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Chronic Urticaria: Disease-Related Quality of Life after 6 Months of Treatment
AB132 Abstracts
424
SUNDAY
Omalizumab Improves Quality of Life (QoL) in Patients with Chronic Spontaneous/Idiopathic Urticaria (CSU/CIU) As Assessed By the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL): A Post-Hoc Analysis of Percent Change from Baseline to Week 12 Nico Janssens, PhD1, Marcus Maurer, MD2, Sam Khalil, PhD3, MariaMagdalena Balp, MD4, Karin Rosen, MD, PhD5; 1Novartis Pharmaceuticals, Switzerland, 2Department of Dermatology and Allergy, Charite – Universit€atsmedizin, Berlin, Germany, 3Novartis Pharmaceuticals, Basel, Switzerland, 4Novartis Pharma AG, Basel, Switzerland, 5Genentech, Inc., South San Francisco, CA. RATIONALE: Omalizumab, an anti-IgE monoclonal antibody, was evaluated in three Phase III trials (ASTERIA-I/II and GLACIAL); we report CU-Q2oL data from all three studies. METHODS: Patients in ASTERIA-I/II and GLACIAL were symptomatic despite approved doses of H1-antihistamines and received omalizumab 75/ 150/300mg, or placebo. Patients in GLACIAL received omalizumab 300mg or placebo and were symptomatic despite H1-antihistamines _4X approved dose) plus H2-antihistamines and/or leukotriene-receptor (< antagonists. CU-Q2oL domains were assessed at baseline and Week 12. Omalizumab 75mg data are not presented. RESULTS: CU-Q2oL domain scores (%[absolute]) were improved for omalizumab 300mg vs placebo at Week 12: Overall: 66[-30.5] vs 42[-19.7],p50.0019[ASTERIA-I]; 69[-31.5] vs 40[-17.7],p<0.0001[ASTERIA-II]; 67[-29.3] vs 32[-16.3],p<0.0001 [GLACIAL] Pruritus: 69[-56.8] vs 34[-28.1],p<0.0001[ASTERIA-I]; 71[-56.5] vs 35[-28.6],p<0.0001[ASTERIA-II]; 65[-51.0] vs 17[-23.0],p<0.0001 [GLACIAL] Swelling: 72[-16.7] vs 36[-10.7],p50.1293[ASTERIA-I]; 66[-18.5] vs 36[-8.7],p50.0134[ASTERIA-II]; 71[-17.6] vs 53 [-8.6],p50.0110[GLACIAL] Impact on life activities: 71[-34.7] vs 34[-23.6],p50.0053[ASTERIA-I]; 78[-34.5] vs 48[-21.1],p50.0005[ASTERIA-II]; 74[-30.8] vs 29 [-16.4],p<0.0001[GLACIAL] Sleep problems: 53[-30.2] vs 38[-18.8],p50.0524[ASTERIA-I]; 64 [-33.3] vs 33[-18.0],p50.0007[ASTERIA-II]; 61[-29.4] vs 35 [-18.3],p<0.0001[GLACIAL] Limits: 64[-19.9] vs 52[-17.9],p50.2774[ASTERIA-I]; 66[-21.5] vs 37[-11.2],p50.0166[ASTERIA-II]; 57[-18.8] vs 33 [-10.7],p50.0008[GLACIAL] Looks: 61[-27.5] vs 39[-16.6],p50.0054[ASTERIA-I]; 56[-27.0] vs 39[-16.3],p50.0061[ASTERIA-II]; 67[-29.6] vs 32 [-15.3],p<0.0001[GLACIAL]. CU-Q2oL domain scores were also improved for omalizumab 150mg: Overall: 53[-23.1] vs 42[-19.7],p50.2891[ASTERIA-I]; 62[-27.0] vs 40[-17.7],p50.0089[ASTERIA-II] Pruritus: 56[-40.6] vs 34[-28.1],p50.0125[ASTERIA-I]; 57[-45.9] vs 35[-28.6],p50.0014[ASTERIA-II] Swelling: 55[-11.2] vs 36[-10.7],p50.4157[ASTERIA-I]; 54[-10.6] vs 36[-8.7],p50.5929[ASTERIA-II] Impact on life activities: 63[-27.7] vs 34[-23.6],p50.3737 [ASTERIA-I]; 67[-30.5] vs 48[-21.2],p50.0563[ASTERIA-II] Sleep problems: 37[-22.1] vs 38[-18.8],p50.5399[ASTERIA-I]; 44 [-25.3] vs 33[-18.0],p50.0935[ASTERIA-II] Limits: 44[-15.8] vs 52[-17.9],p50.6854[ASTERIA-I]; 66[-20.0] vs 37[-11.2],p50.0204[ASTERIA-II] Looks: 53[-20.6] vs 39[-16.6],p50.3140[ASTERIA-I]; 63[-27.7] vs 39[-16.3], p50.0023 [ASTERIA-II]. CONCLUSIONS: Omalizumab significantly improved QoL, as measured by CU-Q2oL, in patients with CSU/CIU refractory to standard of care.
J ALLERGY CLIN IMMUNOL FEBRUARY 2015
425
Chronic Urticaria: Disease-Related Quality of Life after 6 Months of Treatment Jenny Stitt, MD, U. C. Denver, Stephen C. Dreskin, MD, PhD, FAAAAI; University of Colorado Denver, Aurora, CO. RATIONALE: The natural history of chronic urticaria is not well defined. We hypothesized that there would be a differential effect of treatment on improvement in urticaria symptoms. METHODS: We recruited 35 adult subjects with chronic urticaria from our University Hospital Allergy/Immunology Practice for a prospective, longitudinal study of the effects of usual care on symptoms. Quality of life questionnaires validated for use in chronic urticaria were administered at baseline and at 6 months. Medications used for treatment of chronic urticaria were recorded and groups were stratified based on medication(s) used and response to treatment. RESULTS: Follow-up data at 6 months were available for 32 patients, with the 3 lost to follow-up included as non-responders. At baseline, 25% had symptom duration greater than 1 year, but after 6 months two (6%) had complete resolution of symptoms without need for medication. In those who required continued treatment, 15 (43%) achieved complete control of symptoms. Three had control with standard-dose second-generation antihistamines, 6 on greater than standard dose antihistamines or antihistamines plus antileukotrienes. Of the remaining 6, 4 were also treated with immunomodulatory medications and two with levothyroxine. Thirteen subjects (37%) reported significant improvement in quality of life without complete symptom control. Of these, 2 had improvement on greater than standard dose antihistamines, 6 on levothyroxine, 1 on low dose corticosteroids, and 4 on immunomodulatory medications. Two (6%) did not improve. CONCLUSIONS: Clinically meaningful control can be achieved with 6 months of treatment in most patients (86%; p<0.001) with chronic urticaria.
424
SUNDAY
Omalizumab Improves Quality of Life (QoL) in Patients with Chronic Spontaneous/Idiopathic Urticaria (CSU/CIU) As Assessed By the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL): A Post-Hoc Analysis of Percent Change from Baseline to Week 12 Nico Janssens, PhD1, Marcus Maurer, MD2, Sam Khalil, PhD3, MariaMagdalena Balp, MD4, Karin Rosen, MD, PhD5; 1Novartis Pharmaceuticals, Switzerland, 2Department of Dermatology and Allergy, Charite – Universit€atsmedizin, Berlin, Germany, 3Novartis Pharmaceuticals, Basel, Switzerland, 4Novartis Pharma AG, Basel, Switzerland, 5Genentech, Inc., South San Francisco, CA. RATIONALE: Omalizumab, an anti-IgE monoclonal antibody, was evaluated in three Phase III trials (ASTERIA-I/II and GLACIAL); we report CU-Q2oL data from all three studies. METHODS: Patients in ASTERIA-I/II and GLACIAL were symptomatic despite approved doses of H1-antihistamines and received omalizumab 75/ 150/300mg, or placebo. Patients in GLACIAL received omalizumab 300mg or placebo and were symptomatic despite H1-antihistamines _4X approved dose) plus H2-antihistamines and/or leukotriene-receptor (< antagonists. CU-Q2oL domains were assessed at baseline and Week 12. Omalizumab 75mg data are not presented. RESULTS: CU-Q2oL domain scores (%[absolute]) were improved for omalizumab 300mg vs placebo at Week 12: Overall: 66[-30.5] vs 42[-19.7],p50.0019[ASTERIA-I]; 69[-31.5] vs 40[-17.7],p<0.0001[ASTERIA-II]; 67[-29.3] vs 32[-16.3],p<0.0001 [GLACIAL] Pruritus: 69[-56.8] vs 34[-28.1],p<0.0001[ASTERIA-I]; 71[-56.5] vs 35[-28.6],p<0.0001[ASTERIA-II]; 65[-51.0] vs 17[-23.0],p<0.0001 [GLACIAL] Swelling: 72[-16.7] vs 36[-10.7],p50.1293[ASTERIA-I]; 66[-18.5] vs 36[-8.7],p50.0134[ASTERIA-II]; 71[-17.6] vs 53 [-8.6],p50.0110[GLACIAL] Impact on life activities: 71[-34.7] vs 34[-23.6],p50.0053[ASTERIA-I]; 78[-34.5] vs 48[-21.1],p50.0005[ASTERIA-II]; 74[-30.8] vs 29 [-16.4],p<0.0001[GLACIAL] Sleep problems: 53[-30.2] vs 38[-18.8],p50.0524[ASTERIA-I]; 64 [-33.3] vs 33[-18.0],p50.0007[ASTERIA-II]; 61[-29.4] vs 35 [-18.3],p<0.0001[GLACIAL] Limits: 64[-19.9] vs 52[-17.9],p50.2774[ASTERIA-I]; 66[-21.5] vs 37[-11.2],p50.0166[ASTERIA-II]; 57[-18.8] vs 33 [-10.7],p50.0008[GLACIAL] Looks: 61[-27.5] vs 39[-16.6],p50.0054[ASTERIA-I]; 56[-27.0] vs 39[-16.3],p50.0061[ASTERIA-II]; 67[-29.6] vs 32 [-15.3],p<0.0001[GLACIAL]. CU-Q2oL domain scores were also improved for omalizumab 150mg: Overall: 53[-23.1] vs 42[-19.7],p50.2891[ASTERIA-I]; 62[-27.0] vs 40[-17.7],p50.0089[ASTERIA-II] Pruritus: 56[-40.6] vs 34[-28.1],p50.0125[ASTERIA-I]; 57[-45.9] vs 35[-28.6],p50.0014[ASTERIA-II] Swelling: 55[-11.2] vs 36[-10.7],p50.4157[ASTERIA-I]; 54[-10.6] vs 36[-8.7],p50.5929[ASTERIA-II] Impact on life activities: 63[-27.7] vs 34[-23.6],p50.3737 [ASTERIA-I]; 67[-30.5] vs 48[-21.2],p50.0563[ASTERIA-II] Sleep problems: 37[-22.1] vs 38[-18.8],p50.5399[ASTERIA-I]; 44 [-25.3] vs 33[-18.0],p50.0935[ASTERIA-II] Limits: 44[-15.8] vs 52[-17.9],p50.6854[ASTERIA-I]; 66[-20.0] vs 37[-11.2],p50.0204[ASTERIA-II] Looks: 53[-20.6] vs 39[-16.6],p50.3140[ASTERIA-I]; 63[-27.7] vs 39[-16.3], p50.0023 [ASTERIA-II]. CONCLUSIONS: Omalizumab significantly improved QoL, as measured by CU-Q2oL, in patients with CSU/CIU refractory to standard of care.
J ALLERGY CLIN IMMUNOL FEBRUARY 2015
425
Chronic Urticaria: Disease-Related Quality of Life after 6 Months of Treatment Jenny Stitt, MD, U. C. Denver, Stephen C. Dreskin, MD, PhD, FAAAAI; University of Colorado Denver, Aurora, CO. RATIONALE: The natural history of chronic urticaria is not well defined. We hypothesized that there would be a differential effect of treatment on improvement in urticaria symptoms. METHODS: We recruited 35 adult subjects with chronic urticaria from our University Hospital Allergy/Immunology Practice for a prospective, longitudinal study of the effects of usual care on symptoms. Quality of life questionnaires validated for use in chronic urticaria were administered at baseline and at 6 months. Medications used for treatment of chronic urticaria were recorded and groups were stratified based on medication(s) used and response to treatment. RESULTS: Follow-up data at 6 months were available for 32 patients, with the 3 lost to follow-up included as non-responders. At baseline, 25% had symptom duration greater than 1 year, but after 6 months two (6%) had complete resolution of symptoms without need for medication. In those who required continued treatment, 15 (43%) achieved complete control of symptoms. Three had control with standard-dose second-generation antihistamines, 6 on greater than standard dose antihistamines or antihistamines plus antileukotrienes. Of the remaining 6, 4 were also treated with immunomodulatory medications and two with levothyroxine. Thirteen subjects (37%) reported significant improvement in quality of life without complete symptom control. Of these, 2 had improvement on greater than standard dose antihistamines, 6 on levothyroxine, 1 on low dose corticosteroids, and 4 on immunomodulatory medications. Two (6%) did not improve. CONCLUSIONS: Clinically meaningful control can be achieved with 6 months of treatment in most patients (86%; p<0.001) with chronic urticaria.