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Adalimumab weekly, biweekly show similar safety outcomes for psoriasis

Recent findings revealed that adalimumab taken for hidradenitis suppurativa or psoriasis once weekly or every other week have similar safety and adverse event profiles.

Caitriona Ryan, MD, of the department of dermatology, Blackrock Clinic, Dublin, Ireland, and colleagues examined the safety of adalimumab 40-mg provided every other week vs. every week in a series of placebo-controlled and open-label study periods in patients with hidradenitis suppurativa (HS) or psoriasis.

In patients with HS, the researchers evaluated adalimumab in a phase 2, double-blind, placebo-controlled trial (NCT00918255) and two phase 3, double-blind, placebo-controlled trials (PIONEER 1 and 2).

In the phase 2 study, researchers randomly assigned patients 1:1:1 to receive 16 weeks of treatment with placebo, adalimumab 40 mg every other week (EOW), or adalimumab 40 mg every week (EW). In the phase 3 studies, patients with moderate-to-severe HS received adalimumab 40 mg EW for a 12-week period (period A). Period B involved investigators re-randomizing patients who had received 40 mg adalimumab EW in period A to either receive adalimumab 40 mg EOW, placebo or continue taking adalimumab EW for 24 weeks. The current study included all data that directly compared adalimumab EOW or EW and placebo.

Ryan and colleagues evaluated adalimumab’s safety in treating psoriasis in two trials. One study (NCT00645814) was a phase 2, randomized, double-blind, placebo-controlled trial in adults with moderate-to-severe plaque psoriasis. Investigators in this study randomly assigned patients 1:1:1 to receive treatment with placebo, adalimumab 40 mg EOW or adalimumab 40 mg EW for 12 weeks. A 48-week extension phase followed, however Ryan and colleagues included only data from the initial 12-week trial in their evaluation.

The second trial (NCT00195676) was an open-label study of adalimumab in adults with moderate-to-severe chronic plaque psoriasis who received adalimumab EW or EOW for up to 252 weeks.

They also assessed adalimumab treating non-dermatologic conditions such as Crohn’s disease (6 studies), ulcerative colitis (3 studies) and rheumatoid arthritis (1 study).

In the phase 2 trial studying adalimumab in patients with HS, adalimumab had a higher prevalence of adverse events vs. placebo, but the frequency of AEs between adalimumab EW vs. EOW was comparable. Both EOW and EW dosing of adalimumab showed comparable rates of AEs leading to discontinuation, serious AEs, and infections. Of the serious infections, there was one event with EOW dosing and two events with EW dosing.

The phase 3 pooled data of patients with HS showed similar rates of AEs during period B for adalimumab EOW, EW and placebo. Adalimumab EOW and EW had more frequent AEs vs. placebo, while AEs resulting in discontinuation were similar across all groups. Additionally, the EOW and EW groups had similar infection rates.

The phase 2 psoriasis study revealed a higher overall incidence of AEs and serious AEs in the EW group vs. the EOW or placebo groups. The EOW group had two AEs leading to discontinuation while the EW group had three AEs. Further, the EW group had a higher rate of infections vs. the EOW group. The placebo group had the highest rate of worsening or new-onset psoriasis, and the EW group had the highest rate of injection site reactions. The occurrence of other AEs was low and comparable between the groups. In the open-label study of adalimumab in psoriasis, the researchers observed similar rates of any AEs and severe AEs in both the EOW and EW dosing groups. However, the adalimumab EW group had a higher prevalence of AEs resulting in discontinuation vs. adalimumab EOW.

In the analyses of adalimumab for non-dermatologic conditions, the overall AE rates were also similar between the EW and EOW dosing groups.

“In patients with hidradenitis suppurativa, psoriasis and non-dermatologic indications, the safety of adalimumab 40-mg every other week and every week dosing regimens was comparable,” Ryan and colleagues wrote. “The current analysis supports and further adds to the known safety profile of adalimumab.” – by Jennifer Byrne

Disclosure: AbbVie funded the studies, contributed to their design, and was involved in the collection, analysis, and interpretation of the data and in the writing, review, and approval of the publication. Please see the full study for a list of the researchers’ relevant financial disclosures.