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Study · Observational study · n = 117 · 2020

9 results

Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice.

Wensink D, Wagenmakers MAEM, Barman-Aksözen J, Friesema ECH, Wilson JHP, van Rosmalen J, Langendonk JG

JAMA dermatology1 May 2020Cited by 38 (Europe PMC)

PMID32186677 (opens in a new tab)PMCIDPMC7081144 (opens in a new tab)DOI10.1001/jamadermatol.2020.0352 (opens in a new tab)PepBankPUB-32186677
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanObservational studyEfficacy outcome

    In patients with erythropoietic protoporphyria, afamelanotide was associated with a significant increase in time spent outside of 6.1 hours per week versus baseline.

    In plain wordsIn people with erythropoietic protoporphyria, time spent outside rose by 6.1 hours per week compared with before afamelanotide.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    IncreaseTime spent outside during treatment
    Study

    n = 117

    Comparator
    Baseline
    Outcome group
    Exercise and physical function · Skin and wound
    Studied dose
    Dose not stated

    Measurements

    Increase in time spent outside
    6.1 hours per week
    versus baseline

    Source sentences

    Summary
    Compared with baseline, mean time spent outside during treatment increased significantly by an added 6.1 hours per week (95% CI, 3.62-8.67; P < .001).
    2 context sentences
    Summary · context
    This single-center, prospective postauthorization safety and efficacy cohort study was directed and approved by the European Medicines Agency.
    Summary · context
    A total of 117 patients with EPP (59 women [50.4%]; mean [SD] age, 43.0 [15.5] years) were treated with afamelanotide.
  2. 02HumanObservational studyEfficacy outcome

    In patients with erythropoietic protoporphyria, afamelanotide was associated with a significant improvement of 14.01% in mean quality of life score versus baseline.

    In plain wordsIn people with erythropoietic protoporphyria, quality of life scores improved by 14.01% compared with before afamelanotide.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    IncreaseDisease-specific quality of life score
    Study

    n = 117

    Comparator
    Baseline
    Outcome group
    Exercise and physical function · Skin and wound
    Studied dose
    Dose not stated

    Measurements

    Improvement in quality of life score
    14.01%
    versus baseline

    Source sentences

    Summary
    Mean quality of life score improved significantly by 14.01% (95% CI, 4.53%-23.50%; P < .001).
    2 context sentences
    Summary · context
    This single-center, prospective postauthorization safety and efficacy cohort study was directed and approved by the European Medicines Agency.
    Summary · context
    A total of 117 patients with EPP (59 women [50.4%]; mean [SD] age, 43.0 [15.5] years) were treated with afamelanotide.
  3. 03HumanObservational studyEfficacy outcome

    In patients with erythropoietic protoporphyria, phototoxic reactions were less painful during afamelanotide treatment.

    In plain wordsIn people with erythropoietic protoporphyria, reactions to light were less painful during afamelanotide treatment.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    DecreasePain of phototoxic reactions
    Study

    n = 117

    Comparator
    Baseline
    Outcome group
    Pain · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Phototoxic reactions were less painful (β, -0.85; 95% CI, -1.43 to -0.26; P < .001)
    2 context sentences
    Summary · context
    This single-center, prospective postauthorization safety and efficacy cohort study was directed and approved by the European Medicines Agency.
    Summary · context
    A total of 117 patients with EPP (59 women [50.4%]; mean [SD] age, 43.0 [15.5] years) were treated with afamelanotide.
  4. 04HumanObservational studyEfficacy outcome

    In patients with erythropoietic protoporphyria, there was no significant difference in the number of phototoxic reactions during afamelanotide treatment.

    In plain wordsIn people with erythropoietic protoporphyria, the number of light reactions did not change significantly during afamelanotide treatment.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    No significant changeNumber of phototoxic reactions
    Study

    n = 117

    Comparator
    Baseline
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    but there was no significant difference in number or duration of reactions.
    2 context sentences
    Summary · context
    This single-center, prospective postauthorization safety and efficacy cohort study was directed and approved by the European Medicines Agency.
    Summary · context
    A total of 117 patients with EPP (59 women [50.4%]; mean [SD] age, 43.0 [15.5] years) were treated with afamelanotide.
  5. 05HumanObservational studyEfficacy outcome

    In patients with erythropoietic protoporphyria, there was no significant difference in the duration of phototoxic reactions during afamelanotide treatment.

    In plain wordsIn people with erythropoietic protoporphyria, the length of light reactions did not change significantly during afamelanotide treatment.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    No significant changeDuration of phototoxic reactions
    Study

    n = 117

    Comparator
    Baseline
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    but there was no significant difference in number or duration of reactions.
    2 context sentences
    Summary · context
    This single-center, prospective postauthorization safety and efficacy cohort study was directed and approved by the European Medicines Agency.
    Summary · context
    A total of 117 patients with EPP (59 women [50.4%]; mean [SD] age, 43.0 [15.5] years) were treated with afamelanotide.
  6. 06HumanObservational studySafety outcome

    In patients with erythropoietic protoporphyria, 115 of 117 (98%) continued afamelanotide treatment over a median follow-up of 2.0 years.

    In plain wordsIn people with erythropoietic protoporphyria, nearly all (98%) kept using afamelanotide during about 2 years of follow-up.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    Not applicableTreatment continuation
    Study

    n = 117

    Outcome group
    Treatment adherence and retention · Whole body
    Studied dose
    Dose not stated

    Measurements

    Patients continuing treatment
    98%
    median follow-up 2.0 years

    Source sentences

    Summary
    Nearly all patients continued treatment (115 [98%]) with a median (interquartile range) follow-up of 2.0 (1.3-2.1) years.
    2 context sentences
    Summary · context
    This single-center, prospective postauthorization safety and efficacy cohort study was directed and approved by the European Medicines Agency.
    Summary · context
    A total of 117 patients with EPP (59 women [50.4%]; mean [SD] age, 43.0 [15.5] years) were treated with afamelanotide.
  7. 07HumanObservational studySafety outcome

    In patients with erythropoietic protoporphyria, nausea occurred as a minor self-limiting adverse event of afamelanotide.

    In plain wordsIn people with erythropoietic protoporphyria, nausea was a minor side effect of afamelanotide that went away by itself.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    Not applicableNausea
    Study

    n = 117

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Minor self-limiting adverse events occurred, such as nausea, fatigue, and headache.
    2 context sentences
    Summary · context
    This single-center, prospective postauthorization safety and efficacy cohort study was directed and approved by the European Medicines Agency.
    Summary · context
    A total of 117 patients with EPP (59 women [50.4%]; mean [SD] age, 43.0 [15.5] years) were treated with afamelanotide.
  8. 08HumanObservational studySafety outcome

    In patients with erythropoietic protoporphyria, fatigue occurred as a minor self-limiting adverse event of afamelanotide.

    In plain wordsIn people with erythropoietic protoporphyria, fatigue was a minor side effect of afamelanotide that went away by itself.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    Not applicableFatigue
    Study

    n = 117

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Minor self-limiting adverse events occurred, such as nausea, fatigue, and headache.
    2 context sentences
    Summary · context
    This single-center, prospective postauthorization safety and efficacy cohort study was directed and approved by the European Medicines Agency.
    Summary · context
    A total of 117 patients with EPP (59 women [50.4%]; mean [SD] age, 43.0 [15.5] years) were treated with afamelanotide.
  9. 09HumanObservational studySafety outcome

    In patients with erythropoietic protoporphyria, headache occurred as a minor self-limiting adverse event of afamelanotide.

    In plain wordsIn people with erythropoietic protoporphyria, headache was a minor side effect of afamelanotide that went away by itself.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    Not applicableHeadache
    Study

    n = 117

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Minor self-limiting adverse events occurred, such as nausea, fatigue, and headache.
    2 context sentences
    Summary · context
    This single-center, prospective postauthorization safety and efficacy cohort study was directed and approved by the European Medicines Agency.
    Summary · context
    A total of 117 patients with EPP (59 women [50.4%]; mean [SD] age, 43.0 [15.5] years) were treated with afamelanotide.

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

    13 Oct 2026, 21:44 UTC

    Study results updated

  2. Version 1

    13 Oct 2026, 16:31 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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