developed to achieve better stress distribution and be more bone preserving. The purpose of this prospective study was to evaluate the migration pattern of the Proxima™ ultra-short uncemented stem using radiostereometric analysis (RSA), and to review the literature regarding the migration of short stemmed hip arthroplasty. Methods 25 patients (28 hips) with hip osteoarthritis received a Proxima stem during total hip arthroplasty (THA). To measure stem migration, repeated RSA examinations were done during a 2 year follow up period. The patients were evaluated with the hip specific (HOOS) and the generic health (EQ5D) scores up to 1 year, and clinically for 6 years postoperatively. Results Almost all migration occurred within the first 3 months, with mean subsidence of 0.22 mm and varus rotation of 1.04°, being the primary effect variables. After the third postoperative month and up to the 2 year RSA follow up no further significant migration occurred. The outcome scores showed substantial improvement after 1 year. No revisions were performed or indicated for any stem after a mean clinical follow up of 72.1 months. Conclusions Like many other uncemented stems, the Proxima showed early migration up to 3 months hereafter osseointegration seems to have occurred. The achieved stability and clinical outcomes indicate favorable early results for this stem in younger patients who have good bone quality and average BMI. We found, however, the surgical technique to be slightly more demanding compared to conventional stems owing to the unique implant design that necessitates specific adjusted femoral cutting and broaching procedures.

scholarly journals Ixazomib-Based Frontline Therapy in Patients with Newly Diagnosed Multiple Myeloma in Real-Life Practice Showed Comparable Efficacy and Safety Profile with Those Reported in Randomized Clinical Trials: A Multi-Center Study in China

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3181-3181
Author(s):  
Jing Li ◽  
Li Bao ◽  
Zhong-jun Xia ◽  
Sili Wang ◽  
Xin Zhou ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Safety Profile ◽  
Phase 1 ◽  
Real Life ◽  
Routine Practice ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Frontline Therapy ◽  
Grade 3

Jing Li, Li Bao and Zhong-jun Xia contributed equally to this study. Background: Ixazomib (ixa) is the first oral proteasome inhibitor that approved for the use in patients with relapsed/refractory multiple myeloma (RRMM) in > 60 countries. In a recently reported long-term result of a phase 1/2 study (NCT01217957), the all-oral triplet regimen of ixazomib plus Rd (IRd) demonstrated favorable efficacy with acceptable toxicity in patients with newly diagnosed MM (NDMM). Meanwhile, a large phase 3 trial (TOURMALINE-MM2, NCT01850524) evaluating IRd in stem-cell transplantation (SCT) ineligible NDMM patients is ongoing. However, outcomes and toxicity profiles of novel-agent-based MM therapies in real world practice often differ from data reported in clinical trials and data of the efficacy of ixa-based treatment in NDMM in routine practice is currently missing. Aims and Methods: To assess the efficacy and safety profile of ixa-based frontline therapy in NDMM patients in routine practice, we performed a large national, multi-center, observational study enrolling ixa-treated (at least one cycle completed) NDMM patients from 14 China centers. Clinical records on demographics, disease characteristics, treatment regimen and duration, response rate, adverse events (AEs), and treatment discontinuations and survival were collected and analyzed. Results: A total of 60 NDMM patients treated with ixa-based regimens were included. Ixa-based regimens included IRd in 23 (38.3%) patients, the ixa and dexamethaxone (Id) in 17 (28.3%) patients and Id plus chemotherapeutics/other agents (Adriamycin in 12 patients, cyclophosphamide in 5 patients, and thalidomide in 3 patients) in 20 (33.3%). None of the patients included received SCT during follow-up. Median age was 69 years (range 35 - 85) with 33 (55.0%) ≥65 years. At initial diagnosis, ISS stage I/II/III disease were presented in 21.7%/28.3%/50.0% patients at initial diagnosis; high-risk cytogenetic abnormalities (including del 17p, t(4;14), and/or t(14;16) detected by fluorescence in situ hybridization) were detected in 9 patients (19.6%, among 46 patients with FISH results). Twenty-six (43.4%) patients had a ECOG PS ≥2 and 5 patients (8.3%) had extramedullary disease. Eighteen patients were not eligible for ixa phase 1/2 study (NCT01217957) according to its inclusion and exclusion criteria, and even more patients (36, 60%) were not eligible for TOURMALINE-MM2 study. (Table1). The best confirmed ORR (partial response or better) for all 60 patients was 93.3% (56/60), including 63.3% of patients with ≥VGPR and 20.0% with a CR. The median time to response was 41 days. Similar response was observed among different subgroups: the ORR in Ixa phase1/2 study-eligible/ineligible group, MM2 trial- eligible/ineligible group and patients with standard/high-risk cytogenetics was 95.2%, 88.9%, 91.7%, 94.4%, 91.9% and 100.0%, respectively. And no significant difference in response between different ixa-based regimens was observed. After a median follow-up of 137.5 days after the first dose of ixazomib treatment (range, 28 - 372), median overall survival (mOS) and progression-free survival (mPFS) were not reached. (Table2) Adverse events (AEs) of grade 3 or higher were uncommon, reported in 14 (23.3%) patients, including thrombocytopenia (4 patients, 6.7%), diarrhea (5 patients, 8.3%), pneumonia (3 patients, 5.0%) and hypokalemia (1, 1.7%). No drug-related grade 3/4 peripheral neuropathy was recorded. Median cycles of ixa received were 4 cycles (range 1-11); 50 (83.3%) were still on treatment at data cut-off; 6 (10.0%) patients discontinued ixa due to intolerable AEs and 4 (6.7%) stop treatment for other reasons (mostly economic concerns). Discussion and conclusion: Here we reported the first real world, multi-center data on the efficacy and safety profile of ixa-based frontline therapy in patients with NDMM. Our results show that the ixa-based frontline therapy in real-life clinical practice is highly effective and fast in response, with an efficacy data (ORR 93.3%, ≥VGPR rate 63.3%) even better than that reported in NCT01217957 trial (ORR 88.0%, ≥VGPR rate 58.8%). Given the fact that no patients received SCT during follow-up in our cohort, our results maybe more comparable to the ongoing MM2 trial assessing SCT-ineligible NDMM. Ixa-based frontline therapy is well tolerated in NDMM patients treated in routine clinical practice. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: Ixazomib is an oral proteasome inhibitor that approved for the use in patients with relapsed/refractory multiple myeloma (RRMM). Here in this abstract, I will present data on real-life practice of the use of ixazomib in newly diagnosed multiple myeloma.

scholarly journals The efficacy and safety of intra-articular application of a combination of sodium hyaluronate and chondroitin sulfate for osteoarthritis of the knee: a multicenter prospective study

2020 ◽  
Vol 92 (5) ◽  
pp. 46-54
Author(s):  
L. I. Alekseeva ◽  
N. G. Kashevarova ◽  
E. A. Taskina ◽  
E. P. Sharapova ◽  
S. G. Anikin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Prospective Study ◽  
Womac Pain ◽  
Efficacy And Safety ◽  
Knee Oa ◽  
Grade Ii ◽  
Multicenter Prospective Study

in 3 mL on patients with knee osteoarthritis (OA) in a multicenter prospective study. Materials and methods. 79 outpatients (predominantly females 81.0%) from 5 RF constituent territories with primary tibiofemoral KellgrenLawrence score grade II or III knee OA, 40 mm pain intensity during walking on visual analogue scale (VAS), requiring NSAIDs intake (for at least 30 days during 3 months prior to enrollment) were included into the study after signing the informed consent form. Mean age was 60.38.7 years, mean BMI 29.24.7 kg/m2, disease duration 6 (310) years. Grade II OA was documented in 68.4% of patients, Grade III in 31.6%. The study lasted for 6 months. Efficacy and safety evaluations were made based on VAS pain assessment, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [WOMAC pain (0500), WOMAC function (01700), WOMAC stiffness (0200)], VAS patients health status, EQ-5D-based assessment of patients quality of life, global physicians and patients efficacy assessment, and daily NSAIDs requirements. Results. Obtained results demonstrate statistically significant VAS pain reduction during walking already in 1 week after intra-articular injection of the combination [respectively, 62 (5572) and 41 (3251) mm, р0.0001]. Moreover, pain continued to subside during all 3 months of follow up [in 1 month 28 (2042), in 3 month 22 (1437) mm]. A significant pan reduction achieved at Mo 3 persisted until Mo 6 20 (1442) mm, without documented pain increase. Similar trends were observed with total WOMAC score [1125 (8991540) at baseline, and 552 (309837) mm by the end of the study, p0.0001], and all WOMAC sub-scores [268 (189312) baseline WOMAC pain, 91 (48171) mm by the end of the study p0.0001; stiffness 101 (59130) and 40 (2061) mm, p0.0001; function 802 (6471095) and 402 (191638) mm, p0.0001, respectively]. Median time to the onset of therapeutic effect was 7 (518) days. Statistically significant improvement of patients quality of life by EQ-5D and general health status was observed during all follow up period [respectively, 0.52 (-0.020.59) and 0.69 (0.590.80), р0.0001; 48 (3060) and 72 (6080) mm, р0.0001]. One injection of the drug resulted in dose reduction or discontinuation of NSAIDs therapy: at baseline 76 patients (96.2%) were taking NSAIDs, in one week 31 (39.2%) patients discontinued NSAIDs, in 1 month 72.2%, in 3 months 73.4%, and by the end of the study at Mo 6 54.4% were not taking NSAIDs. These data were consistent with physicians and patients global assessment of the efficacy of treatment, who stated significant improvement and improvement in the majority of cases, with only few no effect or worsening cases documented in analyzed population. Adverse events, such as worsening of pain and/or swelling of the joint, were documented in 8 patients (10.1%); they resolved spontaneously or following NSAIDs intake. Conclusion. These results suggest that intra-articular injections of hyaluronic acid plus chondroitin sulfate in patients with knee OA are efficient and safe. A single injection of the drug resulted in statistically significant reduction of pain and stiffness, reduction in NSAIDs intake, as well as improvement in patients quality of life and function.

scholarly journals Analysis of the efficacy and safety of eribulin therapy in patients with HR+/HER2- metastatic breast cancer pretreated with CDK4/6 inhibitors in real Russian practice

2021 ◽  
Vol 23 (1) ◽  
pp. 68-76
Author(s):  
Irina V. Kolyadina ◽  
Natalia R. Abidova ◽  
Arshak A. Akopyan ◽  
Galina V. Antonova ◽  
Oksana I. Arapova ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Observational Study ◽  
Safety Profile ◽  
Endocrine Resistance ◽  
Metastatic Breast ◽  
Efficacy And Safety ◽  
Therapy Regimen ◽  
Response To Chemotherapy

Relevance. Data on the efficacy of endocrine and chemotherapy regimens in patients with hormone-resistant metastatic breast cancer (mBC) after progression with CDK4/6 inhibitors are limited; the search for an effective therapy regimen in this clinical situation is an urgent task of clinical oncology. Aim. Evaluate the efficacy and safety of eribulin therapy in patients with HR+/HER2- mBC after progression with CDK4/6 inhibitors; compare the results of the Russian study and the EMPOWER observational study in the USA. Materials and methods. The Russian observational study included 54 patients (pts) with HR+/HER2- mBC, who were treated with eribulin after CDK4/6 inhibitors in 24 Russian Cancer hospitals. The median age of pts was 56 years; 75.9% of them had recurrent BC, 24.1% de novo BC stage IV; 51.9% of pts had progression with CDK4/6 inhibitors in the first 6 months of therapy (primary endocrine resistance); 48.1% of patients had progression in the period from 6 to 38 months; 89.1% had visceral site of metastases (liver MTS 65.5%, lung MTS 52.8%, brain MTS in 7.5%). Eribulin was used after anthracyclines and taxanes in 94.4% of cases. The efficacy and safety of eribulin therapy in patients with HR+/HER2- mBC after progression with CDK4/6 inhibitors was studied, as well as subgroup analysis according to age, sites of metastasis, and previously treatment options. Results. Eribulin was prescribed in the standard regimen of 1.4 mg/m2 on days 1 and 8, the interval between cycles was 21 days, the number cyclys of chemotherapy was 144 (median 8, the mean number of cycles 10.5). With a median follow-up of 11.5 months (from 3 to 36 months), 30 patients (55.6%) continue therapy with eribulin at present; therapy was cancelled in 24 patients due to progression in 22 (40.7%) cases, and due to intolerable toxicity in 2 (3.7%) patients. The maximum response to eribulin therapy included partial response (in 11 cases, 24.4%), stable disease (in 30 cases, 66.7%) and progression in 4 (8.9%) patients. Median PFS with eribulin therapy was 10.0 months; the 6-month, 1-year, and 2-year PFS were 79.5%, 44.8% and 26.5%, respectively. Eribulin therapy was equally effective in different subgroups (p0.05) and did not depend on the age of patients, the previously received treatment, the presence of visceral MTS and liver damage. The best response to chemotherapy with eribulin was observed in lung metastases: median PFS 24 months vs 9.1 months, p=0.056. The safety profile was favorable; adverse events were registered in 34.5% of patients, which required dose adjustment in 18.5% of cases. With a median follow-up of 11.5 months, 92.6% of patients remain alive. Conclusion. Eribulin has demonstrated high efficacy and favorable safety profile in hormone-resistant HER2- mBC in patients with progression when receiving CDK4/6 inhibitor.

Sign in / Sign up

Export Citation Format

Share Document