Methotrexate vs. ciclosporin in psoriasis: effectiveness, quality of life and safety. A randomized controlled trial

Flytström, Ingela; Stenberg, Berndt; Svensson, Åke; Im, Bergbrant

doi:10.1111/j.1365-2133.2007.08284.x

Cited by 107 publications

(137 citation statements)

References 27 publications

(25 reference statements)

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“…resulted in a mean reduction from baseline of 69% for the Psoriasis Area and Severity Index score after 2 weeks' treatment (20), which is comparable to the efficacy observed with cyclosporine (22). Since psoriasis is a T-cell-mediated disease, the efficacy of sotrastaurin in this setting may predict its immunosuppressive activity in transplant recipients.…”

Section: Sotrastaurin In De Novo Renal Transplantationmentioning

confidence: 69%

Sotrastaurin, a Novel Small Molecule Inhibiting Protein-Kinase C: Randomized Phase II Study in Renal Transplant Recipients

Friman

Arns

Nashan

et al. 2011

American Journal of Transplantation

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†Members of the Study Scientific Committee who contributed to the design of the study.Sotrastaurin, a selective protein-kinase-C inhibitor, blocks early T-cell activation through a calcineurinindependent mechanism. In this study, de novo renal transplant recipients with immediate graft function were randomized 1:2 to tacrolimus (control, n = 44) or sotrastaurin (300 mg b.i.d.; n = 81). All patients received basiliximab, mycophenolic acid (MPA) and steroids. The primary endpoint was the composite of treated biopsy-proven acute rejection (BPAR), graft loss, death or lost to follow-up at month 3. The main safety assessment was estimated glomerular filtration rate (eGFR); modification of diet in renal disease (MDRD) at month 3. Composite efficacy failure at month 3 was higher for the sotrastaurin versus control regimen (25.7% vs. 4.5%, p = 0.001), driven by higher BPAR rates (23.6% vs. 4.5%, p = 0.003), which led to early study termination. Median (± standard deviation [SD]) eGFR was higher for sotrastaurin versus control at all timepoints from day 7 (month 3: 59.0 ± 22.3 vs. 49.5 ± 17.7 mL/min/1.73 m 2 , p = 0.006). The most common adverse events were gastrointestinal disorders (control: 63.6%; sotrastaurin: 88.9%) which led to study-medication discontinuation in two sotrastaurin patients. This study demonstrated a lower degree of efficacy but better renal function with the calcineurin-inhibitor-free regimen of sotrastaurin+MPA versus the tacrolimus-based control. Ongoing studies are evaluating alternative sotrastaurin regimens.

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Section: Sotrastaurin In De Novo Renal Transplantationmentioning

confidence: 69%

Sotrastaurin, a Novel Small Molecule Inhibiting Protein-Kinase C: Randomized Phase II Study in Renal Transplant Recipients

Friman

Arns

Nashan

et al. 2011

American Journal of Transplantation

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“…68 Since our previous review, 14 a substantial number of new head-to-head trials comparing different pharmacological treatments for psoriasis against each other have been published. This is a very positive development highlighting that the Adalimumab 0Á065 (À0Á038 to 0Á168) Etanercept 2 9 50 mg 0Á235 (0Á140-0Á330) 0Á17 (0Á10-0Á24) 60 Etanercept 1 9 50 mg or 2 9 25 mg 0Á367 (0Á270-0Á464) CSA low dose (2Á5-3 mg) 0Á429 (0Á256-0Á602) Alefacept 0Á547 (0Á442-0Á652) MTX 0Á278 (À0Á211 to 0Á767) Ustekinumab 45 mg Adalimumab 0Á020 (À0Á048 to 0Á089) Etanercept 2 9 50 mg 0Á190 (0Á134-0Á246) 0Á11 (0Á03-0Á19) 60 Etanercept 1 9 50 mg or 2 9 25 mg 0Á322 (0Á264-0Á380) CSA low dose (2Á5-3 mg) 0Á384 (0Á229-0Á539) Alefacept 0Á502 (0Á430-0Á574) MTX 0Á233 (À0Á249 to 0Á716) Adalimumab Etanercept 2 9 50 mg 0Á170 (0Á100-0Á240) Etanercept 1 9 50 mg or 2 9 25 mg 0Á302 (0Á230-0Á374) CSA low dose (2Á5-3 mg) 0Á364 (0Á204-0Á524) Alefacept 0Á482 (0Á399-0Á565) MTX 0Á213 (À0Á271 to 0Á697) 0Á44 (0Á32-0Á56) 35 Etanercept high dose 2 9 50 mg Etanercept 1 9 50 mg or 2 9 25 mg 0Á132 (0Á072-0Á192) 0Á17 (0Á12-0Á22) 10,43,48,49 CSA low dose (2Á5-3 mg) 0Á194 (0Á038-0Á349) Alefacept 0Á312 (0Á239-0Á385) MTX 0Á043 (À0Á440 to 0Á526) Etanercept low dose 1 9 50 mg or 2 9 25 mg CSA low dose (2Á5-3 mg) 0Á062 (À0Á094 to 0Á218) Alefacept 0Á180 (0Á105 to 0Á255) MTX 0Á089 (À0Á394 to 0Á572) CSA high dose (5 mg) CSA low dose (2Á5-3 mg) 0Á35 (0Á20 to 0Á51) 20,24 CSA low dose (2Á5-3 mg) Alefacept 0Á118 (À0Á044 to 0Á280) MTX 0Á151 (À0Á353 to 0Á655) 0Á15 (À0Á01 to 0Á30) 23,25 Alefacept MTX 0Á269 (À0Á216 to 0Á754) MTX Fumaric acid 0Á05 (À0Á18 to 0Á27) 30 RD, risk difference, interpreted as the excess chance for PASI 75 response of intervention vs. comparator; CI, confidence interval; CSA, ciclosporin A; MTX, methotrexate. a Based on all placebo-controlled trials on the interventions included (see Fig.…”

Section: Discussionmentioning

confidence: 99%

“…23,25 Adverse events occurred more frequently in patients receiving MTX vs. placebo in one trial. 31 …”

Section: Safetymentioning

confidence: 99%

Efficacy and safety of systemic treatments for moderate‐to‐severe psoriasis: meta‐analysis of randomized controlled trials

et al. 2014

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“…Moreover, patients evaluated the skin pigmentation on the VAS (–50 mm, extremely depigmented; 0 mm, unchanged; +50 mm, extremely hyperpigmented) and efficacy of therapy (–50 mm, extreme worsening; 0 mm, unchanged; +50 mm, extreme improvement) before and after 1, 2, 3 and 4 weeks of irradiation and in the follow-up weeks 5 and 6. In several previous publications, VAS have been evaluated for their efficacy in determining different levels of cosmetic outcome or degrees of clinical improvement in dermatology [13,14,15]. Photographs of both the irradiated plaque and of the control plaque were taken every week.…”

Section: Methodsmentioning

confidence: 99%

Prospective Randomized Study on the Efficacy of Blue Light in the Treatment of Psoriasis Vulgaris

et al. 2011

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Background:Blue light has no known toxic effects on human skin, but reduces the proliferative capacity of keratinocytes in vitro. We therefore investigated the efficacy of blue light in the treatment of psoriasis vulgaris (PV). Methods: Forty patients with mild to moderate PV and bilateral plaques were assigned to two groups. Group 1 (n = 20) received irradiation at home with blue light (light-emitting diode, LED, emission maximum: 420 nm) once daily for 4 weeks. In parallel, group 2 (n = 20) performed irradiations with another blue light device (LED emission maximum: 453 nm). The contralateral control plaques remained untreated in both groups. Results: Thirty-seven patients completed the trial. The main study parameter, the difference of Local Psoriasis Severity Index (LPSI) scores of the irradiated plaques compared to the control plaques, showed statistically significant improvement after 4 weeks of treatment in both groups [group 1 (420 nm): n = 17, p = 0.04; group 2 (453 nm): n = 20, p = 0.04]. Accordingly, plaque status as assessed by both the physicians and the patients improved continuously during the 4 weeks of treatment and steadily declined thereafter. Conclusion: Blue light appears to be a promising treatment modality in PV that warrants further evaluation in larger studies.

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Methotrexate vs. ciclosporin in psoriasis: effectiveness, quality of life and safety. A randomized controlled trial

Cited by 107 publications

References 27 publications

Sotrastaurin, a Novel Small Molecule Inhibiting Protein-Kinase C: Randomized Phase II Study in Renal Transplant Recipients

Sotrastaurin, a Novel Small Molecule Inhibiting Protein-Kinase C: Randomized Phase II Study in Renal Transplant Recipients

Efficacy and safety of systemic treatments for moderate‐to‐severe psoriasis: meta‐analysis of randomized controlled trials

Prospective Randomized Study on the Efficacy of Blue Light in the Treatment of Psoriasis Vulgaris

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