scholarly journals Long-term efficacy and tolerability of TNFα inhibitors in the treatment of non-infectious ocular inflammation: an 8-year prospective surveillance study

2019 ◽  
pp. bjophthalmol-2018-312767 ◽  
Author(s):  
Srilakshmi M Sharma ◽  
Erika Damato ◽  
Ann E Hinchcliffe ◽  
Colm D Andrews ◽  
Katie Myint ◽  
...  

Background/AimTo report the efficacy and tolerability of antitumour necrosis factor-alpha therapy (TNF inhibitors [TNFi]) in the management of non-infectious ocular inflammation, including uveitis and scleritis, in adult patients over an 8-year period.Materials and methodsThis is a prospective cohort study of infliximab and adalimumab in the treatment of non-infectious ocular inflammatory disease. 43 of 85 adult patients on TNFi (34 infliximab, 9 adalimumab) for ≥1 year with non-infectious uveitis or scleritis were followed from 2006 to 2014. Clinical assessments, medication, adverse events and history of steroid rescues were collected at 6 monthly intervals. General quality of life (Short Form Health Survey (SF-36)) and visual quality of life (Vision-related quality of life Core Measure (VCM1)) were assessed annually. Outcome measures included rate of sustained remission, rate of relapse, systemic corticosteroid reduction, adverse events, and VCM1 and SF-36 scores.ResultsThe median time on infliximab was 3.2 years (IQR 4.3) and on adalimumab was 2.4 years (IQR 1.8). Sustained remission was induced in 39 patients (91%) (0.5 per patient year) after a median of 1.2 years on a TNFi. 22 (51%) experienced one relapse, and 5 (12%) had two relapses. 23 (54%) had at least one adverse event; serious adverse events necessitating hospitalisation or cessation of medication occurred in four (9%) patients. 10 patients (23%) switched from the initiation of TNFi, at 1.7 years after starting, to another TNFi or another class of biologic therapy.ConclusionTNFi treatment is associated with long-term drug-induced remission of ocular inflammation, visual stability and corticosteroid reduction. Adverse events were common and no new safety signals occurred. Relapse of inflammation occurs in half of the treated population.

2015 ◽  
Vol 122 (4) ◽  
pp. 833-842 ◽  
Author(s):  
Matthew L. Carlson ◽  
Oystein Vesterli Tveiten ◽  
Colin L. Driscoll ◽  
Frederik K. Goplen ◽  
Brian A. Neff ◽  
...  

OBJECT The optimal treatment for sporadic vestibular schwannoma (VS) is highly controversial. To date, the majority of studies comparing treatment modalities have focused on a narrow scope of technical outcomes including facial function, hearing status, and tumor control. Very few publications have investigated health-related quality of life (HRQOL) differences between individual treatment groups, and none have used a disease-specific HRQOL instrument. METHODS All patients with sporadic small- to medium-sized VSs who underwent primary microsurgery, stereotactic radiosurgery (SRS), or observation between 1998 and 2008 were identified. Subjects were surveyed via postal questionnaire using the 36-Item Short Form Health Survey (SF-36), the 10-item Patient-Reported Outcomes Measurement Information System short form (PROMIS-10), the Glasgow Benefit Inventory (GBI), and the Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale. Additionally, a pool of general population adults was surveyed, providing a nontumor control group for comparison. RESULTS A total of 642 respondents were analyzed. The overall response rate for patients with VS was 79%, and the mean time interval between treatment and survey was 7.7 years. Using multivariate regression, there were no statistically significant differences between management groups with respect to the PROMIS-10 physical or mental health dimensions, the SF-36 Physical or Mental Component Summary scores, or the PANQOL general, anxiety, hearing, or energy subdomains. Patients who underwent SRS or observation reported a better total PANQOL score and higher PANQOL facial, balance, and pain subdomain scores than the microsurgical cohort (p < 0.02). The differences in scores between the nontumor control group and patients with VS were greater than differences observed between individual treatment groups for the majority of measures. CONCLUSIONS The differences in HRQOL outcomes following SRS, observation, and microsurgery for VS are small. Notably, the diagnosis of VS rather than treatment strategy most significantly impacts quality of life. Understanding that a large number of VSs do not grow following discovery, and that intervention does not confer a long-term HRQOL advantage, small- and medium-sized VS should be initially observed, while intervention should be reserved for patients with unequivocal tumor growth or intractable symptoms that are amenable to treatment. Future studies assessing HRQOL in VS patients should prioritize use of validated disease-specific measures, such as the PANQOL, given the significant limitations of generic instruments in distinguishing between treatment groups and tumor versus nontumor subjects.


2021 ◽  
Vol 9 (4) ◽  
pp. 232596712199580
Author(s):  
Erdal Uzun ◽  
Abdulhamit Misir ◽  
Ahmet Guney

Background: The effect of leg dominance on short-term functional outcomes and return to sports after arthroscopic anterior cruciate ligament reconstruction (ACLR) has been evaluated. However, postoperative medium- to long-term recovery and revision rates are not well known. Purpose: To investigate whether leg dominance affects medium- to long-term clinical and functional scores and revision rates after ACLR. Study Design: Cohort study; Level of evidence, 3. Methods: Included in this study were 235 patients (205 male and 30 female) who underwent isolated arthroscopic ACLR. Patients were divided according to the leg dominance status of their injured limb into 2 groups: dominant leg injured (120 patients) and nondominant leg injured (115 patients). Preoperative and postoperative functional outcomes and health-related quality of life (HRQoL) were evaluated using the visual analog scale for pain, Tegner activity scale, Lysholm knee score, International Knee Documentation Committee (IKDC) subjective knee evaluation form, 36-Item Short Form Health Survey (SF-36), and overall patient satisfaction. Moreover, the revision rates of the 2 groups were compared according to leg dominance, patient characteristics, and operative features. Results: The mean follow-up period was 8.0 ± 2.3 years (range, 5-13 years). A significant preoperative to postoperative improvement in range of motion and functional scores was noticed in both groups ( P < .001 for all). However, the improvement was significantly higher in the dominant leg group for the Tegner ( P = .001), Lysholm ( P = .006), and IKDC ( P < .001) scores as well as for the SF-36 domain scores for general health ( P = .009), social role ( P = .048), and emotional role ( P = .032). Also, patient satisfaction was significantly higher in the dominant leg group ( P = .007). The dominant leg group was associated with a lower revision rate compared with the nondominant leg group (5.8% vs 15.7%, respectively; P = .015). Conclusion: High recovery rates were seen after arthroscopic ACLR, regardless of leg dominance. However, leg dominance had a significant effect on postoperative medium- to long-term functional outcomes, HRQoL, and revision rates.


2019 ◽  
Vol 104 (7) ◽  
pp. 2748-2756 ◽  
Author(s):  
Gaia Tabacco ◽  
Yu-Kwang Donovan Tay ◽  
Natalie E Cusano ◽  
John Williams ◽  
Beatriz Omeragic ◽  
...  

Abstract Context Calcium and vitamin D treatment does not improve reduced quality of life (QOL) in hypoparathyroidism. Recombinant human (rh) PTH(1-84) therapy improves QOL metrics for up to 5 years. Data on QOL beyond this time point are not available. Objectives To evaluate the effects of 8 years of rhPTH(1-84) therapy on QOL and factors associated with long-term benefit. Design Prospective, open-label trial. Setting Referral center. Patients Twenty patients with hypoparathyoidism. Main Outcome Measures RAND 36-Item Short Form Health Survey (SF-36). Results rhPTH therapy led to substantial improvement in five of the eight SF-36 domains [vitality, social functioning (SF), mental health (MH), bodily pain (BP) and general health] and three of these domains (SF, MH, BP) were no longer lower than the reference population. The improvement in the mental component summary (MCS) score was sustained through 8 years, while the physical component summary (PCS) score improved through 6 years. A lower baseline QOL score was associated with greater improvement. A threshold value &lt;238 (MCS) and &lt;245 (PCS) predicted long-term improvement in 90% and 100% of the cohort, respectively. In patients whose calcium supplementation was reduced, MCS and PCS scores improved more than those whose supplementation did not decline to the same extent. Improvement in PCS was greater in patients whose calcitriol dosage was reduced and duration of disease was shorter. Conclusions rhPTH(1-84) improves long-term well-being in hypoparathyroidism. The improvements are most prominent in those with impaired SF-36 at baseline and those whose requirements for conventional therapy decreased substantially.


2021 ◽  
Vol 17 (2) ◽  
pp. 72-87
Author(s):  
C. Leggieri ◽  
L. Dezza ◽  
B. Oltolini ◽  
R. Lembo ◽  
B. Noto ◽  
...  

Patients may experience long-term physical, psychological and cognitive impairment after intensive care unit (ICU) discharge, a condition commonly described as post-intensive care syndrome. The relative contribution of each of these components to long-term quality of life was never investigated.The aim of this studyis to identify the type and severity of disability and QoL at the discharge from ICU and up to following 6 months.Material and Methods. All patients (n=218) discharged from a university hospital ICU between April 2016 and July 2017 were eligible. Exclusion criteria included: age <18 years, brain or spinal injury, life expectancy <90 days, and ICU stay <12 hours. The Short Form Health Survey (SF-36), and 5-level EuroQoL-5D (EQ-5D-5L) questionnaires were administered at ICU discharge, and at 30-, 90- and 180-days. We compared patients requiring short-term ICU monitoring (IM, Intensive Monitoring,n=109) or patients requiring ICU treatment (IT, Intensive Treatment,n=109).Results. All dimensions of SF-36 and EQ-5D-5L parameters increased from ICU discharge to 180-days, except for the SF-36 Synthetic index linked to mental health (P=0.08). All EQ-5D-5L parameters improved significantly in the IT group, while only Visual Analog Scale Health Perception improved in the IM group.Conclusion. ICU survivors suffer long-term physical and psychological sequelae. The perception of Quality of Life is reduced after ICU discharge. The psychological and cognitive dimensions were more compromised than physical ones. Patients discharged from the ICU may benefit from specific intensive care follow-up clinics addressing their needs in term of psychological and cognitive support.


SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A290-A290
Author(s):  
A Triller ◽  
A Hof zum Berge ◽  
B Finger ◽  
U Kallweit

Abstract Introduction Pitolisant, a selective histamine H3 receptor antagonist/inverse agonist, increases histamine release in the brain. The efficacy of pitolisant in adults with narcolepsy was demonstrated in randomized, placebo-controlled trials. This study evaluated long-term use of pitolisant in clinical practice. Methods This prospective, open-label, 2-year, observational study was conducted at a major narcolepsy center in Germany and enrolled adults with a diagnosis of narcolepsy who had no prior treatment with pitolisant. Assessments included excessive daytime sleepiness (Epworth Sleepiness Scale [ESS]), weekly rate of cataplexy (WRC), and health-related quality of life (Short-Form Veterans RAND [VR-36]). Results The study enrolled 147 patients: mean age, 29.9 years; 57.1% female, 65.3% with cataplexy, and 66.7% with disrupted nighttime sleep. In patients who were tested, CSF hypocretin-1 was &lt;110 pg/mL in 70.8% (51/72), and 79.4 % (77/97) were HLA-DQB1*0602 positive. The pitolisant dose was 35.6 mg/d in 38.1% of patients at Month 3, and 73.5% at Month 24. Most patients received concomitant narcolepsy medications (63.3% at baseline; 79.6% at month 24). Mean ESS score decreased from 16.2 at baseline to 12.4 at Month 12 and 12.6 at Month 24. Mean WRC was reduced by 31% at Month 24. Significant improvement in quality of life was noted at Months 12 and 24 on VR-36 subscales that assess general health perception, vitality, and social function. In all, 38 patients (25.8%) discontinued from the study before Month 24: 15.0% for lack of efficacy and 10.8% due to adverse events. The most common adverse events were disrupted nighttime sleep (29.3% of patients), headache (15.5%), and nausea (12.2%). Conclusion These real-world data show that long-term treatment with pitolisant (usually with 35.6 mg/d) was efficacious for reducing EDS and cataplexy and improving quality of life in patients with narcolepsy. Treatment was generally well tolerated. Support Writing support funded by Harmony Biosciences, LLC.


F1000Research ◽  
2013 ◽  
Vol 2 ◽  
pp. 61 ◽  
Author(s):  
Alex Cormier-Lavoie ◽  
Monique Ruel ◽  
Marie-Pierre Sylvestre ◽  
Jean-François Hardy

Background: Postoperative anemia is frequent in patients undergoing hip and knee arthroplasty. While it is legitimate to think that anemia could decrease postoperative vigor and, consequently, limit the patient’s rehabilitation, our previous study showed that anemia does not impair functional recovery in patients during the immediate postoperative period (10 days). Here we investigate the possible relationship between the postoperative hemoglobin (Hb) concentration and long-term (6 months or more) functional recovery and quality of life (QoL) in patients.Study design and methods: A follow-up, observational study was conducted in the 305 patients 60 years and older who underwent major hip or knee arthroplasty and participated in the Transfusion Requirements in Orthopedic Surgery (TRIOS) study (phase 2). The relationship between postoperative Hb concentration (or variation thereof) and primary outcomes (Functional Status Index (FSI) score, scores in the two categories of the Short Form 36 (SF-36) test and adverse events) was established by linear regression.Results: 160 patients responded to long-term follow-up. There were no significant correlations between the postoperative Hb concentration (or the variation in perioperative Hb) and either the FSI or SF-36 scores or adverse events. Consequently, moderate postoperative anemia does not appear to affect long-term (6 months or more after surgery) functional recovery or QoL in patients undergoing a major arthroplasty.Conclusion: Our results confirm the lack of longer-term effects of anemia on functional recovery observed in the immediate postoperative period in the TRIOS phase 2 study.


2018 ◽  
Vol 69 (2) ◽  
pp. 332-340 ◽  
Author(s):  
Damien Contou ◽  
Florence Canoui-Poitrine ◽  
Rémi Coudroy ◽  
Sébastien Préau ◽  
Martin Cour ◽  
...  

Abstract Background Long-term health-related quality of life (HR-QOL) of patients surviving the acute phase of purpura fulminans (PF) has not been evaluated. Methods This was a French multicenter exposed-unexposed cohort study enrolling patients admitted in 55 intensive care units (ICUs) for PF from 2010 to 2016. Adult patients surviving the acute phase of PF (exposed group) were matched 1:1 for age, sex, and Simplified Acute Physiology Score II with septic shock survivors (unexposed group). HR-QOL was assessed during a phone interview using the 36-Item Short-Form Health Survey (SF-36) questionnaire, the Hospital Anxiety and Depression (HAD) scale, the Impact of Event Scale–Revised (IES-R), and the activity of daily living (ADL) and instrumental ADL (IADL) scales. The primary outcome measure was the physical component summary (PCS) of the SF-36 questionnaire. Results Thirty-seven survivors of PF and 37 of septic shock were phone-interviewed at 55 (interquartile range [IQR], 35–83) months and 44 (IQR, 35–72) months, respectively, of ICU discharge (P = .23). The PCS of the SF-36 was not significantly different between exposed and unexposed patients (median, 47 [IQR, 36–53] vs 54 [IQR, 36–57]; P = .18). There was also no significant difference between groups regarding the mental component summary of the SF-36, and the HAD, IES-R, ADL and IADL scales. Among the 37 exposed patients, those who required limb amputation (n = 12/37 [32%]) exhibited lower PCS (34 [IQR, 24–38] vs 52 [IQR, 42–56]; P = .001) and IADL scores (7 [IQR, 4–8] vs 8 [IQR, 7–8]; P = .021) compared with nonamputated patients. Conclusions Long-term HR-QOL does not differ between patients surviving PF and those surviving septic shock unrelated to PF. Amputated patients have an impaired physical HR-QOL but a preserved mental health. Clinical Trials Registration NCT03216577.


2006 ◽  
Vol 24 (16) ◽  
pp. 2527-2535 ◽  
Author(s):  
Elizabeth Maunsell ◽  
Lisa Pogany ◽  
Maru Barrera ◽  
Amanda K. Shaw ◽  
Kathy N. Speechley

Purpose We assessed effects of childhood or adolescent cancer on quality of life among adolescent and adult cancer survivors, a group who are thought to be at particular risk for adverse late effects. Patients and Methods We studied 1,334 survivors and 1,477 age- and sex-matched, general population controls from across Canada using a mailed questionnaire which included the Short Form-36 (SF-36) and measures of self-esteem, optimism, and life satisfaction. General linear models and logistic regression were used. Survivor-control differences corresponding to an effect size (ES) ≥ 0.5 were considered clinically important. Results Participants were age 15 years to 37 years. Most survivors (83.8%) were diagnosed ≥ 10 years earlier. Fewer survivors (62.1%) than controls (71.1%) reported very good or excellent general health (adjusted odds ratio, 0.6; 95% CI, 0.5 to 0.7). However, quality of life differences between survivors and controls were small, and for the most part probably not clinically important. Three clinical characteristics—having had CNS or bone cancer, more than one treatment series, and ≥ two organs with a dysfunction at treatment end—were independently associated with poorer quality of life in the physical dimensions. Only survivors with ≥ two organs with dysfunction (8.7%) reported poorer quality of life in both physical and psychosocial domains, with several clinically important ES. The largest ES for the SF-36 physical summary scores were found in the 8% of survivors with two or three of these characteristics simultaneously, compared with those survivors who had none (−0.79 and −1.13, respectively). Conclusion Overall, a sizeable majority of adolescent and adult long-term survivors of childhood cancer in Canada appear to have adapted well.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A639-A640
Author(s):  
Allison Kimball ◽  
Laura E Dichtel ◽  
Melanie S Haines ◽  
Lisa B Nachtigall ◽  
Brooke Swearingen ◽  
...  

Abstract Acromegaly results in impaired quality of life (QoL), which improves but does not normalize after biochemical control of growth hormone (GH) excess. There are few data regarding long-term QoL in patients with sustained biochemical control of acromegaly. We hypothesized that QoL would continue to improve over time but remain poor. We studied 2 cohorts with biochemically controlled (normal IGF-1 level) acromegaly. MED (n=42) underwent surgery but required somatostatin analog (n=30) or GH receptor antagonist monotherapy (n=12); n=16 had undergone radiation. SURG (n=24) were in remission after surgery ± radiation (n=10). GH stimulation testing was performed in all SURG; n=11 had GH deficiency (GHD). QoL was assessed at 2 timepoints by the 36-Item-Short-Form Health Survey (SF-36) (MED, SURG), Acromegaly Quality of Life Questionnaire (AcroQoL) (MED), Gastrointestinal Quality of Life Index (GIQLI) (MED), Symptom Questionnaire (SQ) (SURG), and QoL-Assessment of GHD in Adults (AGHDA) (SURG). Time between timepoints 1 and 2 was 5.4 ± 1.0 vs 13.6 ± 1.2 years (MED vs SURG, p&lt;0.001), and mean duration of biochemical control for MED vs SURG at timepoint 2 was 14.8 ± 6.6 vs 20.8 ± 8.2 years (p&lt;0.001). At timepoint 2, mean (± SD) age (61 ± 12 years), mean BMI (30 ± 7 kg/m2), sex (68% female), and hypopituitarism (64% with ≥1 pituitary hormone deficiency) were similar between MED and SURG; mean IGF-1 index (IGF-1 level/mean normal range) was 1.00 ± 0.37 for MED vs 0.78 ± 0.40 for SURG (p=0.08); 79% of MED remained on medication. In MED, there was no change in SF-36 scores between timepoints, but all AcroQoL subscales and 2 GIQLI domains (Physical State, Emotions) improved, even after controlling for age, BMI, radiation treatment, and hypopituitarism. Results were similar in the 79% who remained on medication at timepoint 2. In SURG, QoL scores worsened on the SF-36 Pain domain and Physical Health Summary Score and SQ Depression and Somatic subscales (p≤0.01) but did not remain significant after controlling for age, BMI, radiation treatment, GHD, and adrenal insufficiency. After controlling for those variables, QoL by AGHDA worsened (p=0.02). At timepoint 2, % scoring in the lowest quartile (&lt;25%) of normal for age on the SF-36 was similar between MED and SURG: 57% scored &lt;25% of normal on ≥1 SF-36 domain and 29% scored &lt;25% of normal on ≥4 of 8 domains. GHD in SURG was associated with poorer SF-36 scores at timepoint 2 (6 domains and Mental Health Summary Score; p&lt;0.05). Radiation treatment did not predict poorer SF-36 scores. In conclusion, an average of 15 to 20 years after biochemical control of acromegaly by surgery ± radiation ± pharmacologic treatment, QoL remained low in many patients. QoL was poorer in patients with GHD than without but overall did not differ between those on and off pharmacologic therapy. Our data suggest that a history of acromegaly and development of GHD, but not medical treatment, are detrimental to QoL.


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