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

Table 4 Prespecified treatment-emergent adverse event categories of interest with risk difference (safety population)

Category	PF-06410293 n = 297 n (%)	Adalimumab-EU n = 299 n (%)	Risk difference (95% CI) (%)
Blood and lymphatic system events	22 (7.4)	14 (4.7)	2.73 (−1.15, 6.79)
Cardiovascular events	9 (3.0)	16 (5.4)	−2.32 (−5.84, 0.96)
Demyelinating conditions	0	0	0 (NA)
Gastric/hepatic events	11 (3.7)	14 (4.7)	−0.98 (−4.44, 2.39)
Hypersensitivity^a	13 (4.4)	25 (8.4)	−3.98 (−8.15, −0.06)
Infections and infestations	74 (24.9)	75 (25.1)	−0.17 (−7.13, 6.80)
Neoplasms	5 (1.7)	5 (1.7)	0.01 (−2.38, 2.42)
Other^b	11 (3.7)	10 (3.3)	0.36 (−2.80, 3.57)

Abbreviations: Adalimumab-EU adalimumab sourced from the European Union, CI confidence interval, MedDRA Medical Dictionary for Regulatory Activities, NA not applicable
^aHypersensitivity events identified by Hypersensitivity Standardized MedDRA Query (broad and narrow), Anaphylactic reactions Standardized MedDRA Query (broad and narrow), and High-Level Group Terms Immunology and allergy investigations
^bOther events identified by High-Level Group Terms Skin Vascular Abnormalities, Central Nervous System Vascular Abnormalities and Medication Errors; Higher Level Terms Connective Tissue Disorders, Vasculitides (not elsewhere classified), Rashes, Eruptions and Exanthems (not elsewhere classified); Lower Level Teams Seizure and Convulsions; and Preferred Terms Lupus-like Syndrome, Headache and Migraine

ISSN: 1478-6362