Table 1.

Studies (clinical trials and RWEs) on guselkumab

Clinical trial
Authors, year	Study type	No. of prt	Study design (study groups)	Study period	Efficacy	Safety	Ref
Gordon et al., 2015	Phase II, dose-ranging, randomized, double-blind, placebo-controlled, active-comparator trial	293	1)Guselkumab 5 mg at weeks 0 and 4 and every 12 weeks thereafter 2)Guselkumab 15 mg every 8 weeks 3)Guselkumab 50 mg at weeks 0 and 4 and every 12 weeks thereafter 4)Guselkumab 100 mg every 8 weeks 5)Guselkumab 200 mg at weeks 0 and 4 and every 12 weeks thereafter 6)Placebo (at week 16: crossed over to receive guselkumab at a dose of 100 mg every 8 weeks) 7)Adalimumab (standard dosage for psoriasis)	40 weeks	Week 16: significantly higher proportion of patients with at least PASI75 score in each guselkumab group than in the placebo group (p < 0.001 for all comparisons) Week 40: significantly higher proportion of patients with a PGA score of 0 or 1 in the 50-mg, 100-mg, and 200-mg guselkumab groups than in the adalimumab group (71%, 77%, and 81%, respectively, vs. 49%) (p < 0.05 for all comparisons)	Infectious AEs (through week 16): guselkumab groups 20%, adalimumab, 12%, placebo 14%	10
Blauvelt et al., 2017	Phase III, multicenter, double-blinded, placebo- and active comparator-controlled VOYAGE 1	837	1)Guselkumab 100 mg at weeks 0, 4, 12, and every 8 weeks 2)Placebo at weeks 0, 4, and 12 followed by guselkumab 100 mg at weeks 16 and 20, and every 8 3)Adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks	44 weeks (first and second groups) 47 weeks (third group)	Guselkumab superior to placebo at week 16 (85.1% vs. 6.9% [IGA 0/1] and 73.3% vs. 2.9% [PASI 90]) (p < 0.001). Guselkumab superior to adalimumab for IGA 0/1 and PASI 90 at week 16 (85.1% vs. 65.9% and 73.3% vs. 49.7%), at week 24 (84.2% vs. 61.7% and 80.2% vs. 53.0%), at week 48 (80.5% vs. 55.4% and 76.3% vs. 47.9%) (p < 0.001)	AEs rates and types (serious ones included), and abnormal laboratory results generally comparable between the 3 groups	11
Reich et al., 2017	Phase III, multicenter, double-blinded, placebo- and active comparator-controlled VOYAGE 2	992	1)Guselkumab 100 mg (weeks 0 and 4, then every 8 weeks) 2)Placebo → guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20) 3)Adalimumab (80 mg week 0, then 40 mg week 1, and every 2 weeks through week 23) Week 28: 1)Guselkumab PASI 90 or greater responders rerandomized to guselkumab or placebo with guselkumab after loss of response 2 + 3)Placebo → guselkumab responders and adalimumab responders received placebo, then guselkumab after loss of response. Nonresponders received guselkumab	72 weeks	Better persistence of response in guselkumab maintenance versus withdrawal groups (p < 0.001)	No discontinuation because of AEs No additional malignancy, NMSC, or MACE No AEs reported among the 16 retreated patients 1 serious infection reported in the maintenance group	12
Foley et al., 2018	Post-hoc analysis of 2 phase III trials (VOYAGE 1 and 2)	1829	1)Guselkumab 100 mg (weeks 0 and 4, then every 8 weeks) 2)Placebo > guselkumab 100 mg (at week 16) 3)Adalimumab 80 mg (week 0) and 40 mg (week 1, then every 2 weeks)	24 weeks	Higher proportion of patients with a ss-IGA score of 0 or 1 in the guselkumab group vs. placebo (81.8% vs. 12.4%, week 16), and vs. adalimumab (85.0% vs. 68.5%, week 24) (both p < 0.001) Higher proportion of patients with hf-PGA score of 0 or 1 in the guselkumab vs. placebo group (75.5% vs. 14.2%, week 16), and vs. adalimumab group (80.4% vs. 60.3%, week 24) Higher proportion of patients with f-PGA score of 0 or 1 in the guselkumab group vs. placebo (46.7% vs. 15.2%, week 16; p < 0.001), and vs. adalimumab (60.0% vs. 64.3%, week 24, p = 0.11)	N/A	44
Griffiths et al., 2018	Phase III, multicentre, double-blinded, placebo- and active comparator-controlled and open-label beyond week 52 VOYAGE 1	992	1)Guselkumab 100 mg at weeks 0, 4, 12, and every 8 weeks 2)Placebo at weeks 0, 4, and 12 followed by guselkumab 100 mg at weeks 16 and 20, and every 8 3)Adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks Placebo (at week 16) and adalimumab (at week 52) group patients crossed over to guselkumab Week 52: open-label guselkumab	100 weeks	Week 100: proportions of patients achieving PASI 75, PASI 90, PASI 100, IGA 0/1, and IGA 0 94.8%, 82.1%, 49.0%, 82.4%, and 53.8%, respectively (similar results for the placebo → guselkumab and adalimumab → guselkumab groups) Efficacy maintained during continuous treatment among guselkumab-treated patients Improved efficacy in adalimumab—> guselkumab group	AEs comparable among groups Higher proportion of ISRs in adalimumab versus guselkumab patients (6.9% vs. 2.6%)	13
Langley et al., 2018	Phase III, multicenter, randomized, double‐blind trial NAVIGATE	871	Week 0 and week 4: open‐label ustekinumab Week 16: if IGA ≥ 2 randomized 1)guselkumab 100 mg at weeks 16, 20 and every 8 weeks 2) ustekinumab continuation (at week 16 and every 12 weeks)	60 weeks	Significantly greater mean number of visits and proportion of patients with achievement of IGA 0/1 and at least a two-grade improvement (p < 0.001), and greater proportions of patients who achieved PASI 90, PASI100 and DLQI 0/1 (week 52) in the guselkumab group vs. the randomized ustekinumab group	Most frequent AE: infections After week 16, at least 1 AE in 64.4% of patients in the guselkumab group and 55.6% in the ustekinumab group At least 1 serious AE in 6.7% of patients in the guselkumab group and in 4.5% of the ustekinumab group	24
Ohtsuki et al., 2018	Phase III, multicenter randomized, double‐blind, placebo‐controlled trial	192	1)Guselkumab 50 mg 2)Guselkumab 100 mg 3)Placebo at weeks 0, 4, and every 8 weeks thereafter Week 16: placebo group crossed over to receive guselkumab 50 mg or 100 mg	52 weeks	Week 16: higher proportion of patients achieved IGA 0/1 (92.3% and 88.9% vs. 7.8%), PASI-75 (89.2% and 84.1% vs. 6.3%), and PASI-90 (70.8% and 69.8% vs. 0%) in the guselkumab 50 mg and 100 mg group versus placebo (p < 0.001) Improvement maintained through week 52	AEs incidences comparable among the 3 groups through week 16 No new safety issues observed until the end of the study Most commonly reported AE: nasopharyngitis	45
Sano et al., 2018	Phase III, single‐arm, open‐label, multicenter trial	24 (GPP and EP)	Open-label: guselkumab 50 mg weeks 0, 4, and every 8 weeks thereafter until week 52 From week 20: dose escalation for patients with a CGI rating of “no change” or “worsened” at any scheduled study visit	52 weeks	Week 16, proportions of GPP and EP patients achieving treatment success: 77.8% and 90.9%, respectively	Most common AE: nasopharyngitis (28.6%)	46
Puig et al., 2019	Phase 3, randomized, double-blind, placebo- and active-comparator-controlled trials VOYAGE 1 and 2	1803	(See VOYAGE 1 and VOYAGE 2)	28 weeks	Week 16: guselkumab versus placebo, percentage points or IGA 0/1 (in the Hispanic and non-Hispanic populations) 67.4 and 77.2; percentage points PASI90 59.2 and 69.2, respectively. Guselkumab versus adalimumab percentage points for IGA 0/1 25.9 and 17.5, PASI90 21.4 and 23.5, respectively Similar results at week 24	Only through weeks 16 and 28 greater AEs frequency in adalimumab versus guselkumab group in the Hispanic population	14
Reich et al., 2019	Phase 3, randomized, double-blind, placebo- and active-comparator-controlled trials VOYAGE 1 and 2	1829	(See VOYAGE 1 and VOYAGE 2)	28 weeks	Week 16: guselkumab versus adalimumab (in the Asian and non-Asian populations) percentage points for IGA 0/1 31.1 and 16.1, PASI90 24.9 and 23.2, respectively. Similar results at week 24	Similar safety profiles	15
Reich et al., 2019	Phase III, multicentre, double-blind, randomized, comparator-controlled trial ECLIPSE	1048	1)Guselkumab 100 mg at weeks 0 and 4 then every 8 weeks 2)Secukinumab 300 mg at weeks 0, 1, 2, 3, and 4, and then every 4 weeks	56 weeks	Week 48: greater proportion of patients with a PASI 90 response in the guselkumab group than in the secukinumab group (84% vs. 70%; p < 0.0001)	Safety profiles similar between the 2 groups Most common AEs: infections (nasopharyngitis and upper respiratory tract)	25
Terui et al., 2019	Phase III, randomized, double-blind, multicenter, placebo-controlled trial	159 (PPP)	1)Guselkumab 100 mg weeks 0, 4, and 12, and every 8 weeks thereafter 2)Guselkumab 200 mg, weeks 0, 4, and 12, and every 8 weeks thereafter 3)Placebo at weeks 0, 4, and 12. rerandomization to guselkumab, 100 or 200 mg (weeks 16 and 20 and every 8 weeks thereafter)	52 weeks	Significant improvement in guselkumab groups in least-squares mean changes in PPPASI score versus placebo (− 15.3 and − 11.7 in the guselkumab 100-mg and 200-mg groups, respectively, and − 7.6 in the placebo group (p < 0.001in the 100 mg group; p < 0.017 in the 200 mg group) Significant least-squares mean changes in PPSI score in guselkumab groups (100 mg: − 2.0; p < 0.001; 200 mg: − 1.0 p = 0.04)	Serious AEs: 8 patients (3.8% in placebo group; 10.5% in combined guselkumab group) No serious infections	40
Blauvelt et al., 2020	Phase IV, multicentre, randomized, double‐blinded, parallel‐group study IXORA-R	1027	1)Ixekizumab (labelled dosage) 2)Guselkumab (labelled dosage, 100 mg at weeks 0, 4, and 12)	12 weeks	PASI 100 in 41% of patients treated with ixekizumab and 25% in the guselkumab (25%) (p < 0.001) All major secondary end points measured up to week 12 were met, including PASI 50 at week 1 and PASI 75 at week 2	No new safety issues	26
Blauvelt et al., 2020	Phase IV, multicentre, randomized, double‐blinded, parallel‐group study IXORA-R	924	1)Ixekizumab (labelled dosage) 2)Guselkumab (labelled dosage, 100 mg at weeks 0, 4, and 12)	24 weeks	Ixekizumab noninferior to guselkumab in skin clearance at week 24	Serious AEs: 3% (each group) No new safety issues	27
Ferris et al., 2020	Phase III, multicentre, double-blind, placebo-controlled novel patient-controlled injector ORION	78	1)Guselkumab 100 mg at Weeks 0/4/12/20/28 2)Placebo at weeks 0/4/12 with crossover to guselkumab 100 mg at weeks 16/20/28	40 weeks	Week 16: significantly greaterproportions of IGA 0/1 and PASI90 achievement in the guselkumab group than placebo (p < 0.001) Self-Injection Assessment Questionnaire (SIAQ) and Patient-Controlled Injection Device Questionnaire showed that 99% of patients were satisfied/very satisfied with the new device (week 28)	Safety profiles comparable between the 2 groups	47
Griffiths et al., 2020	Phase III, multicenter, double-blinded, placebo- and active comparator-controlled and open-label beyond week 52 4-years treatment VOYAGE 1	646	1)Guselkumab 100 mg at weeks 0, 4, 12, and every 8 weeks 2)Placebo at weeks 0, 4, and 12 followed by guselkumab 100 mg at weeks 16 and 20, and every 8 3)Adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks Placebo (at week 16) and adalimumab (at week 52) group patients crossed over to guselkumab Week 52: open-label guselkumab	204 weeks	High efficacy response rates (> 80% with PASI 90 and IGA 0/1 and > 50% with PASI 100 and IGA 0)	Favourable safety profile No new AEs reported	16
Puig et al., 2020	Pooled safety data from VOYAGE 1 and VOYAGE 2 trials	1721	1)Guselkumab‐treated LTBI +  2)Guselkumab-treated LTBI − patients	N/A	100 weeks	Week 100: -no active TB in the guselkumab-treated LTBI- group -2 cases of active TB in adalimumab-treated LTBI- patients Week 16: higher proportions of ALT and AST elevations in LTBI + patients vs. LTBI- patients Comparable AEs	17
Reich et al., 2020	Phase III, multicenter, double-blinded, placebo- and active comparator-controlled open-label beyond week 76 VOYAGE 1 and 2	1483	VOYAGE 1: 1)Guselkumab 100 mg at weeks 0, 4, 12, and every 8 weeks 2)Placebo at weeks 0, 4, and 12 followed by guselkumab 100 mg at weeks 16 and 20, and every 8 3)Adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks Placebo (at week 16) and adalimumab (at week 52) group patients crossed over to guselkumab Week 52: open-label guselkumab VOYAGE 2: 1)Guselkumab 100 mg (weeks 0 and 4, then every 8 weeks) 2)Placebo → guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20) 3)Adalimumab (80 mg week 0, then 40 mg week 1, and every 2 weeks through week 23) Week 28: 1)Guselkumab PASI 90 or greater responders rerandomized to guselkumab or placebo with guselkumab after loss of response 2 + 3)Placebo → guselkumab responders and adalimumab responders received placebo, then guselkumab after loss of response. Nonresponders received guselkumab Week 76: open-label guselkumab	156 weeks	Guselkumab groups, VOYAGE 1 and VOYAGE 2, respectively: PASI 90 82.8% and 77.2%, PASI100 50.8% and 48.8%, IGA 0/1 82.1% and 83.0%, IGA 0 53.1% and 52.9%	Serious adverse events: 5.68/100 PY; serious infections: 1.15/100 PY; nonmelanoma skin cancers: 0.28/100 PY; other malignancies: 0.47/100 PY; major adverse cardiovascular events: 0.28/100 PY	18
Reich et al., 2020	Phase III, multicenter, double-blinded, placebo- and active comparator-controlled open-label beyond week 76 VOYAGE 2	766	1)Guselkumab 100 mg (weeks 0 and 4, then every 8 weeks) 2)Placebo → guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20) 3)Adalimumab (80 mg week 0, then 40 mg week 1, and every 2 weeks through week 23) Week 28: 1)Guselkumab PASI 90 or greater responders rerandomized to guselkumab or placebo with guselkumab after loss of response 2 + 3)Placebo → guselkumab responders and adalimumab responders received placebo, then guselkumab after loss of response. Nonresponders received guselkumab Week 76: open-label guselkumab	204 weeks	Maintenance of efficacy responses in the guselkumab group (from week 100 through to week 204) Comparable rates in the adalimumab → guselkumab group	Maintenance of favourable safety profile	19
Thaçi et al., 2020	Phase III, multicentre, randomized, open‐label, assessor‐blinded, active‐comparator‐controlled trial POLARIS	119	1)Guselkumab 100 mg week 0 and 4, then every 8 weeks 2)Fumaric acid esters tablets (self‐administration according to the local label)	24 weeks	Higher PASI90 response in the guselkumab vs. fumaric acid esters group (82% vs. 14%, p < 0.001), and PASI 75 response (90% vs. 27%, p < 0.001), DLQI 0 or 1 (62% vs. 17%, p < 0.001), and PASI100 (32% vs. 3%, p < 0.001)	Lower AEs with guselkumab than with FAE (73% vs. 98%)	28
Youn et al., 2020	Post-hoc analysis VOYAGE 1 and VOYAGE 2 trials	126 (Korean patients)	VOYAGE 1: 1)Guselkumab 100 mg at weeks 0, 4, 12, and every 8 weeks 2)Placebo at weeks 0, 4, and 12 followed by guselkumab 100 mg at weeks 16 and 20, and every 8 3)Adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks Placebo (at week 16) patients crossed over to guselkumab VOYAGE 2: 1)Guselkumab 100 mg (weeks 0 and 4, then every 8 weeks) 2)Placebo → guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20) 3)Adalimumab (80 mg week 0, then 40 mg week 1, and every 2 weeks through week 23)	28 weeks	Week 16: guselkumab superior to placebo in achieving IGA score of 0 or 1 (90.5 vs. 20.0%, p < 0.001), and PASI90 response (71.4 vs. 3.3%, p < 0.001) Week 24: greater proportion of guselkumab-treated patients with PASI 75 (93.7 vs. 66.7%, p < 0.001) and IGA 0 (52.4 vs. 21.2%, p = 0.004) versus adalimumab-treated patients	Comparable efficacy profile in guselkumab and adalimumab groups	20
Real world experience
Authors, year	Study type	No. of prt	Study design	Study period	Efficacy	Safety	Ref
Bartos et al., 2018	Case report	1, 51-year old man	Guselkumab at labelled dosage	6 months	Complete clearance of psoriatic lesions in a HIV-positive patient	Stable CD4 count	35
Berman et al., 2019	Case report	1, 28-year old woman	Guselkumab at labelled dosage	N/A	good response in a patient with HS, psoriasis, and CD, multifailure to other previous biological therapies	No AEs reported	36
Grossberg et al., 2019	Case report	1, 66-year old woman	Guselkumab at labelled dosage and methotrexate 15 mg weekly	Months (unspecified number)	deep remission of Crohn’s disease	No AEs reported	53
Hall et al., 2019	Case report	1, 20-year old woman	Guselkumab at labelled dosage	6 months	Resolution of guttate psoriasis after 10 weeks of therapy, maintained at 6 months	No AEs reported	54
Hosokawa et al., 2019	Case report	1, 67-year old man	Guselkumab at labelled dosage	N/A	Efficacy on paradoxical psoriatic alopecia	No AE reported	55
Kim et al., 2019	Case report	1, 12-year old girl	Guselkumab at labelled dosage and methotrexate 20 mg weekly 8decreased at 10 mg weekly from week 8)	5 months	Week 4: beginning of improvement Month 5: clinical resolution, PASI 1	No AEs reported	56
Lee et al., 2019	Case report	1, 41-year old man	Guselkumab at labelled dosage	1 year	Complete clearance of psoriatic lesions	Lentigines in areas of resolving psoriatic plaques	43
Rathod et al., 2019	Case report	1, 46-year-old woman	Guselkumab and adalimumab combination therapy	6 months	Baseline PASI 42; 2-month PASI 2 and improvement of psoriatic arthritis symptoms	No serious AEs reported	57
Reyn et al., 2019	Case report	1, 47-year old man	Guselkumab at labelled dosage		Week 7: PASI100, maintained for several weeks	Week 10: eczematous eruption Interruption of treatment	41
Truong et al., 2019	Case report	1, 40-year-old man (palmoplantar psoriasis)	Guselkumab at labelled dosage	3 months	N/A	Nummular dermatitis	42
Benhadou et al., 2020	Multicenter retrospective study	112	Guselkumab at labelled dosage	16 weeks	Mean PASI: baseline 14.8 ± 6.5, week 16 2.03 ± 2.5 32.1% achieved PASI‐100, 55.4% PASI‐90 and 82.1% PASI‐75, respectively	AEs: 2 patients (1.8%) infection of upper respiratory tract and 1 patient (0.9%) asthenia	48
Galluzzo et al., 2020	Single centre retrospective study	52	Guselkumab at labelled dosage	1 year	12 weeks: PASI 75, 90, and 100 response achieved in 68%, 36%, and 18%, respectively 20 weeks: 79.1%, 62.8%, and 46.5%, respectively 1 year: 84.2%, 78.9%, and 63.2%, respectively	Well-tolerated No cases of discontinuation due to AEs	49
Kamiya et al., 2020	Case report	1, 58-year old man	Guselkumab at labelled dosage	N/A	Successful treatment of psoriasis in a patient treated with carboplatin plus nanoparticle albumin-bound paclitaxel therapy for advanced non-small cell lung cancer	No AE reported	58
Kromer et al., 2020	Case series	2/39 treated with guselkumab	Guselkumab at labelled dosage	10 months	Excellent response in both patients	No AE reported for patients treated with guselkumab	52
Lee et al., 2020	Single-centre retrospective chart review		Guselkumab at labelled dosage	16 months	The overall drug survival rate of in patients on guselkumab was higher compared to patients on ixekizumab at the end of the study period	No AE reported	50
Maliyar et al., 2020	Single centre retrospective chart review	71 patients ongoing treatment	Guselkumab at labelled dosage	Median treatment duration 1.2 years	Clinically significant clearance of psoriasis with a global assessment of clear or almost clear (BSA < 1%) in 73.3% of patients	Well-tolerated, no new AEs reported	29
Megna et al., 2020	Case report (erythrodermic psoriasis)	1, 38-year old man	Guselkumab at labelled dosage	48 weeks	Achievement of PASI 100 after 20 weeks of therapy	No AEs reported	59
Megna et al., 2020	Prospective, single-centre	23	Guselkumab at labelled dosage	44 week	Mean PASI score: baseline 15.1 ± 6.1, week 12 3.2 ± 1.9 (p < 0 .001), week 44 0.8 ± 0.7 (p < 0 .001) Mean BSA: baseline 36.4 ± 13.6, week 12 8.3 ± 7.4 (p < 0.001), week 44 2.2 ± 1.4 (p < 0 .001)	AEs: 4 patients (17.4%) mild blood tests alterations and 6 subjects (26%) potential AEs One treatment discontinuation due to increase in liver enzymes	51
Mufti et al., 2020	Multicenter, retrospective case series	27	Guselkumab dosing interval optimization: -22.2% patients increased dosing frequency to 100 mg every 6 weeks -77.8% increased to 100 mg every 4 weeks	Mean follow-up time: 19.0 weeks	Efficacy reached when PASI75 response at 3 to 6 months after dose optimization or PGA 0 or 1: 74.1% after they switched to a shortened dosing interval	11.1% reported AEs: common cold, gastrointestinal-related symptoms (nausea, vomiting), headache, and dizziness	30
Mugheddu et al., 2020	Case report	1, 58‐year‐old woman affected by Cornelia De Lange syndrome	Guselkumab at labelled dosage	6 months	At 3 months: PASI100 achieved At 6 months. maintenance of complete remission	No AEs reported	37
Ruggiero et al., 2020	Single-centre, retrospective study	13	Guselkumab at labelled dosage	52 weeks	mean PASI score: baseline 13.2 ± 6.8, week 4 5.9 ± 2.8 (p < 0 .01), week 12 2.4 ± 1.9 (p < 0 .001), week 52 0.5 ± 0.7 (p < 0.001) mean BSA score: baseline 22.3 ± 10.5, week 4 14.2 ± 7.5 (p < 0.01), week 12 6.3 ± 5.4 (p < 0.001), week 52 0.8 ± 1.1 (p < 0 .001)	AEs: pharyngitis (15.4%, n = 2) and flu (7.7%, n = 1). No AE required guselkumab discontinuation	31
Snast et al., 2020	Retrospective cohort study	33	Guselkumab at labelled dosage	Overall mean duration of treatment: 9.5 ± 3.7 months	Week 24 (n = 29): 22 (76%) achieved >  = PASI 75, 18 (62%) >  = PASI 90, 5 (17%) PASI 100 Week 36 and at the end of the study period: PASI 75/90/100 achieved by a similar proportion of patient Subgroup analysis (PASI 90 response at week 24): -a higher proportion of obese patients failed to achieve PASI 90 response (56% vs. 23%; no statistically significant difference, p = 0 .07) -no association between age, sex, baseline PASI, psoriatic arthritis, or duration of psoriasis	No AEs reported	32
Schwensen et al., 2020	Retrospective, real-world evidence study	50	Guselkumab at labelled dosage	Overall mean time of treatment: 80.6 weeks	Three months: -63.6% and 36.4% experienced ≥ PASI 50 and ≥ PASI 90, respectively from baseline -31.4% and 68.6% PASI < 1 and 3, respectively No statistically significant difference between subgroups if stratifying drug survival rate of guselkumab for sex, psoriatic arthritis, previous treatment with TNF inhibitors or anti-IL‐17or anti-IL‐23, or number of previous biologic treatments before initiating treatment with guselkumab	No new AEs reported	33
Song et al., 2020	Case report	1, 13-year-old girl with active hepatitis B infection	Guselkumab at labelled dosage	12 weeks	At 4 weeks: BSA decreased to 3%, IGA 3; complete clearance of forehead plaques Week 12: BSA 1%, IGA 2, Stable liver enzymes, viral load undetectable	No AEs reported	60
Chiang et al., 2021	Retrospective study	13 (erythrodermic psoriasis)	Guselkumab at labelled dosage	Week 28 (at least)	Week 4, 12, 20, and 28, respectively: -mean PASI improvement: 37.5%, 60.9%, 67.5%, and 64.7%, -PASI 75: 15.4%, 38.4%, 53.8%, and 46.2% -PASI 90: 0%, 7.7%, 23.1%, and 30.8%	Week 36: no nasopharyngitis, headache, upper respiratory tract infection, or injection-site reaction reported	38
Kromer et al., 2021	Multicenter, retrospective study	5/201 with generalized pustular psoriasis treated with guselkumab	Guselkumab at labelled dosage	Mean treatment time until last observation: 5.2 months	1 /5 partial response, 4 /5 response non reported	1 AE reported	39
Ruiz-Villaverde et al., 2021	Observational, longitudinal, retrospective study	87	Guselkumab at labelled dosage	52 weeks (3 patients at 76 weeks, maximum exposition 93.4 weeks)	Week 52: PASI 75 in 90.3%, PASI90 in 71%, and PASI100 in 51.6% After 93.4 weeks (1 year, 9 months, and 14 days), the overall survival rate was 94% (4 events were reported)	4.6% discontinued (average follow‐up of 48 weeks): 1 patient for primary failure, 2 patients for secondary failure, 1 patient due to AE (headache)	34

Abbreviations: AEs, adverse events; FAEs:, fumaric acid esters; IGA, Investigator Global Assessment; ISRs, injection site reactions; LTBI, latent tuberculosis infection; MACE, major adverse cardiac event; NMSC, non melanoma skin cancer; PASI, Psoriasis Area Severity Index; PGA, Physician Global Assessment; PPP, palmo-plantar pustulosis; prt, participants; PY, patient-years; ref., reference