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Poster 411 The Impact of OnabotulinumtoxinA on Severe Headache Days: PREEMPT 24-Week Pooled Analysis
S296
Abstracts / PM R 8 (2016) S151-S332
Poster 411 The Impact of OnabotulinumtoxinA on Severe Headache Days: PREEMPT 24-Week Pooled Analysis Sheena Aurora, MD (Stanford University, Stanford, CA, United States), Rashmi Halker, MD, Patricia Pozo-Rosich, MD, PhD, Ronald DeGryse, MS, MA, Aubrey Manack Adams, PhD, Manjit Matharu, FRCP, PhD Disclosures: Sheena Aurora: Consulting fees or other remuneration (payment) - Allergan, eNeura, Merck, Teva, Speakers bureau - Allergan Objective: To evaluate the effect of onabotulinumtoxinA on headache-day severity in patients with chronic migraine (CM). Design: Two multicenter, phase 3, double-blind, parallel-group, placebo-controlled, 24-week studies. Setting: 122 global sites from the PREEMPT (Phase 3 Research Evaluating Migraine Prophylaxis Therapy) Study. Participants: Participants had a history of migraine and met International Classification of Headache Disorders (2nd edition) migraine diagnostic criteria, with headaches 15 days/month. Interventions: OnabotulinumtoxinA (155 U e 195 U) or placebo every 12 weeks for 2 treatment cycles. Main Outcome Measures: Headache-day severity was assessed at baseline and 24 weeks. Treatment responders were defined as those achieving 1-grade improvement in average daily headache severity (ADHS) score at week 24 compared with baseline. Results: 1384 patients received onabotulinumtoxinA (n¼688) or placebo (n¼696). At baseline, the percentage of severe + moderate headache days was 37.3% + 27.3% in the onabotulinumtoxinA group and 37.0% + 27.3% in the placebo group (P¼.58 and P¼.97 for severe and moderate days, respectively). At week 24, the proportion of patients with severe + moderate headache days was significantly lower for onabotulinumtoxinA (21.3% + 15.6%) compared with placebo (26.3% + 17.3%; P<.001 for both comparisons). OnabotulinumtoxinA produced a significant decrease in the number of severe headache days per 28-day period at week 24 (onabotulinumtoxinA, e4.5; placebo, e3.0; P<.001). Responder analyses indicated that significantly more patients receiving onabotulinumtoxinA than placebo demonstrated 1-grade improvement from baseline in ADHS score (35.8% vs 23.1%, P<.001) at week 24. Conclusions: Among patients with CM, use of onabotulinumtoxinA significantly reduced the number of severe and moderate headache days. In conjunction, significantly more patients treated with onabotulinumtoxinA had 1-grade improvements in ADHS scores compared with placebo. This is consistent with previously reported benefit of onabotulinumtoxinA in reducing daily headache severity in patients with CM. Level of Evidence: Level I Poster 412 Estimation of Disability Associated with Fibromyalgia Clinical Features Using Multiple Regression and the SF-36 Jessie Grewal, BSc, MSc (McMaster University, Hamilton, Ontario, Canada), William L. Parkinson, PhD, Navraj Randhawa, MD, Suneel Upadhye, MD, Michel Rathbone, MB, ChB, PhD, FRCP(C), Jonathan Adachi, MD, Yasir Rehman, MD, MSc, Dinesh A. Kumbhare, MD Disclosures: Jessie Grewal: I Have No Relevant Financial Relationships To Disclose Objective: To measure associations between fibromyalgia (FM) clinical features and disability domains using the Short Form e 36 (SF-36) Health Survey scales for social functioning, and disability attributed to physical and emotional symptoms. Design: Exploratory correlational study using multiple regression.
Setting: Medical Pain Clinic. Participants: 60 consecutively referred adults. Interventions: Not Applicable. Main Outcome Measures: FM New Clinical Diagnostic Criteria, Short Form - 36 Health Survey. Results: Univariate Pearson r correlations showed positive associations between FM Total Symptom Severity and disability in Physical (r ¼ .29, P < .05), Emotional (r ¼ .59, P < .01) and Social (r ¼ .54, P <.01) SF-36 domains, and positive associations between the Widespread Pain Index and disability in Physical (r ¼ .31, P < .05), Emotional (r ¼ 43, P < .01) and Social (r ¼ .42, P <.01) domains. Multiple regression that added all FM diagnostic features showed stronger prediction of disability in the Physical (r ¼ .48, P <.01) domain and potentially more disability in Emotional (r ¼ .67, P >.0001) and Social (r ¼ .63, P <.0001) domains. Conclusions: Individual FM diagnostic domains may underestimate FM related disability measured by the SF-36. Level of Evidence: Level III Poster 413 A Case Study Investigating Opioid Medication Utilization in Patients with Complex Regional Pain Syndrome Before and After Ketamine Infusion Therapy Gabriel Rudd-Barnard, MD, MS (Playa Vista, CA, United States), Agnes S. Wallbom, MD, Sanjog Pangarkar, MD Disclosures: Gabriel Rudd-Barnard: I Have No Relevant Financial Relationships To Disclose Objective: To assess the reduction of opioid use following ketamine infusions for pain in Complex Regional Pain Syndrome (CRPS). Design: Retrospective case review. Setting: Urban tertiary care center. Participants: Six patients with complex regional pain syndrome who have undergone ketamine infusion therapy. Interventions: Ketamine infusion therapy. Main Outcome Measures: To assess the reduction in opioid burden following ketamine infusion therapy in patients with CRPS. Results: In our patients with CRPS who underwent ketamine infusions the average morphine Meq used prior to infusion was 151 compared with 18 Meq after. This was accompanied by a change in the visual analog score (VAS) from an average of 6.5 to 3. Conclusions: Ketamine infusions in patients with treatment refractory CRPS may provide a means of reducing pain, opioid demand, and associated deleterious opioid side effects. Level of Evidence: Level IV Poster 415 Epidemiology of Naloxone use for Opioid Overdose in a Tertiary Care Medical Center Gabriel Rudd-Barnard, MD, MS (Playa Vista, CA, United States), Sanjog Pangarkar, MD, Norwan Moaleji, Pharmacist, Peter Glassman, MD Disclosures: Gabriel Rudd-Barnard: I Have No Relevant Financial Relationships To Disclose Objective: In an attempt to characterize hospital-based opioid overdoses, we conducted a medication use evaluation (MUE) of Naloxone at a tertiary care VA Medical Center. Design: Retrospective medication use evaluation. Setting: Urban tertiary care VA hospital. Participants: Data included in this study were gathered by reviewing inpatient/emergency department Naloxone Omnicell transactions followed by patient chart review. Interventions: Not applicable.
Abstracts / PM R 8 (2016) S151-S332
Poster 411 The Impact of OnabotulinumtoxinA on Severe Headache Days: PREEMPT 24-Week Pooled Analysis Sheena Aurora, MD (Stanford University, Stanford, CA, United States), Rashmi Halker, MD, Patricia Pozo-Rosich, MD, PhD, Ronald DeGryse, MS, MA, Aubrey Manack Adams, PhD, Manjit Matharu, FRCP, PhD Disclosures: Sheena Aurora: Consulting fees or other remuneration (payment) - Allergan, eNeura, Merck, Teva, Speakers bureau - Allergan Objective: To evaluate the effect of onabotulinumtoxinA on headache-day severity in patients with chronic migraine (CM). Design: Two multicenter, phase 3, double-blind, parallel-group, placebo-controlled, 24-week studies. Setting: 122 global sites from the PREEMPT (Phase 3 Research Evaluating Migraine Prophylaxis Therapy) Study. Participants: Participants had a history of migraine and met International Classification of Headache Disorders (2nd edition) migraine diagnostic criteria, with headaches 15 days/month. Interventions: OnabotulinumtoxinA (155 U e 195 U) or placebo every 12 weeks for 2 treatment cycles. Main Outcome Measures: Headache-day severity was assessed at baseline and 24 weeks. Treatment responders were defined as those achieving 1-grade improvement in average daily headache severity (ADHS) score at week 24 compared with baseline. Results: 1384 patients received onabotulinumtoxinA (n¼688) or placebo (n¼696). At baseline, the percentage of severe + moderate headache days was 37.3% + 27.3% in the onabotulinumtoxinA group and 37.0% + 27.3% in the placebo group (P¼.58 and P¼.97 for severe and moderate days, respectively). At week 24, the proportion of patients with severe + moderate headache days was significantly lower for onabotulinumtoxinA (21.3% + 15.6%) compared with placebo (26.3% + 17.3%; P<.001 for both comparisons). OnabotulinumtoxinA produced a significant decrease in the number of severe headache days per 28-day period at week 24 (onabotulinumtoxinA, e4.5; placebo, e3.0; P<.001). Responder analyses indicated that significantly more patients receiving onabotulinumtoxinA than placebo demonstrated 1-grade improvement from baseline in ADHS score (35.8% vs 23.1%, P<.001) at week 24. Conclusions: Among patients with CM, use of onabotulinumtoxinA significantly reduced the number of severe and moderate headache days. In conjunction, significantly more patients treated with onabotulinumtoxinA had 1-grade improvements in ADHS scores compared with placebo. This is consistent with previously reported benefit of onabotulinumtoxinA in reducing daily headache severity in patients with CM. Level of Evidence: Level I Poster 412 Estimation of Disability Associated with Fibromyalgia Clinical Features Using Multiple Regression and the SF-36 Jessie Grewal, BSc, MSc (McMaster University, Hamilton, Ontario, Canada), William L. Parkinson, PhD, Navraj Randhawa, MD, Suneel Upadhye, MD, Michel Rathbone, MB, ChB, PhD, FRCP(C), Jonathan Adachi, MD, Yasir Rehman, MD, MSc, Dinesh A. Kumbhare, MD Disclosures: Jessie Grewal: I Have No Relevant Financial Relationships To Disclose Objective: To measure associations between fibromyalgia (FM) clinical features and disability domains using the Short Form e 36 (SF-36) Health Survey scales for social functioning, and disability attributed to physical and emotional symptoms. Design: Exploratory correlational study using multiple regression.
Setting: Medical Pain Clinic. Participants: 60 consecutively referred adults. Interventions: Not Applicable. Main Outcome Measures: FM New Clinical Diagnostic Criteria, Short Form - 36 Health Survey. Results: Univariate Pearson r correlations showed positive associations between FM Total Symptom Severity and disability in Physical (r ¼ .29, P < .05), Emotional (r ¼ .59, P < .01) and Social (r ¼ .54, P <.01) SF-36 domains, and positive associations between the Widespread Pain Index and disability in Physical (r ¼ .31, P < .05), Emotional (r ¼ 43, P < .01) and Social (r ¼ .42, P <.01) domains. Multiple regression that added all FM diagnostic features showed stronger prediction of disability in the Physical (r ¼ .48, P <.01) domain and potentially more disability in Emotional (r ¼ .67, P >.0001) and Social (r ¼ .63, P <.0001) domains. Conclusions: Individual FM diagnostic domains may underestimate FM related disability measured by the SF-36. Level of Evidence: Level III Poster 413 A Case Study Investigating Opioid Medication Utilization in Patients with Complex Regional Pain Syndrome Before and After Ketamine Infusion Therapy Gabriel Rudd-Barnard, MD, MS (Playa Vista, CA, United States), Agnes S. Wallbom, MD, Sanjog Pangarkar, MD Disclosures: Gabriel Rudd-Barnard: I Have No Relevant Financial Relationships To Disclose Objective: To assess the reduction of opioid use following ketamine infusions for pain in Complex Regional Pain Syndrome (CRPS). Design: Retrospective case review. Setting: Urban tertiary care center. Participants: Six patients with complex regional pain syndrome who have undergone ketamine infusion therapy. Interventions: Ketamine infusion therapy. Main Outcome Measures: To assess the reduction in opioid burden following ketamine infusion therapy in patients with CRPS. Results: In our patients with CRPS who underwent ketamine infusions the average morphine Meq used prior to infusion was 151 compared with 18 Meq after. This was accompanied by a change in the visual analog score (VAS) from an average of 6.5 to 3. Conclusions: Ketamine infusions in patients with treatment refractory CRPS may provide a means of reducing pain, opioid demand, and associated deleterious opioid side effects. Level of Evidence: Level IV Poster 415 Epidemiology of Naloxone use for Opioid Overdose in a Tertiary Care Medical Center Gabriel Rudd-Barnard, MD, MS (Playa Vista, CA, United States), Sanjog Pangarkar, MD, Norwan Moaleji, Pharmacist, Peter Glassman, MD Disclosures: Gabriel Rudd-Barnard: I Have No Relevant Financial Relationships To Disclose Objective: In an attempt to characterize hospital-based opioid overdoses, we conducted a medication use evaluation (MUE) of Naloxone at a tertiary care VA Medical Center. Design: Retrospective medication use evaluation. Setting: Urban tertiary care VA hospital. Participants: Data included in this study were gathered by reviewing inpatient/emergency department Naloxone Omnicell transactions followed by patient chart review. Interventions: Not applicable.