Marcus Maurer

Credit: www.marcus-maurer.com

The use of daily rupatadine leads to both enhanced quality-of-life and enhancement of the activity of chronic spontaneous urticaria (CSU), according to new findings, though these effects were not sustained after discontinuing.¹

This new data resulted from a recent double-blinded study examining on-demand versus daily non-sedating H1-antihistamines (nsAH), the most commonly employed remedy for CSU.²

To assess this distinction, the research was conducted and it was authored by Marcus Maurer, from the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, in Berlin, Germany.

“Here, we sought to assess the longer term potential disease-modifying effects, assess the effects of updosing, and compare OD versus daily treatment to evaluate the efficacy of rupatadine in patients with CSU,” Maurer and colleagues wrote.

Background and Findings

The investigators used a multicenter study design and conducted the research in both Germany and Spain, seeking to assess the safety, efficacy, and long-term outcomes of chronic CSU treatment with rupatadine, comparing on-demand (OD) and daily therapy. Their research involved a randomized, dose-escalating, double-blind design with several unique phases: screening lasting 2 weeks, treatment lasting 8 weeks, and follow-up lasting 6 weeks.

The study participants were assigned to either be in Group A1 (10 mg rupatadine OD) or to be in Group B1 (10 mg rupatadine daily) following the investigators’ screening phase. The individuals with a complete response were kept in their respective groups, and non-responsive ones switched to other groups with false changes or adjustments in dose.

After the participants’ treatment phase, they would begin an open-label follow-up phase—lasting 10-16 weeks—during which only OD therapy was permitted by the research team. The team’s primary objective was to compare CSU activity—measured by UAS7—between those given OD rupatadine and the ones treated each day, at the end of the follow-up phase.

The investigators’ secondary objectives involved examining the effectiveness of 10 mg rupatadine at the time of treatment in OD compared to the daily study groups. It also involved comparing disease activity at the time of treatment and follow-up between participants given different doses, and assessing tolerability and safety of both 10 mg and 20 mg doses.

The investigators found that the baseline qualities of all of the treatment groups were shown to be balanced, though they did note variations in the use of rescue medication at the time of screening, and physicians also commented on differing levels of severity.

The research team also reported that disease activity was not shown to exhibit substantial disparities between the 2 approaches at the treatment’s conclusion, showing that while daily dosing had advantages, it did not offer prolonged benefits following the treatment’s cessation. The noted lack of sustained advantages also was shown to apply to disease activity and quality of life measurements.

In sum, at Week 4, they found a notable enhancement in disease activity and quality of life among those given daily therapy versus participants treated once-per-day. Though increasing dosage of the treatment did not considerably improve average disease activity, the increase did lead to a rise in the proportion of complete responders from 5% to 22%.

By the team’s conclusion at the follow-up period, they found no substantial distinction in disease activity between the study participants treated once per-day and those treated daily. Further analysis by the investigators explored rupatadine updosing, and they found a rise in the total number of complete responders as well as those reporting major symptom reduction, but they added that there were inconsistencies in results.

“Updosing rupatadine did not improve its effectiveness but slightly increased the number of complete responders,” they wrote. “However, after treatment had ceased, rupatadine did not produce any long-term disease-modifying effects in CSU. We, therefore, recommend treating patients with CSU daily rather than OD rupatadine.”

References

1. ^{Weller, K, Gimenez-Arnau, AM, Baron, J, et al. Efficacy and safety of on-demand versus daily rupatadine in chronic spontaneous urticaria: A randomized trial. Allergy. 2023; 00: 1-11. doi:10.1111/all.15854.}
2. ^{Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022; 77(3): 734-766. (In English). doi:10.1111/all.15090.}