Rheumatic Diseases and Biosimilars: Evidence about Switch from Originators to Biosimilars in the Real Life

Biosimilars are broadly available for the treatment of several diseases including inflammatory arthritis. Thanks to biosimilars it has been possible to treat a greater number of rheumatic patients who previously were undertreated due to the high cost of originators, in several countries. There are a lot of data from double blind, randomized, controlled clinical trials, especially on TNF inhibitors (TNFi), concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe mainly for economic reasons. However, despite the considerable saving, such shifts to biosimilar drugs are still being debated, principally over their ethical implications. Since the drugs are similar but not identical, the main issues are related to the possibility to compare the adverse events and/or the lack of efficacy and, to date, the variability in effectiveness for a single patient remains an unpredictable datum before effecting the switch. Despite encouraging data about the maintenance of efficacy and safety after the switch, there are many reports of discontinuation due both lack of efficacy or and adverse events. In this chapter we aim at showing the disease activity trend and the safety after the transition to TNF-i biosimilars in patients with rheumatic diseases in real life..

Download Full-text

AB1158 VACCINATION BARRIERS IN PATIENTS WITH RHEUMATIC DISEASES

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5521 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1869.2-1870

Author(s):

G. Figueroa-Parra ◽

A. Moreno-Salinas ◽

L. Santoyo-Fexas ◽

C. M. Gamboa-Alonso ◽

A. L. De-Leon-Ibarra ◽

...

Keyword(s):

Human Papillomavirus ◽

Herpes Zoster ◽

Hepatitis B ◽

Adverse Events ◽

Rheumatic Diseases ◽

Demographic Characteristics ◽

Specific Patient ◽

Increased Risk ◽

Rheumatic Patients ◽

Vaccination Barriers

Background:Patients with rheumatic diseases (RD) are at increased risk of infections, attributed to the underlying RD, comorbidities and immunosuppressive therapy, including glucocorticoids, disease-modifying antirheumatic drugs, etc. (1). While many infectious diseases can generally be prevented by vaccines, immunization rates in this specific patient population remain suboptimal (2). Despite being recognized as one of the most successful public health measures, vaccination is perceived as unsafe and unnecessary by a growing number of individuals. Lack of confidence in vaccines is now considered a threat to the success of vaccination programs (3).Objectives:To describe the main causes of non-vaccination in patients with RD.Methods:A self-questionnaire was applied to a sample of patients with RD in the rheumatology clinic of the university hospital “Dr. Jose Eleuterio Gonzalez” in Monterrey, Mexico between September and December 2019. The questionnaire evaluated demographic characteristics (age, gender, diagnosis) and the vaccination status for Influenza (last year), pneumococcal (last 5 years), Herpes zoster (ever), Human papillomavirus (any dose) and Hepatitis B (any dose). It also includes a question asking: If you didn’t receive any of the previous vaccines, what was the reason? (multiple-choice are shown in Table 2). Results are shown in frequencies and percentages.Table 2.Vaccination barriersN=82If you didn’t receive any of the previous vaccines,what was the reason? n (%)1)Did not was recommended22 (26.8)2) Lack of availability21 (25.6)3) Vaccines don’t work13 (15.8)4) Fear of adverse events8 (9.7)5) Previous adverse event3 (3.6)6) Other reason- Own decision8 (9.7)- Disinformation7 (8.5)Results:102 patients were evaluated: Mean age was 51.27 (SD 14.68) years; 84 (82.4%) were females; 71 (69.6%) had rheumatoid arthritis, 13 (12.7%) had systemic lupus erythematosus, 6 (5.8%) had other autoimmune diseases and 12 (11.8%) had osteoarthritis. The rate of vaccination for Influenza was 49 (48%), for pneumococcal 25 (24.5%), for Herpes zoster 5 (4.9%), for Human papillomavirus 9 (8.8%), for Hepatitis B 14 (13.7%) (Table 1). 82 (80.3%) patients reported some barriers in vaccination, from these: 22 (26.8%) did not get the recommendation from the rheumatologist, 21 (25.6%) did not found available the vaccine, 13 (15.8%) believes that vaccines don’t work, 8 (9.7%) had fear of adverse events, 3 (3.6%) reported previous adverse events, and 15 (18.2%) reported other reasons, that we classified as own decision 8 (9.7%) and disinformation 7 (8.5%) (Table 2).Table 1.Demographic characteristicsN= 102Age, years, mean (SD)51.27 (14.68)Female, n (%)84 (82.4)Diagnosis, n (%)-RA71 (69.6)-SLE13 (12.7)-OA12 (11.8)-Other AID6 (5.8)Conclusion:The main barriers in vaccination of rheumatic patients reported were the lack of availability of the indicated vaccines and the medical and patient disinformation. This problem must be combated to ensure the complete vaccination of rheumatic patients.References:[1]Ann Rheum Dis. 2020;79:39-52.[2]J Rheumatol. 2019;46(7):751-754[3]Hum Vaccin Immunother. 2013;9(8):1763-73.Disclosure of Interests:None declared

Download Full-text

POS0630 COMPARISON OF THE EFFICACY AND SAFETY OF ORIGINAL AND BIOSIMILAR ADALIMUMAB MOLECULES IN CHILDHOOD RHEUMATIC DISEASES

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.2979 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 553.1-553

Author(s):

K. Ulu ◽

F. Demir ◽

T. Coşkuner ◽

Ş. Çağlayan ◽

B. Sözeri

Keyword(s):

Adverse Events ◽

Disease Activity ◽

Rheumatic Diseases ◽

Behcet’S Disease ◽

Behçet's Disease ◽

Inactive Disease ◽

Efficacy And Safety ◽

Serious Adverse Events ◽

Significant Difference ◽

Abp 501

Background:The TNF-α inhibitor adalimumab is a biological disease modifying anti-rheumatic drug (bDMARD) that has been used in different rheumatic diseases with a resistant course. ABP-501 is a biosimilar product (BP) of adalimumab, recently approved by the FDA and EMA. To our knowledge, there is no study assess the efficacy and safety of these two molecules on pediatric patients.Objectives:We aimed to compare the efficacy and safety of the original and biosimilar adalimumab (ABP-501) molecules in childhood rheumatic diseases.Methods:This non-interventional, retrospective, single-centre analysis carried out in Umraniye Training and Resrach Hospital, Pediatric Rheumatology Clinic, Istanbul, Turkey. The study group consisted of patients who were followed due to chronic rheumatic disease between January 1, 2016 and June 1, 2020, and received reference or biosimilar adalimumab therapy for at least three months. Demographic and clinical data of patients were collected at baseline, 3rd, 6th, and 12th months of treatment. Disease activity assessment was made with JADAS-27 in JIA patients, with SUN criteria in uveitis patients, and with Behçet’s Disease Activity Index in BD patients. Efficacy and safety of treatments were compared between reference and biosimilar adalimumab groups.Results:A total of 89 patients (65 with original and 24 with biosimilar molecule) treated with adalimumab, were included in the study. There were 45 female and 44 male in the study, and the median age at the initiation of the adalimumab was 166 months (min-max: 36-231). Of the 89 patients evaluated, the primary diagnoses of 62 were juvenile idiopathic arthritis, 13 were idiopathic uveitis, eight were Behçet’s disease, three were Blau syndrome, two were chronic recurrent multifocal osteomyelitis and one was Vogt-Koyanagi-Harada syndrome. 63 of the patients were biologic-naïve, and 13 were switched from etanercept, 11 from infliximab, and two from other bDMARDs. The median exposure time of adalimumab was 16 months (min-max:3-70) in RP and 14.5 months (min-max: 3-23) in BP. All patients had active disease before treatment. In the group treated with RP, inactive disease was achieved in 60%, 76.6% and 87.2% of the patients at the 3rd, 6th and 12th months, respectively. Also, inactive disease was achieved in 62.5%, 78.2% and 78.2% of the patients at the 3rd, 6th and 12th months in the group treated with BP, respectively. There was no statistically significant difference in efficacy between the groups at the 3rd, 6th and 12th months (p=0.83, 0.07 and 0.32). Serious adverse events were seen in one patient in each groups (lymphoma in RP group, tuberculous meningitis in BP group). Non-serious adverse events were observed in eight patients (12.3%) in the RP group and in two patients (8.3%) in the BP group, without statistically significant difference between groups (p=0.86).Conclusion:No significant difference was observed between the biosimilar adalimumab ABP-501 and RP adalimumab in terms of efficacy and safety.References:[1]Renton, William D et al. Pediatr Rheumatol Online J. 2019;17(1):67.[2]Lovell DJ, Ruperto N, Goodman S, et al. N Engl J Med. 2008;359(8):810-820.[3]Kingsbury, Daniel J et al. Clin Rheumatol 2014;33(10):1433-41.Disclosure of Interests:None declared

Download Full-text

Efficacy and Safety of Bushenjiangya-Optimized Granule for Left Ventricular Diastolic Dysfunction in Hypertensive Patients: A Double-Blind, Randomized, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/7190352 ◽

2020 ◽

Vol 2020 ◽

pp. 1-6

Author(s):

Qun Gao ◽

Xiao-yun Cui ◽

Fei Dong ◽

Wen-ying Fan ◽

Pin-hui Li ◽

...

Keyword(s):

Adverse Events ◽

Diastolic Dysfunction ◽

Controlled Trial ◽

Left Ventricular Diastolic Dysfunction ◽

Left Ventricular ◽

Major Adverse Cardiovascular Events ◽

Efficacy And Safety ◽

Double Blind ◽

Effective Response ◽

Ventricular Diastolic Dysfunction

Objective. The study aimed to evaluate the efficacy and safety of Bushenjiangya-optimized (BSJYO) granule on left ventricular diastolic dysfunction (LVDD) in hypertensive (HTN) patients. Methods. 120 patients diagnosed with HTN plus LVDD were randomly assigned to the BSJYO granule group and placebo group, and all patients received basal western medicine (WM) treatment. After eight weeks of treatment, we evaluated echocardiography, traditional Chinese medicine (TCM) syndromes, 24-hour ambulatory blood pressure, liver and kidney functions, and adverse events. Major adverse cardiovascular events (MACEs) were collected at 6-month follow-up. Results. Compared with pretreatment, E/Ea (Doppler-derived index of filling pressure and worsening LVDD) significantly decreased significantly after 8 weeks of treatment in the BSJYO granule plus basal WM group (10.52 ± 1.87 vs. 9.49 ± 1.49, P<0.01), alongside reductions in significantly effective response (SER), effective response (ER), and total effective response (TER = SER + ER) in TCM symptom scores (21.59% vs. 71.70%, P<0.01). There were no differences between treatment groups in kidney and liver function, early adverse events, or MACE. Conclusion. BSJYO granule plus basal WM is an effective and safe therapy for HTN patients with LVDD.

Download Full-text

Sertraline in the treatment of panic disorder

The British Journal of Psychiatry ◽

10.1192/bjp.173.1.54 ◽

1998 ◽

Vol 173 (1) ◽

pp. 54-60 ◽

Cited By ~ 87

Author(s):

Peter D. Londborg ◽

Robert Wolkow ◽

Ward T. Smith ◽

Eugene Duboff ◽

Donald England ◽

...

Keyword(s):

Panic Disorder ◽

Adverse Events ◽

Drop Out ◽

Panic Attacks ◽

Efficacy And Safety ◽

Serious Adverse Events ◽

Double Blind ◽

Hamilton Anxiety Scale ◽

Higher Doses ◽

Clinical Global Impression Improvement

BackgroundThis study compared the efficacy and safety of sertraline to placebo in treating panic disorder.Method178 out-patients with panic disorder who exhibited at least four panic attacks during the four weeks prior to screening and three during the two weeks of lead-in were randomly assigned to 12 weeks of double-blind treatment with sertraline (50, 100 or 200 mg) or placebo.ResultsSertraline was superior to placebo in reducing the number of panic attacks, situational attacks, unexpected attacks, limited symptom attacks, and time spent worrying (all P < 0.01) and the Hamilton Anxiety Scale (P < 0.05), although Clinical Global Impression (Improvement) did not significantly differentiate groups at 12 weeks and at end-point. No serious adverse events were associated with sertraline. No dose relationship was found for adverse events; overall drop-out rates were not different for sertraline or placebo, although more sertraline-treated subjects discontinued for adverse events, typically early in the study. Only dry mouth and ejaculation failure (primarily ejaculation delay) were associated significantly with sertraline. Conclusions Sertraline was effective and safe in reducing panic attacks. Higher doses were no more effective than the 50 mg dose.

Download Full-text

Analgesic Efficacy and Safety Comparison of Ketorolac Tromethamine and Doleron for the Alleviation of Orthopaedic Post-Operative Pain

Journal of International Medical Research ◽

10.1177/030006058901700404 ◽

1989 ◽

Vol 17 (4) ◽

pp. 324-332 ◽

Cited By ~ 10

Author(s):

S. Johansson ◽

G. Josefsson ◽

J. Malstam ◽

A. Lindstrand ◽

A. Stenstroem

Keyword(s):

Treatment Group ◽

Adverse Events ◽

Oral Dose ◽

Single Oral Dose ◽

Analgesic Efficacy ◽

Ketorolac Tromethamine ◽

Efficacy And Safety ◽

Double Blind ◽

Post Operative Pain ◽

Parallel Group

The analgesic efficacy and safety of ketorolac tromethamine (ketorolac), a potent analgesic with anti-inflammatory and antipyretic activities, were evaluated and compared with Doleron, a combination analgesic, in 115 patients with moderate to severe orthopaedic post-operative pain. This was a randomized, double-blind (double-dummy), parallel-group comparison of a single oral dose of one capsule of 10 mg ketorolac with a single oral dose of two Doleron tablets (each tablet contained 150 mg dextropropoxyphene napsylate, 350 mg aspirin and 150 mg phenazone). During the 6 h following treatment, 80% of ketorolac treated patients and 82% of Doleron treated patients experienced adequate pain relief. There were no statistically significant differences in the overall analgesic efficacy between the treatment groups. Three patients (one on ketorolac, two on Doleron) withdrew because of adverse events (vomiting). Nausea (two patients in each treatment group), vertigo (none on ketorolac, three on Doleron) and sore throat (none on ketorolac, two on Doleron) were the only drug-related adverse events reported by more than one person in a treatment group during the trial. A total of 82% of patients given ketorolac and 76% given Doleron experienced no adverse events. A single oral dose of 10 mg ketorolac was shown to be as effective and safe as two Doleron tablets in the treatment of moderate to severe orthopaedic post-operative pain.

Download Full-text

170 Efficacy and Safety of Dasotraline in Adults with Binge-Eating Disorder: A Randomized, Double-blind, Fixed-dose Trial

CNS Spectrums ◽

10.1017/s1092852920000863 ◽

2020 ◽

Vol 25 (2) ◽

pp. 308-309

Author(s):

Joyce Tsai ◽

Brad Navia ◽

Susan L McElroy ◽

James I Hudson ◽

Carlos M. Grilo ◽

...

Keyword(s):

Eating Disorder ◽

Adverse Events ◽

Binge Eating ◽

Binge Eating Disorder ◽

Dry Mouth ◽

Fixed Dose ◽

Type I ◽

Efficacy And Safety ◽

Double Blind ◽

Dose Study

Abstract:Background:Dasotraline is a long-acting dopamine/norepinephrine reuptake inhibitor with a PK profile characterized by slow absorption and a t½ of 47-77 hours, permitting once-daily dosing. In a previous flexible dose study, dasotraline demonstrated significant efficacy in the treatment of binge-eating disorder (BED). The aim of this confirmatory fixed-dose study was to evaluate efficacy and safety of dasotraline in the treatment of patients with BED.Methods:Patients meeting DSM-5 criteria for BED were randomized to 12 weeks of double-blind treatment with dasotraline (4 mg/d or 6 mg/d), or placebo. The primary efficacy endpoint was change in number of binge-eating days per week at week 12. Secondary efficacy endpoints included changes at Week 12 on the Binge Eating Clinical Global Impression of Severity Scale (BE-CGI-S), the Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE), and the proportion of patients with 100% cessation of binge-eating episodes during the final 4 weeks of treatment. Efficacy was assessed using an MMRM analysis (and a logistic regression model for cessation) with a pre-specified sequential testing procedure used to control overall type I error rate.Results:A total of 486 were in the ITT population (dasotraline 6 mg/d (N=162), 4 mg/d (N=161), or placebo (N=163). At week 12, treatment with dasotraline was associated with significant reduction in number of binge-eating days per week in the 6 mg/d group vs. placebo (-3.5 vs. -2.9; P=0.0045), but non-significant improvement in the 4 mg/d group vs. placebo (-3.2; P=0.12). Greater improvement was observed vs. placebo for dasotraline 6 mg/d and 4 mg/d, respectively, on the BE-CGI-S (P<0.01 and P<0.03) and the Y-BOC-BE (P<0.001 and P<0.02; all P-values were nominal, not adjusted for multiplicity). The proportion of patients who achieved 4-week cessation of binge-eating episodes was only significant for the dasotraline 6 mg in the completer population (P<0.05; post-hoc analysis) but was not significant for either dose of dasotraline vs. placebo when drop-outs were included in the analysis. The most common adverse events on dasotraline 6 mg/d and 4 mg/d were combined insomnia (early, middle, late), dry mouth, headache, decreased appetite, nausea, and anxiety. Changes in systolic and diastolic blood pressure were minimal. Mean baseline to endpoint changes in supine pulse rate on dasotraline 6 mg/d and 4 mg/d vs. placebo was +6.2 bpm and +4.8 vs. +0.2 bpm.Conclusions:In this 12-week, placebo-controlled, fixed-dose study, treatment with dasotraline 6 mg/d was associated with a significant reduction in frequency of binge-eating days per week; efficacy was not demonstrated for the 4 mg dose. Treatment with both doses of dasotraline resulted in improvement in the Y-BOCS-BE and the BE-CGI-S. Dasotraline was safe and generally well-tolerated at both doses; most common adverse events were insomnia, dry mouth and headache.Clinicaltrials.gov: NCT03107026Funding Acknowledgements:Supported by funding from Sunovion Pharmaceuticals Inc.

Download Full-text

167 Randomized, Double-Blind, Active-Controlled Study of Starting Aripiprazole Lauroxil with 1-Day Initiation in Acutely Ill Patients with Schizophrenia

CNS Spectrums ◽

10.1017/s1092852920000838 ◽

2020 ◽

Vol 25 (2) ◽

pp. 306-307

Author(s):

Peter J. Weiden ◽

Amy Claxton ◽

Yangchun Du ◽

Sergey Yagoda ◽

David Walling ◽

...

Keyword(s):

Adverse Events ◽

Outpatient Setting ◽

Controlled Study ◽

Injection Site Pain ◽

Efficacy And Safety ◽

Double Blind ◽

Secondary Analyses ◽

Site Pain ◽

Over Time ◽

Funding Acknowledgements

Abstract:Objective:Evaluate efficacy and safety of a 2-month dose of aripiprazole lauroxil (AL) with a 1-day initiation regimen during hospitalization for an acute exacerbation of schizophrenia.Methods:In the phase 3b double-blind ALPINE study, adults with schizophrenia were randomized to AL (AL NanoCrystal® Dispersion + oral aripiprazole 30 mg day 1; AL 1064 mg day 8 and every 8 weeks) or paliperidone palmitate (PP 234 mg day 1; PP 156 mg day 8 and every 4 weeks). Patients were discharged after 2 weeks of hospitalization and followed through week 25. Primary endpoint was within-group changes in PANSS total score from baseline to week 4 (observed cases). Secondary analyses included within-group changes at weeks 9 and 25 (observed) and between-group comparisons at weeks 4, 9, and 25 (MMRM). Adverse events (AEs) were monitored throughout the study.Results:200 patients were randomized (AL, n=99; PP, n=101); 56.6% and 42.6%, respectively, completed the study. Within-group changes from baseline in PANSS were −17.4 for AL and −20.1 for PP at week 4 (both groups, P<0.001) and continued to decline at weeks 9 (AL, −19.8; PP, −22.5) and 25 (AL, −23.3; PP, −21.7). The change in PANSS over time was similar between groups. AEs occurring in ≥10% of patients in either group were injection site pain (AL, 17.2%; PP, 24.8%), akathisia (AL, 9.1%; PP, 10.9%), and weight increased (AL, 9.1%; PP, 16.8%).Conclusions:AL and PP were effective and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing in the outpatient setting.Funding Acknowledgements:This study was funded by Alkermes, Inc.

Download Full-text

An Integrated Efficacy and Safety Analysis of Single-Dose Secnidazole 2 g in the Treatment of Bacterial Vaginosis

Reproductive Sciences ◽

10.1007/s43032-019-00048-x ◽

2020 ◽

Vol 27 (2) ◽

pp. 523-528

Author(s):

Helen Pentikis ◽

Nikki Adetoro ◽

Diane Tipping ◽

Sharon Levy

Keyword(s):

Single Dose ◽

Bacterial Vaginosis ◽

Integrated Analysis ◽

Adult Women ◽

Efficacy And Safety ◽

Double Blind ◽

Study Visit ◽

Pivotal Study ◽

The Us ◽

Dose Oral

AbstractBacterial vaginosis (BV) is the most common gynecologic infection in women aged 14 to 49 years. Currently recommended treatments require extended dosing and are thus associated with poor adherence. A single-dose oral granule formulation of secnidazole 2 g (SOLOSEC™ [secnidazole], Symbiomix Therapeutics, a Lupin company, Baltimore, MD), a 5-nitroimidazole antibiotic with antimicrobial activity, has been approved by the US Food and Drug Administration for the treatment of BV in adult women. As part of the US registration package, two randomized, double-blind, placebo-controlled clinical studies were conducted to confirm the efficacy and safety of a novel single-dose oral formulation of secnidazole 2 g. This is an integrated analysis of efficacy and safety results from these studies, pivotal study 1 and pivotal study 2. By combining the results of the two studies, relevant information is presented especially when considering the effect of secnidazole on patients with recurrent episodes of BV and the difference in effect on patients of black race. Single-dose secnidazole 2 g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21–30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.

Download Full-text

Duloxetine in the Treatment of Stress Urinary Incontinence

Women s Health ◽

10.2217/17455057.1.3.345 ◽

2005 ◽

Vol 1 (3) ◽

pp. 345-358 ◽

Cited By ~ 6

Author(s):

Martin C Michel ◽

Matthias Oelke

Keyword(s):

Urinary Incontinence ◽

Stress Urinary Incontinence ◽

Adverse Events ◽

Striated Muscle ◽

Bladder Capacity ◽

Efficacy And Safety ◽

Cytochrome P450 1A2 ◽

Serious Adverse Events ◽

Double Blind ◽

Urethral Striated Muscle

This manuscript reviews the pharmacodynamics and pharmacokinetics of duloxetine and its efficacy and safety in women with stress urinary incontinence. Duloxetine is a selective inhibitor of neuronal serotonin and norepinephrine uptake which increases urethral striated muscle activity and bladder capacity. Duloxetine is readily absorbed and extensively metabolized; cytochrome P450 1A2 (CYP1A2) inhibiting drugs can markedly increase duloxetine exposure. The clinical efficacy of duloxetine has consistently been demonstrated in several randomized, double-blind studies in women with moderate-to-severe stress urinary incontinence, but the additional benefit relative to placebo was moderate. Duloxetine treatment is frequently associated with adverse events such as nausea, dry mouth, fatigue, insomnia and constipation, but serious adverse events are rare. Therefore, duloxetine appears suitable for the treatment of stress urinary incontinence.

Download Full-text

P.027 Efficacy and Safety of Eptinezumab Initiated During a Migraine Attack: Results from the RELIEF Study

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques ◽

10.1017/cjn.2021.309 ◽

2021 ◽

Vol 48 (s3) ◽

pp. S27-S28

Author(s):

PK Winner ◽

P McAllister ◽

G Chakhava ◽

J Ailani ◽

L Mehta ◽

...

Keyword(s):

Adverse Events ◽

Migraine Attack ◽

Rapid Onset ◽

Migraine Treatment ◽

Efficacy And Safety ◽

Serious Adverse Events ◽

Double Blind ◽

Bothersome Symptom ◽

Post Infusion ◽

Headache Pain

Background: Eptinezumab is approved for migraine prevention, with demonstrated rapid onset of preventive benefit. RELIEF evaluated the efficacy and safety of eptinezumab initiated during a migraine attack. Methods: RELIEF (NCT04152083; parallel-group, double-blind, placebo-controlled) randomized adults with migraine (4-15d/mo in 3mo prior to screening) to eptinezumab 100mg or placebo, administered IV within 1-6h of qualifying migraine onset. Co-primary efficacy endpoints were time to headache pain freedom and time to absence of most bothersome symptom (MBS). Results: Eptinezumab (n=238) compared with placebo (n=242) achieved significantly faster headache pain freedom (median 4h vs 9h; hazard ratio=1.54, P=0.0006) and absence of MBS (2h vs 3h; 1.75, P<0.0001). At 2h, 23.5% and 12.0% (P=0.0009) of eptinezumab-treated and placebo patients, respectively, reported headache pain freedom, and 55.5% and 35.8% (P<0.0001) reported absence of MBS. Significantly fewer eptinezumab-treated patients used rescue medication within 24h (31.5% vs 59.9%; P<0.0001). Treatment-emergent adverse events occurred in 10.9% eptinezumab-treated and 10.3% placebo patients; no serious adverse events occurred. Conclusions: Infusion of the preventive migraine treatment, eptinezumab, during a migraine resulted in rapid and sustained freedom from headache pain and MBS vs placebo, starting 2h post-infusion, decreasing need for acute medication within 24h post-infusion. No notable safety findings were identified.

Download Full-text