Reasons For Treatment Changes Research Articles

Treatment patterns of systemic drug use in Japanese patients with plaque psoriasis: A retrospective chart review.

Plaque psoriasis (PsO) is a chronic immune-mediated inflammatory disease with skin lesions accompanied by an inflammation-related comorbidity risk. The development of various oral drugs and biologics for PsO has provided increasing systemic treatment options for patients with PsO, and the guidance regarding the use of biologics and PsO treatment schemes are widespread in Japan. However, no comprehensive guidelines regarding systemic drug use are available, and the current treatment patterns of systemic drugs for PsO in Japan remain unclear. We conducted a retrospective chart review to clarify the current treatment patterns of systemic drugs for PsO. We enrolled 114 patients who started systemic drugs for PsO between January 2017 and December 2020 at four institutes, with a mean follow-up of 37.2 months. The mean disease duration was 7.8 (standard deviation 9.5) years at the systemic drug initiation. Of all the patients, 78.1% started with oral drugs (phosphodiesterase [PDE] 4 inhibitors 56.1%. calcineurin inhibitors 14.0%. vitamin A derivatives 7.9%), whereas 21.9% started with biologics (interleukin [IL]-17 inhibitors 9.6%. tumor necrosis factor inhibitors 7.0%. IL-23 inhibitors 3.5%. IL-12/23 inhibitors 1.8%). Oral drugs had shorter drug persistence than biologics: the 12-month persistence of the oral drugs vitamin A derivative, calcineurin inhibitor, and PDE4 inhibitor, was 35.5%, 25.8%, and 60.1%, respectively, compared with that of the biologics IL-23 and IL-17 inhibitors, which was 85.6% and 84.7%, respectively. During the study period, the incidence of treatment changes was 59.1/100 patient-years. Lack of efficacy was the most common reason for treatment changes from monotherapy (34.1%). This retrospective medical chart review allowed us to understand the real-world, long-term treatment patterns of systemic drugs for PsO and the relationships between the reasons for treatment changes and subsequent treatment selection, indicating that there is still room for improvement in the appropriate use of systemic drugs for PsO in Japan.

Analysis of determinants of treatment change in adult paediatric-onset MS patients.

Paediatric-onset multiple sclerosis (POMS) is increasing worldwide and represents approximately 5% of all MS cases. Although this patient group has similar characteristics to the adult group, it is important for this patient group to receive effective treatment due to the early onset of cognitive involvement, higher lesion burden, and secondary progression at an earlier age than adults. In this study, we aimed to evaluate the factors that cause treatment change in POMS patients. Adult patients with a first MS attack at age 18 years or younger who were followed up with the diagnosis of MS at the Clinical Neuroimmunology and Demyelinating Diseases outpatient clinic of Cerrahpaşa Medical School between 1987 and 2020 were included in our study. Patient files were reviewed retrospectively, and demographic and clinical characteristics, imaging, first attack characteristics, and treatment change were noted. We included 269 patients with a definite diagnosis of MS in the study, and these patients were evaluated in two groups: negative for treatment change and positive for treatment change. Multifocal involvement was detected more frequently in the group with treatment change (p=0,049). Cerebellar involvement as a first attack symptom was more common in male patients (p=0,023) The age at first MS attack was found to be younger (p=0,006), and the disease duration was longer in the positive for treatment change group (p=0,003). Spinal cord involvement was more common in the positive for treatment change group (p=0,016). Abnormal VEP findings were observed more frequently in the group without treatment change (p=0.018). In multivariant analysis, spinal cord involvement, younger age at first attack, and abnormal VEP findings in the group without treatment change were found to be significant. Among the reasons for treatment change, the most common reason was radiological and clinical progression. The higher inflammatory load in POMS patients compared with adults necessitates early initiation of treatment in this group and timely treatment change to prevent disability. Furthermore, this patient group should be followed closely and receive effective treatment.

Patient Characteristics, Treatment Patterns, and Outcomes Following Covalent Btki Discontinuation in a Contemporary Cohort of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Patients

Introduction: Over the last decade, covalent Bruton Tyrosine Kinase inhibitors (BTKi) have transformed the therapeutic landscape for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Prior retrospective studies (Maddocks et al. 2015, Hampel et al. 2019) have reported on outcomes for BTKi discontinuation in cohorts of patients from an era when the majority were relapsed or refractory to multiple prior lines of chemoimmunotherapy. Less is known about the outcomes for patients with CLL/SLL who receive BTKi earlier in their treatment course and subsequently discontinue their BTKi. Here, we report on a cohort of contemporary CLL/SLL patients who discontinued BTKi treatment, a majority of whom received index BTKi as first- or second-line therapy. Methods: We performed a retrospective chart review of adult CLL/SLL patients at Dana-Farber Cancer Institute who were treated with at least one covalent BTKi and found to be treatment resistant/refractory or intolerant to a BTKi. To be included, patients had to have 6 months of records prior to and 12 months of records following index BTKi (i.e., first observed BTKi) initiation. Using a standardized electronic form, data were abstracted from electronic charts including demographics, oncologic and medical histories, clinical variables, treatments initiated, adverse events, reasons for treatment change or discontinuation, and clinical outcomes. Patients who received non-hormonal anti-neoplastic therapy for other primary malignancies between CLL/SLL diagnosis and first BTK inhibitor treatment were excluded from the study. Results: 67 patients who initiated BTKi between 07/2011 and 04/2019 and were later found to be treatment resistant/refractory or intolerant to a BTKi were identified and included in the analysis. 56% of these patients were treated with index BTKi as part of a clinical trial. Median age at first CLL/SLL diagnosis was 58.8 years (Q1-Q3, 53.2-64.8), median age at index BTKi initiation was 66.0 years (Q1-Q3, 60.1-73.1), median time from CLL/SLL diagnosis to index BTKi initiation was 6.9 years (Q1-Q3, 3.3-9.9). Prognostic marker testing revealed: FISH (n=65 assessed) del(13q): 62%, del(11q): 35%, del(17p): 26%, trisomy 12: 25%, complex karyotype (stimulated): 22%; IGHV unmutated (n=50 assessed): 52%, TP53 mutation (n=41 assessed): 56%. Index BTKi treatments were given as: first line (27%), second line (33%), third line (18%), fourth line (12%), fifth or greater line (9%) of therapy (Figure 1); patients were treated with either ibrutinib (88%, 51% as monotherapy and 12% in combination with anti-CD20 mAb) or acalabrutinib (12%, all monotherapy). The duration of index BTKi treatment was a median of 1.7 years (Q1-Q3, 0.6-3.2). 55% of the patients discontinued index BTKi treatment due to adverse events, most commonly atrial fibrillation (22%) and bleeding events (14%); 35% discontinued due to progression of disease, and 5% due to Richter's transformation. Following discontinuation of index BTKi due to adverse events, 19% switched to a second BTKi immediately, and 25% switched to a second BTKi at any point in time. Following last BTKi treatment, 54% of patients received subsequent therapies; among these, 81% received venetoclax-containing regimens. With a median follow-up of 5.4 years from index BTKi initiation to data cutoff, 27 (40%) patients died. Among those with a known primary cause of death (N=21), disease progression (52%), infection (19%), and secondary malignancy (10%) were the most frequently documented causes in the medical record. Conclusions: In this retrospective study characterizing CLL/SLL patients at a large academic center who received covalent BTKi mostly in early lines of therapy, BTKi discontinuation was most commonly driven by adverse events (55%), with CLL/SLL disease progression (35%) the second most common reason. These findings are consistent with earlier studies, although notably we observed a relatively low incidence of Richter's transformation (5%). Following BTKi discontinuation, many patients received venetoclax-based regimens, yet with a median follow-up of 5.4 years, 40% patients died. This suggests that novel treatment approaches are needed for contemporary patients who discontinue covalent BTKi. Figure 1. Sankey diagram of treatment sequence for CLL/SLL patients by line of therapy Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Reasons for Treatment Changes in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Chart Review Study.

This study aimed to examine the reasons underlying treatment changes among pediatric patients with attention-deficit/hyperactivity disorder (ADHD). Data were obtained through online medical chart abstraction (08/2021-09/2021). Eligible patients with ADHD had initiated a treatment regimen at ages 6-17 and within 1-5years of chart abstraction. Reasons contributing to treatment changes were analyzed for a randomly selected treatment episode. ADHD/treatment-related complication rate was also described. Results were reported overall and among children (ages 6-12) and adolescents (ages 13-17), separately. Physicians' perspective on adherence among their child, adolescent, and adult patients was assessed through an online survey. A total of 156 physicians abstracted 434 patient charts (235 children + 199 adolescents). Mean patient age was 11.3years, and 68.7% were male. Inadequate/suboptimal symptom management was the most common reason for treatment discontinuation (50/83 [60.2%]), add-on (17/21 [81.0%]), and dose increase (189/237 [79.7%]). Patient/parent/family attitude/dislike of medication and ADHD/treatment-related complications were common reasons for treatment discontinuation, add-on, switch, and dose decrease. Overall, 42.4% of patients had ≥ 1 documented ADHD/treatment-related complication, insomnia/sleep disturbances being the most common (9.7%). Among patients with ≥ 1 complication, 75.5% reported the experience/fear of complications had a negative impact on their treatment adherence. Results were similar among children and adolescents. Physicians reported taking actions toward patients' non-adherence by further educating patients, closer monitoring, and changing the prescribed ADHD medication. Lack of effectiveness and ADHD/treatment-related complications are important reasons for treatment changes among children and adolescents with ADHD, highlighting the need for more effective and tolerable treatments to mitigate the burden of ADHD.

P57 Reasons for Treatment Changes in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD): A Chart Review Study

P57 Reasons for Treatment Changes in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD): A Chart Review Study

Reasons for treatment changes in adults with attention-deficit/hyperactivity disorder: a chart review study

BackgroundAdults with attention-deficit hyperactivity disorder (ADHD) often cycle through multiple treatments for reasons that are not well documented. This study analyzed the reasons underlying treatment changes among adults treated for ADHD in a real-world setting.MethodsData were collected via an online reporting form completed by eligible physicians between October and November 2020. Data for adult patients in the United States who were diagnosed with ADHD and initiated a treatment regimen within 1 to 5 years of chart abstraction were obtained. Reason for a treatment change was described for a randomly selected regimen episode, which spanned from treatment initiation until the earliest among treatment add-on/switch or discontinuation, death, or date of chart abstraction. The overall rate of ADHD/treatment-related complications were also described. Physician satisfaction with current treatment options for adult ADHD and opinions on areas for improvement were assessed.ResultsData on 320 patients were reported by 152 physicians specializing in psychiatry (40.1%), pediatrics (25.0%), family medicine (21.7%), and internal medicine (13.2%). Patients had a mean age of 29.3 years; most were diagnosed with ADHD as adults (57.5%) and within the previous 5 years (56.5%). Selected treatment regimens included stimulants (79.1%), nonstimulants (14.7%), and combination therapy (5.6%) for an average duration of 1.9 years. Among patients with treatment discontinuation (N = 59), the most common reasons for discontinuation were suboptimal symptom management (55.9%), occurrence of ADHD/treatment-related complications (25.4%), and patient attitude/dislike of medication (25.4%). The main reasons for other key treatment changes were inadequate/suboptimal management of symptoms and cost considerations. Over 40% of patients had ≥ 1 documented ADHD/treatment-related complication, irrespective of whether they led to a treatment change. One in 5 physicians (19.8%) were very dissatisfied, moderately dissatisfied, or neither satisfied nor dissatisfied with current treatment options for ADHD in adults; the top 3 suggested improvements were lower risk of abuse (71.7%), longer effect duration (65.1%), and fewer ADHD/treatment-related complications (61.2%).ConclusionsThe top reasons for treatment changes among adults with ADHD are lack of efficacy and ADHD/treatment-related complications, highlighting the importance of developing more effective and safer treatments to alleviate the burden of ADHD.

Diagnostic Utility of Bronchoalveolar Lavage in Patients with Acute Leukemia under Broad-Spectrum Anti-Infective Treatment.

Simple SummaryInfections of bacterial, viral, or fungal origin pose a major threat to patients with acute leukemia. Empiric antibiotic and antifungal treatment is a commonly used approach in leukemia patients with febrile neutropenia. To investigate the utility of flexible bronchoscopy (FB) with bronchoalveolar lavage (BAL) in acute leukemia (AL) patients with pneumonia who were already treated with broad-spectrum antibiotics and antifungal agents, we investigated bronchoalveolar samples of 88 patients. Our results indicate that despite broad-spectrum anti-infective treatment, in approximately half of all patients, pathogens could still be isolated in bronchoalveolar samples. Nevertheless, the detection of pathogens does not lead to frequent changes in anti-infective treatments, with most changes performed in patients with herpes simplex and influenza virus detection, and these pathogens might also be detected in less invasive examinations. The need for FB with BAL in patients with AL who are already receiving broad-spectrum empiric anti-infective treatment should therefore be weighed carefully.Despite therapeutic advances in the prevention and treatment of febrile neutropenia, acute leukemia (AL) patients still have considerable febrile neutropenia-related mortality. However, the diagnostic yield of flexible bronchoscopy (FB) and bronchoalveolar lavage (BAL) in acute leukemia patients is unclear. In this retrospective single-center study, we analyzed 88 BAL samples of patients with acute leukemia and pulmonary infiltrates in spite of treatment with broad-spectrum anti-infective agents. The aim was to investigate the impact of FB with BAL on detecting causative organisms, which would result in a change in treatment regimens. The median age was 59 years, and 86% had acute myeloid leukemia. In 47%, pathogens were detectable in BAL fluid (pathogen bacteria, viruses, and fungi in 2, 15, and 18%, respectively), with Aspergillus fumigatus detected most frequently. BAL-guided anti-infective therapy changes were performed in 15%. The detection of herpes simplex and influenza viruses were the main reasons for treatment changes. Despite broad-spectrum anti-infective treatment, in approximately half of all patients, pathogens could still be isolated in BAL samples. However, consecutive changes in anti-infective treatment were considerably less frequent, with most changes performed in patients with Herpes simplex virus and Influenza A detection. The need for FB with BAL in patients with AL receiving broad-spectrum empiric anti-infective treatment should therefore be weighed carefully.

Evolution in Real-World Therapeutic Strategies for HIV Treatment: A Retrospective Study in Southern Italy, 2014-2020.

Changes in HIV treatment guidelines over the last two decades reflect the evolving challenges in this field. Our study examined treatment change patterns throughout a 7-year period in a large Italian cohort of HIV patients as well as the reasons and direction of changes. Treatment-naïve and -experienced HIV patients managed by Cotugno Hospital of Naples between 2014 and 2020 were analyzed. During the period, the proportion of single-tablet regimen treatment sharply increased for the naïve and experienced patients. Regimens containing integrase strand transfer inhibitors rapidly replaced those containing protease inhibitor and non-nucleoside reverse transcriptase inhibitors. The use of the tenofovir alafenamide fumarate/emtricitabine backbone increased rapidly after its introduction in the Italian pharmaceutical market, making up 63.7 and 54.9% of all treatments in naïve and experienced patients, respectively, in 2020. The main reason for treatment changes was optimization and/or simplification (90.6% in 2018; 85.3% in 2019; 95.5 in 2020) followed by adverse effects and virological failure. Our real-world analysis revealed that the majority of treatment-naïve and treatment-experienced patients received antiretroviral drugs listed as preferred/recommended in current recommendations. Regimen optimization and/or simplification is a leading cause of treatment modification, while virologic failure or adverse effects are less likely reasons for modification in the current treatment landscape.

Non-IgE-Mediated Drug Hypersensitivity Reactions.

Non-IgE-mediated drug reactions have traditionally been poorly defined and studied, though they are the most common form of hypersensitivity. Their presentations are highly variable and can range in severity from mild, cutaneous-only reactions to severe systemic disease. The most notable advance in non-IgE-mediated hypersensitivity reactions is in diagnostics. HLA alleles have traditionally been used for identifying certain patients at risk for abacavir hypersensitivity syndrome, but more recent studies have shown several other HLA alleles associated with severe cutaneous adverse reactions with various medications. This article also highlights the use of delayed intradermal testing for radiocontrast media and patch testing for delayed antibiotic reactions. Drug reactions remain a major cause of morbidity and reason for treatment changes. Non-IgE-mediated reactions have had an increase in research interest over the past decade with an increased emphasis on better understanding the clinical presentation and underlying pathophysiology.

Drivers of Treatment Patterns in Patients with Chronic Lymphocytic Leukemia (CLL) Treated with B-Cell Receptor Inhibitors (BCRis) — a Medical Chart Review Study

Drivers of Treatment Patterns in Patients with Chronic Lymphocytic Leukemia (CLL) Treated with B-Cell Receptor Inhibitors (BCRis) — a Medical Chart Review Study

SARS-CoV-2 outbreak in immune-mediated inflammatory diseases: the Euro-COVIMID multicentre cross-sectional study.

BackgroundThe COVID-19 pandemic has raised numerous questions among patients with immune-mediated inflammatory diseases regarding potential reciprocal effects of COVID-19 and their underlying disease, and potential effects of immunomodulatory therapy on outcomes related to COVID-19. The seroprevalence of SARS-CoV-2 and factors associated with symptomatic COVID-19 in patients with immune-mediated inflammatory diseases are still unclear. The Euro-COVIMID study aimed to determine the serological and clinical prevalence of COVID-19 among patients with immune-mediated inflammatory diseases, as well as factors associated with COVID-19 occurrence and the impact of the pandemic in its management.MethodsIn this multicentre cross-sectional study, patients aged 18 years or older with a clinical diagnosis of rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Sjögren's syndrome, or giant cell arteritis were recruited from six tertiary referral centres in France, Germany, Italy, Portugal, Spain, and the UK. Demographics, comorbidities, treatments, and recent disease flares, as well as information on COVID-19 symptoms, were collected through a questionnaire completed by participants. SARS-CoV-2 serology was systematically tested. The main outcome was the serological and clinical prevalence of COVID-19. Factors associated with symptomatic COVID-19 were assessed by multivariable logistic regression, and incidence of recent disease flares, changes in treatments for underlying disease, and the reasons for treatment changes were also assessed. This study is registered with ClinicalTrials.gov, NCT04397237.FindingsBetween June 7 and Dec 8, 2020, 3136 patients with an immune-mediated inflammatory disease answered the questionnaire. 3028 patients (median age 58 years [IQR 46–67]; 2239 [73·9%] women and 789 [26·1%] men) with symptomatic COVID-19, serological data, or both were included in analyses. SARS-CoV-2 antibodies were detected in 166 (5·5% [95% CI 4·7–6·4]) of 3018 patients who had serology tests. Symptomatic COVID-19 occurred in 122 (4·0% [95% CI 3·4–4·8]) of 3028 patients, of whom 24 (19·7%) were admitted to hospital and four (3·3%) died. Factors associated with symptomatic COVID-19 were higher concentrations of C-reactive protein (odds ratio 1·18, 95% CI 1·05–1·33; p=0·0063), and higher numbers of recent disease flares (1·27, 1·02–1·58; p=0·030), whereas use of biological therapy was associated with reduced risk (0·51, 0·32–0·82; p=0·0057). At least one disease flare occurred in 654 (21·6%) of 3028 patients. Over the study period, 519 (20·6%) of 2514 patients had treatment changes, of which 125 (24·1%) were due to the pandemic.InterpretationThis study provides key insights into the epidemiology and risk factors of COVID-19 among patients with immune-mediated inflammatory diseases. Overall, immunosuppressants do not seem to be deleterious in this scenario, and the control of inflammatory activity seems to be key when facing the pandemic.FundingPfizer, Sanofi, Amgen, Galapagos, and Lilly.

Defining Treatment Regimens and Lines of Therapy Using Real-World Data in Oncology

Retrospective observational research relies on databases that do not routinely record lines of therapy or reasons for treatment change. Standardized approaches to estimate lines of therapy were developed and evaluated in this study. A number of rules were developed, assumptions varied and macros developed to apply to large datasets. Results were investigated in an iterative process to refine line of therapy algorithms in three different cancers (lung, colorectal and gastric). Three primary factors were evaluated and included in the estimation of lines of therapy in oncology: defining a treatment regimen, addition/removal of drugs and gap periods. Algorithms and associated Statistical Analysis Software (SAS®)macros for line of therapy identification are provided to facilitate and standardize the use of real-world databases for oncology research.

Therapy Changes During Pemphigus Management: A Retrospective Analysis.

Pemphigus diseases are rare, and the treatment response differs between patients. Several therapy changes are often required to achieve disease control and avoid unwanted side effects. We aimed to analyze the treatment courses of pemphigus patients and the clinical responses regarding therapy changes. Pemphigus patients in our center were retrospectively examined according to the medication and dosage, disease activity, reason for treatment changes, and autoantibody concentrations. Therapy changes due to insufficient therapeutic effects or side effects were analyzed. Seventy-seven pemphigus patients with repeated consultations were identified (81% pemphigus vulgaris, 19% pemphigus foliaceus). Disease control was achieved in 66 patients (86%; score “almost clear” or “clear”), with an average of 4 different therapy regimens (range 1–18 changes), after an average of 2 years of treatment (range 0–11 years). Twenty-two patients (29%) with refractory disease received rituximab, of which 19 (86%) subsequently achieved remission. Anti-desmoglein-1 and−3 concentrations correlated with disease severity, but not with the number of treatment changes. The identification of an effective and safe therapy for the individual pemphigus patient is a challenge and often requires time, which is reflected by a high number of therapy changes. Predictive parameters are warranted to directly identify the safest and most efficient treatment regimen for an individual patient.

Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry.

ObjectiveThe aim was to evaluate long-term drug retention, discontinuation, efficacy and safety of CT-P13 and reference infliximab in patients with rheumatoid arthritis (RA) enrolled in the Korean College of Rheumatology Biologics (KOBIO) registry.MethodsPatients included adults with RA who received CT-P13 or reference infliximab between December 2012 and December 2017. Drug retention, efficacy (Disease Activity Score in 28 joints [DAS28]–erythrocyte sedimentation rate [ESR] or DAS28–C-reactive protein [CRP] and American College of Rheumatology [ACR] core set measure), and adverse events (AEs) were assessed over 4-years’ follow-up.ResultsData from 199 RA patients (CT-P13: n = 147; reference infliximab: n = 52) were analyzed. Median treatment duration was 1.22 years for CT-P13 and 1.40 years for reference infliximab (p = 0.67). Overall, 82% of patients received first-line therapy. Drug retention of CT-P13 versus reference infliximab was comparable for the overall population (p = 0.84) and for first-line (p = 0.66) and subsequent treatment lines (p = 0.96). Treatment changes or discontinuations occurred in 65.2% of patients with CT-P13 and 69.6% with reference infliximab. The most common reason for treatment changes or discontinuing treatment was lack of efficacy (CT-P13: 31.9%; reference infliximab: 34.8%). CT-P13 demonstrated comparable improvements in DAS28-ESR, DAS28-CRP and ACR responses to reference infliximab. Overall, 19 grade 3 AEs were reported for CT-P13 and eight for reference infliximab.ConclusionLong-term data from patients with RA treated in routine clinical practice in Korea showed that CT-P13 had a comparable drug retention rate to reference infliximab, with similar efficacy and an acceptable safety profile.ClinicalTrials.gov identifierNCT01965132.Electronic supplementary materialThe online version of this article (10.1007/s40259-019-00393-y) contains supplementary material, which is available to authorized users.

Retention rate and long-term safety of biosimilar CT-P13 in patients with ankylosing spondylitis: data from the Korean College of Rheumatology Biologics registry

To evaluate the long-term drug retention, efficacy, and safety of the infliximab biosimilar CT-P13 in Korean patients with ankylosing spondylitis (AS) in clinical practice. The primary outcome was drug retention (i.e. time to treatment discontinuation or changing to another biologic) in Korean patients with AS. Additional outcomes included efficacy and safety. Data were collected through the Korean College of Rheumatology Biologics (KOBIO) registry (ClinicalTrials.gov identifier: NCT01965132). CT-P13 efficacy was assessed using standard disease activity parameters, and safety was evaluated by adverse events (AEs). Between December 2012 and December 2017, 244 patients with AS treated with CT-P13 were enrolled. Of those, 203 (83.2%) received CT-P13 as first-line therapy. The median duration of treatment was 2.05 years. After 4 years' follow-up, the retention rate of CT-P13 in the overall patient population was 66%. Treatment changes or discontinuations occurred in 38 (15.6%) and 32 (13.1%) patients, respectively. Lack of efficacy was the most common reason for treatment changes, whereas AEs were the most common single cause of discontinuation. Disease activity decreased markedly from baseline following initiation of CT-P13 treatment, and thereafter remained stable. A total of 313 AEs occurred in 118 patients (48.4%); the majority (94.6%) were mild or moderate in severity. The most common treatment-related AEs were infusion or injection-site reactions (4.1% of patients), uveitis (3.7%), and skin rash (3.7%). In this real-world study, CT-P13 demonstrated encouraging drug retention rates and times, together with reasonable long-term efficacy and safety, in Korean patients with AS.

Drivers of treatment patterns in patients with chronic lymphocytic leukemia stopping ibrutinib or idelalisib therapies

ABSTRACTNovel therapies including kinase inhibitors (KI) have led to high and durable response in patients with chronic lymphocytic leukemia (CLL), however, some patients stop therapy. This study evaluates reasons for treatment changes among CLL patients who stopped KI in real-world practice. Sixty-nine US oncologists/hematologists provided patient-level data abstracted from charts of CLL adult patients who initiated a KI and later (1) switched to another anti-neoplastic regimen (Switched cohort), (2) discontinued the KI and remained untreated (Discontinued cohort), or (3) restarted the same KI after an interruption of ≥60 days (Restarted cohort). Demographics, clinical/treatment characteristics, and reasons for stopping, restarting, and switching the KI therapy were described. In the Switched cohort, reasons for stopping included disease progression (72.5%), low/no disease activity (3.9%), adverse event [AE]/ intolerance/comorbidity (15.7%), and planned cellular therapies (7.9%). In the Discontinued cohort, approximately half (46.0%) of patients stopped KI therapy because they were terminally ill/died, or were moved to best supportive care — these patients were older, had more severe disease, and high comorbidity burden. The other half (54.0% of patients) stopped due to low/no disease activity (24.0%), AEs/toxicity (12.0%), or patient-requested drug holiday (18.0%). In the Restarted cohort, the most common reasons for stopping KIs were patient request (37.3%), AEs/intolerance (31.4%), and economic reasons (10%). Patients restarted when disease progressed (60.8%) or when they recovered from the AE (33%). Reasons for KI stop and subsequent treatment patterns were varied and multifactorial, suggesting heterogeneous disease management and a need for more evidence around supporting strategies and physician education.

Short term real world safety data of pertuzumab use in HER2 targeted treatment of metastatic breast cancer

With the development and widely use of HER2 targeted therapies, HER2 expressing metastatic breast cancer have no longer dismal prognosis as once expected. The combination of HER2 targeted therapies with chemotherapatic agents prolongs overall survival. Pertuzumab is a new monoclonal antibody molecule that binds to the extracellular portion of HER2 and works by inhibiting homo- and heterodimerization. The aim of this study is to document the real life data of toxicities seen in metastatic breast cancer patients treated with first line trastuzumab-pertuzumab combination therapy. A retrospective review of 26 cases from the medical oncology patient registry was conducted to include the dates October 2016 through December 2017. The number of cycles of treatment and doses, adverse events, dose changes and course delays, reasons for treatment change and types of second line treatments are noted. The imaging and laboratory test results were obtained from the electronic registration system. The cumulative toxicity incidence was accepted as the primary endpoint. The median age of the 26 cases was 54 years. The median cycle number of pertuzumab and docetaxel treatments were 9 and 7, respectively and the median duration of pertuzumab therapy was 6.75 months. As of the date of last follow-up, 80.7% of the cases were still under treatment. There was a total of 6 cases of delay in treatment, of which five were due to neutropenia, while in one case the cause was diarrhea. When the adverse events were examined, at least one side effect (excluding alopecia) was observed in 16 patients and 7 cases had no toxicity except alopecia. In terms of constitutional symptoms, eight of the 19 patients had grade 1 fatique, one case had itching, and three patients had asthenia. Hematologic toxicity was seen in twelve cases and all had at least grade 1 leukopenia. Grade 3-4 febrile neutropenia occurred only in one case. Left ventriculer ejection fraction was measured stable for all of the cases, none of them experienced any significant decrease. According to the results of this retrospective analysis, the use of pertuzumab-trastuzumab-docetaxel in the first line treatment of HER2 expressing metastatic breast cancer had good safety profile and had positive clinical results and paralleled with the results of the pivotal study.

C.03.03 - Optimisation of care in schizophrenia for relapse prevention with long-acting injectable antipsychotics

With the development and widely use of HER2 targeted therapies, HER2 expressing metastatic breast cancer have no longer dismal prognosis as once expected. The combination of HER2 targeted therapies with chemotherapatic agents prolongs overall survival. Pertuzumab is a new monoclonal antibody molecule that binds to the extracellular portion of HER2 and works by inhibiting homo- and heterodimerization. The aim of this study is to document the real life data of toxicities seen in metastatic breast cancer patients treated with first line trastuzumab-pertuzumab combination therapy.A retrospective review of 26 cases from the medical oncology patient registry was conducted to include the dates October 2016 through December 2017. The number of cycles of treatment and doses, adverse events, dose changes and course delays, reasons for treatment change and types of second line treatments are noted. The imaging and laboratory test results were obtained from the electronic registration system. The cumulative toxicity incidence was accepted as the primary endpoint.The median age of the 26 cases was 54 years. The median cycle number of pertuzumab and docetaxel treatments were 9 and 7, respectively and the median duration of pertuzumab therapy was 6.75 months. As of the date of last follow-up, 80.7% of the cases were still under treatment. There was a total of 6 cases of delay in treatment, of which five were due to neutropenia, while in one case the cause was diarrhea. When the adverse events were examined, at least one side effect (excluding alopecia) was observed in 16 patients and 7 cases had no toxicity except alopecia. In terms of constitutional symptoms, eight of the 19 patients had grade 1 fatique, one case had itching, and three patients had asthenia. Hematologic toxicity was seen in twelve cases and all had at least grade 1 leukopenia. Grade 3-4 febrile neutropenia occurred only in one case. Left ventriculer ejection fraction was measured stable for all of the cases, none of them experienced any significant decrease.According to the results of this retrospective analysis, the use of pertuzumab-trastuzumab-docetaxel in the first line treatment of HER2 expressing metastatic breast cancer had good safety profile and had positive clinical results and paralleled with the results of the pivotal study.

Treatment Changes in Patients With Moderate to Severe Psoriasis: A Retrospective Chart Review.

Psoriasis treatment involves topical medications, oral medications, phototherapy, and/or biologics. The treatments used depend on a myriad of factors that change over time. To characterise the frequency of and reasons for treatment changes in patients with moderate to severe psoriasis. A chart review examined treatment changes at 902 visits by 116 patients seen between January 1, 2010, and June 30, 2015, for moderate to severe psoriasis and the physicians' justifications for those changes. 'Treatment change' was defined as switching between, adding, or removing medication classes or switching within the oral or biologic class. There were 221 visits with treatment changes identified, and a change occurred every 4.1 visits. On average, there were 1.2 treatment changes per year. Patients treated for at least 1 year averaged 1 treatment change every 16 months. The most common type of change was from one biologic to another biologic (24.9%), followed by adding a nonbiologic to a biologic (18.6%). The most common reason for switching was poor control or flare of psoriasis. Affordability was a more common problem for biologics than for nonbiologic treatments. Biologic treatment options provide a major improvement over older systemic treatments, but patients still undergo frequent treatment changes to help control their disease.

Multi-state models for the analysis of time-to-treatment modification among HIV patients under highly active antiretroviral therapy in Southwest Ethiopia

BackgroundHighly active antiretroviral therapy (HAART) has shown a dramatic change in controlling the burden of HIV/AIDS. However, the new challenge of HAART is to allow long-term sustainability. Toxicities, comorbidity, pregnancy, and treatment failure, among others, would result in frequent initial HAART regimen change. The aim of this study was to evaluate the durability of first line antiretroviral therapy and to assess the causes of initial highly active antiretroviral therapeutic regimen changes among patients on HAART.MethodsA Hospital based retrospective study was conducted from January 2007 to August 2013 at Jimma University Hospital, Southwest Ethiopia. Data on the prescribed ARV along with start date, switching date, and reason for change was collected. The primary outcome was defined as the time-to-treatment change. We adopted a multi-state survival modeling approach assuming each treatment regimen as state. We estimate the transition probability of patients to move from one regimen to another.ResultA total of 1284 ART naive patients were included in the study. Almost half of the patients (41.2%) changed their treatment during follow up for various reasons; 442 (34.4%) changed once and 86 (6.69%) changed more than once. Toxicity was the most common reason for treatment changes accounting for 48.94% of the changes, followed by comorbidity (New TB) 14.31%. The HAART combinations that were robust to treatment changes were tenofovir (TDF) + lamivudine (3TC)+ efavirenz (EFV), tenofovir + lamivudine (3TC) + nevirapine (NVP) and zidovudine (AZT) + lamivudine (3TC) + nevirapine (NVP) with 3.6%, 4.5% and 11% treatment changes, respectively.ConclusionMoving away from drugs with poor safety profiles, such as stavudine(d4T), could reduce modification rates and this would improve regimen tolerability, while preserving future treatment options.