Table 1

Characteristics of the studies included in the meta-analysis of severe and global infections.

Author (study name)	Year	Study design registry number	Molecule	Dose	Diagnosis	Patient in treatment group (n)	Study duration (weeks)	Outcome
								SI	NSI
TNF-inhibitors studies
Antoni (IMPACT)	2005	RCT phase 3	Infliximab	5 mg / kg / 6 w	PsA	52	16	X
Van der Heijde (ASSERT)	2005	RCT phase 3	Infliximab	5 mg / kg / 6 w	AS	201	24	X	X
Sieper (INFAST)	2014	RCT phase 3 NCT00844805	Infliximab	5 mg / kg / 6 w	AS	105	28	X	X
Park (PLANETAS)	2016	OLE	Infliximab	5 mg / kg / 6 w	AS	174	102	X	X
Davis	2003	RCT phase 3	Etanercept	25 mg / 2 w	AS	138	24	X
Mease	004	RCT phase 3	Etanercept	25 mg / 2 w	PsA	101	24	X
Braun	2011	RCT phase 3 NCT00247962	Etanercept	50 mg / 1 w	AS	379	16	X
Dougados	2014	RCT phase 3	Etanercept	50 mg / 1 w	Nr-AxSpA	106	12	X	X
Mease	2019	RCT phase 3 NCT02376790	Etanercept	50 mg / 1 w	PsA	567	48	X
Davis	2007	OLE	Etanercept	25 mg / 2 w and 50 mg / 1 w	AS	257	192	X	X
Martin-Mola	2010	OLE	Etanercept	25 mg / 2 w and 50 mg / 1 w	AS	56	156	X	X
Inman (GO RAISE)	2008	RCT phase 3 NCT00265083	Golimumab	50 or 100 mg / 4 w	AS	278	24	X	X
Kavanaugh (GOREVEAL)	2009	RCT phase 3 NCT00265096	Golimumab	50 or 100 mg / 4 w	PsA	292	24	X	X
Kavanaugh (GOVIBRANT)	2017	RCT phase 3 NCT02181673	Golimumab	2 mg / kg / 8 w IV	PsA	240	24	X	X
Deodhar (GO ALIVE)	2018	RCT phase 3 NCT02186873	Golimumab	2 mg / kg / 8 w IV	AS	105	16	X	X
Kavanaugh (GO REVEAL)	2013	OLE	Golimumab	50 or 100 mg / 4 w SC	PsA	394	268	X
Deodhar (GO RAISE)	2014	OLE	Golimumab	50 or 100 mg / 4 w SC	AS	353	268		X
Mease (ADEPT)	2005	RCT phase 3 NCT00195689	Adalimumab	40 mg / 2 w SC	PsA	151	24	X	X
Van der Heijde (ATLAS)	2006	RCT phase 3	Adalimumab	40 mg / 2 w SC	AS	208	24	X	X
Genovese	2007	RCT phase 3	Adalimumab	40 mg / 2 w SC	PsA	51	12	X	X
Huang	2012	RCT phase 3 NCT01114880	Adalimumab	40 mg / 2 w SC	AS	229	12	X	X
Sieper (ABILITY 1)	2013	RCT phase 3 NCT00939003	Adalimumab	40 mg / 2 w SC	Nr-AxSpA	91	12	X	X
Mease (ADEPT)	2008	OLE	Adalimumab	40 mg / 2 w SC	PsA	298	144	X	X
Van der Heijde (ATLAS)	2009	OLE	Adalimumab	40 mg / 2 w SC	AS	311	104	X	X
Van der Heijde (ABILITY1)	2018	OLE	Adalimumab	40 mg / 2 w SC	Nr-AxSpA	190	156	X
Mease (RAPID-PsA)	2014	RCT phase3 NCT01087762	Certolizumabpegol	200 mg / 2 w or 400 mg / 4 w SC	PsA	273	24	X	X
Landewe (RAPID-AxSpA)	2014	RCT phase 3 NCT01087762	Certolizumabpegol	200 mg / 2 w or 400 mg / 4 w SC	AS	218	24	X	X
Kristensen	2007	Observational	Several TNF-inhibitors	NA	PsA	261	105.1	X
Saad	2010	Observational	Several TNF-inhibitors	NA	PsA	596	156	X
Modesti	2012	Observational	Several TNF-inhibitors	NA	AS/PsA	225	132.6	X	X
Moura	2019	Observational	Several TNF-inhibitors	NA	SA	369	103	X
Wallis	2014	Observational	Several TNF-inhibitors	NA	Nr-AxSpA	264	134.7	X	X
Ruberson Da Silva	2018	Observational	Several TNF-inhibitors	NA	PsA	122	24		X
Rusman	2018	Observational	Several TNF-inhibitors	NA	AS	122	221	X	X
Wroński	2019	Observational	Several TNF-inhibitors	NA	AS	103	72	X	X
IL-17 inhibitors
Baeten	2013	RCT phase 2 NCT00809159	Secukinumab	10 mg / kg / 3 w IV	AS	24	28	X	X
McInnes	2014	RCT phase 2 NCT00809614	Secukinumab	10 mg / kg / 3 w IV	PsA	28	24	X
Baeten (MEASURE 2)	2015	RCT phase 3 NCT01649375	Secukinumab	150 or 75 mg / 4 w SC	AS	145	16		X
Mease (FUTURE 1)	2015	RCT phase 3 NCT01392326	Secukinumab	150 or 75 mg / 4 w, after IV loading infusion 10 mg / kg	PsA	406	24		X
McInnes (FUTURE 2)	2016	RCT phase 3 NCT01752634	Secukinumab	75 or 150 or 300 mg SC	PsA	299	16		X
Kivitz (MEASURE 4)	2018	RCT phase 3 NCT02159053	Secukinumab	150 mg / 4 w SC	AS	233	16	X
Mease (FUTURE 5)	2018	RCT phase 3 NCT02404350	Secukinumab	150 or 300 mg / 4 w SC	PsA	664	24	X
Huang (MEASURE 5)	2020	RCT phase 3 NCT02896127	Secukinumab	150 mg / 4 w SC	AS	305	16	X
Deodhar (PREVENT)	2021	RCT phase 3 NCT02696031	Secukinumab	150 mg / 4 w SC	Nr-AxSpA	369	20	X
McInnes (FUTURE 2)	2017	OLE	Secukinumab	75 or 150 or 300 mg SC	PsA	387	104	X	X
Kivitz (MEASURE 4)	2018	OLE	Secukinumab	150 mg / 4 w SC	AS	346	104	X
Nash (FUTURE 3)	2018	OLE	Secukinumab	150 or 300 mg / 4 w SC	PsA	406	52	X
Baraliakos (MEASURE 1)	2019	OLE	Secukinumab	150 or 75 mg / 4 w SC, after IV loading	AS	360	260	X
Kivitz (FUTURE 4)	2019	OLE	Secukinumab	150 mg / 4 w SC	PsA	334	104	X
Huang (MEASURE 5)	2020	OLE	Secukinumab	150 mg / 4 w SC	AS	453	52	X
Van der Heijde (FUTURE 5)	2020	OLE	Secukinumab	150 or 300 mg / 4 w SC	PsA	255	52	X
Deodhar	2021	OLE	Secukinumab	150 mg / 4 w SC	Nr-AxSpA	369	104	X
Kiltz	2020	Observational	Secukinumab	MD	AS/PsA	1001	NA		X
Klavdianou	2020	Observational	Secukinumab	300 mg / 4 w SC	PsA	75	52	X	X
Ramonda	2020	Observational	Secukinumab	150 or 300 mg / 4 w SC	PsA	608	104	X	X
Mease (SPIRIT P1)	2017	RCT phase 3 NCT01695239	Ixekizumab	80 mg / 2 w / 4 w SC	PsA	210	24	X	X
Nash (SPIRIT P2)	2017	RCT phase 3 NCT02349295	Ixekizumab	80 mg / 2 w / 4 w SC	PsA	245	24	X	X
Van der Heijde (COASTV)	2018	RCT phase 3 NCT02696785	Ixekizumab	80 mg / 2 w4 w SC	AS	164	16	X	X
Deodhar (COAST X)	2019	RCT phase 3 NCT02757352	Ixekizumab	80 mg / 2 w / 4 w SC	Nr-AxSpA	198	52	X	X
Deodhar (COAST W)	2019	RCT phase 3 NCT02696798	Ixekizumab	80 mg / 2 w / 4 w SC	AS	212	16	X	X
Dougados (COAST V/W)	2020	OLE	Ixekizumab	80 mg / 2w / 4 w SC	AS	641	52	X	X
Orbai (SPIRIT P2)	2021	OLE	Ixekizumab	80 mg / 2w / 4 w SC	PsA	337	156	X	X
Ritchlin (BE ACTIVE)	2020	RCT phase 2 NCT02969525	Bimekizumab	16, 160 or 320 mg / 4 w SC	PsA	164	12	X
Van der Heijde (BEAGILE)	2020	RCT phase 2 NCT02963506	Bimekizumab	16, 64, 160 or 320 mg / 4 w SC	AS	243	12	X
Coates (BE ACTIVE)	2021	OLE	Bimekizumab	16, 64, 160 or 320 mg / 4 w SC	PsA	204	152	X
Mease	2014	RCT phase 2 NCT01516957	Brodalumab	140 or 280 mg / 2 w SC	PsA	113	12	X
Mease (AMVISION 1–2)	2021	RCT phase 3 NCT02029495NCT02024646	Brodalumab	140 or 210 mg / 2 w SC	PsA	640	24	X	X
IL-23 inhibitors
Gottlieb	2009	RCT phase 2 NCT00267956	Ustekinumab	90 or 63 mg / 1 w SC	PsA	76	12	X	X
McInnes (PSUMITT 1)	2013	RCT phase 3 NCT01009086	Ustekinumab	45 or 90 mg SC	PsA	409	16	X	X
Ritchlin	2014	RCT phase 2 NCT01077362	Ustekinumab	45 or 90 mg w0–w4, then every 12 w SC	PsA	207	24	X	X
Chimenti	2017	Observational	Ustekinumab	MD	PsA	65	104	X	X
Deodhar	2018	RCT phase 2 NCT02319759	Guselkumab	100 mg / 8 w SC	PsA	100	24	X	X
Deodhar (DISCOVER 1)	2020	RCT phase 3 NCT03162796	Guselkumab	100 mg / 4 w / 8 w SC	PsA	255	24	X	X
Mease (DISCOVER 2)	2020	RCT phase 3 NCT03158285	Guselkumab	100 mg / 4 w / w SC	PsA	493	24	X	X
McInnes	2021	OLE	Guselkumab	100 mg / 4 w / 8 w SC	PsA	731	52	X
Baeten	2018	RCT phase 2 NCT02047110	Risankizumab	18, 90, 180 mg / 8 w SC	AS	119	16	X	X
CTLA4-Ig
Mease	2011	RCT phase 2 NCT00534313	Abatacept	3 or 10 mg / kg (±2 initial doses of 30 mg / kg) IV / 28 days	PsA	128	24	X
Mease (ASTRAEA)	2017	RCT phase 3 NCT01860976	Abatacept	125 mg / 1 w SC	PsA	213	24	X	X
JAK-inhibitors
Gladman (OPAL Beyond)	2017	RCT phase 3 NCT01882439	Tofacitinib	5 mg or 10 mg 2x / day	PsA	263	12	X
Mease (OPAL Broaden)	2017	RCT phase 3 NCT01877668	Tofacitinib	5 mg or 10 mg 2x / day	PsA	211	12	X
Van der Heijde	2017	RCT phase 2NCT01786668	Tofacitinib	2, 5 or 10 mg 2x / day	AS	156	16	X	X
Mease (EQUATOR)	2018	RCT phase 2 NCT03101670	Filgotinib	200 mg / day	PsA	65	16	X	X
Van der Heijde (TORTUGA)	2018	RCT phase 2 NCT03117270	Filgotinib	200 mg / day	AS	58	12	X	X
Van der Heijde (SELECT-AXIS 1)	2019	RCT phase 2 NCT03178487	Upadacitinib	15 mg / day	AS	93	14	X	X
PDE4 inhibitors
Schett	2012	RCT phase 2 NCT00456092	Apremilast	20 mg 2x / day or 40 mg / day	PsA	136	12	X
Kavanaugh (PALACE 1)	2014	RCT phase 3 NCT01172938	Apremilast	20 or 30 mg 2x / day	PsA	336	24	X
Cutolo (PALACE 2)	2016	RCT phase 3 NCT01212757	Apremilast	20 or 30 mg 2x / day	PsA	325	16	X
Edwards (PALACE 3)	2016	RCT phase 3 NCT01212770	Apremilast	20 or 30 mg 2x / day	PsA	336	24	X
Nash (ACTIVE)	2018	RCT phase 3 NCT01925768	Apremilast	30 mg 2x / day	PsA	110	24	X
Wells (PALACE 4)	2018	RCT phase 3 NCT01307423	Apremilast	20 or 30 mg 2x / day	PsA	350	24	X
Several treatments
Ritchlin	2019	Observational	Ustekinumab, adalimumab, etanercept, infliximab	NA	PsA	2041	256.4	X
Li	2020	Observational	Ixekizumab, secukinumab, ustekinumab, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab	NA	PsA	5520	31.2	X
Rahman	2020	Observational	Golimumab, infliximab, ustekinumab	NA	PsA	462	416	X	X
Krabbe	2021	Observational	Abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab, ustekinumab	NA	AS/PsA	5387	52	X

AS, ankylosing spondylitis; CTLA4, cytotoxic T-lymphocyte associated protein 4-Ig; IV, intravenous; JAK, Janus kinase; MD, missing data; NA, not applicable; nr-axSpA, non-radiographic axial spondyloarthritis; NSI, non-serious infections; OLE, open-label extension; PDE4, phosphodiesterase 4; PsA, psoriatic arthritis; RCT, randomised controlled trials; SC, subcutaneous; SI, serious infections; TNF, tumour necrosis factor; w, week.