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Clinical Trial
. 2024 Oct 21;83(11):1480-1488.
doi: 10.1136/ard-2024-225833.

Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial

Laure Gossec  1   2 , Laura C Coates  3 , Dafna D Gladman  4 , Jacob A Aelion  5 , Jitendra Vasandani  6 , Andreas Pinter  7 , Joseph F Merola  8 , Arthur Kavanaugh  9 , Jyotsna Reddy  10 , Rebecca Wang  10 , Michele Brunori  10 , Yuri Klyachkin  10 , Cynthia Deignan  10 , Philip J Mease  11   12
Affiliations
Clinical Trial

Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial

Laure Gossec et al. Ann Rheum Dis. .

Abstract

Objectives: Oligoarticular psoriatic arthritis (PsA) is frequent but rarely studied. The objective was to assess the efficacy of apremilast in early oligoarticular PsA.

Methods: FOREMOST (NCT03747939) was a phase 4 multicentre, randomised, double-blind, placebo-controlled trial. Patients had early (symptom duration ≤5 years) oligoarticular PsA (>1 but ≤4 swollen and >1 but ≤4 tender joints; 2-8 total active joints). Patients were randomised 2:1 to apremilast 30 mg two times per day or placebo for 24 weeks, with an early escape at week 16. The primary endpoint was the proportion of patients at week 16 who achieved minimal disease activity (MDA)-Joints (modification of MDA mandating ≤1 swollen joint and ≤1 tender joint) based on sentinel joints (those affected at baseline) with a combination of non-responder imputation and multiple imputations. Exploratory analysis assessed all joints.

Results: Of 308 patients randomised (apremilast: n=203; placebo: n=105), mean (SD) PsA duration was 9.9 (10.2) months, mean (SD) age was 50.9 (12.5) years and 39.9% of patients were using a conventional synthetic disease-modifying antirheumatic drug. MDA-Joints (sentinel joints (primary endpoint) and all joints) were achieved by significantly more patients with apremilast (33.9% and 21.3%) vs placebo (16.0% and 7.9%) at week 16 (p=0.0008 and nominal p=0.0028, respectively). Greater improvements in patient-reported outcomes, clinical disease activity and skin involvement were also seen with apremilast versus placebo.

Conclusions: FOREMOST is the first randomised controlled trial designed for early oligoarticular PsA and showed apremilast improves clinical and patient-reported outcomes. This trial may inform the optimal management of PsA in these patients.

Trial registration number: NCT03747939.

Keywords: Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents; Arthritis, Psoriatic.

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Conflict of interest statement

Competing interests: LG has received medical writing support and honoraria as part of advisory boards for this study. Outside this work: grants or contracts from AbbVie, Biogen, Lilly, Novartis and UCB; consulting fees from AbbVie, BMS, Celltrion, Janssen, Novartis, Pfizer and UCB; honoraria for lectures from AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer and UCB; support for attending meetings and/or travel from MSD, Novartis and Pfizer; and medical writing support from AbbVie, Janssen, Galapagos, and UCB. LCC: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB–grant/research support, consulting fees, and/or speaker honoraria. LCC was supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre (BRC). DDG: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB–grant/research support or consulting fees. JAA: AbbVie, Amgen–speakers bureau; AbbVie, Ardea Biosciences, AstraZeneca, Bristol Myers Squibb, Celgene, Centocor, Eli Lilly, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi-Aventis, Takeda, UCB, Vertex–grant/research support. JV: Nothing to disclose. AP: AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, GSK, Eli Lilly, Galderma, Hexal, Janssen, LEO-Pharma, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pfizer, Tigercat Pharma, Regeneron, Roche, Sandoz Biopharmaceuticals, Schering-Plough, UCB Pharma–investigator/speaker/advisor. JFM: AbbVie, Arena, Avotres, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, EMD, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Serono, Sun, UCB–consultant and/or investigator. AK: Amgen, AbbVie, BMS, Janssen, Novartis, Pfizer, Eli Lilly–grant/research support and consultant. JR, RW, MB, YK and CD: Employment by and stock ownership in Amgen. PJM: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, UCB–grant/research support and consultant; Boehringer Ingelheim, GlaxoSmithKline–consultant; AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB–speakers bureau.

Figures

Figure 1
Figure 1. FOREMOST study design. csDMARD, conventional synthetic disease-modifying antirheumatic drug; MDA, minimal disease activity; NSAID, non-steroidal anti-inflammatory drug.
Figure 2
Figure 2. Patient disposition through week 24 in the FOREMOST trial. FAS. All 45 patients who escaped early completed 24 weeks. FAS, full analysis set.
Figure 3
Figure 3. MDA-joints response at week 16. (A) Based on sentinel joints. (B) Based on all joints. FAS. Error bars represent SE. The number of responders was rounded based on the value given by multiple imputations. MDA-joints is a composite of TJC≤1 and SJC≤1 plus achievement of three of the following: BSA≤3%, patient pain VAS≤15, PtGA≤20, HAQ-DI≤0.5 and LEI≤1. BSA, body surface area; CI, confidence interval; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire Disability Index; LEI, Leeds Enthesitis Index; MDA, minimal disease activity; PtGA, Patient Global Assessment of disease activity; SE, standard error; SJC, swollen joint count; TJC, tender joint count; VAS, Visual Analogue Scale.
Figure 4
Figure 4. Proportion of patients achieving MDA at week 16. FAS. Based on all joints. Error bars represent SE. CI, confidence interval; FAS, full analysis set; MDA, minimal disease activity; SE, standard error.
Figure 5
Figure 5. Proportion of patients who progressed to active joint count >4 among patients with ≤4 active joints at baseline. FAS with ≤4 active joints at baseline. Error bars represent SE based on all joints. Data are as observed. FAS, full analysis set; SE, standard error.
See this image and copyright information in PMC

References

    1. Moll JM, Wright V. Psoriatic arthritis. Semin Arthritis Rheum. 1973;3:55–78. doi: 10.1016/0049-0172(73)90035-8. - DOI - PubMed
    1. Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64:ii14–7. doi: 10.1136/ard.2004.032482. - DOI - PMC - PubMed
    1. Gladman DD, Ye JY, Chandran V, et al. Oligoarticular vs polyarticular psoriatic arthritis: a longitudinal study showing similar characteristics. J Rheumatol. 2021;48:1824–9. doi: 10.3899/jrheum.210434. - DOI - PubMed
    1. Kasiem FR, Luime JJ, Vis M, et al. Lessons learned from clinical phenotypes in early psoriatic arthritis: the real-world Dutch south west early psoriatic arthritis study. Scand J Rheumatol. 2021;50:124–31. doi: 10.1080/03009742.2020.1803398. - DOI - PubMed
    1. Kane D, Stafford L, Bresnihan B, et al. A classification study of clinical subsets in an inception cohort of early psoriatic peripheral arthritis--DIP or not DIP revisited. Rheumatol (Oxford) 2003;42:1469–76. doi: 10.1093/rheumatology/keg445. - DOI - PubMed

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