Adverse events associated with apremilast use and withdrawal for psoriasis in a real-world setting

2018 ◽  
Vol 32 (10) ◽  
pp. e393-e394 ◽  
Author(s):  
E.B. Lee ◽  
M. Amin ◽  
A. Egeberg ◽  
J.J. Wu
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Real World Setting

267-OR: Reduction in Self-Reported Adverse Events Related to Severe Hypoglycemia in Individuals Using a Predictive Low Glucose System: Results from a Real-World Setting

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 267-OR
Author(s):  
HARSIMRAN SINGH ◽  
MICHELLE L. MANNING ◽  
MOLLY MCELWEE-MALLOY ◽  
STEPHANIE HABIF
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Severe Hypoglycemia ◽  
Real World Setting ◽  
Glucose System ◽  
Low Glucose

scholarly journals AB0799 REAL-WORLD EXPERIENCE OF SECUKINUMAB FOR PSORIATIC ARTHRITIS WITH AXIAL INVOLVEMENT.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1699.3-1699
Author(s):  
M. Martin Lopez ◽  
B. Joven-Ibáñez ◽  
J. L. Pablos
Keyword(s):  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Real World ◽  
Spinal Pain ◽  
Tender Joint Count ◽  
P Value ◽  
X Ray ◽  
Activity Assessment ◽  
Real World Setting ◽  
Axial Involvement

Background:Evidence on the efficacy of biologics in the treatment of psoriatic arthritis (PsA) patients with axial manifestations affecting 30-70% of PsA patients is limited. Secukinumab (SEC) has provided significant and sustained improvement in the signs and symptoms of active PsA and ankylosing spondylitis.Objectives:This study aims to analyze the experience of using SEC for PsA patients with axial involvement in real-world setting.Methods:Multicentric observational, longitudinal, retrospective study conducted in a tertiary hospital between January 2016 and December 2019. Patients with PsA (CASPAR criteria) and clinical and/or image diagnosis of axial involvement receiving at least one dose of SEC were included. Patients with non-pathological sacroiliacs x-ray and MRI had to have spinal pain VAS ≥4/10 after failure to NSAIDs, prior to the onset of SEC, to be included. Medical records were reviewed to collect demographic and clinical data, features of PsA (manifestations, treatments and activity assessment). Descriptive statistics and then a comparative analysis with the Studentt-test to analyze the effectiveness of SEC were performed.Results:Of 98 PsA patients treated with SEC, 58 (59.2%) had axial involvement, of which 41 (71%) female. Mean age was 54 y.o (SD 10) and average duration of the disease was 10 years (SD 8). All 58 patients had peripheral disease (33% joint erosions), 55 (95%) had psoriasis, 20 (34%) showed dactilitis and 39 (67%) had enthesitis. Sacroiliacs x-ray was damaged in 38 (66%) patients (grade I-IV) and 23 (40%) pathological MRI, with HLAB27+ at 8 (14%) patients. Average BMI was 29 (SD 8), with an obesity rate of 33% (19 pt). Observed comorbidities were hypertension (27 pt, 47%), diabetes mellitus (6 pt, 10%), dyslipidemia (23 pt, 40%), active smoking (18 pt, 31%) and malignancy (6 pt, 10%). Regarding previous treatments, 90% had received cDMARDs, particularly methotrexate (86%) and 40 (69%) had been exposed to at least one bDMARD (15 pt to one, 9 to two, 6 to three and 10 to four or more). 7 patients were on 300 mg dose and 51 patients on 150 mg dose (dose escalation to 300 mg was performed in 16 patients and 44% respond and maintain SEC). Average drug survival time was 1.4 (SD 1) years. At 6 months of SEC therapy, tender and swollen joint count, spinal pain VAS, CRP, ASDAS-CRP and DAPSA had significantly decreased (Table 1). 29 (50%) patients suspended SEC during follow-up due to primary ineffectiveness (8), secondary ineffectiveness (16), adverse events (3), latex allergy (1) and remission (1). Adverse events do not differ from those reported in clinical trials.Table 1.Disease activity assessment at 6 months of secukinumab therapy.Baseline6 months after SECMean differenceP valueSJC4,8±5,41,9±3,1-2,8 (IC95% -3,9 a -1,7)p<0,0001TJC7,7±5,83,9±4,1-3,8 (IC95% -5,1 a -2,4)p<0,0001Spinal pVAS6,1±3,24,2±2,9-1,9 (IC95% -2,4 a -1,4)p<0,0001CRP (mg/L)7,7±9,94,9±5,9-2,9 (IC95% -4,5 a -1,2)p=0,0009ASDAS-CRP2,5±1,91,8±1,3-0,7 (IC95% -0,9 a -0,4)p<0,0001DAPSA27,7±12,116,7±10,4-11 (IC95% -15,3 a -6,8)p<0,0001SJC: swollen joint count, TJC: tender joint count, Spinal pVAS: spinal pain visual analog scale, CRP: C-reactive protein, SEC: secukinumab.Conclusion:Secukinumab in real-world setting provided improvements in the axial and peripheral manifestations of PsA, using both the 150 mg and 300 mg doses.Disclosure of Interests:MARIA MARTIN LOPEZ: None declared, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, José Luis Pablos: None declared

Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies in a real-world setting.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24072-e24072
Author(s):  
Jun Ma ◽  
Huiqiang Huang ◽  
Peifen Fu ◽  
Nong Xu ◽  
Chenyu Mao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Study Drug ◽  
Secondary Prophylaxis ◽  
Chemotherapy Cycle ◽  
Breast Cancer Patients ◽  
Continuous Administration ◽  
Real World Setting ◽  
Grade 3 ◽  
Long Acting

e24072 Background: The prophylaxis of neutropenia has been evolving from short acting granulocyte colony-stimulating factors (G-CSFs) to long acting G-CSFs. The safety and effectiveness of long acting G-CSF in a real-world setting were still lacking. Methods: We performed a multi-center, non-interventional, real-world study to explore the tolerability and effectiveness of mecapegfilgrastim. Different prophylactic strategy (primary or secondary prophylaxis) were compared. The effect of mecapegfilgrastim by means of continuous administration was also explored. Results: This study included 638 patients who had complete the study from May 2019 to November 15, 2020. About half of the participants were breast cancer patients. The mean age of the patients were 56 years. The most frequently reported adverse event possibly related to study drug was white blood cell increase (6.2 %). No unexpected adverse events were reported. Overall, thirty-six (5.6 %) patients experienced grade ≥ 3 neutropenia in chemotherapy cycle one. The patients in the primary and secondary prophylaxis subgroups had incidence of grade ≥ 3 neutropenia of 4.3 % and 9.2 % in chemotherapy cycle one respectively. There was a decreasing trend of neutropenia from cycle one to cycle four when mecapegfilgrastim were administrated continuously. Conclusions: The mecapegfilgrastim was well tolerable and no unexpected adverse events were observed in real-world setting. Primary prophylaxis using mecapegfilgrastim had lower incidence of neutropenia than secondary usage.

Examination of PD-1/PD-L1 inhibitor use and adverse events in a real-world setting.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19294-e19294
Author(s):  
Debra E. Irwin ◽  
Brenna L. Brady
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Metastatic Cancer ◽  
Immune Checkpoint Blockade ◽  
Administrative Claims ◽  
Treatment Results ◽  
Real World Setting ◽  
Common Diagnosis ◽  
History Of

e19294 Background: Immune checkpoint blockade through PD-1 and PD-L1 inhibition is an effective treatment for multiple cancers. This study used administrative claims to examine potential adverse events (AEs) associated with real-world PD-1 or PD-L1 inhibitor use. Methods: Adult patients newly initiating a PD-1 (pembrolizumab or nivolumab) or PD-L1 (atezolizumab, avelumab, or durvalumab) inhibitor from September 1, 2016 to August 30, 2018 were selected in the MarketScan Commercial and Medicare Supplemental Database. Patients were grouped by use of PD-1 or PD-L1 inhibitor; the study period consisted of 90 days baseline and 60 days follow-up around drug initiation. Patients who used both PD-1 and PD-L1 inhibitors during follow-up were excluded. Clinical characteristics were examined during baseline, while AEs were investigated over follow-up. Results: A total of 6,430 patients qualified for the analysis. The majority of the sample (N = 5,956; 93%) received PD-1 inhibitors. Compared to the PD-1 cohort, the PD-L1 cohort was older (64±10 vs. 61±12 yrs) and more likely to be male (61% vs. 56%), p < 0.05. PD-L1 patients were significantly more likely to have history of chronic pulmonary disease (28% vs. 23%) or myocardial infarction (4% vs. 3%) but less likely to have liver disease (2% vs. 0.6%) compared to PD-1 patients, p < 0.05. Lung cancer was the most common diagnosis in both groups (PD-1: 47%; PD-L1: 62%, p < 0.001). The PD-L1 cohort was more likely to have evidence of bladder cancer (36% vs. 5%), while the PD-1 cohort was more likely to have a melanoma (19% vs. 0.8%) or renal cell carcinoma diagnosis (10% vs. 7%), p < 0.05. Over half of the PD-1 (65%) and PD-L1 (61%) patients had metastatic cancer diagnosis during the study period. Incident AEs occurring in > 5% of the sample included dyspnea (PD-1: 13%; PD-L1: 14%), nausea/vomiting (PD-1: 11%; PD-L1: 8%, p < 0.05), anemia (PD-1: 11%; PD-L1: 12%), fatigue (PD-1: 10%; PD-L1: 12%), abdominal pain (PD-1: 7%; PD-L1: 7%), cough (PD-1: 7%; PD-L1: 10%, p < 0.05), back pain (PD-1: 7%; PD-L1: 10%, p < 0.05), constipation (PD-1: 6%; PD-L1: 8%), arthralgia (PD-1: 6%; PD-L1: 6%), pyrexia (PD-1: 5%; PD-L1: 8%, p < 0.01), and edema (PD-1: 6%; PD-L1: 5%). Conclusions: This study assessed real-world AEs associated with PD-1/PD-L1 inhibitor use in the 60 days following first treatment. Results showed AEs are common soon after starting therapy. Although, PD-1 and PD-L1 inhibitors target the same pathway, slightly different AE profiles exist for the two classes. More longitudinal analyses of real-world AEs are needed to better understand potential impacts of prolonged therapy.

scholarly journals Effectiveness and safety of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single-tablet combination among HIV-infected patients in Turkey: results from a real world setting

2021 ◽  
Vol 21 (4) ◽  
pp. 1593-602
Author(s):  
Bilgul Mete ◽  
Alper Gunduz ◽  
Hayat Kumbasar Karaosmanoglu ◽  
Fatma Gumuser ◽  
Sibel Bolukcu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Tenofovir Disoproxil Fumarate ◽  
Primary Objective ◽  
Real World Data ◽  
Phase 3 ◽  
Hiv Rna ◽  
Real World Setting ◽  
Treatment Naïve ◽  
Study Population

Background: Efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (E/C/F/TDF) in treatment-naïve and experienced patients with HIV infection was demonstrated in phase 3 trials. The primary objective of this study was to evaluate effectiveness and safety of E/C/F/TDF in real world settings. Methods: Retrospective, observational data collected by the Turkish ACTHIV-IST study group between May 2015 and December 2016 were analysed. Results: A total of 387 patients were prescribed E/C/F/TDF; 210 patients with available data at 6th month were eligible; 91.5% were male, and mean age was 35.2 (SD: 10.8) years; 54.0% of males identified themselves as MSM. Sixty-three percent (133) of the study population were treatment-naïve patients, and 37% (77) were treatment experienced. HIV RNA level was below 100 copies/mL in 78.9% of treatment-naïve patients and 89.9% of treatment experienced patients at month 6. Median increase in CD4 T lymphocyte count was 218 copies/mL in treatment-naïve patients and remained stable or increased in treatment experienced patients. Adverse events were observed in 15% of the patients, and the regimen was discontinued in only six patients. Conclusion: Real world data on the effectiveness and safety of E/C/F/TDF is comparable with the phase 3 trial results Adverse events are uncommon and manageable. Keywords: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; HIV; effectiveness; safety.

Treatment of locally advanced or multiple basal cell carcinoma with vismodegib in real world setting.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22065-e22065
Author(s):  
Janja Ocvirk ◽  
Tanja Mesti ◽  
Katja Leskovsek
Keyword(s):  
Basal Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Real World ◽  
Locally Advanced ◽  
Muscle Cramps ◽  
Real World Setting ◽  
Previously Treated ◽  
Baseline Characteristics ◽  
Grade 3

e22065 Background: Evaluation of efficacy and safety of vismodegib (V) was done in a retrospective analysis of patients (pts) with locally advanced or multiple basal cell carcinoma (laBCC or multiple BCC) and pts with Goltz-Gorlin Syndrom (G-G Syn) in routine clinical practice. Methods: Baseline characteristics, efficacy data and treatment-related adverse events were collected from 30 laBCC or multiple BCC and 6 G-G Syn pts who were treated with V. Results: In 86-month period, 36 pts were diagnosed with laBCC (18 pts), multiple BCC (12 pts) or G-G Syn (6 pts), all inappropriate for surgery or radiotherapy. Baseline characteristics: median age was 72.6 years in laBCC + multiple BCC pts group and 51.3 years in G-G Syn pts group. Sixty percent of pts in laBCC + multiple BCC group were females; majority (70%) of pts were previously treated by surgery (S) and/or radiotherapy (RT); 43% of pts had 1 lesion with predominant localization in central face (eyes, nose, lips or ears in 84% of pts), 20% had 2-3 lesions and 37% more than 3 lesions. Fifty percent of pts in G-G Syn pts group were males; all pts were previously treated with S and/or RT. The overall response rate (ORR) was 76% in laBCC + multiple BCC and 83% in G-G Syn pts group. Disease control rate (DCR) was 93% in laBCC + multiple BCC and 100% in G-G Syn pts group. Median duration of treatment (DoT) was 7.8 months (range: 1.3-29.8) in laBCC + multiple BCC group and 27.1 months (range: 4.8-86.4) in G-G Syn group. At the time of analysis in laBCC or multiple BCC group one patient died due to other reasons than cancer, in 30% of pts treatment has been interrupted during the treatment course [in most cases due to complete response or adverse events (AEs)], 40% of pts are still on treatment. In G-G Syn group treatment has been interrupted in 50% of pts (in most cases due to adverse events), 67% of pts are still on treatment. AEs of any grade were reported in 97% of pts in laBCC or multiple BCC group and 83% in G-G Syn group. Majority of AEs in laBCC or multiple BCC group were grade 1 or 2 (96%)., 4% of AEs were grade 3: muscle cramps in 3 pts, respiratory infection, vomiting and anemia in 1 patient each. Majority of AEs in G-G Syn group were also grade 1 or 2 (87%), 13% of AEs were grade 3: muscle cramps in 2 pts, weight loss and diarrhea in 1 patient each. No grade 4 or 5 AEs were reported. Conclusions: Vismodegib has shown meaningful efficacy with manageable safety profile in pts with laBCC or multiple BCC as well as in pts with G-G Syn in real world setting.

Evaluation of Adverse Events of Oral Antihyperglycaemic Monotherapy Experienced by a Geriatric Population in a Real-World Setting

Drugs & Aging ◽  
2008 ◽  
Vol 25 (7) ◽  
pp. 611-622 ◽  
Author(s):  
Carl V Asche ◽  
Carrie McAdam-Marx ◽  
Laura Shane-McWhorter ◽  
Xiaoming Sheng ◽  
Craig A Plauschinat
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Geriatric Population ◽  
Real World Setting
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