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Study · Randomized controlled trial · n = 23 · 2017

7 results

Adrenocorticotropic hormone versus methylprednisolone added to interferon β in patients with multiple sclerosis experiencing breakthrough disease: a randomized, rater-blinded trial.

Berkovich R, Bakshi R, Amezcua L, Axtell RC, Cen SY, Tauhid S, Neema M, Steinman L

Therapeutic advances in neurological disorders19 Oct 2016Cited by 11 (Europe PMC)

PMID28450891 (opens in a new tab)PMCIDPMC5400152 (opens in a new tab)DOI10.1177/1756285616670060 (opens in a new tab)PepBankPUB-28450891
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In breakthrough multiple sclerosis, ACTH gel relapse rate was 0.08 versus 0.80 with IVMP (IVMP/ACTH rate ratio 9.56, 95% CI 1.23-74.6; p = 0.03).

    In plain wordsIn breakthrough multiple sclerosis, ACTH gel reduced relapse rate compared with IV methylprednisolone on shared interferon treatment.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseRelapse rate
    Study

    n = 23

    Comparator
    Intravenous methylprednisolone added to interferon β
    Analysis
    Primary
    Outcome group
    Multiple sclerosis outcomes · Nervous system and cognition
    Studied dose
    Dose not stated · intramuscular · 15 monthsAs given in this study (human).

    Measurements

    Relapse rate
    0.08 rate
    ACTH gel; 95% CI 0.01-0.54
    Relapse rate
    0.8 rate
    IVMP; 95% CI 0.36-1.75
    Rate ratio
    9.56 ratio
    IVMP versus ACTH; 95% CI 1.23-74.6; p = 0.03

    Source sentences

    Summary
    Relapse rates differed significantly [ACTH 0.08, 95% confidence interval (CI) 0.01-0.54 versus IVMP 0.80, 95% CI 0.36-1.75; rate ratio, IVMP versus ACTH: 9.56, 95% CI 1.23-74.6; p = 0.03].
    3 context sentences
    Summary · context
    The objective of this study was to evaluate monthly intramuscular adrenocorticotropic hormone (ACTH) gel versus intravenous methylprednisolone (IVMP) add-on therapy to interferon β for breakthrough disease in patients with relapsing forms of multiple sclerosis.
    Summary · context
    This was a prospective, open-label, examiner-blinded, 15-month pilot study evaluating patients with Expanded Disability Status Scale (EDSS) score 3.0-6.5 and at least one clinical relapse or new T2 or gadolinium-enhanced lesion in the previous year.
    Summary · context
    Twenty-three patients were randomized to ACTH (n = 12) or IVMP (n = 11) and completed the study.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In breakthrough multiple sclerosis, ACTH gel improved Mental Health Inventory scores, with slope 0.95 ± 0.38 points/month versus -0.38 ± 0.43 with IVMP.

    In plain wordsIn breakthrough multiple sclerosis, ACTH gel improved mental health scores compared with IV methylprednisolone.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseMental Health Inventory
    Study

    n = 23

    Comparator
    Intravenous methylprednisolone added to interferon β
    Analysis
    Secondary
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    Dose not stated · intramuscular · 15 monthsAs given in this study (human).

    Measurements

    MHI slope
    0.95 points/month
    ACTH; ±0.38; p = 0.02
    MHI slope
    −0.38 points/month
    IVMP; ±0.43; p = 0.39
    MHI comparison p value
    0.03 p value
    ACTH versus IVMP

    Source sentences

    Summary
    ACTH improved (p = 0.03) MHI (slope 0.95 ± 0.38 points/month; p = 0.02 versus slope -0.38 ± 0.43 points/month; p = 0.39).
    3 context sentences
    Summary · context
    The objective of this study was to evaluate monthly intramuscular adrenocorticotropic hormone (ACTH) gel versus intravenous methylprednisolone (IVMP) add-on therapy to interferon β for breakthrough disease in patients with relapsing forms of multiple sclerosis.
    Summary · context
    This was a prospective, open-label, examiner-blinded, 15-month pilot study evaluating patients with Expanded Disability Status Scale (EDSS) score 3.0-6.5 and at least one clinical relapse or new T2 or gadolinium-enhanced lesion in the previous year.
    Summary · context
    Twenty-three patients were randomized to ACTH (n = 12) or IVMP (n = 11) and completed the study.
  3. 03HumanRandomized controlled trialSafety outcome

    In breakthrough multiple sclerosis, psychiatric symptoms per patient were 0 with ACTH gel versus 0.55 with IVMP (p < 0.0001).

    In plain wordsIn breakthrough multiple sclerosis, psychiatric symptoms were less frequent with ACTH gel than with IV methylprednisolone.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreasePsychiatric symptoms per patient
    Study

    n = 23

    Comparator
    Intravenous methylprednisolone added to interferon β
    Analysis
    Secondary
    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    Dose not stated · intramuscular · 15 monthsAs given in this study (human).

    Measurements

    Psychiatric symptoms per patient
    0 symptoms per patient
    ACTH gel
    Psychiatric symptoms per patient
    0.55 symptoms per patient
    IVMP; 95% CI 0.12-2.6
    P value
    < 0.0001
    psychiatric symptoms IVMP versus ACTH

    Source sentences

    Summary
    Psychiatric symptoms per patient were greater with IVMP than ACTH (0.55, 95% CI 0.12-2.6 versus 0; p < 0.0001).
    3 context sentences
    Summary · context
    The objective of this study was to evaluate monthly intramuscular adrenocorticotropic hormone (ACTH) gel versus intravenous methylprednisolone (IVMP) add-on therapy to interferon β for breakthrough disease in patients with relapsing forms of multiple sclerosis.
    Summary · context
    This was a prospective, open-label, examiner-blinded, 15-month pilot study evaluating patients with Expanded Disability Status Scale (EDSS) score 3.0-6.5 and at least one clinical relapse or new T2 or gadolinium-enhanced lesion in the previous year.
    Summary · context
    Twenty-three patients were randomized to ACTH (n = 12) or IVMP (n = 11) and completed the study.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In breakthrough multiple sclerosis, EDSS, MSFC, MS-QOL, BMD, and MRI lesion changes did not differ significantly between ACTH gel and IVMP.

    In plain wordsIn multiple sclerosis, disability, function, quality of life, bone density, and MRI changes did not differ significantly between ACTH gel and IVMP.

    Peptide
    ACTH (corticotropin)
    Outcome
    No significant changeDisability, function, quality of life, bone density and MRI changes
    Study

    n = 23

    Comparator
    Intravenous methylprednisolone added to interferon β
    Outcome group
    Multiple sclerosis outcomes · Nervous system and cognition
    Studied dose
    Dose not stated · intramuscular · 15 monthsAs given in this study (human).

    Source sentences

    Summary
    However, on-study EDSS, MSFC, MS-QOL, BMD, and MRI lesion changes were not significant between groups.
    3 context sentences
    Summary · context
    The objective of this study was to evaluate monthly intramuscular adrenocorticotropic hormone (ACTH) gel versus intravenous methylprednisolone (IVMP) add-on therapy to interferon β for breakthrough disease in patients with relapsing forms of multiple sclerosis.
    Summary · context
    This was a prospective, open-label, examiner-blinded, 15-month pilot study evaluating patients with Expanded Disability Status Scale (EDSS) score 3.0-6.5 and at least one clinical relapse or new T2 or gadolinium-enhanced lesion in the previous year.
    Summary · context
    Twenty-three patients were randomized to ACTH (n = 12) or IVMP (n = 11) and completed the study.
  5. 05HumanNon-randomized trialEfficacy outcome

    In breakthrough multiple sclerosis, eight cytokine levels decreased during treatment only in the ACTH gel group (all p < 0.05).

    In plain wordsIn breakthrough multiple sclerosis, eight cytokine levels decreased only in the ACTH gel group.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseEight cytokine levels
    Study

    n = 12

    Analysis
    Secondary
    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    Dose not stated · intramuscular · 15 monthsAs given in this study (human).

    Measurements

    Cytokine levels decreased
    8 cytokines
    ACTH group only, all p < 0.05

    Source sentences

    Summary
    On-study decreases (all p < 0.05) in eight cytokine levels occurred only in the ACTH group.
    3 context sentences
    Summary · context
    The objective of this study was to evaluate monthly intramuscular adrenocorticotropic hormone (ACTH) gel versus intravenous methylprednisolone (IVMP) add-on therapy to interferon β for breakthrough disease in patients with relapsing forms of multiple sclerosis.
    Summary · context
    This was a prospective, open-label, examiner-blinded, 15-month pilot study evaluating patients with Expanded Disability Status Scale (EDSS) score 3.0-6.5 and at least one clinical relapse or new T2 or gadolinium-enhanced lesion in the previous year.
    Summary · context
    Twenty-three patients were randomized to ACTH (n = 12) or IVMP (n = 11) and completed the study.
  6. 06HumanNon-randomized trialSafety outcome

    In breakthrough multiple sclerosis, the ACTH gel group had five fatigue adverse events.

    In plain wordsIn breakthrough multiple sclerosis, the ACTH gel group had five fatigue events.

    Peptide
    ACTH (corticotropin)
    Outcome
    Not applicableFatigue adverse events
    Study

    n = 12

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · intramuscular · 15 monthsAs given in this study (human).

    Measurements

    Fatigue adverse events
    5 events
    ACTH group

    Source sentences

    Summary
    Other common adverse events were insomnia and urinary tract infections (IVMP, seven events each) and fatigue or flu symptoms (ACTH, five events each).
    3 context sentences
    Summary · context
    The objective of this study was to evaluate monthly intramuscular adrenocorticotropic hormone (ACTH) gel versus intravenous methylprednisolone (IVMP) add-on therapy to interferon β for breakthrough disease in patients with relapsing forms of multiple sclerosis.
    Summary · context
    This was a prospective, open-label, examiner-blinded, 15-month pilot study evaluating patients with Expanded Disability Status Scale (EDSS) score 3.0-6.5 and at least one clinical relapse or new T2 or gadolinium-enhanced lesion in the previous year.
    Summary · context
    Twenty-three patients were randomized to ACTH (n = 12) or IVMP (n = 11) and completed the study.
  7. 07HumanNon-randomized trialSafety outcome

    In breakthrough multiple sclerosis, the ACTH gel group had five flu symptom adverse events.

    In plain wordsIn breakthrough multiple sclerosis, the ACTH gel group had five flu symptom events.

    Peptide
    ACTH (corticotropin)
    Outcome
    Not applicableFlu symptoms adverse events
    Study

    n = 12

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · intramuscular · 15 monthsAs given in this study (human).

    Measurements

    Flu symptom adverse events
    5 events
    ACTH group

    Source sentences

    Summary
    Other common adverse events were insomnia and urinary tract infections (IVMP, seven events each) and fatigue or flu symptoms (ACTH, five events each).
    3 context sentences
    Summary · context
    The objective of this study was to evaluate monthly intramuscular adrenocorticotropic hormone (ACTH) gel versus intravenous methylprednisolone (IVMP) add-on therapy to interferon β for breakthrough disease in patients with relapsing forms of multiple sclerosis.
    Summary · context
    This was a prospective, open-label, examiner-blinded, 15-month pilot study evaluating patients with Expanded Disability Status Scale (EDSS) score 3.0-6.5 and at least one clinical relapse or new T2 or gadolinium-enhanced lesion in the previous year.
    Summary · context
    Twenty-three patients were randomized to ACTH (n = 12) or IVMP (n = 11) and completed the study.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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