scholarly journals 2778. Impact of Reactogenicity on Quality of Life and Physical Functioning in Adults ≥50 Years Receiving Both Doses of the Adjuvanted Recombinant Zoster Vaccine

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S980-S981
Author(s):  
Kenneth E Schmader ◽  
Myron J Levin ◽  
Michael Chen ◽  
Sean Matthews ◽  
Megan Riley ◽  
...  

Abstract Background The adjuvanted recombinant zoster vaccine (RZV) is efficacious in preventing herpes zoster in adults ≥ 50 years. The current study investigates whether the vaccinees’ quality of life (QoL) and physical functioning (PF) are impacted by local and systemic reactions due to RZV. In a previous report of this phase III, open-label, multicenter study (NCT02979639), overall PF and QoL were not significantly affected by a first RZV dose. [1] Here we report the results from the same study after a second RZV dose and safety results from dose 1 up to study end. Methods Adults aged ≥ 50 years were to receive 2 doses of RZV 2 months apart. Changes in mean Short Form health survey (SF-36) PF score between pre- and post-each RZV dose for 7 days, QoL, reactogenicity and safety were assessed. Results 401 adults received dose 1 and 391 received dose 2 of RZV. Post-second RZV dose, the reported solicited local symptoms were pain (75.1%), erythema (22.4%) and swelling (13.9%), and the most frequent solicited systemic symptoms were fatigue (46.3%), headache (37.5%) and myalgia (32.9%). Grade 3 solicited symptoms were reported by 7.2% (local) and 11.1% (general) of participants, and 5 (1.2%) participants reported reactogenicity triggering medical attention post-second RZV dose. From first dose up to study end, 14 (3.5%) participants reported 21 serious adverse events, none related to RZV. In days 1–2, post-second RZV dose, a transient, clinically-important decrease in SF-36 PF score (table) was seen in those reporting grade 3 solicited symptoms, which impacted activities such as walking and climbing stairs. Overall, during the 7 days post-second RZV dose, a mean change of −0.4 points was observed from the mean baseline score, indicating the PF was not clinically meaningfully impacted. No overall quality-adjusted-life-year loss was recorded. Conclusion Overall, the QoL and PF of adults ≥ 50 years were not affected post-second RZV dose; a transient impact was observed in adults with grade 3 reactogenicity. These results and the observed reactogenicity and safety profile are consistent with first RZV dose results, as well as that of previous studies with the RZV vaccine in adults of similar age. Funding: GlaxoSmithKline Biologicals SA. 1. Schmader et al., Abstract 2488, IDWeek 2018 Disclosures All authors: No reported disclosures.

Author(s):  
Kenneth E Schmader ◽  
Myron J Levin ◽  
Michael Chen ◽  
Sean Matthews ◽  
Megan E Riley ◽  
...  

Abstract Background Herpes zoster may significantly impact quality of life (QoL) in older adults. The recombinant zoster vaccine (RZV) is efficacious in adults aged ≥50 and older and is associated with increased reactogenicity compared to placebo. We report here on the impact of reactogenicity of the second RZV dose on the QoL and physical functioning (PF) of vaccine recipients, and summarize findings following both doses. Method In this single-arm study, 401 adults aged ≥50 and older were enrolled to receive two RZV doses 2 months apart. Change in mean Short Form Survey-36 (SF-36) PF and EuroQol-5 Dimension (EQ-5D) scores, reactogenicity, safety, productivity loss, and healthcare resource utilization were evaluated. Results In total, 391 (97.5%) participants received dose 2. Post-dose 2, the most common solicited local symptoms were injection site pain (75.1%), erythema (22.4%), and swelling (13.9%), and the most common systemic symptoms were fatigue (46.3%), headache (37.5%), and myalgia (32.9%). Grade 3 solicited (local and systemic) adverse events were reported by 61 (15.6%) participants and were associated with a transient clinically significant decrease in SF-36 PF score on Days 1–2 post-dose 2 that recovered by Day 3. Overall, no clinically important reduction in mean SF-36 PF scores was observed from baseline to post-dose 2 (mean change −0.4), and no quality-adjusted-life-year loss was recorded. Conclusions Overall, QoL and PF of RZV vaccinees were not affected by vaccine-related reactogenicity. A transient reduction was observed in the first 2 days after RZV vaccination in individuals with Grade 3 adverse events. No safety concerns were identified.


2001 ◽  
Vol 94 (2) ◽  
pp. 211-216 ◽  
Author(s):  
Helen C. Martin ◽  
Jagjit Sethi ◽  
Dorothy Lang ◽  
Glen Neil-Dwyer ◽  
Mark E. Lutman ◽  
...  

Object. The aim of this study was to assess whether outcomes from excision of acoustic neuroma vary among patients and have a material impact on their quality of life (QOL). Methods. A questionnaire concerning postoperative symptoms and the Short Form 36 (SF-36) QOL instrument were mailed to 97 consecutive patients who had undergone acoustic neuroma surgery via the translabyrinthine approach. The survey response rate was 78% and the symptomatology was consistent with other reports, supporting the representativeness of the sample. The respondents' QOL was rated significantly below published norms and their work capacity was reportedly reduced. Specifically, the following SF-36 dimensions were reduced: physical functioning and role-physical, together with vitality, general health, and social functioning. Greater numbers of postoperative symptoms and larger tumors were associated with a worse rating of physical functioning. More severe balance problems were associated with lower ratings of social functioning. The disparity between the patient's self-estimate and self-measurement and the clinician's assessment of the patient's facial functioning raises doubts about the validity of subjective reports and assessment. Conclusions. The present study supports the use of generic QOL measures to assess outcome and to draw comparisons between different populations.


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S746-S747 ◽  
Author(s):  
Kenneth E Schmader ◽  
Myron J Levin ◽  
Katrijn Grupping ◽  
Sean Matthews ◽  
David Butuk ◽  
...  

2018 ◽  
Vol 36 (6) ◽  
pp. 563-571 ◽  
Author(s):  
Julie Lemieux ◽  
Michael D. Brundage ◽  
Wendy R. Parulekar ◽  
Paul E. Goss ◽  
James N. Ingle ◽  
...  

Purpose MA.17R was a Canadian Cancer Trials Group–led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor–positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL.


2018 ◽  
Vol 74 (8) ◽  
pp. 1231-1238 ◽  
Author(s):  
Desmond Curran ◽  
Lidia Oostvogels ◽  
Thomas Heineman ◽  
Sean Matthews ◽  
Janet McElhaney ◽  
...  

Abstract Background To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life. Methods The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of patients aged 70 years and older from the trials combined. Results The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset. Conclusions Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients’ utility loss.


F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 282
Author(s):  
Alessia Saverino ◽  
Eva Zsirai ◽  
Raphael Sonabend ◽  
Lorenza Gaggero ◽  
Isabella Cevasco ◽  
...  

Background: Health-related quality of life (HRQL) is important for evaluating the impact of a disease in the longer term across the physical and psychological domains of human functioning. The aim of this study is to evaluate HRQL in COVID-19 survivors in Italy using the short form 36-items questionnaire (SF-36). Methods: This is an observational study involving adults discharged home following a coronavirus disease 2019 (COVID-19)-related hospital admission. Baseline demographic and clinical data including the Cumulative Illness Rating Scale (CIRS) and the Hospital Anxiety and Depression Scale (HADS) were collected. The validated Italian version of SF-36 was administered cross-sectionally. The SF-36 contains eight scales measuring limitations in physical and social functioning, the impact on roles and activities, fatigue, emotional well-being, pain and general health perception. Results: A total of 35 patients, with a mean age of 60 years, completed the SF-36. The results showed difficulties across the physical and psychological domains, particularly affecting the return to previous roles and activities. A higher burden of co-morbidities as well as a more severe muscle weakness was associated to a lower physical functioning. Younger age, rather than older, correlated to a perceived greater limitation in physical functioning and vitality. Conclusions: COVID-19 survivors particularly the ones of working age may need support for resuming their premorbid level of functioning and returning to work.


2016 ◽  
Vol 10 (1) ◽  
pp. 1
Author(s):  
ANDREE KURNIAWAN ◽  
NATA PRATAMA HARDJO LUGITO

ABSTRACTCancer is related to a deterioration of nutritional status and quality of life (Qol), but the extent of these conditions in patients with breast cancer has not been studied well. Malnutrition is prevalent among cancer patients and maybe correlated with altered quality of life. The aim of this study is to evaluate the association of QoL and nutritional status after breast cancer diagnosed. Nutritional status was evaluated with Patient Generated Subjective Global Assessment and QoL using Short form 36 (SF-36) and also with the specific module for breast cancer patients. A consecutive sampleof twenty two patients diagnosed with breast cancer was evaluated. The associations of QoL with stadium and nutrition status were evaluated using T-test analysis. The mean of body mass index was 21.3 kg/m2. Fifty percent patient have menopause. Most patients were stage II (77.3%), the others stage III (18.2%) and stage I (4.5%). Sixty eight point two percent had risk of malnutrition. The stadium of tumor was significantly related to physical functioning (p < 0.000), physical limitation (p < 0.024), emotional limitation (p < 0.013), well-being (p < 0.020), health changes (p < 0.010). Thestatus of nutrition was significantly related to physical functioning (p < 0.001), loss of energy (p < 0.010) and general health (p <0.005). For Conclusion, the status of nutrition breast cancer patients were related to QoL especially physical functioning, loss of energy and general health after they were diagnosed.ABSTRAKKanker sangat terkait dengan perburukan status nutrisi dan kualitas hidup. Namun demikian, belum banyak studi yang yang melaporkan masalah nutrisi dan kulitas hidup pada kanker payudara. Malnutrisi sering ditemukan pada kanker dan mungkin terkait dengan perubahan kulaitas hidup. Tujuan penelitian ini adalah untuk mengevaluasi hubungan antara kualitas hidup dengan status nutrisi setelah kanker payudara terdiagnosis. Evaluasi status nutrisi dilakukan dengan Patient Generated Subjective Global Assessment dan kualitas hidup dengan Short form 36 (SF-36) sertakarakteristik pada kanker payudara. Sampel diambil dengan teknik konsekutif terhadap 22 pasien yang terdiagnosis kanker payudara. Hubungan kualitas hidup dengan stadium kanker dan status nutrisi dinilai menggunakan analisis T-test. Indeks massa tubuh rata-rata adalah 21,3 kg/m2. Lima puluh pasien telah menopause. Terbanyak adalah stadium 2 (77,3%), stadium 3 (18,2%), dan stadium 1 (4,5%). Enam puluh dua koma dua persen berisiko malnutrisi. Stadium tumor secara bermakna berhubungan dengan fungsi fisik (p <0,000), keterbatasan fisik (p<0,024), keterbatasan emosi(p<0,013), rasa nyaman (p<0,020), dan perubahan kesehatan (p<0,000). Status nutrisi berhubungan secara bermakna dengan fungsi fisik (p<0,001), kehilangan energi (p<0,010), dan kesehatan secara umum (p<0,005). Simpulan, status nutrisi pasien kanker payudara berhubungan dengan kualitas hidup, terutama fungsi fisik, kehilangan energi, status kesehatan umum setelah mereka terdiagnosis.


2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Vibeke Strand ◽  
Susan H. Boklage ◽  
Toshio Kimura ◽  
Florence Joly ◽  
Anita Boyapati ◽  
...  

Abstract Background Increased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and have been shown to be predictive of therapeutic responses, fatigue, pain, and depression in patients with rheumatoid arthritis (RA), but limited data exist on associations between IL-6 levels and health-related quality of life (HRQoL). This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL-6 receptor α (anti-IL-6Rα) versus adalimumab, a tumor necrosis factor α inhibitor, both approved for treatment of active RA. Methods Baseline serum IL-6 levels in 300/369 randomized patients were categorized into low (1.6–7.1 pg/mL), medium (7.2–39.5 pg/mL), and high (39.6–692.3 pg/mL) tertiles. HRQoL was measured at baseline and week (W)24 and W52 by Short Form 36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores, Functional Assessment of Chronic Illness Therapy -fatigue, and duration of morning stiffness visual analog scale (AM-stiffness VAS). Linear regression of changes from baseline in HRQoL (IL-6 tertile, treatment, region as a stratification factor, and IL-6 tertile-by-treatment interaction as fixed effects) assessed predictivity of baseline IL-6 levels, with low tertile as reference. Pairwise comparisons of improvements between treatment groups were performed by tertile; least squares mean differences and 95% CIs were calculated. Similar analyses evaluated W24 patient-level response on minimum clinically important differences (MCID). Results At baseline, patients with high versus medium or low IL-6 levels (n = 100, respectively) reported worse (nominal p < 0.05) SF-36 MCS and role-physical, bodily pain, social functioning, role-emotional domain, and AM-stiffness VAS scores. There was a greater treatment effect with sarilumab versus adalimumab in high tertile versus low tertile groups in SF-36 PCS, physical functioning domain, and AM-stiffness VAS (nominal interaction p < 0.05). PCS improvements ≥MCID were higher in high (odds ratio [OR] 6.31 [2.37, 16.81]) versus low (OR 0.97 [0.43, 2.16]) tertiles with sarilumab versus adalimumab (nominal interaction p < 0.05). Adverse events between IL-6 tertiles were similar. Conclusions Patients with high baseline IL-6 levels reported better improvements in PCS, physical functioning domain, and AM-stiffness scores with sarilumab versus adalimumab and safety consistent with IL-6R blockade. Trial registration NCT02332590. Registered on 5 January 2015


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 418-418
Author(s):  
Yasuyoshi Miyata ◽  
Kojiro Ohba ◽  
Tomohiro Matsuo ◽  
Hideki Sakai

418 Background: Various chemotherapeutic regimens have been examined. However, there is no effective regimen, and some studies have been stopped because of severe adverse events. Therefore, maintenance of quality of life is also important. This study examine the anti-cancer effects, changes in the quality of life (QoL), and safety of combined therapy of low dose gemcitabine, paclitaxel, and sorafenib in these patients. Methods: Twenty patients were treated with gemcitabine (700 mg/m2 on day 1), paclitaxel (70 mg/m2 on day 1), and sorafenib (400 mg/day on days 8–22). QoL and pain relief were evaluated using the short-form survey (SF)-36 and the visual analogue scale (VAS). Data on QoL and pain were collected on the day before the first cycle was started and 8 weeks after starting the therapy. A total of 124 cycles were administered and the median (IQR) number of treatment cycles per patient was 5 (3–8) cycles. Results: Among 20 patients, 12 and 8 patients were received as 2nd- and 3rd-line therapy, respectively. In 2nd-line therapy, median / interquartile range of VAS scores after therapy (2 / 2–3) significantly decreased (p = 0.012) compared to their pretreatment levels (3 / 2–5). Likewise, a significant decrease was also found in 3rd-line therapy (5/ 4–6 to 3/ 2–3, p = 0.028). Similar findings were confirmed by the bodily pain score from the SF-36 survey. A decrease in analgesic consumption was seen in three patients (17.6%), and 2 patients (11.8%) was improved the pain without increasing the dose. Complete responses, partial responses, and stable disease were found in 0 (0.0%), 1 (5.0%), and 13 patients (65%), respectively. The period of overall survival after starting of this therapy was 7 (5–11) months. Three patients (15.0%) stopped therapy because of grade 3 fatigue and hand-foot reactions. Conclusions: Combined therapy of low dose gemcitabine, paclitaxel, and sorafenib was well tolerated. QoL was maintained and improvements in their pain levels were found after treatment. We suggest that this treatment regimen is worthy of consideration as 2nd- and 3rd-line therapy for patients with CDDP-resistant UC. Clinical trial information: 000010957.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S3-S4
Author(s):  
Joon Hyung Kim ◽  
Robert Johnson ◽  
Martina Kovac ◽  
Anthony L Cunningham ◽  
Srikanth Emmadi ◽  
...  

Abstract Background Older and immunocompromised adults are at increased risk for herpes zoster (HZ) and often experience persistent, severe HZ-related pain, impacting their quality of life and activities of daily living. High vaccine efficacy (VE) of the adjuvanted recombinant zoster vaccine (RZV) in preventing HZ and reducing severe and clinically significant HZ-related pain has been shown in adults ≥ 50 years of age (YOA; ZOE-50 study; NCT01165177), ≥ 70 YOA (ZOE-70; NCT01165229) and ≥ 18 YOA undergoing autologous hematopoietic stem cell transplantation (ZOE-HSCT; NCT01610414). Methods In patients with confirmed HZ from the above phase III, randomized, placebo-controlled studies, we analyzed VE of RZV in reducing the duration of clinically significant HZ-related pain and in reducing the use and duration of HZ-related pain medication. Pain was assessed by the Zoster Brief Pain Inventory (ZBPI). Use of all HZ-related medication was recorded. Results VE in reducing the duration of clinically significant HZ-related pain (ZBPI pain score ≥3) during HZ episodes was 38.5% (p-value: 0.0099) in RZV-vaccinated patients from the ZOE-HSCT study compared to placebo. A similar trend (not statistically significant) was observed in the ZOE-50 (VE: 26.9%; p-value: 0.4318) and ZOE-70 (VE: 28.4%; p-value: 0.1877) studies. VE in reducing the use (Table 1) and duration (Table 2) of HZ-related pain medication was 39.6% (p-value: 0.0083) and 49.3%(p-value: 0.0404), respectively, in the ZOE-70 study; corresponding positive VE estimates were also seen in the ZOE-50 and ZOE-HSCT studies. Non-opioids were used by 61.2%, 44.3% and 22.1% of patients in the ZOE-50, ZOE-70 and ZOE-HSCT studies, respectively; weak opioids by 18.6%, 13.0% and 10.8% of patients, and strong opioids by 8.0%, 2.0% and 5.3% of patients (Table 3). Table 1. Reduction in the use of HZ-related pain medication in patients with confirmed HZ Table 2. Reduction in the duration of HZ-related pain medication use in patients with confirmed HZ Table 3. HZ-related medication types in patients with confirmed HZ Conclusion In addition to a high VE in preventing HZ in these studies, we also observed an attenuation of HZ-related pain, and thus lower use and duration of pain medication in breakthrough cases after RZV vaccination, thereby potentially improving patient quality of life. Funding: GlaxoSmithKline Biologicals SA Acknowledgment: Kristel Vercauteren/Sander Hulsmans (Modis c/o GSK) provided medical writing/editorial support Disclosures Joon Hyung Kim, MD, GSK (Employee, Shareholder) Robert Johnson, MD, FRCA, GSK (Other Financial or Material Support, I accept no fees but have had expense reimbursement in the past.) Martina Kovac, MD, GSK (Other Financial or Material Support, I was an employee of GSK at the time of the study) Anthony L. Cunningham, MBBS, MD, FRACP, FRCPA, GSK (Consultant) Srikanth Emmadi, MSc, GSK (Employee) Keith Sullivan, MD, FASTCT, GSK (Consultant) Alemnew F. Dagnew, MD, GSK group of companies (Employee, Shareholder) Desmond Curran, PhD, GSK (Employee, Shareholder) Anne Schuind, MD, GSK (Employee, Other Financial or Material Support, own GSK stock options or restricted shares as part of renumeration)


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