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Table 3 All-causality treatment-emergent adverse events of special interest with risk difference (safety population)

From: A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis

Event of special interest

PF-06410293

n = 297

n (%)

Adalimumab-EU

n = 299

n (%)

Risk difference

(95% CI) (%)

Injection-site reactions

5 (1.7)

6 (2.0)

−0.32 (−2.84, 2.12)

Opportunistic infections

7 (2.4)

5 (1.7)

0.69 (−1.80, 3.32)

 Herpes zoster

1 (0.3)

3 (1.0)

−0.67 (−2.61, 0.97)

 Latent tuberculosis

5 (1.7)

1 (0.3)

1.35 (−0.35, 3.59)

 Confirmed active tuberculosis

0

0

0 (NA)

 Oral candidiasis

0

1 (0.3)

−0.33 (−1.87, 0.95)

Pneumocystis jirovecii pneumonia

1 (0.3)

0

0.34 (−0.94, 1.88)

Urticaria, angioedema, anaphylactic reactiona

0

2 (0.7)

−0.67 (−2.41, 0.61)

  1. Abbreviations: Adalimumab-EU adalimumab sourced from the European Union, CI confidence interval, NA not applicable
  2. aOnly urticaria reported