A systematic review investigating at what proportion clinical images are shared in prospective randomized controlled trials involving patients with psoriasis and biological agents

Figures & data

Figure 1. PRISMA flow chart. PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses. #All excluded reports are available in Table S2. From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71.doi: 10.1136/bmj.n71.

Table 1. List of investigations (n = 35) with included patient images in running manuscripts and supplements.

First author	Year	Journal	Primary outcome	Time to primary outcome	Number of randomized patients	Number of patients depicted in manuscript^#	Number of patient images in manuscript^#	Proportion of depicted patients^#	Digital object identifier link
Chaudhariet al. (42)	2001	Lancet	PGA	10 weeks	33	3	6	9.1%	https://doi.org/10.1016/s0140-6736(00)04954-0
Gottlieb et al. (64)	2003	Arch Dermatol	PASI 75	12 weeks	112	1	3	0.9%	https://doi.org/10.1001/archderm.139.12.1627
Lebwohl et al. (83)	2003	N Engl J Med	PASI 75	12 weeks	597	2	4	0.3%	https://doi.org/10.1056/NEJMoa030002
Leonardi et al. (89)	2005	J Am Acad Dermatol	PASI 75	12 weeks	498	1	4	0.2%	https://doi.org/10.1016/j.jaad.2004.09.029
Menter et al. (96)	2005	Arch Dermatol	PASI 75	12 weeks	556	1	3	0.2%	https://doi.org/10.1001/archderm.141.1.31
Papp et al. (118)	2005	Br J Dermatol	PASI 75	12 weeks	611	2	6	0.3%	https://doi.org/10.1111/j.1365-2133.2005.06688.x
Reich et al. (132)	2005	Lancet	PASI 75	10 weeks	378	1	4	0.3%	https://doi.org/10.1016/S0140-6736(05)67566-6
Papp et al. (111)	2006	Int J Dermatol	Other outcome	12 weeks	686	3	6	0.4%	https://doi.org/10.1111/j.1365-4632.2006.02777.x
Menter et al. (97)	2008	J Am Acad Dermatol	PASI 75	16 weeks	1212	1	3	0.1%	https://doi.org/10.1016/j.jaad.2007.09.010
Papp et al. (112)	2008	Lancet	PASI 75	12 weeks	1230	1	3	0.1%	https://doi.org/10.1016/S0140-6736(08)60726-6
Wolf et al. (165)	2009	Br J Dermatol	Percentage improvement in PASI	6 weeks	5	1	2	20.0%	https://doi.org/10.1111/j.1365-2133.2008.08926.x
Asahina et al. (23)	2010	J Dermatol	PASI 75	16 weeks	169	1	5	0.6%	https://doi.org/10.1111/j.1346-8138.2009.00748.x
Thaci et al. (154)	2010	Br J Dermatol	PASI 75	16 weeks	730	1	4	0.1%	https://doi.org/10.1111/j.1365-2133.2010.09791.x
Bissonnette et al. (31)	2011	JEADV	m-PPPASI 75	14 weeks	24	4	12	16.7%	https://doi.org/10.1111/j.1468-3083.2011.03984.x
Leonardi et al. (86)	2011	Arch Dermatol	hfPGA	16 weeks	72	1	4	1.4%	https://doi.org/10.1001/archdermatol.2010.384
Tsai et al. (157)	2011	J Dermatol Sci	PASI 75	12 weeks	121	1	6	0.8%	https://doi.org/10.1016/j.jdermsci.2011.05.005
Wolf et al. (166)	2011	Photodermatol Photoimmunol Photomed	Percentage improvement in PASI	6 weeks	4	1	12	25.0%	https://doi.org/10.1111/j.1600-0781.2011.00594.x
Igarashi et al. (71)	2012	J Dermatol	PASI 75	12 weeks	158	2	6	1.3%	https://doi.org/10.1111/j.1346-8138.2011.01347.x
Papp et al. (114)^†	2012	N Engl J Med	Percentage improvement in PASI	12 weeks	198	1	6	0.5%	https://doi.org/10.1056/NEJMoa1109017
Wolf et al. (167)	2012	Br J Dermatol	Percentage improvement in PASI	6 weeks	10	1	12	10.0%	https://doi.org/10.1111/j.1365-2133.2011.10616.x
Ortonne et al. (106)	2013	Br J Dermatol	NAPSI	24 weeks	72	1	4	1.4%	https://doi.org/10.1111/bjd.12060
Saraceno et al. (142)	2013	Expert Opin Biol Ther	NAPSI	12 and 24 weeks	72	1	2	1.4%	https://doi.org/10.1517/14712598.2013.736960
Zhu et al. (171)	2013	J Drugs Dermatol	PASI 75	12 weeks	322	6	1	1.9%	NA
Sofen et al. (146)	2014	J Allergy Clin Immunol	NA	24 weeks	24	2	4	8.3%	https://doi.org/10.1016/j.jaci.2014.01.025
Kopp et al. (75)	2015	Nature	Other outcome	NA	77	1	12	1.3%	https://doi.org/10.1038/nature14175
Krueger et al. (76)	2015	J Allergy Clin Immunol	Other outcome	NA	39	2	4	5.1%	https://doi.org/10.1016/j.jaci.2015.01.018
Papp et al. (108)	2015	Br J Dermatol	PASI 75	16 weeks	355	1	3	0.3%	https://doi.org/10.1111/bjd.13932
Bagel et al. (26)^†	2017	J Am Acad Dermatol	PSSI 90	12 weeks	102	2	4	2.0%	https://doi.org/10.1016/j.jaad.2017.05.033
Gottlieb et al. (58)	2017	J Am Acad Dermatol	ppIGA 0 or 1	16 weeks	205	4	12	2.0%	https://doi.org/10.1016/j.jaad.2016.07.058
Reich et al. (135)^†	2017	Lancet	PASI 75 + PGA	12 weeks	772	1	6	0.1%	https://doi.org/10.1016/S0140-6736(17)31279-5
Khattri et al. (74)	2018	J Clin Aesthet Dermatol	PatGA	12 weeks	12	3	12	25.0%	NA
Nemoto et al. (102)	2018	Br J Dermatol	Other outcome	24 weeks	24	1	3	4.2%	https://doi.org/10.1111/bjd.16236
Ryan et al. (141)	2018	Br J Dermatol	sPGA-G	12 weeks	149	1	3	0.7%	https://doi.org/10.1111/bjd.16736
Reich et al. (138)	2019	Br J Dermatol	NAPSI	16 weeks	198	2	16	1.0%	https://doi.org/10.1111/bjd.17351
Yu et al. (169)	2019	Int Immunopharmacol	Percentage improvement in PASI	24 weeks	30	2	6	6.7%	https://doi.org/10.1016/j.intimp.2019.05.042
					9857	60	203	0.6%

^#Running manuscript and all supplementary material combined. † Image material were made available in supplementary material.

Arch Dermatol: Archives of dermatology; Br J Derm: British Journal of Dermatology; Expert Opin Biol Ther: Expert Opinion on Biological Therapy; Int Immunopharmacol: International immunopharmacology; Int J Dermatol: International journal of dermatology; J Allergy Clin Immunol: Journal of Allergy and Clinical Immunology; J Clin Aesthet Dermatol: Journal of Clinical and Esthetic Dermatology; J Dermatol Sci: Journal of dermatological science; J Dermatol: Journal of Dermatology; J Drugs Dermatol: Journal of Drugs in Dermatology; J Am Acad Dermatol: Journal of the American Academy of Dermatology; JEADV: Journal of the European Academy of Dermatology and Venereology; N Engl J Med: New England Journal of Medicine; Photodermatol Photoimmunol Photomed: Photodermatology Photoimmunology and Photomedicine. Primary outcome abbreviations: hfPGA: Physician’s Global Assessment of hands and/or feet; m-PPPASI 75: 75% improvement in the modified palmoplantar psoriasis area and severity index; NA: not available or not available; NAPSI: Nail Psoriasis Severity Index; PASI 75: 75% improvement of the PASI value as compared to baseline; PASI: Psoriasis area severity index; PatGA: Patient’s Global Assessment; PGA: Physician Global Assessment; ppIGA 0 or 1: Palmoplantar Investigator’s Global Assessment (ppIGA) 0 (clear) or 1 (almost clear/minimal); PSSI 90: 90% improvement of Psoriasis Scalp Severity Index; sPGA-G: static Physician’s Global Assessment of Genitalia.

Table 2. Proportion of depicted patients in the five journals with most randomized patients.

Journal	Number of investigations	Number of randomized patients	Number of patients depicted in running manuscript	Number of patient images in running manuscript	Number of patients depicted in supplements*	Number of patient images in supplements*	Proportion of depicted patients^#
Br J Dermatol	43	15,124	11	53	0	0	0.08%
J Am Acad Dermatol	20	11,851	6	19	2	4	0.07%
Lancet	14	11,440	5	13	1	6	0.05%
N Engl J Med	12	10,265	2	4	1	6	0.03%
JEADV	10	2,129	4	12	0	0	0.19%
	99	50,809	28	101	4	16	0.06%

*Including video supplements.

^#Including both running manuscript and any supplementary material.

Br J Dermatol: British Journal of Dermatology; J Am Acad Dermatol: Journal of the American Academy of Dermatology; JEADV: Journal of the European Academy of Dermatology and Venereology; N Engl J Med: New England Journal of Medicine.

Chaudhari U, Romano P, Mulcahy LD, et al. Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. Lancet. 2001;357(9271):1842–1847. doi: 10.1016/s0140-6736(00)04954-0.

 PubMed Web of Science ®Google Scholar

Gottlieb AB, Matheson RT, Lowe N, et al. A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol. 2003;139(12):1627–1632; discussion 1632. doi: 10.1001/archderm.139.12.1627.

 PubMed Web of Science ®Google Scholar

Lebwohl M, Tyring SK, Hamilton TK, et al. A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med. 2003;349(21):2004–2013. doi: 10.1056/NEJMoa030002.

 PubMed Web of Science ®Google Scholar

Leonardi CL, Papp KA, Gordon KB, et al. Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial. J Am Acad Dermatol. 2005;52(3 Pt 1):425–433. doi: 10.1016/j.jaad.2004.09.029.

 PubMed Web of Science ®Google Scholar

Menter A, Gordon K, Carey W, et al. Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis. Arch Dermatol. 2005;141(1):31–38. doi: 10.1001/archderm.141.1.31.

 PubMed Web of Science ®Google Scholar

Papp KA, Tyring S, Lahfa M, et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005;152(6):1304–1312. doi: 10.1111/j.1365-2133.2005.06688.x.

 PubMed Web of Science ®Google Scholar

Reich K, Nestle FO, Papp K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005;366(9494):1367–1374. doi: 10.1016/S0140-6736(05)67566-6.

 PubMed Web of Science ®Google Scholar

Papp KA, Bressinck R, Fretzin S, et al. Safety of efalizumab in adults with chronic moderate to severe plaque psoriasis: a phase IIIb, randomized, controlled trial. Int J Dermatol. 2006;45(5):605–614. doi: 10.1111/j.1365-4632.2006.02777.x.

 PubMed Web of Science ®Google Scholar

Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58(1):106–115. doi: 10.1016/j.jaad.2007.09.010.

 PubMed Web of Science ®Google Scholar

Papp KA, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625):1675–1684. doi: 10.1016/S0140-6736(08)60726-6.

 PubMed Web of Science ®Google Scholar

Wolf P, Hofer A, Legat FJ, et al. Treatment with 311-nm ultraviolet B accelerates and improves the clearance of psoriatic lesions in patients treated with etanercept. Br J Dermatol. 2009;160(1):186–189. doi: 10.1111/j.1365-2133.2008.08926.x.

 PubMed Web of Science ®Google Scholar

Asahina A, Nakagawa H, Etoh T, et al. Adalimumab in japanese patients with moderate to severe chronic plaque psoriasis: efficacy and safety results from a phase II/III randomized controlled study. J Dermatol. 2010;37(4):299–310. doi: 10.1111/j.1346-8138.2009.00748.x.

 PubMed Web of Science ®Google Scholar

Thaci D, Ortonne JP, Chimenti S, et al. A phase IIIb, multicentre, randomized, double-blind, vehicle-controlled study of the efficacy and safety of adalimumab with and without calcipotriol/betamethasone topical treatment in patients with moderate to severe psoriasis: the BELIEVE study. Br J Dermatol. 2010;163(2):402–411. doi: 10.1111/j.1365-2133.2010.09791.x.

 PubMed Web of Science ®Google Scholar

Bissonnette R, Poulin Y, Guenther L, et al. Treatment of palmoplantar psoriasis with infliximab: a randomized, double-blind placebo-controlled study. J Eur Acad Dermatol Venereol. 2011;25(12):1402–1408. doi: 10.1111/j.1468-3083.2011.03984.x.

 PubMed Web of Science ®Google Scholar

Leonardi C, Langley RG, Papp K, et al. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011;147(4):429–436. doi: 10.1001/archdermatol.2010.384.

 PubMed Web of Science ®Google Scholar

Tsai TF, Ho JC, Song M, et al. Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in taiwanese and korean patients (PEARL). J Dermatol Sci. 2011;63(3):154–163. doi: 10.1016/j.jdermsci.2011.05.005.

 PubMed Web of Science ®Google Scholar

Wolf P, Hofer A, Weger W, et al. 311 nm ultraviolet B-accelerated response of psoriatic lesions in adalimumab-treated patients. Photodermatol Photoimmunol Photomed. 2011;27(4):186–189. doi: 10.1111/j.1600-0781.2011.00594.x.

 PubMed Web of Science ®Google Scholar

Igarashi A, Kato T, Kato M, et al. Efficacy and safety of ustekinumab in japanese patients with moderate-to-severe plaque-type psoriasis: long-term results from a phase 2/3 clinical trial. J Dermatol. 2012;39(3):242–252. doi: 10.1111/j.1346-8138.2011.01347.x.

 PubMed Web of Science ®Google Scholar

Papp KA, Leonardi C, Menter A, et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012;366(13):1181–1189. doi: 10.1056/NEJMoa1109017.

 PubMed Web of Science ®Google Scholar

Wolf P, Weger W, Legat FJ, et al. Treatment with 311-nm ultraviolet B enhanced response of psoriatic lesions in ustekinumab-treated patients: a randomized intraindividual trial. Br J Dermatol. 2012;166(1):147–153. doi: 10.1111/j.1365-2133.2011.10616.x.

 PubMed Web of Science ®Google Scholar

Ortonne JP, Paul C, Berardesca E, et al. A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis. Br J Dermatol. 2013;168(5):1080–1087. doi: 10.1111/bjd.12060.

 PubMed Web of Science ®Google Scholar

Saraceno R, Pietroleonardo L, Mazzotta A, et al. TNF-alpha antagonists and nail psoriasis: an open, 24-week, prospective cohort study in adult patients with psoriasis. Expert Opin Biol Ther. 2013;13(4):469–473. doi: 10.1517/14712598.2013.736960.

 PubMed Web of Science ®Google Scholar

Zhu X, Zheng M, Song M, et al. Efficacy and safety of ustekinumab in chinese patients with moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS). J Drugs Dermatol. 2013;12:166–174.

 PubMed Web of Science ®Google Scholar

Sofen H, Smith S, Matheson RT, et al. Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis. J Allergy Clin Immunol. 2014;133(4):1032–1040. doi: 10.1016/j.jaci.2014.01.025.

 PubMed Web of Science ®Google Scholar

Kopp T, Riedl E, Bangert C, et al. Clinical improvement in psoriasis with specific targeting of interleukin-23. Nature. 2015;521(7551):222–226. doi: 10.1038/nature14175.

 PubMed Web of Science ®Google Scholar

Krueger JG, Ferris LK, Menter A, et al. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2015;136(1):116–124 e117. doi: 10.1016/j.jaci.2015.01.018.

 PubMed Web of Science ®Google Scholar

Papp K, Thaci D, Reich K, et al. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol. 2015;173(4):930–939. doi: 10.1111/bjd.13932.

 PubMed Web of Science ®Google Scholar

Bagel J, Duffin KC, Moore A, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol. 2017;77(4):667–674. doi: 10.1016/j.jaad.2017.05.033.

 PubMed Web of Science ®Google Scholar

Gottlieb A, Sullivan J, van Doorn M, et al. Secukinumab shows significant efficacy in palmoplantar psoriasis: results from GESTURE, a randomized controlled trial. J Am Acad Dermatol. 2017;76(1):70–80. doi: 10.1016/j.jaad.2016.07.058.

 PubMed Web of Science ®Google Scholar

Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017;390(10091):276–288. doi: 10.1016/S0140-6736(17)31279-5.

 PubMed Web of Science ®Google Scholar

Khattri S, Goldblum O, Solotkin K, et al. Early onset of clinical improvement with ixekizumab in a randomized, open-label study of patients with moderate-to-severe plaque psoriasis. J Clin Aesthet Dermatol. 2018;11:33–37.

 PubMedGoogle Scholar

Nemoto O, Hirose K, Shibata S, et al. Safety and efficacy of guselkumab in japanese patients with moderate-to-severe plaque psoriasis: a randomized, placebo-controlled, ascending-dose study. Br J Dermatol. 2018;178(3):689–696. doi: 10.1111/bjd.16236.

 PubMed Web of Science ®Google Scholar

Ryan C, Menter A, Guenther L, et al. Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis. Br J Dermatol. 2018;179(4):844–852. doi: 10.1111/bjd.16736.

 PubMed Web of Science ®Google Scholar

Reich K, Sullivan J, Arenberger P, et al. Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial. Br J Dermatol. 2019;181(5):954–966. doi: 10.1111/bjd.17351.

 PubMed Web of Science ®Google Scholar

Yu Q, Tong Y, Cui L, et al. Efficacy and safety of etanercept combined plus methotrexate and comparison of expression of pro-inflammatory factors expression for the treatment of moderate-to-severe plaque psoriasis. Int Immunopharmacol. 2019;73:442–450. doi: 10.1016/j.intimp.2019.05.042.

 PubMed Web of Science ®Google Scholar