00:00
[Music begins with title and Lilly logo on screen.]
Caption: Raising the bar with ASAS40
00:05
[Frame transitions to Dr. Lisse with his name and title on the bottom left corner of the screen. Dr. Lisse is speaking to camera. At 00:12, camera zooms out to show more of Dr. Lisse.]
Dialogue: Dr. Jeffrey Lisse: Hello, I'm doctor Jeffrey Lisse. I'm a rheumatologist and a medical fellow with Eli Lilly and I'm here today to talk to you about the ASAS response criteria for patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis.
Caption: Jeffrey R. Lisse, MD
00:23
[Frame transitions to the four domains of patient response. Domains appear as red rounded rectangular quadrants each with a text and an icon. Dr. Lisse continues to speak and discusses the four domains.]
Dialogue: Dr. Jeffrey Lisse: What you see in front of you on this slide has the 4 overall domains that we look at to measure this response. It includes the patient's global assessment, their spinal pain, inflammation, and function. These are the overall problems that most patients will complain of when they come in to the physician's office.
Caption: Domains defined1, Patient global assessment, Spinal pain, Inflammation, Function
00:47
[Frame transitions to a chart comparing the differences between ASAS20 and ASAS40 response. Dr. Lisse describes the graph information.]
Dialogue: Dr. Jeffrey Lisse: The ASAS20 was originally developed as a measure for non-steroidal anti-inflammatory drug, or NSAID, trials. It's used as a regulatory endpoint however, and many clinical trials have used it as their primary endpoint. In order to reach an ASAS20, patients have to have an improvement of at least 20% and at least one unit on a numerical rating scale in 3 out of the 4 domains that I just mentioned to you. The last domain can get worse but it cannot worsen by more than 20% or 1 unit. The ASAS40 is more stringent. Here the patient requires a 40% improvement and 2 units in 3 of the 4 domains, plus the remaining domain cannot worsen at all. So, the ASAS40 is obviously a higher bar than the ASAS20.
Caption: ASAS40 is a higher bar than ASAS201,2 The difference between ASAS20 and ASAS40 is more than a 20% vs 40% improvement, ASAS40 Improvement: ≥40% and ≥2 units in 3 of 4 domains* + Does NOT allow for any worsening*, ASAS20 Improvement: ≥20% and ≥1 unit in 3 of 4 domains* + No worsening of ≥20% and ≥1 unit in the remaining domain*
*All 4 domains are based on a rating scale of 0-10.
01:47
[Frame transitions to a graph showing ASAS response criteria. Dr. Lisse describes the graph information.]
Dialogue: Dr. Jeffrey Lisse: To give you an example of how this works in a given patient in a clinical trial, here we've got the 4 domains measured. So this patient came into the clinical trial and their global assessment is at a 7 out of 10, the spinal pain and inflammation are 6 out of 10, and function is again at 7 out of 10.
Caption: ASAS response criteria, Assessment of the 4 ASAS core domains*, Lilly | CIQ, USCIQ-RES-221-QQQ Accessibility Resource (Version 0), Hypothetical patient example, Score at baseline, 10 9 8 7 6 5 4 3 2 1 0, Patient global assessment, Spinal pain, Inflammation, Function
*All 4 domains are based on a rating scale of 0-10.
02:06
[Title and content of chart is built upon with more data as Dr. Lisse continues to speak to the graph.]
Dialogue: Dr. Jeffrey Lisse: In order to achieve an ASAS40 for example, here are some of the potential measurements for this patient over time. So here we have the patient's global assessment has not changed. Their spinal pain has improved by 50% or 3 units, as has their inflammation. And their function has improved by 40% or 2 units. So 3 of the domains have gotten 40% better, and at least 2 units better, and the remaining domain has not worsened at all. So this patient's achieved an ASAS40.
Caption: Scoring the higher benchmark: ASAS40, Assessment of the 4 ASAS core domains*, Hypothetical patient example, Score at baseline, ASAS40 score at week 16, 10 9 8 7 6 5 4 3 2 1 0, ASAS40 Improvement at week 16, Patient global assessment 0% 0 units, Spinal pain 50% 3 units, Inflammation 50% 3 units, Function 40% 2 unit
*All 4 domains are based on a rating scale of 0-10.
02:38
[Title and content of chart is built upon with more data as Dr. Lisse continues to speak to the graph.]
Dialogue: Dr. Jeffrey Lisse: By comparison, these lighter arrows show you what the patient could look like if they achieved just an ASAS20. So in this case the patient's spinal pain and inflammation got 2 units better at 33%. The patient's function got 1 unit better and 20%. So 3 of the units are 20% better and 1 unit better. The 4th domain however, the global assessment, got worse. It did not worsen up to 20%, so this patient would achieve an ASAS20. Clearly this is not adequate for an ASAS40 in this person.
Caption: Scoring ASAS20 vs ASAS40, Assessment of the 4 ASAS core domains*, Hypothetical patient examples, Score at baseline, ASAS40 score at week 16, ASAS20 score at week 16, 10 9 8 7 6 5 4 3 2 1 0, ASAS40 Improvement at week 16, Patient global assessment -7% 0.5 units, Spinal pain 33% 2 units, Inflammation 33% 2 units, Function 20% 1 unit
*All 4 domains are based on a rating scale of 0-10.
03:18
[Frame transitions to two rounded rectangles comparing ASAS20 to ASAS40. Dr. Lisse highlights how ASAS40 can raise the bar for patients.]
Dialogue: Dr. Jeffrey Lisse: The ASAS40 can raise the bar and is most likely a more clinically relevant outcome for patients and physicians.
Caption: ASAS40 can raise the bar for your patients1,2, ASAS40 is a more stringent endpoint, ASAS40, ASAS20, ASAS20 is a less stringent endpoint
03:28
[Frame transitions back to Dr. Lisse. He is speaking to the camera.]
Dialogue: Dr. Jeffrey Lisse: Thank you.
03:30
[Frame transitions to Lilly logo and references.]
Caption: Lilly
References:
- Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum. 2001;44:1876-1886.
- Brandt J, Listing J, Sieper J, Rudwaleit M, van der Heijde D, Braun J. Development and preselection of criteria for short term improvement after anti-TNF alpha treatment in ankylosing spondylitis. Ann Rheum Dis. 2004;63:1438-1444.
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