Antifungal treatment of severe asthma
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1 Antifungal treatment of severe asthma David W. Denning University Hospital of South Manchester [Wythenshawe Hospital] The University of Manchester
2 Severe asthma Bel EH, Severe asthma. Breath magazine Dec 2006
3 Skin prick testing O Driscoll, unpublished
4 20.0 Multiple Admissions Mean sensitization score (mm) (Mean and 95% CI) P= < No Hospital Admission Single Admission Multiple Admissions No Hospital Admission Single Admission 0.0 Mould allergens Non-Mould allergens O Driscoll et al, BMC Pulmonary Medicine 2005;5:4
5 Zureik et al, Br Med J 2002;325:411 Severe asthma and moulds Mild asthma 564 (50%) Moderate asthma 333 (29%) Severe asthma 235 (21%)
6 Denning et al, Eur Resp J 2006; 27;27:615 Fungi and asthma Needs new nomenclature Asthma with fungal sensitisation or Severe Asthma with Fungal Sensitisation ie And what can we do about it? Is antifungal therapy useful? SAFS
7 Antifungal treatment of severe asthma with fungal sensitisation (SAFS) 11 patients with Trichophyton skin test allergy and moderate/severe asthma, Rx with fluconazole or placebo for 5 months, then all received fluconazole. Fluconazole v. placebo at 5 months Bronchial hypersensitivity reduced (p = 0.012) Steroid requirements reduced (p= 0.01) Peak flow increased in 9/11 at 10 months Ward et al, J Allergy Clin Immunol 1999;104:541;
8 Randomised trial of itraconazole in ABPA - results Phase 1 Corticosteroid dependant ABPA with asthma Phase 1-200mg BID v placebo, 16 weeks Phase II - 200mg daily in all patients, 16 weeks Itra Placebo then Itra Overall response 13/28 (46%) 5/27 (19%) p=0.04 Phase 2 No prior response (n=33) 4/13 (31%) 8/20 (40%) NS Stevens D A et al, New Engl J Med 2000; 342:756
9 Retrospective comparison of antifungal treatment of SAFS with ABPA 22 patients with SAFS were compared with 11 with ABPA Pasquallotto et al, unpublished data
10 Proof of concept RCT of antifungal Rx in SAFS Inclusion criteria Severe asthma [BTS 4 or 5] (ie high dose inhaled steroids, continuous oral steroids for >6 mo, or 4 courses of high dose oral/iv steroids in last 12 months, or 6 courses in last 24 mo. + Fungal sensitisation (RAST or skin test +ve) to Aspergillus, Cladosporium, Alternaria, Penicillium, Candida, Trichophyton and/or Botrytis Exclusion criteria Not ABPA (IgE <1000IU/mL) + -ve Aspergillus precipitins Recurrent bacterial chest infections (6 weekly) Prior azole therapy Cardiac failure LFTs>3x ULN FAST study
11 Proof of concept RCT of antifungal Rx in SAFS - endpoints Primary endpoint Improvement in score of Asthma Quality of Life Questionnaire (AQLQ) Secondary endpoints Improvement in weekly peak flow FEV1 at 4, 8 and 12 months Exacerbation rate (both total and steroid requiring) Total IgE Rhinitis score Adrenal suppression indices Juniper et al, Thorax 1992;47:76.
12 Proof of concept RCT of antifungal Rx in SAFS - study plan Study plan Randomised to itraconazole capsules (200mg BID) or placebo for 8 months (concealed by over-encapsulating) Assessments are regular intervals, including scores, respiratory function, blinded itraconazole levels, LFTs FU at 4 months post treatment 108 patients planned 58 enrolled
13 Baseline demographics - asthma Mean (range) or % (no.) Active (n=29) Placebo (n=29) Gender (Male) 48% (14) 48% (14) Age 49.2 (18, 79) 51.7 (19, 76) Severity of asthma (BTS) 1 (>4) 3% (1) 11% (3) Baseline total serum IgE (IU/L) # 212 (24,820) 245 (36,990) Baseline eosinophilia (>0.4 x 10 9 ) 1 24% (7) 43% (12) No. of hospitalisations last 12 months 4 (range) none Median % with 0 (0, 5) 0 (0, 8) 61% (14) 83% (20) Requiring continuous oral steroids 7% (2) 14% (4) Requiring > 1000ug/d inhaled steroid 69% (20) 72% (21) FEV 1 (L/min) (0.5, 4.35) 2.14 (0.65, 3.85) FEV 1 (% predicted) (18, 121) 71.1 (27, 124) Baseline rhinitis score 1.27 (0, 3.88) 1.29 (0, 2.70) Baseline AQLQ score 4.12 (2.2, 7.0) 4.14 (1, 6.6)
14 Baseline demographics - fungal Superficial fungal infection (in past) Mean (range) or % (no.) Active (n=29) Placebo (n=29) Oral thrush 31% (9) 41% (12) Genital thrush 17% (5) 21% (6) Fungal nail infection 17% (5) 21% (6) Fungal skin rash 3% (1) 3% (1) Athletes foot 21% (6) 31% (9) Any of above five 62% (18) 83% (20) Baseline positive fungal RAST Aspergillus 52% (15) 52% (15) Cladosporium 31% (9) 17% (5) Alternaria 21% (6) 32% (9) Penicillium 39% (11) 17% (5) Candida 1 52% (15) 46% (13) Trichophyton 31% (8) 19% (5) Botrytis 17% (5) 14% (4)
15 Proof of concept RCT of antifungal Rx in SAFS key results Patients enrolled & randomised N = 58 Active (itraconazole) N = 29 Placebo N = 29 Withdrawal in <4 weeks Active N= 3 Placebo N=1 (p=0.60) MITT analysis set (active) N =26 MITT analysis set (placebo) N =28 Withdrawal 4-32 weeks P=0.014 AQLQ = 0.82 Active N= 8 Placebo N=5 (p=0.25) Per protocol analysis set (active) N= 18 Per protocol analysis set (placebo) N=23 P=0.002 AQLQ = 1.18
16 Proof of concept RCT of antifungal Rx in SAFS outcomes at 32 weeks MITT Mean (95% CI) or % (n) P-value Active Placebo Change in AQLQ score (0.28, 1.41) (-0.43, 0.42) Improvement in AQLQ score of >0.5 54% (14) 32% (9) 0.18 Percentage change in total IgE (IU/L) -27% (-14%, -38%) +12% (-5%, +31%) Change in FEV1 (L/min) (-0.56, 0.11) (-0.16, 0.11) 0.22 Change in FEV1 (% predicted) (-9.39, 2.08) 0.13 (-3.67, 3.93) 0.24 Change in average PEFR (am) 20.8 (3.5, 38.1) -5.5 (-21.6, 10.7) Change in average PEFR (pm) 16.8 (1.5, 35.2) 8.9 (-33.9, 51.8) 0.74
17 Proof of concept RCT of antifungal Rx in SAFS AQLQ change P= FAST study
18 RCT of anti-ige (omalizumab) v. placebo, moderate and severe asthma omalizumab Improvement in AQLQ = ~0.4 placebo Buhl et al Eur Resp J 2002;20:1088
19 Proof of concept RCT of antifungal Rx in SAFS improvement in rhinitis P= FAST study
20 Proof of concept RCT of antifungal Rx in SAFS respiratory function change P= 0.22
21 Proof of concept RCT of antifungal Rx in SAFS respiratory function change Juniper change vs itraconazole level Juniper score change (week 32 lvcf - week 1) No relationship between itraconazole level and change in AQLQ at wk 32 p= mean itraconazole
22 Why is antifungal therapy effective? Three reasonable hypotheses: Reduction in fungal burden/exposure Enhanced corticosteroid effect Immune system effect of itraconazole
23 Colonisation or infection with fungus Short-lived exposure to viable hyphal fragments Sinus colonisation Gut colonisation with Candida Skin infection with dermatophytes (Athlete s foot for example)
24 Proof of concept RCT of antifungal Rx in SAFS Fungi that patients are sensitised to (skin test or IgE) FAST study
25 Colonisation in normal lungs 22 of 30 (73%) grew a fungus in both lung samples taken 10/30 (33%) grew >1 species Lass-Florl et al, Br J Haematol 1999;104:745
26 Airborne fungal fragments Fungal fragment Diffusing allergen leeching out of fungus in contact with liquid Green et al, J Allergy Clin Immunol 2005;115:1043
27 Proof of concept RCT of antifungal Rx in SAFS itraconazole inhaled steroid interaction Study group Concentrations - mean (range) Plasma cortisol Baseline 4 weeks 4 months post treatment Itraconazole (92-386) (<30-642) ( ) Placebo (75-770) ( ) ( ) Detectable concentrations (>50 mmol/l) number positive/number tested (%) Itraconazole 13/13 (100) 6/12 (50) 7/7 (100) Placebo 14/14 (100) 13/13 (100) 9/9 (100) AQLQ score improvement in Itraconazole + interaction = 1.0 Itraconazole & no interaction = 0.97
28 Comparison of ABPA and SAFS Denning et al, Eur Resp J 2006; 27;27:615
29 Carvalho et al, J Immunol In press. CPA and TLRs SNP Study groups (n) Genotype n (% frequency) Allele n (% frequency) Χ 2 p value OR (95% CI) LR2 A/A A/G G/G A G rg753gln Controls (80) 0 (0.0) 5 (6.2) 75 (93.8) 5 (3.1) 155 (96.9) ABPA (22) 0 (0.0) 0 (0.0) 22 (100) 0 (0.0) 44 (100.0) ( ) SAFS (14) 0 (0.0) 2 (14.3) 12 (85.7) 2 (7.1) 26 (92.9) ( ) CCPA (40) 0 (0.0) 2 (5.0) 38 (95.0) 2 (2.5) 78 (97.5) ( ) LR4 A/A A/G G/G A G sp299gly Controls (80) 70 (87.5) 10 (12.5) 0 (0.0) 150 (93.8) 10 (6.3) ABPA (22) 21 (95.5) 1 (4.5) 0 (0.0) 43 (97.7) 1 (2.3) ( ) SAFS (14) 12 (85.7) 2 (14.3) 0 (0.0) 26 (92.9) 2 (7.1) ( ) CCPA (40) 25 (62.5) 15 (37.5) 0 (0.0) 65 (81.3) 15 (18.8) ( ) LR9-1237C T/T T/C C/C T C Controls (80) 65 (81.2) 15 (18.8) 0 (0.0) 145 (90.6) 15 (9.4) ABPA (22) 14 (63.6) 7 (31.8) 1 (4.54) 35 (79.5) 9 (20.5) ( ) SAFS (14) 13 (92.9) 1 (7.1) 0 (0.0) 27 (96.4) 1 (3.6) ( ) CCPA (40) 33 (82.5) 7 (17.5) 0 (0.0) 73 (91.3) 7 (8.8) ( )
30 Likely SAFS caseload In ,960,496 adults with self-reported asthma in the USA In Europe - >17,000,000 adults with asthma ~20% have severe asthma = 6,600,000 adults 20-50% of severe asthmatics have SAFS SAFS cases (US +EU) = 1,320,000 3,300,000 Zureik et al, Br Med J 2002;325:411
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