Comparison of Combined Bevacizumab plus Dexamethasone Vs. Ranibizumab Monotherapy as First-Line Therapy in Patients with Treatment Naive Neovascular Age-Related Macular Degeneration in Real-Life Clinical Practice: A Retrospective Case-Series Analysis

Purpose: To assess the 13-month effectiveness and safety of aflibercept in naïve patients with neovascular age-related macular degeneration (nvAMD) in a real-life clinical setting. Methods: Thirty-two treatment-naïve patients with nvAMD participated in a prospective two-center study. Patients received intravitreal injections of aflibercept (Eylea®), a loading dose of three monthly injections (2 mg/0.05 ml) every 4 weeks for the first 3 months, followed by intravitreal injections every 2 months. Results: At 3 and 13 months, the mean best-corrected visual acuity improved significantly as compared with baseline (logMAR 0.53 ± 0.30 and 0.55 ± 0.32 vs. 0.30 ± 0.24, respectively, p < 0.001). At 3 and 13 months, 46.8% of patients (15/32) gained ≥15 ETDRS letters. The mean decrease in central macular thickness was also significant at 3 months (252 ± 35 µm) and at 13 months (249 ± 38 µm) as compared with pretreatment values (383 ± 76 µm) (p < 0.01). Also, 50% resolution of pigment epithelial detachment (PED) was observed in 8 out of 9 eyes (88.9%) with PED at baseline. Intravitreal injections were well tolerated and no adverse events were recorded. Conclusion: Aflibercept was effective and safe for treating nvAMD in naïve patients in routine daily practice.

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Four-Year Outcome of Aflibercept Treatment-Naïve Patients for Neovascular Age-Related Macular Degeneration: Evidence from a Clinical Setting

Journal of Ophthalmology ◽

10.1155/2020/7465270 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Yanel Gayadine-Harricham ◽

Virginie Rufin ◽

Sandrine Law-Koune ◽

Thi Ha Chau Tran

Keyword(s):

Macular Degeneration ◽

Clinical Setting ◽

Real Life ◽

Case Series ◽

Analysis Data ◽

Age Related Macular Degeneration ◽

Age Related ◽

Treatment Naïve ◽

Number Of Injections

Introduction. The objective of the study is to report 4-year treatment outcome with intravitreal Aflibercept injections for neovascular age-related macular degeneration (nAMD) as first life therapy in real-life. Patients and Methods. This is a prospective, monocenter, observational case series analysis. Data from treatment-naïve patients with nAMD with at least 4 years of follow-up were included in the analysis. Data including age, gender, and visual acuity measured on Early Treatment of Diabetic Retinopathy Study charts (ETDRS) and injection numbers were recorded. Spectral domain optical coherence tomography (SD-OCT) data at baseline, month 3, month 6, month 12, year 2, 3, and 4 were also recorded. Patients were treated with a modified treat and extend (T&E) regimen. Results. Of the 48 eyes with nAMD treated, only 31 eyes were available at the 4-year follow-up. The mean age was 81 ± 8 years. The VA gain was 7.3 ± 12.7 letters at 1 year 6.5 ± 12.5 letters at 2 years, VA gain 5.2 ± 17 letters at 3 years, and 6.2 ± 18.6 letters at 4 years. The reduction of central retinal thickness was 118 ± 187 μm at 4 years. Complete resolution of fluid was obtained in 18/31 eyes. The total number of injections was 5.7 ± 2.0 during the first year, 2.9 ± 2.9 during the second year, 3.5 ± 3.3 during the third year, and 4.0 ± 3.4 during the fourth year. The total number of injections was 16 ± 10.6, ranging from 3 to 52 injections. Ten eyes developed macular atrophy over the 4-year period. Conclusion. The results suggest that good long-term morphological and functional outcome can be achieved using Aflibercept in clinical setting.

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Nintedanib Treatment for Idiopathic Pulmonary Fibrosis Patients Who Have Been Switched from Pirfenidone Therapy: A Retrospective Case Series Study

Journal of Clinical Medicine ◽

10.3390/jcm9020422 ◽

2020 ◽

Vol 9 (2) ◽

pp. 422 ◽

Cited By ~ 1

Author(s):

Andrea Vianello ◽

Francesco Salton ◽

Beatrice Molena ◽

Cristian Turato ◽

Maria Laura Graziani ◽

...

Keyword(s):

Idiopathic Pulmonary Fibrosis ◽

Pulmonary Fibrosis ◽

Disease Progression ◽

Safety Profile ◽

Real Life ◽

Case Series ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Case Series Study

Background: The efficacy and effectiveness of nintedanib as a first-line therapy in idiopathic pulmonary fibrosis (IPF) patients have been demonstrated by clinical trials and real-life studies. Our aim was to examine the safety profile and effectiveness of nintedanib when it is utilized as a second-line treatment in subjects who have discontinued pirfenidone. Methods: The medical charts of 12 patients who were switched from pirfenidone to nintedanib were examined retrospectively. The drug’s safety was defined by the number of adverse events (AEs) that were reported; disease progression was evaluated based on the patient’s vital status and changes in forced vital capacity (FVC) at 12-month follow-up. Results: The numbers of patients experiencing AEs and of the AEs per patient in our study group didn’t significantly differ with respect to a group of 56 individuals who were taking nintedanib as a first-line therapy during the study period (5/12 vs. 22/56; p = 0.9999, and 0.00 (0.00–1.00) vs. 0.00 (0.00–3.00); p = 0.517, respectively). Two out of the 3 patients who had been switched to nintedanib due to a rapid disease progression showed stabilized FVC values. Conclusions: Nintedanib was found to have an acceptable safety profile in the majority of the IPF patients switched from pirfenidone. Prospective studies are warranted to determine if the drug can effectively delay disease progression in these patients.

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Different Outcomes of Anti-VEGF Treatment for Neovascular AMD according to Neovascular Sutypes and Baseline Features: 2-Year Real-Life Clinical Outcomes

BioMed Research International ◽

10.1155/2021/5516981 ◽

2021 ◽

Vol 2021 ◽

pp. 1-5

Author(s):

Alessandro Arrigo ◽

Andrea Saladino ◽

Emanuela Aragona ◽

Stefano Mercuri ◽

Ugo Introini ◽

...

Keyword(s):

Primary Outcome ◽

Real Life ◽

Case Series ◽

Visual Outcome ◽

Age Related Macular Degeneration ◽

Retrospective Case ◽

Anti Vegf ◽

Age Related ◽

Life Analysis

Purpose. To evaluate the effects of anti-VEGF treatment of neovascular age-related macular degeneration (nAMD) in a real-life clinical setting. Methods. Study design is a retrospective case series. Naïve nAMD patients treated with intravitreal injection of aflibercept or ranibizumab were analyzed over a 24-month follow-up. Each patient received the loading dose, followed by a PRN regimen. Patients were further subdivided into subgroups according to macular neovascularization type, best corrected visual acuity (BCVA) at baseline ( BCVA > 0.3 LogMAR and BCVA ≤ 0.3 LogMAR ), and different anti-VEGF drugs. Primary outcome was the changes in BCVA and central macular thickness (CMT) over 24 months. Secondary outcomes included the influence of the selected drug and of the baseline BCVA on the final outcomes. Results. 439 patients (224 males; 51%) with naïve AMD-related macular neovascularization were included in the analyses. Mean age was 78 ± 8 years old. Compared to baseline evaluations, not significant BCVA changes were found at 1-year and 2-year examinations. CMT was significantly reduced at both 1-year and 2-year follow-ups ( p < 0.01 ). Classic, polypoidal choroidal vasculopathy and mixed subtypes significantly correlated with worse visual outcome ( p < 0.01 ). Overall, baseline BCVA significantly correlated with both 1-year and 2-year follow-up changes ( p < 0.01 ). Moreover, BCVA at 1-year significantly correlated with BCVA changes at 2-year follow-up ( p < 0.01 ). Furthermore, CMT changes from baseline significantly correlated with both 1-year and 2-year follow-up measurements ( p < 0.01 ). Conclusion. Anti-VEGF approach is generally effective in stopping nAMD progression in our real-life analysis. No difference was found comparing patients treated with ranibizumab and aflibercept, nor in patients with drug switching.

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Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study

European Journal of Ophthalmology ◽

10.1177/11206721211005703 ◽

2021 ◽

pp. 112067212110057

Author(s):

Pierre Gascon ◽

Prithvi Ramtohul ◽

Charles Delaporte ◽

Sébastien Kerever ◽

Danièle Denis ◽

...

Keyword(s):

Macular Degeneration ◽

Real Life ◽

Age Related Macular Degeneration ◽

Cumulative Number ◽

Treat And Extend ◽

Treatment Interval ◽

Age Related ◽

Treatment Naïve ◽

The Mean

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.

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One-year outcomes of fixed-dosing Aflibercept therapy for pre treated and naive polypoidal choroidal vasculopathy patient

BMC Ophthalmology ◽

10.1186/s12886-021-01829-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Hun Gu Choo ◽

Jin Hae Lee ◽

Hyun Sub Oh ◽

Soon Hyun Kim ◽

Yong Sung You ◽

...

Keyword(s):

Polypoidal Choroidal Vasculopathy ◽

Vision Loss ◽

Case Series ◽

Age Related Macular Degeneration ◽

Research Information ◽

Age Related ◽

Case Series Study ◽

Treatment Naïve ◽

One Year ◽

Choroidal Vasculopathy

Abstract Background Polypoidal choroidal vasculopathy (PCV) is a type of age-related macular degeneration that can cause permanent vision loss. The purpose of this paper was to report the one-year outcomes of fixed-dosing aflibercept therapy for the treatment of PCV. Methods This was a prospective, single-arm, interventional case series study of 25 PCV patients; 12 pre-treated and 13 treatment-naïve patients. The patients were treated and monitored for 12 months. Each patient was administered with an aflibercept (2.0 mg) injection every month for the first 3 months (the loading phase), and thereafter, once every 2 months. At every follow-up visit, best-corrected visual acuity (BCVA) test, fundus examination, and optical coherence tomography for measuring the central subfield macular thickness (CSMT) were performed. Fluorescein and indocyanine green angiography were conducted at baseline and at 4 and 12 months. Results After 12 months of aflibercept therapy, the mean BCVA of the patients significantly improved from 65.48 letters at baseline to 69.91 letters (p=0.001), and the CSMT significantly decreased from 406.92 um at baseline to 276.12 um (p< 0.001). Additionally, ten patients (40%) showed complete polyp regression. The treatment-naïve patients showed a statistically significant improvement in BCVA from 66.58 letters at baseline to 76.36 letters at 12 months, and a significant decrease in CSMT, from 462 to 243 um. In the pre-treated group, there was no change in BCVA (64.46 letters), and the decrease in CSMT from 356.08 to 303.69 um was not statistically significant. Conclusions The fixed-dosing aflibercept regimen is effective for treating patients with PCV and is more effective in treatment-naïve patients than in pre-treated patients. Trial registration Clinical Research Information Service (CRiS), Republic of Korea. Identifer: KCT0005798, Registered: Jan 20, 2021. Retrospectively registered, URL: https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=18546

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Immune and virologic responses to Truvada or Combivir as a first-line therapy of HIV-infected, treatment-naïve patients

Journal of the International AIDS Society ◽

10.1186/1758-2652-11-s1-p206 ◽

2008 ◽

Vol 11 (Suppl 1) ◽

pp. P206

Author(s):

R Maserati ◽

M Clerici ◽

M Lauriola ◽

M Pacei ◽

M De Gennaro ◽

...

Keyword(s):

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Treatment Naïve

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The first-line therapy of aggressive non-Hodgkin’s lymphomas in russian clinical practice: data from the EQUILIBRIUM study

Oncohematology ◽

10.17650/1818-8346-2020-15-2-10-18 ◽

2020 ◽

Vol 15 (2) ◽

pp. 10-18

Author(s):

L. G. Babicheva ◽

I. V. Poddubnaya

Keyword(s):

Overall Survival ◽

Clinical Practice ◽

Complete Remission ◽

B Cell ◽

Long Term Results ◽

First Line ◽

Therapy Efficacy ◽

First Line Therapy ◽

Line Therapy ◽

Hodgkin's Lymphomas

The objective: evaluation of effectiveness of the first-line therapy with rituximab of B-cell lymphoproliferative diseases in Russian clinical practice in the period from 2014 to 2017.Materials and methods. The EQUILIBRIUM post-registration multicenter study included 1000 patients aged 21 to 91 years old with a verified diagnosis of B-cell non-Hodgkin’s lymphoma, or chronic lymphocytic leukemia, who received at least 4 cycles of rituximab-containing therapy with Acellbia®. The group of aggressive non-Hodgkin’s lymphomas (aNHL), which is the subject of this article, included 295 patients with a median age of 55.9 years: diffuse B-large cell lymphoma – 87 %, primary mediastinal lymphoma – 11 %, Burkitt’s lymphoma – 1 %. Group characterized by the presence of aggressive clinical signs reflecting the poor prognosis: in the majority of patients, generalized stages were diagnosed (61 %), in half of the cases (50.2 %), extranodal localization of tumor foci was detected (in 32.4 % of patients there were 2 or more). The overwhelming majority of patients (84.5 %) received adequate treatment complying with national and international recommendations (R-CHOP, R-CHOEP and R-EPOCH, high-intensity NHL-BFM-R, R-HyperCVAD and R-MACOP-B regimes). The use of R-CVP, FCR, RB, Chl-R, R-monotherapy treatment programs (which received 15.5 % of patients) was considered inadequate for this category of patients.Results. According to the results of the final assessment, high therapy efficacy was established: the overall response exceeded 90 %, complete remission was achieved in most patients with aNHL (68.5 %), partial remission – in every 5th patient (21.8 %). With a median follow-up of 15 months, 16 (5.42 %) deaths and 34 (11.53 %) events were registered. Median of event-free survival and overall survival have not been achieved. Statistically significant differences depending on first-line therapy efficacy were found in overall survival (p = 0.00000) and eventfree survival (p = 0.00000), once again confirming that the main goal of aNHL treatment is to achieve complete remission.Conclusion. Available and compliant with national clinical guidelines treatment of aNHL patients with Russian bioanalogue of anti-CD20 monoclonal antibodies (Acellbia®) demonstrates high immediate efficacy and acceptable long-term results, comparable to a retrospective analysis of previous clinical studies of the original drug rituximab.

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