Table 7, Adverse events reported in RCTs - Disease-Modifying Antirheumatic Drugs (DMARDs) in Children With Juvenile Idiopathic Arthritis (JIA)

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Table 7Adverse events reported in RCTs

Table 7, Part 1. Dropout and adverse events related to organ systems
DMARD	Study	Intervention	Sample size	Dropouts due to AEs	Gastrointestinal	Dermatologic	Renal/Urologic	Respiratory	Neurologic	Ophthalmologic
Biologic agents
Abatacept	Ruperto et al., 2008²⁴	Drug	62	-	-	-	-	-	-	-
Abatacept	Ruperto et al., 2008²⁴	Placebo	60	-	-	-	-	-	-	-
Anakinra	llowite et al., 2009³⁰	Drug	25	-	6	2	-	8	6	-
Anakinra	llowite et al., 2009³⁰	Placebo	25	-	1	10	-	7	4	-
Etanercept	Lovell et al., 2000²⁶	Drug	25	0	1	1
	Lovell et al., 2000²⁶	Placebo	26	0	-	-	-	-	-	-
	Smith et al., 2005¹⁶	Drug	7	-	-	-	-	-	-	-
	Smith et al., 2005¹⁶	Placebo	5	-	-	-	-	-	-	-
Infliximab + MTX	Ruperto et al., 2007¹⁷	Drug + MTX	60	2	-	-	-	-	-	-
Infliximab + MTX	Ruperto et al., 2007¹⁷	Placebo + MTX	62	1	-	-	-	-	-	-
IVIG	Giannini et al., 1996²⁸	Drug	10	0	-	-	-	-	-	-
	Giannini et al., 1996²⁸	Placebo	9	0	-	-	-	-	-	-
	Silverman et al., 1994²⁰	Drug	14	-	-	-	-	-	-	0
	Silverman et al., 1994²⁰	Placebo	17	-	-	1	-	-	-	-
Tocilizumab	Yokota et al., 2008²⁹	Drug	20	1	1	-	-	2	-	-
Tocilizumab	Yokota et al., 2008²⁹	Placebo	23	1	1	-	-	4	-	-
Non-biologic agents
Azathioprine	Kvien et al., 1986¹⁸	Drug	17	3	-	1	2	-	-	-
Azathioprine	Kvien et al., 1986¹⁸	Placebo	15	0	-	-	-	-	-	-
Hydroxychloroquine	Brewer et al., 1986¹¹	Drug	57	3	-	2	7	-	-	-
Hydroxychloroquine	Brewer et al., 1986¹¹	Placebo	51	3	-	-	4	-	-	-
Methotrexate	Giannini et al., 1992¹³	Drug	86	3	10	0	0	-	-	-
Methotrexate	Giannini et al., 1992¹³	Placebo	41	0	5	-	-	-	-	-
Penicillamine	Brewer et al., 1986¹¹	Drug	54	2	-	4	2	-	-	1
	Brewer et al., 1986¹¹	Placebo	51	2	-	-	4	-	-	-
	Prieur et al., 1985¹⁹	Drug	38	-	6	3	-	-	-	-
	Prieur et al., 1985¹⁹	Placebo	36	-	4	1	-	-	-	-
Sulfasalazine	van Rossum et al., 1998¹⁵	Drug	35	10	24	9	-	-	9	-
Sulfasalazine	van Rossum et al., 1998¹⁵	Placebo	34	0	18	3	-	-	5	-

Table 7, Part 2. Specific symptoms
DMARD	Study	Intervention	Sample size	Fever	Nausea/vomiting	Pain	Alopecia/Hirsutism	Bleeding	Infection
Biologic agents
Abatacept	Ruperto et al., 2008²⁴	Drug	62	-	-	-	-	-	-
Abatacept	Ruperto et al., 2008²⁴	Placebo	60	-	-	-	-	1	1
Anakinra	Ilowite et al., 2009³⁰	Drug	25	3	-	0	-	-	-
Anakinra	Ilowite et al., 2009³⁰	Placebo	25	2	-	2	-	-	-
Etanercept	Lovell et al., 2000²⁶	Drug	25	-	-	-	-	-	-
	Lovell et al., 2000²⁶	Placebo	26	-	-	-	-	-	-
	Smith et al., 2005¹⁶	Drug	7	-	-	-	-	-	5
	Smith et al., 2005¹⁶	Placebo	5	-	-	-	-	-	3
Infliximab + MTX	Ruperto et al., 2007¹⁷	Drug + MTX	60	-	-	-	-	-	41
Infliximab + MTX	Ruperto et al., 2007¹⁷	Placebo + MTX	62	-	-	-	-	-	28
IVIG	Giannini et al., 1996²⁸	Drug	10	-	-	-	-	-	-
	Giannini et al., 1996²⁸	Placebo	9	-	-	-	-	-	-
	Silverman et al., 1994²⁰	Drug	14	-	-	-	-	-	-
	Silverman et al., 1994²⁰	Placebo	17	-	-	-	-	-	-
Tocilizumab	Yokota et al., 2008²⁹	Drug	20	-	-	-	-	-	1
Tocilizumab	Yokota et al., 2008²⁹	Placebo	23	-	-	-	-	-	1
Non-biologic agents
Azathioprine	Kvien et al., 1986¹⁸	Drug	17	1	1	1	1	1	3
Azathioprine	Kvien et al., 1986¹⁸	Placebo	15	-	-	2	1	0	-
Hydroxychloroquine	Brewer et al., 1986¹¹	Drug	57	-	-	-	-	-	-
Hydroxychloroquine	Brewer et al., 1986¹¹	Placebo	51	-	-	-	-	-	-
Methotrexate	Giannini et al., 1992¹³	Drug	86	-	-	6	-	-	-
Methotrexate	Giannini et al., 1992¹³	Placebo	41	-	-	0	-	-	-
Penicillamine	Brewer et al., 1986¹¹	Drug	54	-	-	-	-	-	-
	Brewer et al., 1986¹¹	Placebo	51	-	-	-	-	-	1
	Prieur et al., 1985¹⁹	Drug	38	-	-	-	-	-	2
	Prieur et al., 1985¹⁹	Placebo	36	-	-	-	-	-	-
Sulfasalazine	van Rossum et al., 1998¹⁵	Drug	35	-	-	-	-	-	-
Sulfasalazine	van Rossum et al., 1998¹⁵	Placebo	34	-	-	-	-	-	-

Table 7, Part 3. Other
DMARD	Study	Intervention	Sample size	Anemia	Other hematologic abnormality	Macrophage activation syndrome	Other laboratory abnormality	Elevated liver enzymes	Other	Serious AEs	Death
Biologic agents
Abatacept	Ruperto et al., 2008²⁴	Drug	62	-	-	-	-	-	-	0	-
Abatacept	Ruperto et al., 2008²⁴	Placebo	60	-	-	-	-	-	-	2	-
Anakinra	Ilowite et al., 2009³⁰	Drug	25	-	-	-	-	-	7	-	-
Anakinra	Ilowite et al., 2009³⁰	Placebo	25	-	-	-	-	-	9	-	-
Etanercept	Lovell et al., 2000²⁶	Drug	25	-	-	-	-	-	-	-	-
	Lovell et al., 2000²⁶	Placebo	26	-	-	-	-	-	1	-	-
	Smith et al., 2005¹⁶	Drug	7	-	-	-	-	-	-	-	-
	Smith et al., 2005¹⁶	Placebo	5	-	-	-	-	-	-	-	-
Infliximab + MTX	Ruperto et al., 2007¹⁷	Drug + MTX	60	-	-	-	-	-	-	19	-
Infliximab + MTX	Ruperto et al., 2007¹⁷	Placebo + MTX	62	-	-	-	-	-	-	3	1
IVIG	Giannini et al., 1996²⁸	Drug	10	-	-	-	-	-	-	-	-
	Giannini et al., 1996²⁸	Placebo	9	-	-	-	-	-	-	-	-
	Silverman et al., 1994²⁰	Drug	14	-	-	1	-	1	-	-	-
	Silverman et al., 1994²⁰	Placebo	17	-	-	-	-	-	-	-	-
Tocilizumab	Yokota et al., 2008²⁹	Drug	20	-	-	-	-	-	-	-	0
Tocilizumab	Yokota et al., 2008²⁹	Placebo	23	-	-	-	-	-	-	-	0
Non-biologic agents
Azathioprine	Kvien et al., 1986¹⁸	Drug	17	-	2	-	-	-	1	-	-
Azathioprine	Kvien et al., 1986¹⁸	Placebo	15	-	-	-	-	-	0	-	-
Hydroxychloroquine	Brewer et al., 1986¹¹	Drug	57	6	4	-	8	-	-	-	-
Hydroxychloroquine	Brewer et al., 1986¹¹	Placebo	51	2	2	-	5	-	-	-	-
Methotrexate	Giannini et al., 1992¹³	Drug	86	-	-	-	30	0	3	-	-
Methotrexate	Giannini et al., 1992¹³	Placebo	41	-	-	-	5	-	0	-	-
Penicillamine	Brewer et al., 1986¹¹	Drug	54	2	4	-	9	-	-	-	-
	Brewer et al., 1986¹¹	Placebo	51	2	2	-	5	-	-	-	-
	Prieur et al., 1985¹⁹	Drug	38	-	1	-	-	-	1	-	-
	Prieur et al., 1985¹⁹	Placebo	36	-	-	-	-	-	0	-	-
Sulfasalazine	van Rossum et al., 1998¹⁵	Drug	35	-	2	-	4	2	-	1	-
Sulfasalazine	van Rossum et al., 1998¹⁵	Placebo	34	-	0	-	0	0	-	0	-

: Abbreviations to Table 7, Parts 1-3: AEs = adverse events; DMARD = disease-modifying antirheumatic drug; IVIG = intravenous immunoglobulin; MTX = methotrexate; RCTs = randomized controlled trials

From: Results

Cover of Disease-Modifying Antirheumatic Drugs (DMARDs) in Children With Juvenile Idiopathic Arthritis (JIA)

Disease-Modifying Antirheumatic Drugs (DMARDs) in Children With Juvenile Idiopathic Arthritis (JIA) [Internet].

Comparative Effectiveness Reviews, No. 28.

Kemper AR, Coeytaux R, Sanders GD, et al.

Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Sep.

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