Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Hefiya

Hefiya 20 mg solution for injection in pre-filled syringe Hefiya 40 mg solution for injection in pre-filled syringe Hefiya 40 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 23

HOS-142509 · Präparat HOS-098832

During the controlled portions of pivotal adalimumab studies in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95 % confidence interval) of 6.8 (4.4, 10.5) per 1 000 patient years among 5 291 adalimumab-treated patients versus a rate of 6.3 (3.4, 11.8) per 1 000 patient years among 3 444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients). The rate (95 % confidence interval) of non- melanoma skin cancers was 8.8 (6.0, 13.0) per 1 000 patient years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1 000 patient years among control patients. Of these skin cancers, squamous cell carcinomas occurred at rates (95 % confidence interval) of 2.7 (1.4, 5.4) per 1 000 patient years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1 000 patient years among control patients. The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1 000 patient years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1 000 patient years among control patients.

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