Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial

April 1, 2025

This plain-language research summary was generated by AI, courtesy of HS Simplified.

AI Generated Content Verified By: Afsaneh Alavi, M.D. | Mayo Clinic

Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial

In a 2025 study published in the British Journal of Dermatology, researchers examined the long-term use of secukinumab in treating hidradenitis suppurativa (HS), a chronic skin condition causing painful boils. Despite not meeting the primary endpoint of time to loss of response (LOR) compared to placebo, many patients retained clinical benefits, and safety was consistent with known profiles. These findings suggest secukinumab as a viable, safe long-term treatment for moderate-to-severe HS.

What Was This Study About?

Hidradenitis suppurativa (HS) is a long-lasting skin condition that causes painful bumps, boils, and tunnels under the skin. These bumps can be very uncomfortable and often come back again and again. HS can make life hard for those who have it. Doctors have a few medicines called biologics (special drugs made from living cells) that can help people with severe cases. One of these drugs is called secukinumab.

How Did the Researchers Study This?

In two big studies named SUNSHINE and SUNRISE, researchers showed that secukinumab helped patients with HS for at least one year. Dr. Kimball and her team wanted to know if it would keep working and remain safe for even longer. So, they took people who finished the first year of treatment and followed them for another year (making two years in total).

Some patients kept getting secukinumab, while others were switched to a placebo (a "dummy" medicine with no active drug). The main thing the researchers watched for was if and when patients lost the benefits of secukinumab, which they called loss of response (LOR). LOR meant that the number of painful bumps and nodules (called abscesses and inflammatory nodules) went up a lot compared to before.

What Did They Find?

The main goal was to see if secukinumab could prevent LOR better than placebo. This main goal was not met. Patients who kept getting secukinumab did not have a clearly lower risk of LOR compared to those switched to placebo, at least not by the strict rules set for the study. However, people on secukinumab usually went longer before they lost response than those on the placebo. For example, some went about 4-6 months longer without getting worse.

Even when people did get worse, many still had fewer bumps than when they started the study. Some even got back to their better status after a while. The medicine was generally safe—no new major side effects were found, and most problems were mild, like colds or mild infections.

What Does This Mean for Patients?

For people with moderate-to-severe HS, secukinumab can help keep symptoms under control for a long time. Even if some patients lose some benefit after a while, many still feel better than before treatment. The drug seems safe to use for at least two years, with no new worries.

What Are the Limitations?

There are some important limits to this study. First, the way they measured "loss of response" might have been too sensitive, meaning that even small changes in the number of bumps could be counted as losing response. Also, HS naturally comes and goes, so it's hard to tell if changes are from the medicine or just how the disease acts. Finally, some people in the placebo group had already taken secukinumab earlier, so the groups weren't completely different.

Bottom Line

Secukinumab continues to help many people with serious HS after two years, and it is safe to use for this long. While the main goal of the study wasn’t reached, most patients still did better than before treatment, and there were no new safety problems.

Important words explained:
Biologic drug: A medicine made from living cells, used to target specific parts of the immune system.
Placebo: A fake medicine, used as a comparison in studies.
Abscesses and nodules: Swollen, painful lumps under the skin, common in HS.
Loss of response (LOR): When a medicine stops working as well as before.

Author(s)

Alexa B Kimball, Falk G Bechara, Aysha Badat, Evangelos J Giamarellos-Bourboulis, Alice B Gottlieb, Gregor B E Jemec, Ziad Reguiai, Axel P Villani, Ivette Alarcon, Amita Bansal, Francesca Gasperoni, Ruvie Martin, Bertrand Paguet, Lorenz Uhlmann, Hichem Zouater, Shoba Ravichandran, Afsaneh Alavi

Read Original Paper

https://academic.oup.com/bjd/article/192/4/629/7913451