Treatment with secukinumab without concomitant antibiotic therapy is effective for the management of patients with moderate to severe hidradenitis suppurativa, according to study results presented at the 2023 Annual Meeting of the American Academy of Dermatology (AAD), held from March 17 to 21, 2023, in New Orleans, Louisiana.
Pharmacologic therapies, such as antibiotics, steroids, and biologics, and surgery are often needed for the management of hidradenitis suppurativa. More severe cases require a combination of antibiotics and biologics. Therefore, it is important to understand what effects these combined treatments may have on patients with the condition.
Using logistic regression models, researchers analyzed efficacy and safety results up to week 52 of secukinumab for hidradenitis suppurativa in the SUNSHINE (ClinicalTrials.gov Identifier: NCT03713619) and SUNRISE (ClinicalTrials.gov Identifier: NCT03713632) identical phase 3 clinical trials. In these trials, patients (N=1084) were randomly assigned into groups that received secukinumab 300 mg or placebo up to week 16.
Patients in SUNSHINE and SUNRISE were randomly assigned to the following:
SUNSHINE: secukinumab every 2 weeks (SECQ2W; n=181); secukinumab every 4 weeks (SECQ4W; n=180); or placebo (n=180)
SUNRISE: secukinumab every 2 weeks (SECQ2W; n=180); secukinumab every 4 weeks (SECQ4W; n=180); or placebo (n=183)
At week 16, patients who were receiving placebo began receiving secukinumab.
Patients in the antibiotic stratum from baseline received tetracycline up to 500 mg, minocycline up to 100 mg, or doxycycline up to 100 mg twice daily. Patients in the nonantibiotic stratum did not receive antibiotics until week 16.
Researchers reported that 11.7% of patients in the trials received antibiotics with secukinumab or placebo (SECQ2W, 12.2%; SECQ4W, 12.8%; placebo, 10.2%).
The primary endpoint at week 16 was Hidradenitis Suppurativa Clinical Response (HiSCR50), defined as a 50% or greater decrease in number of abscesses and inflammatory nodules, “with no increase in the number of abscesses and/or draining tunnels compared with baseline.”
At week 16, HiSCR50 rates were better among those who received secukinumab therapy compared with those who received placebo. The researchers also found that at week 16, concomitant antibiotics did not appear to significantly affect HiSCR50 rates.
The HiSCR50 rates were similar among patients with concomitant antibiotic use and those without concomitant antibiotic use.
Patients with concomitant antibiotic use: SECQ2W, n=44; 50.4% (OR, 4.78; 95% CI, 1.64-13.95); SECQ4W, n=46; 30.5% (OR, 2.01; 95% CI, 0.67-6.06); placebo, n=18; 18.1%)
Patients without concomitant antibiotic use: SECQ2W, n=317; 42.8% (OR, 1.45; 95% CI, 1.05-2.01); SECQ4W, n=314; 45.9% (OR, 1.64; 95% CI, 1.18-2.27); placebo, n=326; 34.1%).
Researchers observed similar results for the number of abscesses and inflammatory nodules, hidradenitis suppurativa flares, or adverse events.
Patients on SECQ2W had greater skin pain responses, regardless of concomitant antibiotic use.
No new safety signals were observed when secukinumab was used with systemic antibiotics.
“Following treatment with secukinumab (either SECQ2W or SECQ4W), improvements
versus placebo were observed at week 16 for the primary and secondary endpoints in
patients with or without a concomitant stable dose of systemic antibiotics,” the researchers said. “Regardless of concomitant antibiotic use, the improvements in efficacy seen at week 16 with SECQ2W and SECQ4W were sustained to week 52.”
Study limitations include a low number of patients in the concomitant antibiotic use stratum.
Disclosure: This research was supported by Novartis Pharma. Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Kokolakis G, Martorell A, Kerdel F, et al. Secukinumab and concomitant antibiotic use in patients with moderate-to-severe hidradenitis suppurativa: week 16 efficacy and safety results from the Phase 3 SUNSHINE and SUNRISE trials. Abstract presented at: AAD 2023; March 17-21, 2023; New Orleans, LA. Abstract 42981.