Adalimumab Safe for Long-Term Use

06/06/2018

biologic

A recent extension study demonstrated long-term safety and efficacy of adalimumab (Humira) for the treatment of moderate to severe hidradenitis suppurativa (HS).

In their study, the researchers pooled data from the PIONEER phase 3 trials and an open-label extension study that included patients with HS. The duration of PIONEER I and II periods A and B were 12 and 24 weeks, respectively, and the duration of the open-label extension period was 52 weeks or more. Participants involved in the open-label extension period received 40 mg of adalimumab every week continuously (ADAew) and responders plus partial responders (PRR) were evaluated. The primary endpoints included HS clinical Response (HiSCR) measure, lesion counts, skin pain, and Dermatology Life Quality Index (DLQI), as well as treatment-emergent adverse events.
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At week 12, 52.3% (ADAew) and 73% of participants achieved HiSCR, reported the researchers, which was maintained through week 168 by 52.3% of ADAew participants and 57.1% of PRR participants. In addition, the researchers observed sustained improvements in lesion counts, skin pain, and DLQI.

The safety profile of adalimumab was similar between the open label extension study and PIONEER studies.

“Continuous weekly dosing with adalimumab 40 mg is a reasonable treatment option for long-term control of moderate to severe HS,” the researchers concluded.

Reference

Zouboulis CC, Okun MM, Prens EP, et al. Long-term adalimumab efficacy in patients with moderate-to-severe hidradenitis suppurativa/acne inversa: 3-year results of a phase 3 open-label extension study [published online May 31, 2018]. J Am Acad Dermatol. https://doi.org/10.1016/j.jaad.2018.05.040.