Fatigue in patients with. Riet Strik Albers Nurse Practitioner immunology and infectious diseases April 19, 2016
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1 Fatigue in patients with Primary Immunodeficiency dfii (PID) Riet Strik Albers Nurse Practitioner immunology and infectious diseases April 19, 2016
2 Fatigue: up to date Definition: ADULTS Fatigue can be manifested as difficulty or inability initiating activity (perception of generalized weakness); reduced capacity maintaining activity (easy fatigability); and difficulty with concentration, memory, and emotional stability (mental fatigue) CHILDREN Fatigue is always linked to a disease. Fatigue was not found as a presenting symptom Page 2
3 Page 3
4 Two studies (PID) Children: fatigue >< quality of life Adults: fatigue >< intravenous immunoglobulin suppletion and psychosocial variables Page 4
5 Background: study 1 In the Netherlands 1/ children are born with a primary immunodeficiency Approximately 70% humoral immunodeficiency Patients often report fatigue as a dominant complaint No study found in the Netherlands about quality of live in children with PID just tired? Page 5
6 Research questions 1. Are children between 8 18 years with PID more fatigued than healthy children? 2. What is the difference of quality of live (QOL) between these children and healthy ones? Is fatigue associated with QOL? with a specific age? a specific immunodeficiency? Is there a relation between fatigue and IgG level in the blood? fatigue and different treatments? Page 6
7 Methods Population: Children from 8 18y with a humoral immunodeficiency No comorbidity Different treatment options No medication Antibiotics prophylaxis (AB) Immunoglobulin substitution (IVIG/SCIG) Combination of AB and IVIG/SCIG Controls: Dutch studies in healthy children, performed with the same questionnaires and the same age Design: cross sectional descriptive study Gordijn et al., 2010; Engelen et al., 2009 Page 7
8 Methods PedsQL Multidimensional Fatigue Scale (Higher scores = lower problems) 18 items in 3 subscales (past month) General fatigue Sleep/rest fatigue Cognitive fatigue Varni et al., 2002; Gordijn et al., 2010 Pediatric Quality of Life Inventory (PedsQL) (Higher scores = better QOL) 23 items in 4 subscales (past month) Physical functioning Social functioning Emotional functioning School functioning Psychosociale score (sum van SES) Varni et al., 1999; Engelen et al., 20 Age specific questionnaires: 8 12 y and y of age Children score on a 5 point Likert scale, transferred in a scale of Page 8
9 Results: Demographics 8 12 y n = y n = 8 Age (year, month) Mean, range ( ) ( ) 17.6) Gender Boys/Girl 10/5 4/4 PID IgA deficiency IgG subclass deficiency Specific polysaccharide antibody deficiency CVID Agammaglobulinemia Therapy SCIG/IVIG 7 3 Antibiotic prophylaxis None Periods of sickness/school absence (days) Past 2 months Page 9
10 Results: PedsQL Fatigue Scale 8 12 y Totale vermoeidheid Total score Cognitieve Cognitive vermoeidheid fatigue Slaap/rust Sleep/rest vermoeidheid fatigue Algemene General fatigue vermoeidheid Mean healthy (n=143) Mean gezond kind (n = 143) Mean patient (n=15) Mean kind met humorale immuundeficiëntie Higher scores indicate lower problems Page 10
11 Results: PedsQL Fatigue Scale 8 12 y Totale vermoeidheid Total score p value 0.02 Cognitieve Cognitive vermoeidheid fatigue Slaap/rust Sleep/rest vermoeidheid fatigue Algemene General fatigue vermoeidheid p value 0.04 p value 0.01 Mean healthy (n=143) Mean gezond kind (n = 143) Mean patient (n=15) Mean kind met humorale immuundeficiëntie Higher scores indicate lower problems Page 11
12 Results: PedsQLFatigue Scale y Total Totale fatigue vermoeidheid Cognitieve Cognitive vermoeidheid fatigue Slaap/rust vermoeidheid Sleep/rest fatigue Mean healthy (n=155) Mean gezond kind (n=155) Mean kind patient humorale immuundeficiëntie (n=8) Algemene General vermoeidheid fatigue Higher scores indicate lower problems
13 Results: PedsQLFatigue Scale y Total Totale fatigue vermoeidheid Cognitieve Cognitive vermoeidheid fatigue Slaap/rust vermoeidheid Sleep/rest fatigue Mean healthy (n=155) Mean gezond kind (n=155) Mean kind patient humorale immuundeficiëntie (n=8) Algemene General vermoeidheid fatigue Higher scores indicate lower problems
14 Results: PedsQL Quality of live 8 12 y Total score Totale score Psychosocial Psychosociale domein functioning* School School domein functioning Emotional Emotionele domein functioning Mean healthy (n=192) Mean gezond kind (n = 192) Mean kind patient met een humorale immuundeficiëntie (n=15) Social Sociale functioning domein Physical Fysieke domein functioning i Higher scores indicate better HRQOL * Sum of SES 14
15 Results: PedsQL Quality of live 8 12 y Total score Totale score * p value 0.03 Psychosocial Psychosociale domein functioning** School School domein functioning Emotional Emotionele domein functioning * p value 0.03 Mean healthy (n=192) Mean patient (n=15) Mean gezond kind (n = 192) Mean kind met een humorale immuundeficiëntie Social Sociale functioning domein Physical Fysieke domein functioning i * p value Higher scores indicate better HRQOL ** Sum of SES 15
16 Results: PedsQL Quality of live y Total score Totale score Psychosocial Psychosociale domein functioning* School functioning School domein Emotional Emotionele domein functioning Mean healthy (n=148) Mean gezond kind (N=148) Mean kind patient met een humorale immuundeficiëntie (n=8) Social Sociale functioning domein Physical Fysieke domein functioning Higher scores indicate better HRQOL * Sum of SES 16
17 Correlation fatigue QOL Significant correlation Fatigue and Quality of Life in the age of 8 12 years and years Correlation fatigue IgG through level No significant correlation (small numbers) Fatigue and IgG through levels In the age of 8 12 years and years 17
18 Isfatigue associated with a specific immunodeficiency? Mean total group with PID = 65 Mean healthy children = 79 Specific humoral immunodeficiency Mean [range] IgA deficiency (n=3) 56 [43 73] IgG subclass deficiency (n=2) 62 [43 80] Specific polysaccharide antibody deficiency (n=3) 80 [66 88] 8 12y CVID (n=4) 68 [41 90] Agammaglobulinemia (n=2) 56 [45 68] Mean total group with PID = 81 Mean healthy children = 75 Specific humoral immunodeficiency Mean [range] IgA deficiency (n=4) 79 [54 100] Specific polysaccharide antibody deficiency (n=1) 77 [NA] 13 18y CVID (n=3) 85 [65 96] 18
19 Relation between fatigue and different treatments? Meanscore total group 65, range Antibiotic prophylaxis IVIG/SCIG n Mean [range] [NA] [41 88] [45 89] 4 66 [43 80] 8 12 y Meanscore total group 81, range Antibiotic prophylaxis IVIG/SCIG n Mean [range] [94 96] [NA] [NA] 4 71 [54 91] y 19 + = medication = no medication
20 Conclusions Children between 8 12 y with PID are significant more fatigued and they have a lower QOL of life than their healthy peers Children between y with PID are not more fatigued and have almost equal QOLcomparing to peers Children with IgA deficiency and agammaglobulinemia are more fatigued than children with other immunodeficiency's in the younger group We found no correlation lti bt between fatigue fti and the IGth IgG through h level lor the different treatments 20
21 Fatigue in adult PID patients Study 2 We don t know what s wrong with him whatever, a little cognitive therapy never hurt anybody Strik Albers R. et al, submitted 21
22 Background Patients often report fatigue as a dominant complaint Some report fatigue just before the IVIG infusion, some just after and some notice no effect of IVIG infusion Immunologists often don t understand this complaint and do not know how to handle it Is it serious? Is there a relation to underlying immunodeficiency/disease? Is there a relation with the frequency or severity of infections? Is it related dto the patients t own behaviour and beliefs f? Is there a relation with IVIG therapy? fluctuating IgG serum concentrations or dosage or dosage interval or infusion rate? 22
23 Research questions What is the severity and prevalence of fatigue in hypogamma patients treated with IVIG infusion Isthereanassociation association betweenfatigue andtheivig infusion What is therelationship between fatigue and somatic and psychosocial patient characteristics ti 23
24 Methods Population: Adult hypogammaglobulinaemia patients treated with IVIG in 2013 Exclusion criteria: Co morbidity that could explain fatigue (Obesitas, COPD, heart failure, depression) Controls for the CIS score: From a cohort of 1900 panel members: age, sex matched selection of 222 healthy people (CentErdata research institute, Tilburg ) Controls for data obtained by the other questionnaires: Normal values as obtained in the (non matched) normal Dutch population Prospective study 24
25 Methods a. Questionnaire(s) (CIS=Checklist Individual Strength) b. Actometer = daily activity score 24/7 c. A special ilstudy ipod = report of level lof fti fatigue 5x/day SF36: 36 item Short Form; SIP8: Sickness Impact Profile 8; BDI: Beck Depression Inventory; SES: Self Efficacy Scale; FCS : Fatigue Catastrophizing Scale; PHQ15: Patients Health Questionnaire 15; PARS: Physical Activity Rating Scale; CBQS:Cognitive and Behavorial Responses to Symtoms; ADIQ: Acceptance of Disease and Impairment Questionnaire; IPAQ: Internationale Physical Activity Questionnaire Page 25
26 Study participants 74 patients Group I n=31 Group II n=43 Group III n=38 26
27 Results: Demographics Group I (n=31) Group II (n=43) Total group n=74 Mean age (years) 51 (SD 17.8) 45 (SD 7.8) (SD=16.51) Gender (F/M) 17/14 18/25 35/39 Mean BMI Unknown 25.5 (SD 4.4) Unknown Type of immunodeficiency CVID Hypogammaglobulinemia of other cause 19 (61%) 12 (39%) 27 (63%) 16 (37%) 46 (62%) 28 (38%) * p value Duration of illness (yrs) 13.7 (SD 14.5) 13.1 (SD 12.3) (SD 13.17) Immunoglobulin dose (mg/kg/wk) 147 (SD 88) 106 (SD 42) 123 (SD 68) Ig infusion frequency 1x every 2 weeks 1x every 3 weeks 1x every 4 weeks 1x every 5 weeks 5 (16 %) 19 (61%) 5 (16%) 2 (7%) 1 (2%) 31 (72%) 10 (23%) 1 (2%) 6 (8%) 50 (68%) 15 (20%) 3(4%) Mean frequency 3.13 (SD 0.76) 3.26 (SD 0.54) 3.2 (SD 0.64) Co morbidity (not excluded) None 13 (42%) 17 (40%) 28 (38%) Lung disease 15 (48%) 14 (33%) 29 (39%) Other 3 (10%) 12 (28%) 17 (23%) Infections with fever in last 4 wks Yes No Missing data 5 (16%) 25 (81%) 1 (3%) 17 (40%) 14 (33%) 12 (28%) 11 (37%) 60 (81%) 3(4%) Education in yrs Primary school Secondary school Higher education k Unknown 7 (16%) 17 (40%) 17 (40%) 2 ( %) Unknown 2 (4%) Unknown 27 Paid job Yes Disability pension No Unknown 27 (63%) 5 (12%) 11 (25%) Unknown
28 Results: Prevalence and severity of fatigue Mean CIS score All participants (n=74) 36.6 (SD 13.1) = severely fatigued Age and sex matched controls (n=222) 22.9 (SD 10.3) ( p <0.001) 58.1% = severely fatigued Group I (n=31) Group II (n=43) 32.7 (SD 13.1) 1) Group I vs Group II p= (SD 11.3) = severely fatigued 28
29 Results: Impact of being severely fatigued fti Not severly Severely Mean score Pearson Correlation CIS Fatigue (n=41) fatigued; fatigued; Dutch Correlation CIS < 35 population Significance CIS 35 of correlation P Coefficient (n= r 18) (n=23) (not matched) Functional impairment in daily life (total Pearson (mean 0.57 Correlation (SD)) (mean CIS <0.001 Fatigue (SD)) (n=41) score) (SIP) General Health, Physical problems (9) 73 (22) <.001 Physocal functioning Social Depression limitations (BDI) Correlation (24) Significance 66 <0.001 (28) of correlation.045 Coefficient r (SF 36) a Fatigue Emotional related problems beliefs (totale score) 77 (SES) (11) (14).001 Bodily pain (22) 74 (19).026 Dose immunoglobulin Catastrophizing (per week) Fatigue (totale score) (FCS) (19) 50 <0.001 (16).001 Cognitive and behavioral responses to Functional impairment Frequency Sleep/rest of IVIG in weeks (44) 92 (63) symptoms (CBRSQ) in daily life (Sickness Home management (19) 101 <0.001 (95) <.001 Impact Profile, Co morbidity SIP) b resting / avoidance (not Mobility excluded) yes/no (12) (78) all or nothing behavior Social linteractionsi (65) (199).001 symptom focusing Infections (4 weeks Ambulation before IVIG) yes/no (20) (50).006 embarrassment 0.28 Work limitations (103) (160).015 damaging beliefs Fever (4 weeks Recreation before IVIG) yes/no (36) (85) catastrophizing Total DisabilityScore (286) 864 <0.001 (691) 001 <.001 anxiety Level of physical Dyspnea (4 weeks before IVIG) Believes about physical activity (PARS) activity c (28) 77 (34) faith one week before IVIG Years since diagnosis of PID < (23) 77 (33) 0.06 fatigue 0.69 < one week after IVIG 29 a Higher scores indicate higher level of physical and social health b Higher scores indicate more disability c Higher scores indicate more activity, measured by the actometer
30 Results: Association between fatigue and the IVIG No statistical significant difference of any of the combined data obtained before and after IVIG This counts for the data obtained by a. Questionnaires b. Actometer c. ipod 30
31 Results (n=15) ipod score better after IVIG Actometer: no difference ipod: 3 subgroups reporting detrimental beneficial no effect (n=14) ipod score worse after IVIG (n=10) ipod score similar after IVIG 31
32 Conclusion The majority (58%) of patients with PID who are treated with IVIGinfusion is severely fatigued and this has a significant impact on their daily lf life Fatigue is not related to dose or frequency of IVIG infusion Fatigue is related to dyspnea and cognitive behavioral factor Opens new insights into possible role of cognitive behavioral interventions 32
33 Disclosure Study 2 was financed by CSL Behring Page 33
34 Thanks Study 1 Children who participated Prof. dr. Adilia Warris Children s department, Radboud University Medical Center Dr. Betsie van Gaal IQ Healthcare, Radboud University Medical Center Study 2 Patients who participated i t Dr. Anna Simon and Dr. Marcel van Deuren Department of Internal Medicine, Radboudumc Expert Center for Immunodeficiency and Autoinflammation Dr. Hans Knoop and Dr. Stephanie Nikolaus Expert Center for Chronic Fatigue, Radboud University Medical Center Page 34
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