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Abstract Details

Real-World Retrospective Safety Analysis in Patients Treated with OnabotulinumtoxinA for Multiple Therapeutic Indications over Repeat Treatment Periods
General Neurology
S27 - General Neurology 2 (2:00 PM-2:12 PM)
006

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.

Evaluate the real-world safety of onabotulinumtoxinA use over repeat treatment periods (TPs) in patients with concomitant multiple therapeutic indications.
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.

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.

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.
Authors/Disclosures
Grace I. Forde, MD
PRESENTER
Dr. Forde has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Atul T. Patel Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for IPSEN. Atul T. Patel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for IPSEN. The institution of Atul T. Patel has received research support from Abbvie. The institution of Atul T. Patel has received research support from IPSEN.
Kenneth P. Martinez, MD (Neurology & Pain Specialty Center) The institution of Dr. Martinez has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. The institution of Dr. Martinez has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie/Allergan. The institution of Dr. Martinez has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. The institution of Dr. Martinez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. The institution of Dr. Martinez has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie/Allergan. The institution of Dr. Martinez has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Merz. The institution of Dr. Martinez has received research support from Medtronic. The institution of Dr. Martinez has received research support from Abbvie/Allergan.
Angeli Mayadev, MD (Multiple Sclerosis Center) Dr. Mayadev has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. The institution of Dr. Mayadev has received research support from Ipsen.
Ben Brucker, MD Dr. Brucker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie . Dr. Brucker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic . Dr. Brucker has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sumitomo pharma . The institution of Dr. Brucker has received research support from Abbvie. The institution of Dr. Brucker has received research support from Sumitomo pharma.
Theodore R. Brown, MD (MS Center At Evergreen) Dr. Brown has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Astellas. The institution of Dr. Brown has received research support from Merck.
Ziyad Ayyoub, MD Prof. Ayyoub has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Prof. Ayyoub has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Ipsen.
Rita Singh, PharmD (Allergan) Dr. Singh has received personal compensation for serving as an employee of AbbVie. Dr. Singh has stock in AbbVie.
Mariana Nelson, PhD (AbbVie/Allergan US Medical Affairs) Dr. Nelson has received personal compensation for serving as an employee of AbbVie. Dr. Nelson has stock in AbbVie Inc.
Ahunna Ukah (Abbvie) Ahunna Ukah has received personal compensation for serving as an employee of AbbVie. Ahunna Ukah has stock in AbbVie.
Irina Yushmanova, MD Dr. Yushmanova has received personal compensation for serving as an employee of AbbVie.
Simona Battucci, MD Dr. Battucci has received personal compensation for serving as an employee of AbbVie . Dr. Battucci has stock in AbbVie .
Kimberly Ifantides Kimberly Ifantides has received personal compensation for serving as an employee of AbbVie. Kimberly Ifantides has stock in Abbvie.
Christopher P. Rhyne, MD (Diamond Headache Clinic) Dr. Rhyne has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie/Allergan. Dr. Rhyne has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie/Allergan. Dr. Rhyne has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck.