Table 2

Immunological consequences of biologicals in juvenile idiopathic arthritis: incidence rates per 100 patient-years (weighted per study)

Generic name

Serious infections

Malignancies

Autoimmune diseasea

Antibody formation


Normal childhood population

1.0 [17]

0.032 [53,54,56]

0.0069 new onset uveitis [77]

-

0.0083 IBD [78]

0.00015 optic neuritis [79]

0,0001 multiple sclerosis [80]

JIA without MTX, steroids or anti-TNF

2.2 [17]

0.025 [53,56]

2.5 new onset uveitisb [81,82]

-

JIA with MTX

3.3 [17]

0.033 [56] to 0.046c [54]

0.83 uveitis [83]

-

JIA with steroids

6.9 [17]

No data

No data

-

Abatacept

1.3 [57]

No data

0.22 uveitis flare (1 per 448 EY) [19]

23 (no adverse events) [57]

0.22 multiple sclerosis (1 per 448 EY) [19]

Adalimumab

2.9 [28-30]

No data

0 demyelinating diseases (0 per 348 EY) [28,30]

7.6 with MTX within year; 15 after first year (no adverse events) [28,30]

25.3 without MTX within first year; 60 after first year (no adverse events) [28,30]

Anakinra

8.7 [20-22]

No data

No data

75.0 non-neutralizing antibodies within first year; 81.8 after first year [73]

6.3 neutralizing antibodies within first year; 0 after first year [73]

Etanercept

2.7 [17,31-34]

0.015 [59]

0.44 new onset uveitis [32,34] and 0.57 flares of uveitis [33,35]

2.9 non-neutralizing antibodies [74]

0.31 newly diagnosed IBD [35,70]

0.15 optic neuritis [31-35]

0.11 new onset lupus [31,34,35]

0.64 newly diagnosed sarcoidosis [32]

Infliximab

1.0 [36,37]

No data

5.1 new onset uveitis [36]

36.6 positive and 32.4 inconclusive (infusion-reaction-related) [36]

25.9 new ANA (≥1:320) without symptoms [36]

6.6 new anti-double-stranded DNA antibodies without symptoms [36]

Rituximab

14.5d [24]

No data

No data

No data

Tocilizumab

11.6e [38-40]

No data

No data

7.1 (one anaphylactoid reaction without anti-IgE antibody) [38]


aOnly mentioned if at least 100 exposure years (EY) available. bMajority of these patients did not use MTX, steroids or anti-TNF agents. cThis study used biologic naïve patients who might have used MTX. dMajority of these patients also used MTX and cyclosporine and half of them also used steroids. eMajority of these patients concomitantly used steroids. EY, exposure years; IBD, inflammatory bowel disease; JIA, juvenile idiopathic arthritis; MTX, methotrexate.

Swart et al. Arthritis Research & Therapy 2013 15:213   doi:10.1186/ar4213