PMID- 31741282
OWN - NLM
STAT- MEDLINE
DCOM- 20200921
LR  - 20200921
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 37
IP  - 1
DP  - 2020 Jan
TI  - The Long-Term Effectiveness and Safety of Omalizumab on Patient- and 
      Physician-Reported Asthma Control: A Three-Year, Real-Life Observational Study.
PG  - 353-363
LID - 10.1007/s12325-019-01135-w [doi]
AB  - INTRODUCTION: Allergic asthma is a chronic inflammatory disease caused by 
      immunoglobulin E (IgE)-mediated allergy. Omalizumab is a monoclonal anti-IgE 
      antibody for the treatment of severe allergic asthma (SAA). OBJECTIVES: The 
      primary objective of the study was to assess asthma-related control in patients 
      with SAA receiving omalizumab therapy. Secondary objectives included quality of 
      life, treatment effectiveness, rate of severe exacerbations, and safety. METHODS: 
      This was a prospective, multi-centre, non-interventional study to assess 
      patient-related long-term outcomes of omalizumab treatment in Germany. This 
      3-year study enrolled patients aged >/= 18 years with SAA. Asthma control was 
      assessed using the asthma control questionnaire (ACQ-6) and physician-assessed 
      global evaluation of treatment effectiveness (GETE). Exacerbations were recorded, 
      and quality of life was assessed using the mini-asthma quality of life 
      questionnaire (mini-AQLQ). RESULTS: Of 161 patients screened, 153 participated in 
      this study. Most patients (92.2%) had been receiving prior omalizumab therapy for 
      mean (SD) 2.9 (2.3) years. Omalizumab slightly decreased mean ACQ-6 score from 
      2.0 (1.22) at baseline to 1.7 (1.23) at the end of the 3-year treatment period 
      [difference: -0.18 (1.07), P = 0.340]. Post-hoc analyses of ACQ-6 for the small 
      number of treatment-naive patients showed a decrease in mean (SD) ACQ-6 from 2.7 
      (1.08) at baseline to 1.4 (1.40) after 3 years of omalizumab treatment. Mini-AQLQ 
      increased from 4.5 (1.26) at baseline to 4.7 (1.48) after 3 years [difference: 
      0.26 (1.35), P = 0.186]. GETE was reported as excellent or good for most patients 
      (67.46-84.69%) and more than two-thirds had no severe exacerbation. There were no 
      unexpected safety signals during the study period and no tachyphylaxis was 
      observed. CONCLUSIONS: In conclusion, despite most patients receiving prior 
      omalizumab treatment for approximately 3 years, there was no decrease in 
      effectiveness or safety over the subsequent 3 years during this study. This 
      supports the long-term use of omalizumab in maintaining asthma control and 
      quality of life. FUNDING: Novartis Pharma GmbH, Germany.
FAU - Schreiber, Jens
AU  - Schreiber J
AD  - Department of Pulmonology, University Hospital, Otto-von-Guericke-University 
      Magdeburg, Magdeburg, Germany. jens.schreiber@med.ovgu.de.
FAU - Schwab Sauerbeck, Inessa
AU  - Schwab Sauerbeck I
AD  - Novartis Pharma GmbH, Clinical Research Respiratory, Nuremberg, Germany.
FAU - Mailander, Claudia
AU  - Mailander C
AD  - Novartis Pharma GmbH, Clinical Research Respiratory, Nuremberg, Germany.
LA  - eng
SI  - figshare/10.6084/m9.figshare.10011848
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20191118
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Asthmatic Agents/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Female
MH  - Follow-Up Studies
MH  - Germany
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Omalizumab/*therapeutic use
MH  - *Patient Safety
MH  - Prospective Studies
MH  - Quality of Life
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Asthma control questionnaire
OT  - Global evaluation of treatment effectiveness
OT  - Omalizumab
OT  - Safety
OT  - Severe allergic asthma
EDAT- 2019/11/20 06:00
MHDA- 2020/09/22 06:00
CRDT- 2019/11/20 06:00
PHST- 2019/09/18 00:00 [received]
PHST- 2019/11/20 06:00 [pubmed]
PHST- 2020/09/22 06:00 [medline]
PHST- 2019/11/20 06:00 [entrez]
AID - 10.1007/s12325-019-01135-w [pii]
AID - 10.1007/s12325-019-01135-w [doi]
PST - ppublish
SO  - Adv Ther. 2020 Jan;37(1):353-363. doi: 10.1007/s12325-019-01135-w. Epub 2019 Nov 
      18.