Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety

Alonso-Ruiz, Alberto; Pijoan, Jose Ignacio; Ansuategui, Eukene; Urkaregi, Arantxa; Calabozo, Marcelo; Quintana, Antonio

doi:10.1186/1471-2474-9-52

Table 5 Number of patients who presented adverse effects in trials with anti TNFα drugs

From: Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety

Trial (reference) Anti-TNFα drug	Groups	N of patients	Withdrawn adverse event	Total adverse events	Serious adverse events	Infections	Serious infections	Infusion reactions	Injection- site reactions	Malignancies	Mortality
Lipsky et al. (19) Infliximab	3 mg/Kg 8	86	5	_	_	_	_			_	_
	wk +MTX	86	9	_	_	_	_			_	_
	3 mg/Kg 4	87	4	_	_	_	_			_	_
	wk +MTX	81	8	_	_	_	_			_	_
	10 mg/Kg 8	340	26	323	58	244	22			5	5
	wk +MTX	88	7	83	18	53	7	NA		0	3
	10 mg/Kg 4
	wk +MTX
	Total
	Infliximab
	MTX
St. Clair et al. (20) Infliximab	3 mg/Kg 8	373	34		_	_	21	_		0	1
	wk +MTX	378	35		_	_	19	_		4	1
	6 mg/Kg 8	751	69		103	414	40	135		4	2
	wk +MTX	298	9	NA	32	141	6	20		0	2
	Total
	Infliximab
	MTX
Quinn et al. (22) Infliximab	3 mg/Kg 8	10	1		1		0	1		0	0
	wk +MTX	10	0	NA	0	NA	0	0		0	0
	MTX
Westhovens et al. (23) Infliximab	3 mg/Kg 8	360	18	_	_		6			2	0
	wk +MTX	361	20	_	_		18			2	2
	10 mg/Kg 8	721	38	512	55		24			4	2
	wk +MTX	363	8	239	27	NA	6	NA		1	1
	Total
	Infliximab
	MTX
Moreland et al. (24) Etanercept	25 mg twice	78	2				0		_	0	0
	weekly	76	5				0		_	0	0
	10 mg twice	154	7				0		71	0	0
	weekly	80	3	NA	NA	NA	0		10	0	0
	Total
	Etanercept
	Placebo
Weinblatt et al. (25) Etanercept	25 mg twice	59	2			30	0		23	0	0
	weekly	30	1	NA	NA	19	0		2	0	0
	+MTX MTX
Bathon et al. (26) Etanercept	25 mg twice	207	11						_	3	1
	weekly	208	12						_	2	1
	10 mg twice	415	23						140	5	2
	weekly	217	24	NA	NA	NA	NA		16	2	0
	Total
	Etanercept
	MTX
van der Heijde et al. (28) (TEMPO) Etanercept	25 mg twice	231	37	_	_	_	23			5	1
	weekly	223	34	_	_	_	24			5	1
	+MTX	454	71	379	64	285	47		69	10	2
	25 mg twice	228	47	185	37	147	25		4	2	1
	weekly
	Total
	Etanercept
	MTX
Weinblatt et al. (29) (ARMADA) Adalimumab	40 mg/2 wk	67	0				_		_	_	_
	+MTX	69	4				_		_	_	_
	20 mg/2 wk	73	1				_		_	_	_
	+MTX	209	5				2		32	1	0
	80 mg/2 wk	62	2	NA	NA	NA	0		2	0	0
	+MTX
	Total
	Adalimumab
	MTX
van de Putte et al. (30) Adalimumab	40 mg/2 wk	113	7	_	_		_		_	_	1
	20 mg/2 wk	106	4	_	_		_		_	_	0
	20 mg/wk	112	3	_	_		_		_	_	0
	40 mg/wk	103	3								0
	Total	434	17	429	53		10		46	4	3
	Adalimumab	110	2	105	16	NA	0		1	1	1
	Placebo
Furst et al. (31) (STAR) Adalimumab	40 mg/2 wk	318	9	275	17	166	4		62	1	1
	DMARD	318	8	275	22	157	6		37	0	1
Keystone y cols. (32) Adalimumab	40 mg/2 wk	207	26	_	_	_	11		_	_	2
	+MTX*	212	16	_	_	_	5		_	_	1
	20 mg/wk	419	42	391	97	269	16		101	4	3
	+MTX	200	13	181	37	111	1		48	0	0
	Total
	Adalimumab
	MTX
Breedveld et al. (33) (PREMIER) Adalimumab	40 mg/2 wk	268	32	_			9			2	1
	+MTX*	274	26	_			3			4	4
	40 mg/2 wk	542	58	524			12			6	5
	Total	257	19	245	NA	NA	7		NA	4	1
	Adalimumab
	MTX

NA: not available
* Overall data provided although specific data per arm not provided

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ISSN: 1471-2474

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