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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