Cooperative study in the evaluation of therapy in multiple sclerosis

Rose, Augustus S.; Kuzma, Jan W.; Jf, Kurtzke; Namerow, Norman S.; Sibley, W. A.; Tourtellotte, W. W.

doi:10.1212/wnl.20.5_part_2.1

Cited by 175 publications

(18 citation statements)

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“…The National Cooperative Clinical Trial45–47 assessed therapeutic response to a 2-week course of RCI IM (vs placebo) in treating 197 relapse-remitting patients with acute MS relapses; no relapse definition was provided. In the RCI group, a consistently larger proportion of patients showed improvement (≥1-unit change DSS) at 1, 2, 3, and 4 weeks after initiation of treatment with RCI versus placebo (RCI: 38%, 57%, 61%, and 65%; placebo: 26%, 38%, 49%, and 48%, respectively).…”

Section: Resultsmentioning

confidence: 99%

“…No statistical differences were observed between groups. IVIG vs placebo, with IVMP add-on TARIMS Study (2004)41N=76Mean age, years: IVIG, 35.3; placebo, 35.2 ( P =0.99)Germany, Denmark, Sweden Intervention IVIG followed by IVMP 24 hrs later (n=36) vs placebo followed by IVMP 24 hrs later (n=40) Treatment duration NRPatients with ≥1 AE, n (%): IVIG, 26 (72); placebo, 30 (75)No patients discontinued because of AEsNROverall, the treatment was well tolerated.Visser et al (2004)42N=19Mean age, years: IVMP followed by IVIG, 37.5; IVMP, 38.1The Netherlands Intervention IVMP followed by IVIG (n=10) vs IVMP followed by placebo (n=9) Treatment duration 5 daysAEs NRNo SAEs occurredNRNo SAEs occurred. However, there was not enough information on safety assessment to conclude whether the treatments were well tolerated. RCI National Cooperative Clinical TrialHenderson et al (1978)45Rose et al (1969)46Rose et al, 197047N=197Age: NRUS Intervention RCI IM (n=103) vsPlacebo (n=94) Treatment duration: 14 daysRCI: 44% (53% females, 28% males) with AEsPlacebo: 9% with AEs ( P ≤0.05)No SAE in either group RCI Acne: 30.9%Hirsutism: 6.8%Moon face: 6.8%Weight gain: 4.9%Impaired glucose tolerance: 4.9%Peptic ulcer or GI bleeding: 1.0%Severe depression: 1.0%Striae of subcutaneous tissue: 0 Placebo Acne: 2.1%Hirsutism: 1.1%Peptic ulcer or GI bleeding: 3.2%Severe depression: 1.1%Striae of subcutaneous tissue: 1.1%No SAEs in either group; AEs present in 44% of patients on RCI, significantly more than the 9% of those on placebo, of which the most common was acne 46Simsarian et al (2011)48N=20Age: 39.5US Intervention RCI SC (n=10) vs RCI IM (n=10) Treatment duration: 5 daysSevere AE SC (n=1): 10%Severe AE IM (n=1): 10%No SAEs in either groupNRInjections were well tolerated in both groups, with an equivalent proportion of patients affected by severe AEs in each group Abbreviations: AE, adverse event; COPOUSEP, Corticothérapie Orale dans les Poussées de Sclérose en Plaques; EPO, erythropoietin; IA, immunoadsorption; IM, intramuscular; IV, intravenous; IVIG, intravenous immunoglobulin; IVMP, intravenous methylprednisolone; NR, not reported; OMP, oral methylprednisolone; OPT, oral prednisone taper; PMP, plasmapheresis; RCI, repository corticotropin injection; SAE, serious adverse event; tx, treatment; US, United States.…”

Section: Resultsmentioning

confidence: 99%

“…Occurrence of severe AEs in the RCI studies was limited, and no SAE occurred. The most common AE was acne; however, incidence of this or other common AEs was not reported 47. None of the RCI studies reported QOL information.…”

Section: Discussionmentioning

confidence: 99%

“…There are limited data available on the duration, dosing, and route of administration of ACTH gel in the treatment of acute exacerbations of multiple sclerosis 48. Data from a large US RCT suggested the efficacy of RCI gel administered IM over 15 days increased versus baseline (as measured by proportion of patients improved in DSS scores) 45–47. Results from a pilot RCT of 20 patients conducted in the US suggested that a shorter 5-day course of self-administered RCI given either IM or SC resulted in improvement in EDSS scores versus baseline 48.…”

Section: Discussionmentioning

confidence: 99%

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<p>Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials</p>

Costello¹,

Njue²,

Lyall³

et al. 2019

DNND

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Background Intravenous methylprednisolone (IVMP), repository corticotropin injection (RCI), plasmapheresis (PMP), and intravenous immunoglobulin (IVIG) are used in the treatment of acute multiple sclerosis (MS) relapse. A systematic literature review (SLR) of randomized controlled trials (RCTs) was conducted to examine the highest quality evidence available for these therapies. Methods English-language articles were searched in MEDLINE, Embase, and Cochrane Library through May 2016 per Preferred Reporting Items for Systematic Reviews and Meta-Analyses standards. MS conferences, SLRs, and bibliographies of included studies were also searched. Eligible studies included adults treated with ≥1 aforementioned therapy. Results Twenty-three RCTs were identified: 22 on efficacy, 11 on safety, and 3 on QOL (ie 18 IVMP, 2 RCI, 2 PMP, and 2 IVIG). IVMP and RCI improved relapse-related disability; however, IVIG and PMP showed inconsistent efficacy. QOL data were only ascertained for IVMP. Conclusions RCTs indicate IVMP and RCI are efficacious and well tolerated treatments for MS relapse. Overall, many RCTs were dated, with sample sizes of fewer than 30 patients and no definitions for relapse nor clinically significant change. Contemporary evidence generation for all relapse treatments of interest, across efficacy, safety, and QOL outcomes, is still needed.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

<p>Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials</p>

Costello¹,

Njue²,

Lyall³

et al. 2019

DNND

View full text Add to dashboard Cite

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“…Numerous studies have demonstrated that RCI treatment increases recovery rates and improves disability scores in patients experiencing acute MS relapse exacerbations [15][16][17][18][19][20]. Other studies assessing the economic benefits of RCI have found that RCI treatment for MS relapse is associated with fewer hospitalizations and outpatient service visits as well as lower costs in inpatient and outpatient services when compared to alternative second-line treatments [21,22].…”

Section: Introductionmentioning

confidence: 99%

Consequences of Insurance Denials Among U.S. Patients Prescribed Repository Corticotropin Injection for Acute Exacerbations of Multiple Sclerosis

et al. 2020

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Introduction Repository corticotropin injection (RCI; Acthar ® Gel) is indicated for the treatment of acute exacerbations of multiple sclerosis (MS) in adults. Despite the well-documented clinical and economic benefits of RCI, many patients are denied use of the therapy by third-party payers. This study aims to understand the demographic and clinical characteristics of MS relapse patients who received a prescription for RCI from their physicians and then were either approved or denied treatment by their insurers. The study compares measurable clinical outcomes and healthcare resource utilization (HCRU) between approved and denied cohorts. Methods A retrospective analysis of adults experiencing MS relapse from January 2015 to December 2018 was conducted using a de-identified open-source claims database [Symphony Health Integrated Dataverse ® (IDV)]. Patients were identified using ICD codes for MS and considered to have relapsing/remitting type according to established claims-based methodology. Clinical characteristics and HCRU were analyzed during the year preceding (“baseline”) and the year following (“follow-up”) each patient’s index date, defined as the date of a patient’s first approved RCI claim (for patients with ≥ 1 approved claim) or first denied RCI claim (for patients with only denied claims). Baseline characteristics were reported with unadjusted differences and p values indicating the significance of characteristics between the two cohorts. For outcomes, match-adjusted results were reported using propensity matching to account for underlying differences between cohorts. Results The study sample included 1902 MS relapse patients with at least one claim for RCI. At baseline, approved patients were slightly older compared to denied patients (mean age 48.0 vs. 47.2), had higher rates of hemiplegia/paraplegia (6.7% vs. 3.3%), greater mobility impairment (17% vs. 11.5%), more exacerbation episodes (66.2% vs. 59.9%), and a higher number of physical therapy/rehab claims (23.5 vs. 14.0), respectively. Outcomes among the matched sample show an increased use of corticosteroids for patients denied access to RCI compared to approved patients (51.1% vs. 42.4%), more exacerbation episodes (36.6% vs. 28.2%), and an increased number of physical therapy/rehab claims (11.5% vs. 9.9%), respectively. Conclusion The results of this study may aid providers and payers in evaluating scenarios where RCI may be beneficial and improve quality of care for patients experiencing MS relapse.

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