| Autor: |
Forde G; NeuroPain Care Center, Lake Success, NY 11042, USA., Brucker BM; NYU Langone Health, New York, NY 10017, USA., Becker Ifantides K; AbbVie, Irvine, CA 92612, USA., Patel AT; Kansas City Bone & Joint Clinic, Overland Park, KS 66211, USA., Mayadev A; Swedish Neuroscience Institute, Seattle, WA 98122, USA., Brown T; EvergreenHealth Kirkland, Kirkland, WA 98034, USA., Ayyoub Z; Ranchos Los Amigos National Rehabilitation Center, Downey, CA 90242, USA., Martinez K; Neurology & Pain Specialty Center, Aliso Viejo, CA 92656, USA., Singh R; AbbVie, Irvine, CA 92612, USA., Nelson M; AbbVie, Irvine, CA 92612, USA., Battucci S; AbbVie, 00144 Rome, Italy., Yushmanova I; AbbVie, Irvine, CA 92612, USA., Ukah A; AbbVie, Irvine, CA 92612, USA., Rhyne C; Diamond Headache Clinic, Chicago, IL 60642, USA. |
| Abstrakt: |
OnabotulinumtoxinA (onabotA) is approved in the US for 12 therapeutic indications. Real-world data on onabotA multi-indication use are limited, often leading to delayed or reduced treatment. This study provides real-world evidence on the safety of onabotA when treating multiple indications concomitantly. SYNCHRONIZE was a multicenter, retrospective, chart-review study evaluating onabotA's safety for adults treated for ≥2 therapeutic indications within a 3-month period. The primary outcome was treatment-emergent adverse events (TEAEs) within 6 months post-treatment. A total of 279 patients were included. The most common concomitant indications treated were cervical dystonia and chronic migraine (43.4%). The average 3-month cumulative dose for multiple indications was 282.2 U. The treatment interval for multiple indications was ≤24 h for most patients (62.4%). Overall, 28.7% of patients reported ≥1 TEAE with no apparent trends in TEAEs and dose interval or cumulative dose. Reported TEAEs included UTI (5.7%), neck pain (5.0%), and headache (4.3%). No patient had a lack of effect according to clinical objective measurements. SYNCHRONIZE described the real-world safety of onabotA for patients treated concomitantly for ≥2 indications within a 3-month period. TEAEs were generally consistent with the known safety profiles of individual indications. No new safety signals were identified). |
