@article{KirstenOhmGehrdauetal.2022,
  author    = {Kirsten, Natalia and Ohm, Frenz and Gehrdau, Kathrin and Girbig, Gefion and Stephan, Brigitte and Ben-Anaya, Nesrine and Pinter, Andreas and Bechara, Falk G. and Presser, Dagmar and Zouboulis, Christos C. and Augustin, Matthias},
  title     = {Switching from adalimumab originator to biosimilar in patients with hidradenitis suppurativa results in losses of response — data from the German HS registry HSBest},
  series = {Life},
  volume    = {12},
  journal   = {Life},
  number    = {10},
  issn      = {2075-1729},
  doi       = {10.3390/life12101518},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-288213},
  year      = {2022},
  abstract  = {Since 2021, adalimumab biosimilar ABP 501 can be used alternatively to adalimumab originator (ADAO) in the treatment of hidradenitis suppurativa (HS). Effectiveness and safety data remain scarce. We investigated the impact of switching from ADAO to ABP 501 on disease severity and the occurrence of adverse events (AEs) in patients with HS. We analyzed clinical data on patients enrolled in the German HSBest registry. Evaluation outcomes were assessed at three time points (baseline of originator (t0), prior to switching to biosimilar (t1) and 12 to 14 weeks after switching (t2)) and included patient-reported AEs and disease severity using the International Hidradenitis Suppurativa Severity Score System (IHS4) score. In total, 94 patients were switched from ADAO to ABP 501. Overall, 33.3\% (n = 31/94) of the patients developed AEs and/or loss of response (LoR) within 12 to 14 weeks after switching. Of these, 61.3\% (n = 19/31) experienced LoR but no AEs, 22.6\% (n = 7/31) LoR combined with AEs and 16.1\% (n = 5/31) AEs only. Our study showed that switching HS patients from ADAO to ABP 501 does significantly affect treatment effectiveness. Switching patients who are on remission maintenance therapy should be viewed critically.},
  language  = {en}
}
@article{NeugebauerHeuschmannJuettler2012,
  author    = {Neugebauer, Hermann and Heuschmann, Peter U. and J{\"u}ttler, Eric},
  title     = {DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY - Registry (DESTINY-R): design and protocols},
  series = {BMC Neurology},
  volume    = {12},
  journal   = {BMC Neurology},
  number    = {115},
  doi       = {10.1186/1471-2377-12-115},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-133892},
  year      = {2012},
  abstract  = {Background: Randomized controlled trials (RCT) on the treatment of severe space-occupying infarction of the middle cerebral artery (malignant MCA infarction) showed that early decompressive hemicraniectomy (DHC) is life saving and improves outcome without promoting most severe disablity in patients aged 18-60 years. It is, however, unknown whether the results obtained in the randomized trials are reproducible in a broader population in and apart from an academical setting and whether hemicraniectomy has been implemented in clinical practice as recommended by national and international guidelines. In addition, they were not powered to answer further relevant questions, e. g. concerning the selection of patients eligible for and the timing of hemicraniectomy. Other important issues such as the acceptance of disability following hemicraniectomy, the existence of specific prognostic factors, the value of conservative therapeutic measures, and the overall complication rate related to hemicraniectomy have not been sufficiently studied yet. Methods/Design: DESTINY-R is a prospective, multicenter, open, controlled registry including a 12 months follow-up. The only inclusion criteria is unilateral ischemic MCA stroke affecting more than 50\% of the MCA-territory. The primary study hypothesis is to confirm the results of the RCT (76\% mRS <= 4 after 12 months) in the subgroup of patients additionally fulfilling the inclusion cirteria of the RCT in daily routine. Assuming a calculated proportion of 0.76 for successes and a sample size of 300 for this subgroup, the width of the 95\% CI, calculated using Wilson's method, will be 0.096 with the lower bound 0.709 and the upper bound 0.805. Discussion: The results of this study will provide information about the effectiveness of DHC in malignant MCA infarction in a broad population and a real-life situation in addition to and beyond RCT. Further prospectively obtained data will give crucial information on open questions and will be helpful in the plannig of upcomming treatment studies.},
  language  = {en}
}