Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial

Mulder, Michelle L M; Vriezekolk, Johanna E; Hal, Tamara W van; Nieboer, L M; Broeder, Nathan den; Jong, E.M.G.J. de; Broeder, Alfons A den; Hoogen, F.H.J. van den; Helliwell, Philip S.; Wenink, Mark H.

doi:10.1016/s2665-9913(22)00028-5

Cited by 12 publications

(12 citation statements)

References 29 publications

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“…The continued prioritisation of csDMARDs reflects consensual expert opinion within the taskforce that favoured the benefit–risk–cost balance of csDMARDs and in particular MTX over targeted drugs. The absence of new data indicating the superiority of a b/tsDMARD as first-line, and in the presence of new data on MTX, was seen as confirming the efficacy of this drug in PsA 5 37–39…”

Section: Resultsmentioning

confidence: 99%

“…Other csDMARDs (ie, leflunomide and sulfasalazine) are potential treatment options and have demonstrated efficacy in PsA peripheral arthritis 15. A recent trial of the combination of MTX with leflunomide indicated a low efficacy to safety ratio; thus, this association is not recommended 38…”

Section: Resultsmentioning

confidence: 99%

“…Unequivocal enthesitis refers (as in 2019) to definite entheseal inflammation (which might need additional diagnostic imaging) to avoid overtreatment of entheseal pain not related to PsA (eg, in the context of widespread pain syndrome or repetitive mechanical stress) 68 69. In terms of treatment options, the taskforce discussed the recent data indicating indirectly some efficacy for MTX in enthesitis 5 38 39. However, it was felt that the data for MTX were not sufficiently strong to propose MTX in the bullet point.…”

Section: Resultsmentioning

confidence: 99%

“… 15 A recent trial of the combination of MTX with leflunomide indicated a low efficacy to safety ratio; thus, this association is not recommended. 38 …”

Section: Resultsmentioning

confidence: 99%

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EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update

Gossec,

Kerschbaumer,

Ferreira

et al. 2024

Ann Rheum Dis

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ObjectiveNew modes of action and more data on the efficacy and safety of existing drugs in psoriatic arthritis (PsA) required an update of the EULAR 2019 recommendations for the pharmacological treatment of PsA.MethodsFollowing EULAR standardised operating procedures, the process included a systematic literature review and a consensus meeting of 36 international experts in April 2023. Levels of evidence and grades of recommendations were determined.ResultsThe updated recommendations comprise 7 overarching principles and 11 recommendations, and provide a treatment strategy for pharmacological therapies. Non-steroidal anti-inflammatory drugs should be used in monotherapy only for mild PsA and in the short term; oral glucocorticoids are not recommended. In patients with peripheral arthritis, rapid initiation of conventional synthetic disease-modifying antirheumatic drugs is recommended and methotrexate preferred. If the treatment target is not achieved with this strategy, a biological disease-modifying antirheumatic drug (bDMARD) should be initiated, without preference among modes of action. Relevant skin psoriasis should orient towards bDMARDs targeting interleukin (IL)-23p40, IL-23p19, IL-17A and IL-17A/F inhibitors. In case of predominant axial or entheseal disease, an algorithm is also proposed. Use of Janus kinase inhibitors is proposed primarily after bDMARD failure, taking relevant risk factors into account, or in case bDMARDs are not an appropriate choice. Inflammatory bowel disease and uveitis, if present, should influence drug choices, with monoclonal tumour necrosis factor inhibitors proposed. Drug switches and tapering in sustained remission are also addressed.ConclusionThese updated recommendations integrate all currently available drugs in a practical and progressive approach, which will be helpful in the pharmacological management of PsA.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“… 15 A recent trial of the combination of MTX with leflunomide indicated a low efficacy to safety ratio; thus, this association is not recommended. 38 …”

Section: Resultsmentioning

confidence: 99%

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EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update

Gossec,

Kerschbaumer,

Ferreira

et al. 2024

Ann Rheum Dis

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“…For PsA, other csDMARDs are available in the clinic, including leflunomide, sulfasalazine, and cyclosporine. The recently published Complete-PsA Study showed benefit with the combination of leflunomide added to MTX in csDMARD-naive PsA patients, although the small sample size precluded adequate safety assessments (8). Despite the option to select an alternative csDMARD to treat PsA, patients with inadequate response to MTX are commonly prescribed a TNFi.…”

Section: Introductionmentioning

confidence: 99%

Expert Perspective: Management of the Psoriatic Arthritis Patient After Failure of One Tumor Necrosis Factor Inhibitor

Leung

Kavanaugh

Ritchlin

2023

Arthritis & Rheumatology

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The index case, a 36-year-old woman, had psoriasis (PsO) on her scalp, arms, legs, and trunk since age 25 years that was inadequately controlled with topical agents. She has a past medical history of treated hypertension and depression. She is an active smoker. Three years prior to our case evaluation, she developed polyarthritis, inflammatory back pain, and plantar fasciitis. Methotrexate (MTX) was added to her treatment regimen, first administered orally then subcutaneously, but the patient stated she could only tolerate 12.5 mg/week due to gastrointestinal and systemic adverse events. The dose of 12.5 mg/week resulted in minimal benefit. In addition, the patient was recently married and reported that pregnancy was being considered, and therefore treatment with MTX was stopped. She then experienced a flare of PsO and arthritis.Physical examination was notable for the presence of moderate-to-severe PsO (12% affected body surface area [BSA]), 6-7 swollen and tender joints, and evidence of mild erosive changes on hand radiographs. Monotherapy with adalimumab 40 mg every other week was initiated. The patient improved during treatment with adalimumab over 10 weeks, with 60-70% improvement in her clinical symptoms overall, but continued to experience mild residual joint pain and signs of PsO (2-4% BSA). Approximately 3 months ago, she noted profound fatigue, 90 minutes of morning stiffness, and diffuse joint pain. She found it difficult to continue her work in retail and reported feeling frustrated, anxious, and depressed. Her skin PsO also worsened and became more bothersome to her. On physical examination, her blood pressure was 140/90 mm Hg, pulse rate was 72 beats per minute, and body mass index was 35 kg/m 2 . She had psoriasiform plaques on her trunk and extremities (8% BSA). Musculoskeletal examination revealed 6 tender and 4 swollen joints, and she had a Disease Activity Index for PsA (DAPSA) score of 29 (a DAPSA score of >28 represents high disease activity). There were multiple tender entheses, most notably in the plantar fasciae, left Achilles tendon, and the left elbow lateral condyle. Pain was elicited in the right sacroiliac (SI) joint on provocative testing, and also at several locations unassociated with entheses.

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Clinical practice guideline for the treatment of psoriatic arthritis in Colombia

Fernández-Ávila

González

Arteaga

et al. 2023

Revista Colombiana de Reumatología

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Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial

Cited by 12 publications

References 29 publications

EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update

EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update

Expert Perspective: Management of the Psoriatic Arthritis Patient After Failure of One Tumor Necrosis Factor Inhibitor

Clinical practice guideline for the treatment of psoriatic arthritis in Colombia

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