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Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis.

Abstract

BACKGROUND

The efficacy and safety of apremilast were assessed in patients with psoriatic arthritis (PsA) in three phase III clinical trials with similar designs (PALACE 1, 2, and 3).

METHODS

Following a 24-week, randomized (1:1:1 to apremilast 30 mg twice daily, 20 mg twice daily, or placebo), double-blind phase and a 28-week blinded active treatment phase, patients could receive apremilast in open-label extension studies for an additional 4 years. Eligible adult patients had active PsA for ≥ 6 months and three or more swollen joints and three or more tender joints despite prior treatment with disease-modifying anti-rheumatic drugs.

RESULTS

A total of 1493 randomized patients received one or more doses of study medication (placebo: n = 496; apremilast 30 mg twice daily: n = 497; apremilast 20 mg twice daily: n = 500). In patients continuing apremilast treatment, response was sustained without new safety issues. At week 260, 67.2% of remaining patients achieved an ACR20 response, and 44.4% and 27.4% achieved ACR50 and ACR70 responses, respectively. Among patients with baseline enthesitis and dactylitis, 62.4% achieved a Maastricht Ankylosing Spondylitis Enthesitis Score of 0 and 80.9% achieved a dactylitis count of 0, respectively. In patients who had ≥ 3% baseline psoriasis body surface area involvement, 43.6% achieved ≥ 75% reduction from the baseline Psoriasis Area and Severity Index scores. The most commonly reported adverse events (AEs) were diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis, with most diarrhea and nausea AEs occurring within the first 2 weeks of treatment and usually resolving within 4 weeks. Reported rates of depression during the study were low (≤ 1.8%). The majority of patients maintained their weight within 5% of baseline during the study. No new safety concerns or increases in the incidence or severity of AEs were observed over the long term.

CONCLUSIONS

Apremilast maintained clinical benefit and a favorable safety profile for up to 5 years among patients with PsA.

TRIAL REGISTRATION

ClinicalTrials.gov NCT01172938 , NCT01212757 , NCT01212770.

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  • Authors+Show Affiliations

    ,

    School of Medicine, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92037, USA. akavanaugh@ucsd.edu.

    ,

    Division of Rheumatology, Krembil Research Institute, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.

    ,

    NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, Southampton, UK.

    ,

    Friedrich-Alexander-Universität Erlangen-Nürnberg und Universitätsklinikum Erlangen, Erlangen, Germany.

    ,

    Celgene Corporation, Summit, NJ, USA.

    ,

    Celgene Corporation, Summit, NJ, USA.

    ,

    Celgene Corporation, Summit, NJ, USA.

    ,

    Celgene Corporation, Summit, NJ, USA.

    Rheumatology Clinical Research Division, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.

    Source

    Arthritis research & therapy 21:1 2019 May 10 pg 118

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    31077258

    Citation

    Kavanaugh, Arthur, et al. "Long-term Experience With Apremilast in Patients With Psoriatic Arthritis: 5-year Results From a PALACE 1-3 Pooled Analysis." Arthritis Research & Therapy, vol. 21, no. 1, 2019, p. 118.
    Kavanaugh A, Gladman DD, Edwards CJ, et al. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019;21(1):118.
    Kavanaugh, A., Gladman, D. D., Edwards, C. J., Schett, G., Guerette, B., Delev, N., ... Mease, P. J. (2019). Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Research & Therapy, 21(1), p. 118. doi:10.1186/s13075-019-1901-3.
    Kavanaugh A, et al. Long-term Experience With Apremilast in Patients With Psoriatic Arthritis: 5-year Results From a PALACE 1-3 Pooled Analysis. Arthritis Res Ther. 2019 May 10;21(1):118. PubMed PMID: 31077258.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. AU - Kavanaugh,Arthur, AU - Gladman,Dafna D, AU - Edwards,Christopher J, AU - Schett,Georg, AU - Guerette,Benoit, AU - Delev,Nikolay, AU - Teng,Lichen, AU - Paris,Maria, AU - Mease,Philip J, Y1 - 2019/05/10/ PY - 2018/12/12/received PY - 2019/04/18/accepted PY - 2019/5/12/entrez PY - 2019/5/12/pubmed PY - 2019/5/12/medline KW - Apremilast KW - Drug safety KW - Psoriatic arthritis KW - Treatment efficacy SP - 118 EP - 118 JF - Arthritis research & therapy JO - Arthritis Res. Ther. VL - 21 IS - 1 N2 - BACKGROUND: The efficacy and safety of apremilast were assessed in patients with psoriatic arthritis (PsA) in three phase III clinical trials with similar designs (PALACE 1, 2, and 3). METHODS: Following a 24-week, randomized (1:1:1 to apremilast 30 mg twice daily, 20 mg twice daily, or placebo), double-blind phase and a 28-week blinded active treatment phase, patients could receive apremilast in open-label extension studies for an additional 4 years. Eligible adult patients had active PsA for ≥ 6 months and three or more swollen joints and three or more tender joints despite prior treatment with disease-modifying anti-rheumatic drugs. RESULTS: A total of 1493 randomized patients received one or more doses of study medication (placebo: n = 496; apremilast 30 mg twice daily: n = 497; apremilast 20 mg twice daily: n = 500). In patients continuing apremilast treatment, response was sustained without new safety issues. At week 260, 67.2% of remaining patients achieved an ACR20 response, and 44.4% and 27.4% achieved ACR50 and ACR70 responses, respectively. Among patients with baseline enthesitis and dactylitis, 62.4% achieved a Maastricht Ankylosing Spondylitis Enthesitis Score of 0 and 80.9% achieved a dactylitis count of 0, respectively. In patients who had ≥ 3% baseline psoriasis body surface area involvement, 43.6% achieved ≥ 75% reduction from the baseline Psoriasis Area and Severity Index scores. The most commonly reported adverse events (AEs) were diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis, with most diarrhea and nausea AEs occurring within the first 2 weeks of treatment and usually resolving within 4 weeks. Reported rates of depression during the study were low (≤ 1.8%). The majority of patients maintained their weight within 5% of baseline during the study. No new safety concerns or increases in the incidence or severity of AEs were observed over the long term. CONCLUSIONS: Apremilast maintained clinical benefit and a favorable safety profile for up to 5 years among patients with PsA. TRIAL REGISTRATION: ClinicalTrials.gov NCT01172938 , NCT01212757 , NCT01212770. SN - 1478-6362 UR - https://www.unboundmedicine.com/medline/citation/31077258/Long-term_experience_with_apremilast_in_patients_with_psoriatic_arthritis:_5-year_results_from_a_PALACE_1-3_pooled_analysis L2 - https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-019-1901-3 DB - PRIME DP - Unbound Medicine ER -