scholarly journals OP0163 COMPARATIVE ANALYSIS OF ETANERCEPT BIOSIMILAR AND ORIGINATOR USE IN CLINICAL PRACTICE: DATA FROM THE GERMAN BIKER-REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 98.1-98
Author(s):  
G. Horneff ◽  
D. Windschall ◽  
T. Hospach ◽  
S. Mrusek ◽  
M. Rühlmann ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Disease Activity ◽  
Special Interest ◽  
Global Assessment ◽  
Drug Exposure ◽  
Disease Onset ◽  
Injection Site Reaction ◽  
Physician Global Assessment ◽  
First Line

Background:In 2017, 2 Etanercept biosimilars became approved. Comparative studies performed in adult patients with rheumatoid arthritis, ankylosing spondylitis or psoriasis by extrapolation led to approval for juvenile idiopathic arthritis (JIA).Objectives:So far there is limited experience with Etanercept biosimilars in JIA: The large national data base of the BIKER-registry was used to describe experience with Etanercept biosimilars in clinical practice.Methods:In this retrospective analysis patients exposed to ETA were identified in the German BIKER-registry and grouped into cohorts according to initiation of treatment after 2017, use of the originator and of biosimilars. The course of JADAS10, Physician global assessment VAS 0–100-mm, Parent/patient global assessment VAS 0–100-cm, Active joint count 0-71, truncated at 10, ESR and CHAQ-DI was analyzed. Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESI).Results:Until 31.10.2020, 2917 JIA patients were reported to have received Etanercept. Since January 1 2017, in 39 centres treatment with Etanercept was started in 439 patients (377 (85.9%) started with the originator and 62 (14.1%) started a Biosimilar). Biosimilars were prescribed n 17 centres (44%). In 12 centres (31%), Etanercept biosimilars were used first line in 62 patients. In 17 centres (44%), 63 patients switched for the originator to a biosimilar. 3 patients reswitched from the biosimilar to the originator. 4 patient switched from a biosimilar to the originator). 22 centres (56%) had not prescribed a biosimilars so far.In not a single centre, initiation of a biosimilar was more frequent than of the originator.The patients’ characteristics and disease activity parameters were widely comparanble. Patients receiving biosimilar first line were slightly older at disease onset and had a longer disease duration. Patients receiving biosimilar first line had more often rheumatoid factor (RF) negative polyarthritis while extended oligoarthritis was more frequent in the originator cohort. In the switching cohort, more patients had extended oligoarthritis and fewer had RF negative polyarthritis and ERA JIA.No difference in disease activity parameters was noted, neither at baseline, during the course of treatment nor at last observation upon treatment. A decrease of the JADAS10 indicates improvement in both groups (Figure 1). At the time of switching, 68% had JADAS minimal disease activity (MDA) and 43% were in JASDAS remission. At month 6 and 12 these numbers increased to 74%/65% and 62%/50%.In total, 66 adverse events (AE) were reported in 45 patients upon biosimilar treatment.33 patients had 1, 5 patients 2, 5 patients had 3 and 2 reported 4 events. Adverse event of special interest were hypersensitivity n=1, injection site reaction n=1, new onset of psoriasis n=1, celiac disease n=1, Crohn‘s diesease n=1, elevated transaminases n=2, depression n=1 and disease deterioration (arthritis flare) in n=21. In 20 patients, the etanercept biosimilar was discontinued.Conclusion:This analysis is the first attempt to present a large data sample on JIA patients exposed to Etanercept biosimilars. Biosimilar were used in a minority of patients and by a minority of centers although no difference in efficacy or safety was noted from our analysis. Until today, the use of the originator is by far exceeding the use of biosimilars. The prescription of a biosimilar either first line or by switching from the originator is limited to a part of centres. Differences in efficacy between first line biosimilar users and originator users could not be observed. Also, after switching, no loss of efficacy was observed.Disclosure of Interests:Gerd Horneff Speakers bureau: Pfizer, Daniel Windschall: None declared, Toni Hospach: None declared, Sonja Mrusek: None declared, Michael Rühlmann: None declared, Ariane Klein: None declared

scholarly journals POS1303 EXPERIENCE WITH ADALIMUMAB BIOSIMILAR USE IN CLINICAL PRACTICE: DATA FROM THE GERMAN BIKER-REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 933.2-934
Author(s):  
G. Horneff ◽  
F. Dressler ◽  
M. Rühlmann ◽  
T. Geikowski ◽  
S. Mrusek ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Special Interest ◽  
Global Assessment ◽  
Female Adolescent ◽  
Physician Global Assessment ◽  
First Line ◽  
Limited Experience

Background:In 2017, Adalimumab Biosimilars became approved. Comparative studies to the originator have been performed in adult patients with rheumatoid arthritis, ankylosing spondylitis and psoriasis and extrapolation led to approval for juvenile idiopathic arthritis (JIA).Objectives:So far there is limited experience with biosimilars in JIA: The large national data base of the BIKER-registry was used to describe experience with Adalimumab biosimilars in clinical practiceMethods:This retrospective analysis used data of the German BIKER-registry. The data basis war screened for patients exposed to Adalimumab. Subcohorts with initiation of treatment after 2017, use of the originator and of biosimilars were built. The course of JADAS10, Physician global assessment VAS 0–100-mm, Parent/patient global assessment VAS 0–100-cm, Active joint count 0-71, truncated at 10, ESR and CHAQ-DI was analyzed. Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESI).Results:Until 31.10.2020, 1173 JIA patients were reported to have received Adalimumab. 352 treatments have been started after January 1, 2017. A biosimilar was used first line in 44 patients. Further 55 patients switched for the originator to a biosimilar. 2 patient switched from a biosimilar to the originator. 3 patients switched to a second biosimilar while 5 patients who switched from the originator to a biosimilar reswitched back to the originator.After 2017, 33 pediatric rheumatology centres reported initiation of Adalimumab treatment. 17 have used a biosimilar. 15 centres have swichted at least 1 patient from the originator to a biosimilar and 14 have used first line a biosimilar in at least 1 patient. In a single centre, initiation of a biosimilar was used more frequently (8 versus 7).The patients’ characteristics and disease activity parameters were brightly comparable. The JIA category rheumatoid factor (RF) negative polyarthritis was less frequent in the biosimilar first cohort while RF positive polyarthritis and psoriatic arthritis was more frequent. In patients with idiopathic uveitis the originator was used more often. In the switching cohort, more patients had RF negative polyarthritis, persistent oligoarthritis but less had psoriatic arthritis and no had RF positive polyarthritis.No difference in disease activity parameters between patients receiving the originator or biosimilars were noted, neither at baseline, during the course of treatment nor at last observation upon treatment (Figure 1). At the time of switching, 46 (92%) had JADAS minimal disease activity (MDA) and 30 (69%) were in JASDAS remission. At last observation, those numbers were comparable with 42 (86%) with JADAS MDA and 28 (57%) with JADAS remission.In total, 45 adverse events (AE) were reported in 45 patients upon biosimilar treatment. 26 patients had 1, 12 patients had 2 and 6 patients reported 3 and 1 reported 4 events. Adverse event of special interest were Infection associated leukopenia (n=1), COVID 19 infection (n=1), Uveitis flare (n=8), other disease deterioration (arthritis flare) (n=20), injection site reaction n=2. A single serious AE was reported. A 16 year old female adolescent was admitted for unexpected CK elevation. In 10 patients, Adalimumab was discontinued, in 2 it was temporarily paused.Conclusion:This article is the first attempt to present a large sample of data on JIA patients exposed to Adalimumab biosimilars. Since approval of Adalimumab-Biosimilars, limited experience from clinical practice is available. Biosimilars are used in a minority of patients and by a minority of centers although no difference in efficacy or safety was noted from our analysis.Disclosure of Interests:Gerd Horneff Speakers bureau: Novartis, MSD, Sobi, Grant/research support from: MSD, Roche, Frank Dressler: None declared, Michael Rühlmann: None declared, Tilmann Geikowski: None declared, Sonja Mrusek: None declared, Ariane Klein: None declared

Extracutaneous Involvement Is Common and Associated with Prolonged Disease Activity and Greater Impact in Juvenile Localized Scleroderma

Rheumatology ◽  
2021 ◽  
Author(s):  
Suzanne C Li ◽  
Gloria C Higgins ◽  
Mallory Chen ◽  
Kathryn S Torok ◽  
C Egla Rabinovich ◽  
...  
Keyword(s):  
Disease Activity ◽  
Global Assessment ◽  
Disease Onset ◽  
Response To Treatment ◽  
Localized Scleroderma ◽  
Physician Global Assessment ◽  
Treatment Needs ◽  
Organ Systems ◽  
Disease Impact ◽  
Juvenile Localized Scleroderma

Abstract Objective To evaluate factors associated with extracutaneous involvement (ECI) in juvenile localized scleroderma (jLS). Methods A prospective, multi-center, 6-month observational study was performed. Collected data included disease features, global assessments, and subject symptoms. Bivariate and linear multilevel regression analyses were performed. Results Eighty-six jLS subjects (80% female, 80% Caucasian), median age of disease onset 7.7 years, were evaluated. Most had linear scleroderma or mixed morphea. Fourty-nine subjects (57%) had 125 extracutaneous problems (median 2 (IQR 1, 3) per subject) from 9 organ systems. Most of these subjects had multiple musculoskeletal problems. ECI was associated with more extensive cutaneous involvement, higher number of symptoms, family history of autoimmunity, and ANA and rheumatoid factor positivity. Subjects with ECI had higher scores for physician global assessment of damage (PGA-D), and parental global assessment of disease impact, but not baseline physician global assessment of disease activity (PGA-A). Although subjects with ECI received more methotrexate and glucocorticoid treatment, they had a slower reduction in PGA-A scores and symptoms over time, suggesting a poorer response to treatment. In logistic regression modeling, female sex had the largest effect on parental impact scores. Conclusions ECI occurred in the majority of subjects with jLS, and was associated with more medication use, longer treatment duration, higher PGA-D scores, and higher parental assessment of disease impact. Our findings suggest that jLS subjects with ECI have greater overall disease burden, both cutaneous and extracutaneous, and poorer response to treatment. More study of the treatment needs of this population is warranted.

scholarly journals POS0997 PERFORMANCE OF ASDAS VERSUS BASDAI DURING PREGNANCY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 767.1-767
Author(s):  
P. Fischer ◽  
A. Zbinden ◽  
F. Foerger
Keyword(s):  
Disease Activity ◽  
Pregnant Women ◽  
Global Assessment ◽  
Signs And Symptoms ◽  
First Trimester ◽  
Point Estimation ◽  
High Disease Activity ◽  
Physician Global Assessment ◽  
Pregnancy And Postpartum ◽  
Pregnant State

Background:Disease activity in patients with axial spondyloarthritis (axSpA) can be measured by BASDAI and ASDAS. Both instruments were validated in non-pregnant patients with cutoff values for active diseases. In pregnant women with axSpA, however, BASDAI and ASDAS scores might be biased by signs and symptoms of pregnancy itself.Objectives:To compare the performance of ASDAS and BASDAI during pregnancyMethods:Patients with axSpA were prospectively followed before pregnancy, at each trimester and 6 to 12 weeks postpartum. Disease activity was assessed by BASDAI, ASDAS, patient global assessment (PGA) and physician global assessment (PhGA). We analysed the disease course throughout pregnancy and postpartum, the correlation between BASDAI and ASDAS and the agreement in the classification of active disease. We applied receiver operating curves (ROC) to evaluate the cut-off points in pregnant patients.Results:The study involved 40 women with axSpA. Disease activity scores were higher during pregnancy (median ASDAS score: 2.5, median BASDAI score 3.1) than during a non-pregnant state (median ASDAS score 2.3, median BASDAI score 2.1). Median BASDAI scores were highest at the first trimester, median ASDAS scores were highest at the second trimester. ASDAS strongly correlated with BASDAI, both in the pregnant and in the non-pregnant state (r=0.796, r=0.727). However, there was a discordance when analysing the proportion of patients with high disease activity using the common cut-off values (ASDAS >2.1, BASDAS >4). More patients had high disease activity when measured by ASDAS (1st trimester (T): 63%, 2nd T: 76%, 3rd T: 61%) compared to those measured by BASDAI (1st T 43%, 2nd T: 39%, 3rd T: 34%). The κ coefficient showed only fair agreement (κ=0.39). ROC analysis among pregnant patients showed that the cut-off point estimation for high disease activity using ASDAS >2.75 corresponded to a BASDAI >4. The ASDAS >2.75 cut-off for high disease activity had a good agreement with BASDAI >4 (κ=0.657). When ASDAS >2.75 was applied in pregnant women with axSpA, about 40% experienced high disease activity.Conclusion:During pregnancy, the majority of women with axSpA experience ongoing disease activity. However, the cut-off values defining low and high disease activity might differ between pregnant and non-pregnant individuals since BASDAI and ASDAS are biased by pregnancy related symptoms like fatigue and mechanical back pain.Disclosure of Interests:None declared.

scholarly journals Switching first-line targeted therapy after not reaching low disease activity within 6 months is superior to conservative approach: a propensity score-matched analysis from the ATTRA registry

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Lucie Nekvindová ◽  
Jiří Vencovský ◽  
Karel Pavelka ◽  
Pavel Horák ◽  
Zlatuše Křístková ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Targeted Therapy ◽  
Propensity Score ◽  
Disease Activity ◽  
Treatment Response ◽  
Daily Clinical Practice ◽  
Current Therapy ◽  
First Line ◽  
Treatment Target ◽  
Low Disease Activity

Abstract Background Treat-to-target (T2T) is a widely accepted strategy for patients with rheumatoid arthritis (RA). It recommends attaining a goal of at least low disease activity (LDA) within 6 months; otherwise, the current therapy should be modified. We aimed to investigate whether switching a first-line targeted therapy (TT) in patients not reaching LDA within 6 months leads to a higher probability of meeting LDA at the 12-month visit in daily clinical practice using data from Czech registry ATTRA. Methods We included patients with RA starting the first-line TT from 1 January 2012 to 31 January 2017 with at least 1-year follow-up. We created four mutually exclusive cohorts based on (1) switching to another TT within the first year and (2) reaching a treatment target (DAS28-ESR ≤ 3.2) at the 6-month visit. The primary outcome was the comparison of odds for reaching remission (REM) or LDA at the 12-month visit between patients switching and not switching TT after not reaching treatment target at 6 months. Before using logistic regression to estimate the odds ratio, we employed the propensity score to match patients at the 6-month visit. Results A total of 1275 patients were eligible for the analysis. Sixty-two patients switched within the first 5 months of the treatment before evaluating treatment response at the 6-month visit (C1); 598 patients reached the treatment target within 6 months of therapy (C2); 124 patients did not reach treatment response at 6-month visit and switched to another therapy (C3), and 491 patients continued with the same treatment despite not reaching LDA at the 6-month visit (C4). We matched 75 patients from cohort C3 and 75 patients from C4 using the propensity score. Patients following the T2T principle (C3) showed 2.8 (95% CI 1.4–5.8; p = 0.005) times increased likelihood of achieving REM/LDA at the 12-month visit compared to patients not following the T2T strategy (C4). Conclusions In daily clinical practice, the application of the T2T strategy is underused. Switching TT after not reaching REM/LDA within the first 6 months leads to a higher probability of achieving REM/LDA in RA patients at the 12-month visit.

Laboratory investigation results influence Physician’s Global Assessment (PGA) of disease activity in SLE

2020 ◽  
pp. annrheumdis-2019-216753 ◽  
Author(s):  
Cynthia Aranow ◽  
Anca Askanase ◽  
Shereen Oon ◽  
Molla Huq ◽  
Alicia Calderone ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Intraclass Correlation ◽  
Physician Global Assessment ◽  
Systemic Lupus ◽  
Laboratory Test Results ◽  
Laboratory Results ◽  
The Impact

ObjectiveTo evaluate the impact of laboratory results on scoring of the Physician Global Assessment (PGA) of disease activity in systemic lupus erythematosus.MethodsFifty clinical vignettes were presented via an online survey to a group of international lupus experts. For each case, respondents scored the PGA pre and post knowledge of laboratory test results (pre-lab and post-lab PGAs). Agreement between individual assessors and relationships between pre-lab and post-lab PGAs, and PGAs and Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) were determined. Respondents were also asked about factors they incorporate into their PGA determinations.ResultsSixty surveys were completed. The inter-rater PGA reliability was excellent (pre-lab intraclass correlation coefficient (ICC) 0.98; post-lab ICC 0.99). Post-lab PGAs were higher than pre-lab PGAs: median (IQR) pre-lab PGA 0.5 (1.05), post-lab PGA 1 (1.3) (p<0.001), with a median (IQR) difference of 0.2 (0.45). In general, all abnormal labs including elevated anti-double stranded DNA antibody level (dsDNA) and low complement impacted PGA assessment. Cases with weakest correlations between pre-lab and post-lab PGA were characterised by laboratory results revealing nephritis and/or haematological manifestations. Both pre-lab and post-lab PGAs correlated with SLEDAI-2K. However, a significantly stronger correlation was observed between post-lab PGA and SLEDAI-2K. Multiple factors influenced PGA determinations. Some factors were considered by an overwhelming majority of lupus experts, with less agreement on others.ConclusionsWe found excellent inter-rater reliability for PGAs in a group of international lupus experts. Post-lab PGA scores were higher than pre-lab PGA scores, with a significantly stronger correlation with the SLEDAI-2K. Our findings indicate that PGA scoring should be performed with knowledge of pertinent laboratory results.

scholarly journals Clinical and associated inflammatory biomarker features predictive of short-term outcomes in non-systemic juvenile idiopathic arthritis

Rheumatology ◽  
2020 ◽  
Vol 59 (9) ◽  
pp. 2402-2411 ◽  
Author(s):  
Elham Rezaei ◽  
Daniel Hogan ◽  
Brett Trost ◽  
Anthony J Kusalik ◽  
Gilles Boire ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Features ◽  
Global Assessment ◽  
Systemic Juvenile Idiopathic Arthritis ◽  
Area Under The Curve ◽  
Inactive Disease ◽  
Physician Global Assessment ◽  
Active Joint ◽  
Short Term ◽  
Prospective Longitudinal

Abstract Objective To identify early predictors of disease activity at 18 months in JIA using clinical and biomarker profiling. Methods Clinical and biomarker data were collected at JIA diagnosis in a prospective longitudinal inception cohort of 82 children with non-systemic JIA, and their ability to predict an active joint count of 0, a physician global assessment of disease activity of ≤1 cm, and inactive disease by Wallace 2004 criteria 18 months later was assessed. Correlation-based feature selection and ReliefF were used to shortlist predictors and random forest models were trained to predict outcomes. Results From the original 112 features, 13 effectively predicted 18-month outcomes. They included age, number of active/effused joints, wrist, ankle and/or knee involvement, ESR, ANA positivity and plasma levels of five inflammatory biomarkers (IL-10, IL-17, IL-12p70, soluble low-density lipoprotein receptor-related protein 1 and vitamin D), at enrolment. The clinical plus biomarker panel predicted active joint count = 0, physician global assessment ≤ 1, and inactive disease after 18 months with 0.79, 0.80 and 0.83 accuracy and 0.84, 0.83, 0.88 area under the curve, respectively. Using clinical features alone resulted in 0.75, 0.72 and 0.80 accuracy, and area under the curve values of 0.81, 0.78 and 0.83, respectively. Conclusion A panel of five plasma biomarkers combined with clinical features at the time of diagnosis more accurately predicted short-term disease activity in JIA than clinical characteristics alone. If validated in external cohorts, such a panel may guide more rationally conceived, biologically based, personalized treatment strategies in early JIA.

Prospective, Observational Study To Assess The Safety Of Rituximab In Combination With Chemotherapy In Patients With Previously-Untreated Or Relapsed Or Refractory B Cell-Lineage Chronic Lymphocytic Leukaemia (B-CLL): Preliminary Results

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5310-5310
Author(s):  
Andres Lopez ◽  
Eduardo Rios ◽  
Javier De la Serna ◽  
Felix Carbobnell ◽  
Cristina Garcia Bernaldez ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Observational Study ◽  
Response Rate ◽  
Disease Free Survival ◽  
First Line ◽  
Large Patient ◽  
Binet Stage ◽  
Grade 3 ◽  
Normal Clinical Practice

Abstract Aim and Background The efficacy and safety of rituximab plus chemo (R+chemo) for first-line and relapsed B-CLL patients(pts) have been widely investigated in clinical trials and large patient cohorts, but much less is known about whether such regimens can be effectively and safely administered to unselected pts in the community setting to reflect the routine care of B-CLL pts. Therefore, this observational study was designed to characterize the type, severity and frequency of all adverse events occurring on-treatment and in the year following rituximab infusion. A secondary objective was to assess response rate (CR/nPR/PR), duration of response, disease-free survival, overall survival, and to evaluate the relationship between various baseline markers and clinical outcome parameters in a subset of pts in each study group. Methods Data were collected prospectively from B-CLL pts, in 47 Spanish hospitals, commencing a new treatment with prescribed R+chemo in accordance with normal clinical practice at the time of enrollment. Data cut-off for this interim analysis was May 31, 2013. Results A total of 218 pts have been enrolled, 108 and 110 pts in the first-line and relapsed arm, respectively. The median age (range) of the whole series was 69 (r: 29–87) years. ECOG status varied across the two groups, with a 1 ECOG status score of 23%, and 55% of first-line and relapsed pts, respectively. In the first-line arm, 26%, 47%, and 27%, had a Binet stage of A, B and C, respectively. In the relapsed arm, 11%, 42%, and 46% had a Binet stage of A, B and C, respectively. By first-line / relapsed arm, the proportion of pts with del(11q), del(17p), and unmutated IgVH) was: 14%/15%; 17%/10%; and 10%/9%, respectively. Treated pts were categorized as receiving fludarabine/cyclophosphamide/rituximab (FCR) 60%/20%, bendamustine/rituximbab (BR) 15%/42%, chlorambucil/rituximbab (ClbR) 12%/19%, or other R-based therapy 13%/20%, in the first-line and relapsed arm, respectively. The overall response rate (ORR) in the first-line arm was as follows: BR cohort (81%; 13/16), ClbR (69%; 9/13) and FCR cohort (68%; 44/65), while in the relapsed group the ORR was higher in the ClbR cohort (55%; 11/20), followed by other R-based (48%; 10/21) and FCR cohort (43%; 9/21). Adverse events were most frequently hematologic and infusion-related and included nuetropenia (34% first-line; 28% relapsed); fever (19%; 12%); nausea (14%; 11%); lymphopenia (12%; 9%), and vomiting (11%; 8%). CTC grade 3-5 adverse events occurred in 55% of all 218 pts. Grade3 and 4 neutropenia occurred in 23% (FCR), 25%(BR) and 15% (ClbR) of first-line pts. In the relapsed group this incidence was of 14% (FCR), 16% (BR), and 25% (ClbR). The reported incidence of CTC grade 3 or 4 febtrile neutropenia (FN) in the first-line FCR, and BR cohort was of 9%, and 6%, respectively, while pts in the relapsed group the incidence of grade 3-4 FN was of 19% for FCR and 16% for BR. No FN was reported in the ClbR cohort, on both arms. Infection was reported in 61% and 17% of pts in the first-line/relapsed CFR cohort; 13% and 50% in the first-line/relapsed BR cohort, and 16% and 12% in the first-line/relapsed ClbR cohort, respectively. Treatment discontinuations due to AEs in the first-line and relapsed arm was of 12% and 9%, while treatment related mortality occurred in 3% and 4%, respectively. Conclusion In this unselected group of B-CLL patients taken from normal clinical practice, in first-line, or relapsed approach, rituximab seems an effective and relatively safe option when added to any chemotherapy regimen. Additional analysis of the whole study will give us further information on late toxicity and outcome. Disclosures: Garcia Bernaldez: Roche Pharma: Employment. Gonzalez-Grande:Roche Pharma: Employment.

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