S170 S290
Poster 110:
Effectiveness and Safety of Intrathecal Ziconotide
Use as the First Agent in Pump
Michael F. Saulino, MD, PhD, FAAPMR (Moss Rehab, Elkins Park, PA,
United States), Gladstone C. McDowell, MD, Richard L. Rauck, MD,
Philip Kim, MD, Mark Wallace, MD, I-Zu Huang, MD, Robert Ryan, MS,
Timothy R. Deer, MD
Disclosures:
Michael Saulino: Speakers bureau - Medtronic, Jazz
Pharmaceuticals, Ipsen, Mallinckrodt; Research Grants - Mallinckrodt,
Jazz Pharmaceuticals
Objective:
To evaluate the effectiveness and safety associated with
intrathecal (IT) ziconotide use in the Patient Registry of Intrathecal
Ziconotide Management (PRIZM) study.
Design:
Open-label, long-term, multicenter, observational study.
Setting:
Clinical practice.
Participants:
Adult patients with severe chronic pain who met zico-
notide prescribing information criteria.
Interventions:
IT therapy.
Main Outcome Measures:
This interim analysis (data as of July 5,
2016) of ziconotide as the first versus second-or-later IT agent in pump
reports change from baseline to month 6 and month 12 in “average
pain for the past 24 hours,” on the 11-point Numeric Pain Rating Scale
(NPRS).
Results:
Enrollment has closed at 93 patients; data collection is
ongoing. Fifty-one patients (54.8%) received ziconotide as the first
agent in pump (FIP+), whereas 42 (45.2%) did not (FIP-). Mean (stan-
dard deviation) baseline NPRS scores were 7.4 (1.9) and 7.9 (1.6) in
FIP+ and FIP- patients, respectively. Mean percentage change (stan-
dard error of the mean) in NPRS scores at month 6 were
e
28.2% (5.4) in
FIP+ (n
¼
30) and 0.7% (6.6) in FIP- (n
¼
26) patients and at month 12
were
e
31.6% (7.4) in FIP+ (n
¼
19) and
e
12.8% (7.4) in FIP- (n
¼
16)
patients. For response defined as 30% decrease in NPRS score,
response rates were 43.3% and 15.4%, respectively, at month 6 and
52.6% and 31.3%, respectively, at month 12. The most common adverse
events (AEs; 15% of patients combined) were nausea (25.5% vs.
21.4%; FIP+ vs. FIP- patients, respectively), confusional state (15.7%
vs. 21.4%), dizziness (17.6% vs. 16.7%), auditory hallucination (17.6%
vs. 11.9%), and diarrhea (15.7% vs. 14.3%).
Conclusions:
In this interim PRIZM analysis, greater treatment
response (as assessed by the primary efficacy measure) was observed
when ziconotide was initiated as first-line IT therapy versus second-or-
later IT agent in pump. The AE profile of ziconotide was consistent
with the prescribing information.
Funding: Jazz Pharmaceuticals.
Level of Evidence:
Level II
Poster 111:
Sustained Effectiveness of Intrathecal Ziconotide Use
in Patients with Severe Chronic Pain
Michael F. Saulino, MD, PhD, FAAPMR (Moss Rehab, Elkins Park, PA,
United States), Gladstone C. McDowell, MD, Richard L. Rauck, MD,
Philip Kim, MD, Mark Wallace, MD, I-Zu Huang, MD, Robert Ryan, MS,
Timothy R. Deer, MD
Disclosures:
Michael Saulino: Speakers bureau - Medtronic, Jazz
Pharmaceuticals, Ipsen, Mallinckrodt; Research Grants - Mallinckrodt,
Jazz Pharmaceuticals
Objective:
To evaluate the effectiveness and safety associated with
intrathecal (IT) ziconotide use in the Patient Registry of Intrathecal
Ziconotide Management (PRIZM) study.
Design:
Open-label, long-term, multicenter, observational study
Setting:
Clinical practice.
Participants:
Adult patients with severe chronic pain who met zico-
notide prescribing information criteria.
Interventions:
IT therapy.
Main Outcome Measures:
This interim analysis (data as of July 5,
2016) reports change from baseline over time (months 3, 6, 9, and 12)
in “average pain for the past 24 hours” on the 11-point Numeric Pain
Rating Scale (NPRS).
Results:
Enrollment closed at 93 patients; data collection is ongoing.
All 93 patients were enrolled 12 months prior to this analysis; 66
and 44 patients were still active in the study at months 6 and 12,
respectively, of whom 77.3% (51/66) at month 6 and 59.1% (26/44) at
month 12 remained on ziconotide monotherapy. Thirty-three pa-
tients had NPRS scores at months 3, 6, 9, and 12 and are included in
this analysis. Mean (standard deviation) NPRS score at baseline was
7.8 (1.3). Mean percentage change (standard error of the mean) in
NPRS score was
e
15.8% (4.2) at month 3,
e
25.1% (5.2) at month 6,
e
22.8% (5.1) at month 9, and
e
23.1% (5.5) at month 12. The most
common adverse events (AEs; 15% of patients in this analysis) were
auditory hallucination (30.3%), memory impairment (24.2%), periph-
eral edema (21.2%), amnesia (18.2%), dizziness (18.2%), confusional
state (15.2%), headache (15.2%), nausea (15.2%), and pruritus
(15.2%).
Conclusions:
Data from this small interim analysis of the PRIZM
database suggest that there may be a sustained treatment response
for up to 12 months with IT ziconotide therapy. The AE profile was
consistent with ziconotide prescribing information.
Funding: Jazz Pharmaceuticals.
Level of Evidence:
Level II
Poster 112:
Spinal Dorsal Rami Injection and Radiofrequency
Neuroablation for Low Back Pain Related to Thoraco-
Lumbar Vertebral Compression Fracture
David A. Janerich, DO (Professional Pain Associate, Woodbury, New
Jersey, United States), Linqiu Zhou, MD, Priyanca M. Mody, DO,
Julia Coleman, PA-C
Disclosures:
David A. Janerich, DO: I Have No Relevant Financial Re-
lationships To Disclose
Objective:
To evaluate the efficacy of spinal dorsal rami injections
and subsequent radiofrequency (RF) neurolysis for low back pain (LBP)
among the patients with thoracolumbar vertebral compression
fracture.
Design:
Retrospective chart review (2/2008 - 12/2016).
Setting:
Academic and private pain clinics.
Participants:
Forty-Five patients with acute or chronic LBP (15 male,
30 female, range: 32-93, average age: 71) were diagnosed with low
thoracolumbar vertebral compression fracture by imaging studies (X-
Ray and MRI). Thirty-one patients presented with single level fracture
(T11: 3, T12: 9, L1: 15, L2: 2, and L3:2), and fourteen patients had
multi-level fractures (T12/L1: 3, T12/L1/L2: 2, L1/L2: 8, L1/L2/L3: 1).
Four patients had previous lumbar vertebroplasties. Two patients’
compression fracture was caused by multiple myeloma. The patients’
clinical presentation and physical examination correlated with the
involved levels of dorsal rami.
Interventions:
Based on the clinical presentation, involved dorsal
rami were identified (unilateral, bilateral, single level or multiple
level) and injected with 1.0 cc mixture of depo-medrol and 0.25%
lidocaine under fluoroscopic guidance. If 50% pain reduction was
achieved and lasted for less than three months post injection, then RF
neurolysis was performed (24 patients).
Main Outcome Measures:
Overall pain level, functional improve-
ments, and opioid medication usage.
Results:
All patients had 50-100% pain reduction three or more days
after the injections. 24 patients who received pain relief for less than
three months from the injection underwent RF neurolysis and received
standard osteoporosis treatment with Calcium, Vitamin D, Fosamax or
Forteo. All patients reported long-term pain relief, functional im-
provements and decreased opioid medication usage. No patient
required surgical intervention.
S170
Abstracts / PM R 9 (2017) S131-S290