Impact of Visit Compliance on Response to Omalizumab Therapy in a Real-Life Clinical Setting: Reality Study

Rationale: Omalizumab is indicated for patients with poorly controlled allergic asthma. Compliance and impact on response to omalizumab therapy has not been studied. To evaluate visit compliance and investigate impact on response rate to omalizumab therapy in a real-world clinical setting.

Methods: A retrospective review of patients who received omalizumab therapy for a minimum of two years during 2004-2011.  Visit compliance and response rates to therapy were evaluated at three time-periods: P1(16-wk), P2(1-yr) and P3(2-yr). Compliance was calculated by comparing number of recommended injections to injections actually received. Patients were grouped based on compliance rates: C1(<50%, non-compliant);C2(50-75%); C3(76%-89%) and C4(≥90%, high compliance). A positive response was identified by combination of complete control or marked improvement by Physician’s GETE (Global Evaluation of Treatment Effectiveness), AND improvement in asthma symptoms pre- and post-omalizumab therapy in three or more of the following six parameters: Decrease by ≥50% in asthma exacerbations (AE); steroid-bursts; ER-visits; hospitalizations; improvement in FEV1(≥200cc); increase in ACT score(≥3).

Results: Visit compliance and response rates were evaluated for 124 patients at P1, P2 and P3. Overall compliance: P1[98.4%]; P2[89.5%] and P3[87.1]. Overall response rate: P1[33.0%]; P2[62.9%] and P3[63.7%]. Responder-rate for C2[P2(70.0%);P3(71.0%)] and C3[P2(64.0%);P3(66.7%)] is higher than C4[P2(60.7%);P3(62.5%)]. Number of Patients with very high compliance (C4) drastically drops from P1 [89(72%)] to P2[56(45%)]. Response rates for C1 and C4 are not statistically different (p-value,0.257).

Conclusions: In this analysis, visit compliance does not statistically impact response rate to omalizumab therapy. Compliance to omalizumab therapy decreases over time. Higher compliance does not correspond to high response rate.