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

Reviews 2017, Issue 12.

NB: compte tenu de la longueur des articles en annexe, certains tableaux et figures ne sont par

reproduits ici

Ils sont disponibles dans leur intégralité sur la Cochrane Library

CochraneDatabase of Systematic Reviews

Interventions for chronic palmoplantar pustulosis (Review)

Obeid G, Do G, Kirby L, Hughes C, Sbidian E, Le Cleach L

Obeid G, Do G, Kirby L, Hughes C, Sbidian E, Le Cleach L. Interventions for chronic palmoplantar pustulosis.

Cochrane Database of Systematic Reviews 2019, Issue 4. Art. No.: CD011628. DOI: 10.1002/14651858.CD011628.pub2.

www.cochranelibrary.com

Interventions for chronic palmoplantar pustulosis (Review)

T A B L E O F C O N T E N T S 1 HEADER . . . . 1 ABSTRACT . . . . 3 PLAIN LANGUAGE SUMMARY . . . .

5 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . .

8 BACKGROUND . . . . 10 OBJECTIVES . . . . 10 METHODS . . . . 13 RESULTS . . . . Figure 1. . . 15 Figure 2. . . 19 Figure 3. . . 20 30 ADDITIONAL SUMMARY OF FINDINGS . . . .

56 DISCUSSION . . . . 58 AUTHORS’ CONCLUSIONS . . . . 59 ACKNOWLEDGEMENTS . . . . 59 REFERENCES . . . . 65 CHARACTERISTICS OF STUDIES . . . . 135 DATA AND ANALYSES . . . .

Analysis 1.1. Comparison 1 Vit analog ointment v/s placebo, Outcome 1 Proportion of participants cleared or almost cleared in the short term. . . 139 Analysis 1.2. Comparison 1 Vit analog ointment v/s placebo, Outcome 2 Proportion of participants with side effects in the

short term. . . 139 Analysis 2.1. Comparison 2 UVA v/s narrowband UVB, Outcome 1 Within participants study. . . 140 Analysis 3.1. Comparison 3 Etretinate v/s placebo, Outcome 1 Proportion of participants cleared or almost cleared in the

short term. . . 141 Analysis 3.2. Comparison 3 Etretinate v/s placebo, Outcome 2 Proportion of participants without relapse in the

long-term. . . 141 Analysis 3.3. Comparison 3 Etretinate v/s placebo, Outcome 3 Proportion of participants with adverse effects on the short

term. . . 142 Analysis 4.1. Comparison 4 Etretinate v/s placebo or no treatment with PUVA as co-intervention, Outcome 1 Proportion

of participants cleared or almost cleared in the short term. . . 143 Analysis 4.2. Comparison 4 Etretinate v/s placebo or no treatment with PUVA as co-intervention, Outcome 2 Proportion

of participants with adverse effects in the short term. . . 143 Analysis 5.1. Comparison 5 Alitretinoin v/s placebo, Outcome 1 Proportion of participants achieving a 50% reduction in

disease severity in the short-term. . . 144 Analysis 5.2. Comparison 5 Alitretinoin v/s placebo, Outcome 2 Proportion of participants with adverse effects in the short

term. . . 145 Analysis 6.1. Comparison 6 Etretinate v/s PUVA, Outcome 1 Proportion of participants cleared or almost cleared in the

short term. . . 145 Analysis 6.2. Comparison 6 Etretinate v/s PUVA, Outcome 2 Proportion of participants with adverse effects in the short

term. . . 146 Analysis 7.1. Comparison 7 Oral cyclosporine v/s placebo, Outcome 1 Proportion of participants with adverse effects in

the short term. . . 146 Analysis 8.1. Comparison 8 Etanercept v/s placebo, Outcome 1 Proportion of participants cleared or almost cleared in the

short term. . . 147 Analysis 9.1. Comparison 9 Ustekinumab v/s placebo, Outcome 1 Proportion of participants achieving a 50% reduction

indisease severity in the short-term. . . 147 Analysis 10.1. Comparison 10 Guselkumab v/s placebo, Outcome 1 Proportion of participants cleared or almost cleared in

the short term. . . 148 Analysis 10.2. Comparison 10 Guselkumab v/s placebo, Outcome 2 Proportion of participants achieving a 50% reduction

indisease severity. . . 149 i Interventions for chronic palmoplantar pustulosis (Review)

Analysis 10.3. Comparison 10 Guselkumab v/s placebo, Outcome 3 Proportion of participants with adverse effects serious or severe enough to have caused withdrawal of the participants from the study.. . . 149 Analysis 11.1. Comparison 11 Secukinumab v/s placebo, Outcome 1 Proportion of participants with adverse effects in the

short term. . . 150 Analysis 11.2. Comparison 11 Secukinumab v/s placebo, Outcome 2 Proportion of participants achieving a 50% reduction

in disease severity in the short-term. . . 151 Analysis 12.1. Comparison 12 Tetracyclines v/s placebo, Outcome 1 Proportion of participants with adverse effects in the

short term. . . 151 Analysis 13.1. Comparison 13 Colchicine v/s placebo, Outcome 1 Proportion of participants with adverse effects in the

short term. . . 152 152 ADDITIONAL TABLES . . . . 157 APPENDICES . . . . 158 CONTRIBUTIONS OF AUTHORS . . . . 159 DECLARATIONS OF INTEREST . . . . 159 SOURCES OF SUPPORT . . . . 159 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . .

ii Interventions for chronic palmoplantar pustulosis (Review)

[Intervention Review]

Interventions for chronic palmoplantar pustulosis

Grace Obeid1, Giao Do1, Lisa Kirby2, Carolyn Hughes3, Emilie Sbidian1, Laurence Le Cleach1

1Department of Dermatology, Hôpital Henri Mondor, Créteil, France.²General Medicine, Wirral University Teaching Hospital NHS Foundation Trust, Liverpool, UK.3c/o Cochrane Skin Group, The University of Nottingham, Nottingham, UK

Contact address: Grace Obeid, Department of Dermatology, Hôpital Henri Mondor, 51 Avenue du Maréchal de Lattre de Tassigny, Créteil, 94000, France.obeid_grace@yahoo.com.

Editorial group: Cochrane Skin Group.

Publication status and date: New, published in Issue 4, 2019.

Citation: Obeid G, Do G, Kirby L, Hughes C, Sbidian E, Le Cleach L. Interventions for chronic palmoplantar pustulosis.Cochrane Database of Systematic Reviews 2019, Issue 4. Art. No.: CD011628. DOI: 10.1002/14651858.CD011628.pub2.

A B S T R A C T Background

Palmoplantar pustulosis is a chronic inflammatory disease in which sterile pustules appear abruptly on the palms of the hands and the soles of the feet. These pustules relapse over time possibly in conjunction with hyperkeratosis, erythema, scaling, and fissuring. Whether palmoplantar pustulosis is a variant of psoriasis or is a separate condition is still subject to discussion.

Objectives

To assess the effects of interventions for chronic palmoplantar pustulosis both to induce and maintain complete remission.

Search methods

We searched the following databases up to March 2019: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We also searched five trials registers, and checked the reference lists of the included studies for further references to relevant randomised controlled trials. We searched trials databases of relevant pharmaceutical companies, as well as relevant trials submitted to the U.S. Food and Drug Administration for drug registration. We contacted research leaders in the field to investigate additional published or unpublished data, and we contacted authors of reports of included studies published in or after 2007 in order to request information regarding the primary outcomes of interest to our review.

Selection criteria

We considered randomised controlled trials (RCTs) assessing topical, systemic therapy, combination of topical and/or systemic therapy, non-pharmacological therapy compared with placebo or no intervention, or between each other.

Data collection and analysis

We used the standard methodological procedures expected by Cochrane. Our primary outcomes were: proportion of participants cleared or almost cleared, and proportion of participants with adverse effects serious or severe enough to have caused withdrawal. Our secondary outcomes included: proportion of participants with at least 50% improvement of disease severity, and proportion of participants with adverse effects.

1 Interventions for chronic palmoplantar pustulosis (Review)

Main results

We included 36 studies involving 1504 participants. The mean age of the participants across studies was 49 (34 to 63 years) and 26 % were males. Mean duration of the included trials was 11 weeks (3 to 24 weeks). Twenty studies were at high risk of bias in at least one domain (mainly performance and detection bias).

Our primary outcome “proportion of participants with adverse effects serious or severe enough to have caused withdrawal” was reported by two of the included studies discussed below.

For topical treatment, one trial (188 participants) showed low quality evidence that a topical vitamin D derivative (maxacalcitrol) may be more effective to achieve clear or almost clear status compared to placebo at 8 weeks (RR 7.83, 95% CI 1.85 to 33.12). Proportion of participants with adverse effects was similar in both groups (RR 0.87, 0.64 to 1.19, moderate quality evidence) and included mild local irritation and pruritus. From one trial (19 participants) it is uncertain whether a superpotent corticosteroid (triamcinolone acetonide 0.1% cream) with occlusive dressing improves clearance when compared with another superpotent corticosteroid (clobetasol 0.05% cream) without occlusion (RR 1.20, 95% CI 0.72 to 2.00) because the certainty of this evidence was very low. No adverse effects was observed in either group. Proportion of participants achieving 50% improvement of disease severity was not reported for either comparison.

For phototherapy, only very low quality evidence was available. Two within-participant trials assessed PUVA therapy versus placebo or no treatment but there was no available data to undertake analysis taking into account the within-participant variability. In one RCT, clearance was obtained in 12/22 PUVA treated sides and 0/22 with no treatment; in addition, 10/22 versus 13/22 sides, respectively, showed 50% reduction in disease severity at 8 weeks. In another study, clearance was not achieved in any palms and soles for local PUVA therapy or placebo at 8 weeks, and proportion of participants achieving 50% reduction in disease severity was not reported. Adverse effects were reported with oral PUVA (including nausea and non-purulent conjunctivitis) and with local PUVA (including blistering and pruritus).

Very low-quality evidence from the comparison UVA1 versus UVB was based on one within-participant trial but there was no available data to undertake analysis: 22/33 treated sides were markedly improved with UVA1 compared to 11/33 with UVB. Burning or hyperpigmentation was reported in 6/33 and 2/33 of the treated sides, respectively. Proportion of participants achieving a 50% reduction in disease severity was not reported.

Concerning the systemic retinoid alitretinoin, one trial (33 participants) showed alitretinoin probably makes little or no difference to risk of achieving 50% reduction in disease severity (RR 0.69; 95% CI 0.36 to 1.30; moderate quality evidence) and a similar number of adverse events were reported in both groups including headache and nasopharyngitis (RR 0.84, 0.61 to 1.17). Proportion of participants cleared or almost cleared was not reported.

Concerning biologic treatments, we found low quality evidence that there was no evidence of a difference between etanercept (anti TNF) and placebo in achieving clear or almost clear status (one study, 15 participants, RR 1.64, 95% CI 0.08 to 34.28); proportion of participants achieving 50% improvement of disease severity was not measured. We also found low quality evidence that there was no evidence of a difference between ustekinumab (anti IL17-IL23) and placebo in achieving a 50% reduction in disease severity (one study, 33 participants, RR 0.48, 95% CI 0.11 to 2.13); proportion of clear or almost clear participants was not reported. Occurence of adverse effects were not reported in these trials. We found respectively low and moderate quality evidence that there was no evidence of a difference between guselkumab (antiI L23) and placebo in achieving clear or almost clear status (one study, 49 participants, RR 2.88 95% CI 0.64 to 12.90); and in achieving 50% improvement of disease severity (one study, 49 participants,RR 2.88 95% CI 0.24 to 6.69).

There was a low level of evidence that there was no difference between guselkumab and placebo in the proportion of participants with adverse effects serious or severe enough to have caused withdrawal of the participants from the study (one study, 49 participants, RR 2.88, 95% CI 0.32, 25.80)

We found moderate quality of evidence that secukinumab (anti IL17) was superior to placebo in achieving 50% improvement of disease severity (one study, 157 participants, RR 1.55

95% CI 1.02 to 2.35);

There was a moderate level of evidence that the proportion of participants with adverse effects serious or severe enough to have caused withdrawal of the participants from the study was superior with secukinumab compared to placebo (one study, 157 participants, RR 3.29, 95% CI 1.40 to 7.75)

2 Interventions for chronic palmoplantar pustulosis (Review)

Authors’ conclusions

We found low quality evidence that topical vitamin D derivative (maxacalcitrol) was more effective than placebo in the short term. Evidence is lacking in terms of this review’s chosen outcomes for major treatments used in chronic palmoplantar pustulosis such as superpotent corticosteroids, phototherapy, acitretin, methotrexate and ciclosporin. The quality of evidence for interventions assessed was moderate to very low due to high risk of bias and imprecision. We found a moderate level of evidence that alitretinoin is no more effective than placebo. Low quality evidence that three biological treatments (etanercept (anti TNF)ustekinumab (anti IL17-IL23) and guselkumab) were no more effective than placebo.

Moderate quality of evidence that secukinumab (anti IL17) was superior to placebo and that

the proportion of participants with adverse effects serious or severe enough to have caused withdrawal of the participants from the study was superior with secukinumab compared to placebo

Future trials should assess efficacy of commonly used treatments for chronic palmoplantar pustulosis using among outcomes a validated scale for severity assessment, quality of life and work impairment assessment.

P L A I N L A N G U A G E S U M M A R Y

Treating long-term palmoplantar pustulosis (long-term pustules on the hands and feet) Review question

We wanted to assess different treatments for small, pus-filled blisters on the hands and feet (palmoplantar pustulosis), to find out which worked best, what side effects they had and whether they stopped the condition from coming back. We reviewed the evidence about all treatments used and found 34 studies.

Background

Palmoplantar pustulosis is a condition in which small, pus-filled blisters develop on the palms of the hands and the soles of the feet. The condition affects a person’s quality of life. Over time, the skin becomes thicker, redder and may develop cracks or flake off as scales. It affects more women than men and usually appears in later life, between 45 and 65 years.

There is no cure for palmoplantar pustulosis and no standard treatment. Symptoms are treated with topical medicines (put on the skin surface; usually corticosteroids), systemic medicines (injected or taken by mouth; usually medicines based on vitamin A or D) or phototherapy (ultraviolet light treatment, called PUVA therapy).

Study characteristics

This review is up-to-date to March 2019.

The 36 studies involved 1504 adults (mostly women) aged 34 to 63 years (average age 49 years). In 17 studies participants had had palmoplantar pustulosis from 2 years to 16 years (average 6.4 years). The condition’s severity was reported differently by all studies. In 17 studies, the pustulosis affected the palms and soles in 250 participants (57%)

Different treatments were used for different lengths of time, ranging from 3 to 24 weeks (average 11 weeks).

We wanted to find out the numbers of participants whose skin became clear or almost clear of pustules after treatment, and how many participants dropped out of a study because of side effects.

Of 36 studies, 17 were funded by pharmaceutical companies.

Key results

We found low quality evidence that topical vitamin D derivative (maxacalcitrol) may work better than placebo, and the number of side effects is probably similar in both groups, including itching and irritation. We are uncertain whether a superpotent corticosteroid cream (triamcinolone acetonide 0.1%) used with a dressing improves clearance more than another superpotent corticosteroid cream (clobetasol 0.05%) used with no dressing because the quality of evidence was very low. No side effects were seen in either group. None of these studies measured the proportion of participants achieving 50% improvement of disease severity.

3 Interventions for chronic palmoplantar pustulosis (Review)

Only very low quality evidence was available for the comparison of PUVA therapy versus placebo or no treatment, and we weren’t able to undertake any analyses assessing clearance or disease severity due to the limited information available. Low-quality evidence showed PUVA may be associated with more side effects than placebo treatment, and they include skin blisters and feeling sick. When comparing UVA1 to UVB, very low quality evidence showed that the skin treated with UVA1 cleared more than with UVB but there was limited information available to undertake an analysis. Similar cases of burning and the development of dark patches of skin were reported with both treatments. Proportion of participants achieving a 50% reduction in disease severity was not reported.

One study showed alitretinoin probably makes little or no difference in disease severity when compared to placebo (moderate quality). A similar number of side effects were reported in both groups including headaches. The proportion of participants cleared or almost cleared was not reported.

Low quality evidence showed that a biological treatment (etanercept) was no more effective than placebo in acheiving clearance of skin; however, proportion of participants achieving 50% improvement of disease severity was not measured. We also found low quality evidence that there is no evidence to support that twoothers biological treatment (ustekinumab, guselkumab) reduces disease severity more than placebo. Proportion of clear or almost clear participants was not reported. We are not certain whether any side effects occured in these studies.

Moderate quality of evidence showed that secukinumab (anti IL17) was superior to placebo in achieving 50% improvement of disease severity and that

serious side effects was more frequent with secukinumab compared to placebo

Quality of the evidence

We rated this as low or very low in most studies; usually because of small numbers of participants and results that had a wide margin of error. Some studies were rated low quality because not all the results were reported. Several studies had a high risk of bias for blinding because the participants and assessors knew which treatment each participant was having.

4 Interventions for chronic palmoplantar pustulosis (Review)

S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]

Triamcinolone acetonide 0.1% cream with occlusive dressing compared to clobetasol cream 0.05% cream for for chronic palmoplantar pustulosis Patient or population: f or chronic palm oplantar pustulosis

Setting: not reported

Intervention: triam cinolone acetonide 0.1% cream with occlusive dressing Comparison: clobetasol cream 0.05% cream

Outcomes Anticipated absolute effects∗(95% CI) Relative effect (95% CI)

of participants (studies)

Certainty of the evi-dence

(GRADE)

Comments Risk with clobetasol

cream 0.05% cream

Risk with triamci-nolone acetonide 0.1% cream with occlusive dressing

Proportion of partici-pants cleared or alm ost cleared

assessed with: over-all assessm ent 5 point scale at 4 weeks

See com m ent See com m ent RR 1.20 (0.72 to 2.00) 19 (1 RCT)

⊕

Very lowa

Within participant study, lef t or right side were random ized. In the triam cinolone side, 13/ 19 cleared or alm ost cleared com pared to 3/ 19 in the clobeta-sol side (p=0.26, when within-participant unit of analysis is taken into account)

Proportion of participants with adverse ef -f ects serious or severe enough to have caused withdrawal - not re-ported - - - Not reported 5 In te rv e n ti o n s fo r c h ro n ic p a lm o p la n ta r p u st u lo si s (R e v ie w ) C o p y ri g h t © 2 0 1 9 T h e C o c h ra n e C o lla b o ra ti o n . P u b lis h e d b y Jo h n W ile y & S o n s, L td .

Proportion of partici-pants with at least 50% im provem ent of their quality of lif e - not m ea-sured

- - - Not m easured

Proportion of partici-pants achieving a 50% reduction in disease severity - not reported

- - - Not reported

Proportion of partici-pants without relapse in the long-term - not m ea-sured

- - - Not m easured

Proportion of participants with adverse ef -f ects

See com m ent See com m ent not estim able 19 (1 RCT)

⊕

Very lowa

Within participant study, lef t or right side were random ized. The study author reported no adverse events and no skin atrophy in both groups

Ease of com pliance to an intervention or a treatm ent - not m ea-sured

- - - Not m easured

* The risk in the intervention group (and its 95% conf idence interval) is based on the assum ed risk in the com parison group and the relative effect of the intervention (and its 95% CI).

CI: Conf idence interval; RR: Risk ratio; OR: Odds ratio;

6 In te rv e n ti o n s fo r c h ro n ic p a lm o p la n ta r p u st u lo si s (R e v ie w ) C o p y ri g h t © 2 0 1 9 T h e C o c h ra n e C o lla b o ra ti o n . P u b lis h e d b y Jo h n W ile y & S o n s, L td .

GRADE Working Group grades of evidence

High certainty: We are very conf ident that the true ef f ect lies close to that of the estim ate of the ef f ect

M oderate certainty: We are m oderately conf ident in the ef f ect estim ate: The true ef f ect is likely to be close to the estim ate of the ef f ect, but there is a possibility that it is

substantially dif f erent

Low certainty: Our conf idence in the ef f ect estim ate is lim ited: The true ef f ect m ay be substantially dif f erent f rom the estim ate of the ef f ect

Very low certainty: We have very little conf idence in the ef f ect estim ate: The true ef f ect is likely to be substantially dif f erent f rom the estim ate of ef f ect

a Downgraded by three levels to very low quality evidence. Two levels due to study lim itations because of high risk of bias f or blinding and at unclear risk of bias f or other item s, and one level due to im precision because the com parison was assessed in single sm all study

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