A Randomized Controlled Trial of Methotrexate and Cyclosporine in the Treatment of Psoriasis

Bigby, Michael

doi:10.1001/archderm.140.3.347

Cited by 10 publications

(4 citation statements)

References 4 publications

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“…Question A RCT evaluating CyA for the induction of remission of psoriasis Nine RCT addressed the question of dose selection for the induction of remission of plaque psoriasis. [1][2][3][4][5][6][7][8][9] The criterion for success was expressed as a 75% decrease in PASI when compared with baseline. The dose of CyA ranged from 2.5 to 5 mg ⁄ kg ⁄ day and the duration of treatment in the trials ranged from 10 to 16 weeks.…”

Section: Cyclosporin In Psoriasismentioning

confidence: 99%

“…Cyclosporin (CyA) is an oral calcineurin inhibitor approved for the treatment of plaque psoriasis since the early 1990s. The efficacy of CyA in the treatment of severe plaque‐type psoriasis was demonstrated for inducing remission and maintenance treatment in randomized clinical trials 1–14 . Patients on CyA need to be carefully monitored because of long‐term risk of nephrotoxicity, hypertension and malignancies 15 .…”

Section: Introductionmentioning

confidence: 99%

“…The efficacy of CyA in the treatment of severe plaque-type psoriasis was demonstrated for inducing remission and maintenance treatment in randomized clinical trials. [1][2][3][4][5][6][7][8][9][10][11][12][13][14] Patients on CyA need to be carefully monitored because of long-term risk of nephrotoxicity, hypertension and malignancies. 15 As with most therapeutic agents in psoriasis, there is limited data regarding the efficacy of CyA in other forms of psoriasis such as chronic palmoplantar pustulosis (PPP), generalized pustular psoriasis (GPP), nail psoriasis, guttate psoriasis and erythrodermic psoriasis.…”

Section: Introductionmentioning

confidence: 99%

“…RCT evaluating CyA for the induction of remission of psoriasis Nine RCT addressed the question of dose selection for the induction of remission of plaque psoriasis 1–9 . The criterion for success was expressed as a 75% decrease in PASI when compared with baseline.…”

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confidence: 99%

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Oral cyclosporin in psoriasis: a systematic review on treatment modalities, risk of kidney toxicity and evidence for use in non‐plaque psoriasis

Maza

Montaudié²,

Sbidian

et al. 2011

Acad Dermatol Venereol

110

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Oral CyA is indicated for patients with plaque psoriasis, pustular psoriasis or erythrodermic psoriasis. The starting dose of 5 mg/kg is associated with a higher degree of clearance. The benefit-risk appears to be better for patients without risk factors for nephrotoxicity: non-obese patients without hypertension and aged below 60. Although CyA is ideally suited for crisis intervention, continuous maintenance treatment with CyA may be envisaged in some patients provided serum creatinin is regularly monitored and the cumulative treatment duration is preferably limited to 2 years or less.

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Section: Cyclosporin In Psoriasismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Oral cyclosporin in psoriasis: a systematic review on treatment modalities, risk of kidney toxicity and evidence for use in non‐plaque psoriasis

Maza

Montaudié²,

Sbidian

et al. 2011

Acad Dermatol Venereol

110

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Systemic pharmacological treatments for chronic plaque psoriasis

Sbidian

Cleach

Trinquart³

et al. 2015

Cochrane Database of Systematic Reviews

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Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis

Sbidian

Chaimani

García‐Doval

et al. 2017

Cochrane Database of Systematic Reviews

266

309

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Our review shows that compared to placebo, the biologics ixekizumab, secukinumab, brodalumab, guselkumab, certolizumab, and ustekinumab are the best choices for achieving PASI 90 in people with moderate to severe psoriasis on the basis of moderate- to high-certainty evidence. At class level, the biologic treatments anti-IL17, anti-IL12/23, anti-IL23, and anti-TNF alpha were significantly more effective than the small molecules and the conventional systemic agents, too. This NMA evidence is limited to induction therapy (outcomes were measured between 12 to 16 weeks after randomisation) and is not sufficiently relevant for a chronic disease. Moreover, low numbers of studies were found for some of the interventions, and the young age (mean age of 44 years) and high level of disease severity (PASI 20 at baseline) may not be typical of patients seen in daily clinical practice.Another major concern is that short-term trials provide scanty and sometimes poorly reported safety data and thus do not provide useful evidence to create a reliable risk profile of treatments. Indeed, we found no significant difference in the assessed interventions and placebo in terms of SAEs. Methotrexate appeared to have the best safety profile, but as the evidence was of very low to moderate quality, we cannot be sure of the ranking. In order to provide long-term information on the safety of the treatments included in this review, it will be necessary to evaluate non-randomised studies and postmarketing reports released from regulatory agencies as well.In terms of future research, randomised trials comparing directly active agents are necessary once high-quality evidence of benefit against placebo is established, including head-to-head trials amongst and between conventional systemic and small molecules, and between biological agents (anti-IL17 versus anti-IL23, anti-IL23 versus anti-IL12/23, anti-TNF alpha versus anti-IL12/23). Future trials should also undertake systematic subgroup analyses (e.g. assessing biological-naïve patients, baseline psoriasis severity, presence of psoriatic arthritis, etc.). Finally, outcome measure harmonisation is needed in psoriasis trials, and researchers should look at the medium- and long-term benefit and safety of the interventions and the comparative safety of different agents.

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A Randomized Controlled Trial of Methotrexate and Cyclosporine in the Treatment of Psoriasis

Cited by 10 publications

References 4 publications

Oral cyclosporin in psoriasis: a systematic review on treatment modalities, risk of kidney toxicity and evidence for use in non‐plaque psoriasis

Oral cyclosporin in psoriasis: a systematic review on treatment modalities, risk of kidney toxicity and evidence for use in non‐plaque psoriasis

Systemic pharmacological treatments for chronic plaque psoriasis

Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis

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