WEBVTT 1 00:00:00.810 --> 00:00:02.689 line:0% Please see the end of the video for 2 00:00:02.690 --> 00:00:04.549 line:0% important safety information, 3 00:00:04.550 --> 00:00:06.629 line:0% including boxed warning, and visit 4 00:00:06.630 --> 00:00:08.229 line:0% XEOMIN.com for full prescribing 5 00:00:08.230 --> 00:00:09.230 line:0% information. 6 00:00:10.360 --> 00:00:12.079 Hello, my name's Warner Carr. 7 00:00:12.080 --> 00:00:14.039 I'm a allergist and clinical 8 00:00:14.040 --> 00:00:14.999 immunologist. 9 00:00:15.000 --> 00:00:16.759 It is my pleasure today to talk to 10 00:00:16.760 --> 00:00:18.839 you about immunogenicity associated 11 00:00:18.840 --> 00:00:20.859 with botulinum type 12 00:00:20.860 --> 00:00:22.779 A toxins for the treatment of 13 00:00:22.780 --> 00:00:24.279 movement disorders. 14 00:00:24.280 --> 00:00:25.979 Neutralizing antibodies are 15 00:00:25.980 --> 00:00:28.679 antibodies that your body makes and 16 00:00:28.680 --> 00:00:30.819 they're targeted against a pathogen 17 00:00:30.820 --> 00:00:32.739 or a toxin or something that 18 00:00:32.740 --> 00:00:35.159 your body sees as a foreign invader. 19 00:00:35.160 --> 00:00:36.899 And what they do is they neutralize 20 00:00:36.900 --> 00:00:38.519 the function of that foreign 21 00:00:38.520 --> 00:00:40.629 invader. Formation of 22 00:00:40.630 --> 00:00:42.569 neutralizing antibodies can 23 00:00:42.570 --> 00:00:44.469 lead to clinical resistance. 24 00:00:44.470 --> 00:00:46.149 If the patient is developing a 25 00:00:46.150 --> 00:00:48.349 neutralizing antibody against the 26 00:00:48.350 --> 00:00:50.509 therapy, you're going to see issues. 27 00:00:50.510 --> 00:00:52.629 You're going to see a decrease in 28 00:00:52.630 --> 00:00:53.929 effectiveness. You're going to see a 29 00:00:53.930 --> 00:00:55.149 dose creep. 30 00:00:55.150 --> 00:00:56.269 The patient's going to have to come 31 00:00:56.270 --> 00:00:58.229 back into the doctor's office more 32 00:00:58.230 --> 00:00:59.729 frequently. 33 00:00:59.730 --> 00:01:01.629 In patients that have these movement 34 00:01:01.630 --> 00:01:03.509 disorders, they're 35 00:01:03.510 --> 00:01:05.589 line:85% going to be on these biological 36 00:01:05.590 --> 00:01:07.090 line:85% therapies for the long term. 37 00:01:08.310 --> 00:01:10.589 line:85% So it's very important, especially 38 00:01:10.590 --> 00:01:12.629 line:85% in the young patient, the 39 00:01:12.630 --> 00:01:14.429 line:85% teenagers and the adolescents, to 40 00:01:14.430 --> 00:01:16.689 line:85% choose something that 41 00:01:16.690 --> 00:01:18.709 line:85% has a very low potential for 42 00:01:18.710 --> 00:01:20.789 line:85% the generation of a neutralizing 43 00:01:20.790 --> 00:01:22.769 antibody. A higher protein 44 00:01:22.770 --> 00:01:24.709 load increases 45 00:01:24.710 --> 00:01:26.629 your risk of developing 46 00:01:26.630 --> 00:01:27.630 an antibody, 47 00:01:28.790 --> 00:01:30.609 and developing in particular a 48 00:01:30.610 --> 00:01:32.609 neutralizing antibody. 49 00:01:32.610 --> 00:01:34.429 The immunogenicity 50 00:01:34.430 --> 00:01:36.189 of these biological products are 51 00:01:36.190 --> 00:01:38.229 very, very important. 52 00:01:38.230 --> 00:01:41.209 So much so that the FDA has 53 00:01:41.210 --> 00:01:43.349 a guidance document for 54 00:01:43.350 --> 00:01:46.499 any company that is developing 55 00:01:46.500 --> 00:01:48.529 these biological therapies. 56 00:01:48.530 --> 00:01:50.409 line:70% When choosing a therapy, 57 00:01:50.410 --> 00:01:51.249 line:70% especially when you're treating 58 00:01:51.250 --> 00:01:52.969 line:70% patients with movement disorders, 59 00:01:52.970 --> 00:01:55.349 line:70% it's very important to 60 00:01:55.350 --> 00:01:56.350 line:70% think about immunogenicity. 61 00:01:57.110 --> 00:01:59.769 It's important to choose a 62 00:01:59.770 --> 00:02:01.189 product that has a very low protein 63 00:02:01.190 --> 00:02:02.049 load. 64 00:02:02.050 --> 00:02:04.529 Xeomin is just 65 00:02:04.530 --> 00:02:07.009 the biologically active 150 66 00:02:07.010 --> 00:02:08.579 Kilo-Dalton Toxin. 67 00:02:08.580 --> 00:02:10.119 And if you look at the clinical 68 00:02:10.120 --> 00:02:11.559 trials that were conducted to 69 00:02:11.560 --> 00:02:13.059 line:80% support the approval of XEOMIN, 70 00:02:13.060 --> 00:02:15.339 line:80% you'll see it's a very low incidence 71 00:02:15.340 --> 00:02:17.379 line:80% of production of neutralizing 72 00:02:17.380 --> 00:02:18.380 line:80% antibodies. 73 00:02:19.220 --> 00:02:21.199 line:80% And in addition to that, in 74 00:02:21.200 --> 00:02:22.759 line:80% those patients, and in the adult 75 00:02:22.760 --> 00:02:23.979 line:80% population, there was only 9. 76 00:02:25.560 --> 00:02:27.719 line:80% And in the adolescent population, 77 00:02:27.720 --> 00:02:29.179 line:80% there was only 4. 78 00:02:29.180 --> 00:02:30.999 line:80% In those patients, there was no 79 00:02:31.000 --> 00:02:32.959 line:80% signs of clinical resistance. 80 00:02:32.960 --> 00:02:35.019 It's really my pleasure today to 81 00:02:35.020 --> 00:02:36.219 talk to you guys about 82 00:02:36.220 --> 00:02:38.759 immunogenicity and the importance 83 00:02:38.760 --> 00:02:40.819 of immunogenicity in 84 00:02:40.820 --> 00:02:43.039 treating patients with botulinum 85 00:02:43.040 --> 00:02:44.479 type A toxin that have movement 86 00:02:44.480 --> 00:02:45.480 disorders.