WEBVTT 00:00:01.144 --> 00:00:03.727 line:0% (upbeat music) 00:00:07.090 --> 00:00:08.740 line:0% Hello, my name's Warner Carr, 00:00:08.740 --> 00:00:11.580 line:0% I'm a allergist and clinical immunologist, 00:00:11.580 --> 00:00:12.990 line:0% and it is my pleasure today 00:00:12.990 --> 00:00:14.830 line:0% to talk to you about immunogenicity 00:00:14.830 --> 00:00:18.730 line:0% associated with botulinum type A toxins 00:00:18.730 --> 00:00:20.498 line:0% for the treatment of movement disorders. 00:00:20.730 --> 00:00:25.010 Neutralizing antibodies are antibodies that your body makes, 00:00:25.010 --> 00:00:28.320 and they're targeted against a pathogen or a toxin 00:00:28.320 --> 00:00:31.830 or something that your body sees as a foreign invader. 00:00:31.830 --> 00:00:34.393 And what they do is they neutralize the function 00:00:34.418 --> 00:00:36.240 of that foreign invader. 00:00:36.240 --> 00:00:38.760 Formation of neutralizing antibodies 00:00:38.760 --> 00:00:41.090 can lead to clinical resistance. 00:00:41.090 --> 00:00:43.980 If the patient is developing a neutralizing antibody 00:00:43.980 --> 00:00:47.120 against the therapy, you're going to see issues, 00:00:47.120 --> 00:00:49.830 you're going to see a decrease in effectiveness, 00:00:49.830 --> 00:00:51.760 you're going to see a dose creep, 00:00:51.760 --> 00:00:53.140 the patient's going to have to come back 00:00:53.140 --> 00:00:56.290 into the doctor's office more frequently. 00:00:56.290 --> 00:00:59.860 In patients that have these movement disorders, 00:00:59.860 --> 00:01:02.790 they're going to be on these biological therapies 00:01:02.790 --> 00:01:04.003 for the long term. 00:01:04.980 --> 00:01:09.030 line:70% So it's very important, especially in the young patient, 00:01:09.030 --> 00:01:10.787 line:70% the teenagers, and the adolescents, 00:01:10.812 --> 00:01:15.200 line:70% to choose something that has a very low potential 00:01:15.200 --> 00:01:18.130 line:70% for the generation of a neutralizing antibody. 00:01:18.130 --> 00:01:21.820 When you look at all of the different types 00:01:21.820 --> 00:01:25.550 of botulinum type A formulations 00:01:25.550 --> 00:01:27.850 that are currently available on the market, 00:01:27.850 --> 00:01:28.730 they're different. 00:01:28.730 --> 00:01:31.120 line:0% Some have accessory proteins 00:01:31.120 --> 00:01:32.930 line:0% that have a protein load in there, 00:01:32.930 --> 00:01:35.103 line:0% and then there's a product, XEOMIN, 00:01:35.128 --> 00:01:38.550 line:0% that is a 150-kilodalton toxin, 00:01:38.550 --> 00:01:42.130 line:0% and that's the one that has the lowest protein load. 00:01:42.130 --> 00:01:46.318 The higher protein load increases your risk 00:01:46.343 --> 00:01:48.911 line:0% of developing an antibody, 00:01:49.470 --> 00:01:53.460 line:0% and developing, in particular, a neutralizing antibody. 00:01:53.460 --> 00:01:56.890 The immunogenicity of these biological products 00:01:56.890 --> 00:01:59.170 are very, very important. 00:01:59.170 --> 00:02:01.490 So much so that the FDA 00:02:01.490 --> 00:02:05.150 has a guidance document for any company 00:02:05.150 --> 00:02:09.460 that is developing these biological therapies. 00:02:09.460 --> 00:02:11.260 line:0% When choosing a therapy, 00:02:11.260 --> 00:02:12.660 line:0% especially when you're treating patients 00:02:12.660 --> 00:02:13.990 line:0% with movement disorders, 00:02:13.990 --> 00:02:18.560 line:0% it's very important to think about immunogenicity. 00:02:18.560 --> 00:02:21.440 line:0% You're going to want to choose a therapy 00:02:21.440 --> 00:02:23.760 line:0% that has the least likelihood 00:02:23.760 --> 00:02:26.950 line:0% of developing a neutralizing antibody over time. 00:02:26.950 --> 00:02:30.000 line:0% It's important to choose a product 00:02:30.000 --> 00:02:31.600 line:0% that has a very low protein load. 00:02:31.600 --> 00:02:38.107 line:0% XEOMIN is just the biologically active 150-kilodalton toxin, 00:02:38.500 --> 00:02:40.470 and if you look at the clinical trials 00:02:40.470 --> 00:02:42.900 line:0% that were conducted to support the approval of XEOMIN, 00:02:42.900 --> 00:02:45.740 line:0% you'll see it's a very low incidence 00:02:45.740 --> 00:02:48.870 line:0% of production of neutralizing antibodies. 00:02:48.870 --> 00:02:50.880 line:0% And in addition to that, 00:02:50.880 --> 00:02:53.270 line:0% in those patients and in the adult population, 00:02:53.270 --> 00:02:54.270 line:0% there was only 9. 00:02:55.270 --> 00:02:59.090 line:0% And in the adolescent population, there was only 4. 00:02:59.090 --> 00:03:02.800 line:0% In those patients, there was no signs of clinical resistance. 00:03:02.800 --> 00:03:04.370 It's really my pleasure today 00:03:04.370 --> 00:03:07.077 to talk to you guys about immunogenicity 00:03:07.077 --> 00:03:10.430 and the importance of immunogenicity 00:03:10.430 --> 00:03:13.760 in treating patients with botulinum type A toxin 00:03:13.760 --> 00:03:15.373 that have movement disorders. 00:03:15.373 --> 00:03:17.956 (upbeat music)