Prednisolone vs. ciclosporin for severe adult eczema. An investigator-initiated double-blind placebo-controlled multicentre trial

Schmitt, Jochen; Schäkel, Knut; Fölster‐Holst, Regina; Bauer, Andrea; Oertel, R.; Augustin, M.; Aberer, Werner; Luger, Thomas A.; Meurer, Michael

doi:10.1111/j.1365-2133.2009.09561.x

Cited by 119 publications

(127 citation statements)

References 36 publications

(60 reference statements)

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“…In a recent randomised controlled trial (RCT) of oral prednisolone versus ciclosporin in severe AD, the latter was more efficacious in maintaining a stable remission. 7 …”

Section: Oral Corticosteroidsmentioning

confidence: 99%

Systemic treatment of adult atopic dermatitis

Cookson

Smith

2012

Clinical Medicine

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“…In a recent randomised controlled trial (RCT) of oral prednisolone versus ciclosporin in severe AD, the latter was more efficacious in maintaining a stable remission. 7 …”

Section: Oral Corticosteroidsmentioning

confidence: 99%

Systemic treatment of adult atopic dermatitis

Cookson

Smith

2012

Clinical Medicine

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“…The trial by Schmitt and colleague 402 seems to suggest that short courses also lead to high rates of eczema relapse, some of which can be very severe (10/15 participants who relapsed were on prednisolone). As this treatment was also not as effective as ciclosporin, and the trial was underpowered, these results should be treated with caution.…”

Section: Overall Implications For Research and Practicementioning

confidence: 99%

“…These studies suggest that a short course of ciclosporin might be more effective than intravenous immunoglobulin or oral prednisolone. 401,402 For oral prednisolone treatment, there is evidence that this lack of benefit results from serious eczema exacerbations when oral prednisolone has to be stopped, rather than because it is less effective when being taken. There was some evidence that UVAB phototherapy, 390 or methotrexate, 404 is not significantly more beneficial than a short course of ciclosporin.…”

Section: Overall Implications For Research and Practicementioning

confidence: 99%

“…The trial by Schmitt and colleagues 402 assessed the number of participants in stable remission at the end of treatment. Because of rebound/exacerbation of eczema, half (11/21) of the participants taking prednisolone and six out of 17 of the participants taking ciclosporin dropped out before the study was stopped prematurely.…”

Section: Systemic Immunomodulatory Agentsmentioning

confidence: 99%

“…One small, well-reported trial by Schmitt and colleagues 402 included 38 adults with severe eczema and compared a 2-week tapering dose of oral prednisolone with a constant daily dose of ciclosporin for 6 weeks. This mimics the treatment regimens frequently used in clinical practice.…”

Section: Studiesmentioning

confidence: 99%

See 2 more Smart Citations

Scoping systematic review of treatments for eczema

Nankervis

Kim

Delamere

et al. 2016

Programme Grants Appl Res

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BackgroundEczema is a very common chronic inflammatory skin condition.ObjectivesTo update the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) systematic review of treatments for atopic eczema, published in 2000, and to inform health-care professionals, commissioners and patients about key treatment developments and research gaps.Data sourcesElectronic databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Skin Group Specialised Register, Latin American and Caribbean Health Sciences Literature (LILACS), Allied and Complementary Medicine Database (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL) were searched from the end of 2000 to 31 August 2013. Retrieved articles were used to identify further randomised controlled trials (RCTs).Review methodsStudies were filtered according to inclusion criteria and agreed by consensus in cases of uncertainty. Abstracts were excluded and non-English-language papers were screened by international colleagues and data were extracted. Only RCTs of treatments for eczema were included, as other forms of evidence are associated with higher risks of bias. Inclusion criteria for studies included availability of data relevant to the therapeutic management of eczema; mention of randomisation; comparison of two or more treatments; and prospective data collection. Participants of all ages were included. Eczema diagnosis was determined by a clinician or according to published diagnostic criteria. The risk of bias was assessed using the Cochrane Collaboration risk-of-bias tool. We used a standardised approach to summarising the data and the assessment of risk of bias and we made a clear distinction between what the studies found and our own interpretation of study findings.ResultsOf 7198 references screened, 287 new trials were identified spanning 92 treatments. Trial reporting was generally poor (randomisation method: 2% high, 36% low, 62% unclear risk of bias; allocation concealment: 3% high, 15% low, 82% unclear risk of bias; blinding of the intervention: 15% high, 28% low, 57% unclear risk of bias). Only 22 (8%) trials were considered to be at low risk of bias for all three criteria. There was reasonable evidence of benefit for the topical medications tacrolimus, pimecrolimus and various corticosteroids (with tacrolimus superior to pimecrolimus and corticosteroids) for both treatment and flare prevention; oral ciclosporin; oral azathioprine; narrow band ultraviolet B (UVB) light; Atopiclair™ and education. There was reasonable evidence to suggest no clinically useful benefit for twice-daily compared with once-daily topical corticosteroids; corticosteroids containing antibiotics for non-infected eczema; probiotics; evening primrose and borage oil; ion-exchange water softeners; protease inhibitor SRD441 (Serentis Ltd); furfuryl palmitate in emollient; cipamfylline cream; andMycobacterium vaccaevaccine. Additional research evidence is needed for emollients, bath additives, antibacterials, specialist clothing and complementary and alternative therapies. There was no RCT evidence for topical corticosteroid dilution, impregnated bandages, soap avoidance, bathing frequency or allergy testing.LimitationsThe large scope of the review coupled with the heterogeneity of outcomes precluded formal meta-analyses. Our conclusions are still limited by a profusion of small, poorly reported studies.ConclusionsAlthough the evidence base of RCTs has increased considerably since the last NIHR HTA systematic review, the field is still severely hampered by poor design and reporting problems including failure to register trials and declare primary outcomes, small sample size, short follow-up duration and poor reporting of risk of bias. Key areas for further research identified by the review include the optimum use of emollients, bathing frequency, wash products, allergy testing and antiseptic treatments. Perhaps the greatest benefit identified is the use of twice weekly anti-inflammatory treatment to maintain disease remission. More studies need to be conducted in a primary care setting where most people with eczema are seen in the UK. Future studies need to use the same core set of outcomes that capture patient symptoms, clinical signs, quality of life and the chronic nature of the disease.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

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