Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries

Abstract

Long-term safety of adalimumab in psoriasis clinical studies has been established. The objective of this research was to review real-world evidence of adalimumab safety from registries of adult patients with psoriasis treated in clinical practice. Databases (BIOSIS Previews, Current Contents Search, Derwent Drug File, EMBASE, EMBASE Alert, EMCare, MEDLINE, SciSearch) were searched for psoriasis registries with adalimumab safety data. Eligible papers were English language manuscripts (conference abstracts excluded) from psoriasis registries presenting safety data for adult patients with psoriasis receiving adalimumab. The incidence and rate (events/100 patient-years [PY]) of adverse events (AEs), serious AEs (SAEs) and AEs of special interest are reported. Abstracts of 425 publications were screened, and 401 publications excluded (208 conference abstracts; 193 papers). Remaining manuscripts were fully screened; 14 were excluded (no adalimumab data, n = 10; no safety data, n = 2; no on-treatment data, n = 1; not English, n = 1), and 10 selected. Overall rates of AEs (4273 [22.2/100PY]) and SAEs (827 [4.3/100PY]) were reported in the ESPRIT registry (N = 6059). Rates of infections (7.7-14.7/100PY) and serious infections (<0.6-2.0/100PY) were reported in four studies. Cardiovascular-related events were reported in three studies: ≤0.1/100PY per major cardiac event in ESPRIT, <0.5/100PY major cardiac events in PsoBest and serious cardiovascular events in two patients (<1%) in DERMBIO. Malignancies were reported in three studies (any malignancy, 0.9/100PY; malignancies excluding non-melanoma skin cancer [NMSC], <0.6/100PY; NMSC, 0.6-<0.5/100PY). These findings suggest that real-world safety of adalimumab is consistent across different psoriasis registries, which supports the existing long-term safety profile of adalimumab from clinical studies.

Real‐world comparative effectiveness of adalimumab, etanercept and methotrexate: a Swedish register analysis

“…Availability of biosimilar subcutaneous tumor necrosis factor‐alpha inhibitors (SC‐TNFis) adalimumab (ADA) and etanercept (ETN) has reduced prices, making biologic treatment more affordable. Furthermore, ADA and ETN have been on the market for more than 15 years and have solid safety records . The combination of new treatment guidelines, reassuring long‐term safety, and reduced prices may render ADA and ETN viable alternatives to methotrexate (MTX) as first‐line systemic treatment for moderate‐to‐severe psoriasis.…”

“…Furthermore, ADA and ETN have been on the market for more than 15 years and have solid safety records. [7][8][9][10] The combination of new treatment guidelines, reassuring long-term safety, and reduced prices may render ADA and ETN viable alternatives to methotrexate (MTX) as first-line systemic treatment for moderate-to-severe psoriasis. Given resource constraints in health care and the price of biologics and novel small molecules protected by patents, ETN, ADA and MTX are likely to be the most frequently prescribed systemic treatments in many European countries in the coming years.…”

Malignancy Rates in Brodalumab Clinical Studies for Psoriasis

“…However, for NMSC, incidence rates per 100 PY were lower for infliximab (1.68) and higher for adalimumab (2.41) compared with the psoriasis population (1.80) [25]. A systematic review of adalimumab safety in psoriasis registries found event rates of 0.9 per 100 PY for malignancy, < 0.6 per 100 PY for malignancies excluding NMSC, and a range of < 0.5-0.6 per 100 PY for NMSC [26]. Another systematic review found an increased risk of NMSC, but not other malignancies, among patients with psoriasis treated with anti-TNFα therapy,…”

Treat-to-Target Approach for the Management of Patients with Moderate-to-Severe Plaque Psoriasis: Consensus Recommendations

“…Concern about the safety of systemic therapies is one of the main reasons why patients with moderate-to-severe psoriasis are often inadequately treated. However, a large body of evidence from clinical trials and post-marketing pharmacovigilance registries supports the safety of biologicals for the treatment of psoriasis [57][58][59][60][61][62][63][64]. Biologicals are better tolerated than conventional systemic therapies, particularly for long-term treatment.…”