Real-World Retrospective Safety Analysis in Patients Treated with OnabotulinumtoxinA for Multiple Therapeutic Indications over Repeat Treatment Periods
Grace Forde1, Atul Patel2, Kenneth Martinez3, Angeli Mayadev4, Benjamin Brucker5, Theodore Brown6, Ziyad Ayyoub7, Ritu Singh8, Mariana Nelson8, Ahunna Ukah8, Irina Yushmanova8, Simona Battucci8, Kimberly Becker Ifantides8, Christopher Rhyne9
1NeuroPain Care Center, 2Kansas City Bone & Joint Clinic, 3Neurology & Pain Specialty Center, 4Swedish Neuroscience Institute, 5NYU Langone Health, 6EvergreenHealth Kirkland, 7Ranchos Los Amigos National Rehabilitation Center, 8AbbVie, 9Norton Neuroscience Institute
Objective:
Evaluate the real-world safety of onabotulinumtoxinA use over repeat treatment periods (TPs) in patients with concomitant multiple therapeutic indications.
Background:
In the US, onabotulinumtoxinA is approved for the treatment of 12 therapeutic indications, but long-term real-world safety and utilization data for treatment of concomitant multiple indications are limited.
Design/Methods:
SYNCHRONIZE, a retrospective chart review study conducted at 10 US clinics, evaluated onabotulinumtoxinA safety for ≥2 different therapeutic indications within 3-month TPs in adults. This analysis evaluated onabotulinumtoxinA safety for up to seven repeat TPs within 24mo.
Results:
279 patients were treated for ≥2 different therapeutic indications across analyzed treatment indication combination groups (Period 1; mean age, 49.2y; 79% female; 56% White) and gradually decrease to 80 patients during the last TP (Period 7). Mean treatments over the study were 9.3 (range 2-48); most common combination was cervical dystonia and chronic migraine (range 34-44%). No significant change in comorbidities and concomitant medications were observed over repeat TPs. 28.7% (80/279) patients reported ≥1 treatment-emergent adverse event (TEAE) after Period 1; this proportion remained broadly constant after each TP; 29.7%, 29.6%, and 31.3% after Periods 3, 5 and 7, respectively. Most common TEAEs were UTI (range 0.7-5.7%), neck pain (range 3.7-9.1%), headache (range 2.9-6.5%), and migraine (range 2.5-6.4%). Most patients had a dosage interval (time between multiple indications treatments) of ≤24h (range 62-98%) and received ≥200-<400U of cumulative 3-months dose for multiple indications (range 43-50%). Mean total 3-month dose ranged from 232-287U. No trend was observed between TEAE incidence and dosage intervals or cumulative 3-month dose over the study period. No patients showed lack of effect based on clinical objective measurement.
Conclusions:
OnabotulinumtoxinA demonstrated consistent safety with no new signals observed in patients treated concomitantly for ≥2 therapeutic indications over repeat treatments up to 24mo. TEAEs were consistent with those previously reported for the individual indications treated.
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.