van Beek, Nina and Eming, Ruediger and Reuss, Alexander and Zillikens, Detlef and Sardy, Miklos and Guenther, Claudia and Kiritsi, Dimitra and Benoit, Sandrine and Beissert, Stefan and Glaeser, Regine and Gollnick, Harald and Horvath, Orsolya N. and Pfeiffer, Christiane and Roecken, Martin and Schauer, Franziska and Schreml, Stephan and Steinbrink, Kerstin and Zink, Alexander and Schade-Brittinger, Carmen and Hertl, Michael and Schmidt, Enno (2024) Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus (IA-Pem Study): a multicentre randomized controlled trial. BRITISH JOURNAL OF DERMATOLOGY, 190 (5). pp. 657-667. ISSN 0007-0963, 1365-2133
Full text not available from this repository. (Request a copy)Abstract
Background Pemphigus vulgaris (PV) and pemphigus foliaceus (PF) are potentially life-threatening autoimmune blistering diseases. Treatment is based on long-term immunosuppression with high doses of glucocorticosteroids in combination with potentially corticosteroid-sparing agents and/or rituximab. Immunoadsorption (IA) has emerged as a fast-acting adjuvant treatment option.Objectives To assess the clinical efficacy of IA in addition to best medical treatment (BMT).Methods We conducted a multicentre (26 centres from Germany and Austria) randomized controlled trial in 72 patients with newly diagnosed, relapsed or chronic active PV or PF (34 female patients and 38 male patients, aged 42-72 years) comparing BMT (prednisolone 1.0 mg kg-1 per day plus azathioprine or mycophenolate) with adjuvant IA (BMT + IA). Central 1 : 1 randomization was done at the coordinating centre for clinical trials (KKS Marburg). The primary endpoint was analysed using Kaplan-Meier and Cox regression methods.Results The study was ended prematurely owing to safety concerns after random allocation of 72 patients to BMT + IA (n = 34) or BMT (n = 38). The primary endpoint, time to complete remission on therapy, was not significantly different for the two groups [hazard ratio (HR) 1.35, 95% confidence interval (CI) 0.68-2.69; P = 0.39]. The cumulative dose of prednisolone was significantly lower in the BMT + IA group compared with BMT alone (difference -1214, 95% CI -2225 to -70; P = 0.03). In a post hoc analysis, patients with more extensive PV/PF showed a tendency towards a shorter time to remission in the BMT + IA group compared with the BMT group (HR 1.87, P = 0.17 in patients with baseline Pemphigus Disease Area Index >= 15). While more adverse events were observed in patients in the BMT group (29 vs. 25), severe adverse events were more frequent in patients in the BMT + IA group (17 events in 10 patients vs. 11 events in 8 patients).Conclusions In this study, adjuvant IA did not demonstrate a shorter time to clinical remission, but a corticosteroid-sparing effect was observed. In patients with extensive PV/PF, post hoc analysis suggests that adjuvant IA may lead to earlier remission, but potential adverse events must be carefully weighed against the expected benefits. Immunoadsorption (IA) has been proposed as a fast and effective adjuvant treatment option for pemphigus vulgaris and pemphigus foliaceus in case series. In this randomized controlled trial, IA combined with the best medical treatment, comprising oral prednisolone and azathioprine or mycophenolate, was compared with best medical treatment alone. The primary endpoint, i.e. time to clinical remission, was not significantly different between the two treatment groups. In contrast, the cumulative prednisolone dose was significantly lower in the IA group and in patients with extensive disease, and a tendency towards faster remission was observed in the IA arm. We conclude that adjuvant IA may be valuable in the initial treatment phase of patients with severe pemphigus.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PROTEIN-A IMMUNOADSORPTION; PROLONGED CLINICAL REMISSION; INTENSITY SCORE ABSIS; RITUXIMAB; AUTOANTIBODIES; DESMOGLEIN; REMOVAL; COMBINATION; GUIDELINE; DIAGNOSIS |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Dermatologie und Venerologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 22 Jan 2026 06:27 |
| Last Modified: | 22 Jan 2026 06:27 |
| URI: | https://pred.uni-regensburg.de/id/eprint/65399 |
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