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Items: 22

1.

Patient-reported outcomes with subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy: the PATH study.

Hartung HP, Mallick R, Bril V, Lewis RA, Sobue G, Lawo JP, Mielke O, Durn BL, Cornblath DR, Merkies ISJ, van Schaik IN; PATH study group.

Eur J Neurol. 2020 Jan;27(1):196-203. doi: 10.1111/ene.14056. Epub 2019 Sep 23.

PMID:
31400231
2.

Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study.

van Schaik IN, Mielke O, Bril V, van Geloven N, Hartung HP, Lewis RA, Sobue G, Lawo JP, Praus M, Durn BL, Cornblath DR, Merkies ISJ; PATH study group.

Neurol Neuroimmunol Neuroinflamm. 2019 Jul 3;6(5):e590. doi: 10.1212/NXI.0000000000000590. eCollection 2019 Sep.

3.

Indirect comparison of intravenous vs. subcutaneous C1-inhibitor placebo-controlled trials for routine prevention of hereditary angioedema attacks.

Bernstein JA, Li HH, Craig TJ, Manning ME, Lawo JP, Machnig T, Krishnarajah G, Fridman M.

Allergy Asthma Clin Immunol. 2019 Mar 7;15:13. doi: 10.1186/s13223-019-0328-3. eCollection 2019.

4.

Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies.

Merkies ISJ, van Schaik IN, Léger JM, Bril V, van Geloven N, Hartung HP, Lewis RA, Sobue G, Lawo JP, Durn BL, Cornblath DR, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Tackenberg B, Mielke O; PRIMA Trial Investigators and the PATH Study Group.

J Peripher Nerv Syst. 2019 Mar;24(1):48-55. doi: 10.1111/jns.12302. Epub 2019 Feb 15.

5.

Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study.

Mielke O, Bril V, Cornblath DR, Lawo JP, van Geloven N, Hartung HP, Lewis RA, Merkies ISJ, Sobue G, Durn B, Shebl A, van Schaik IN; PATH study group.

J Peripher Nerv Syst. 2019 Mar;24(1):72-79. doi: 10.1111/jns.12303. Epub 2019 Mar 1.

6.

Privigen® has similar pharmacokinetic properties in primary and secondary immune deficiency.

Tortorici MA, Lawo JP, Weide R, Jochems J, Puli S, Hofmann J, Pfruender D, Rojavin MA.

Int Immunopharmacol. 2019 Jan;66:119-126. doi: 10.1016/j.intimp.2018.11.008. Epub 2018 Nov 15.

7.

Long-Term Efficacy and Safety of Hizentra® in Patients with Primary Immunodeficiency in Japan, Europe, and the United States: a Review of 7 Phase 3 Trials.

Jolles S, Rojavin MA, Lawo JP, Nelson R Jr, Wasserman RL, Borte M, Tortorici MA, Imai K, Kanegane H.

J Clin Immunol. 2018 Nov;38(8):864-875. doi: 10.1007/s10875-018-0560-5. Epub 2018 Nov 10. Review.

8.

Health-Related Quality of Life with Subcutaneous C1-Inhibitor for Prevention of Attacks of Hereditary Angioedema.

Lumry WR, Craig T, Zuraw B, Longhurst H, Baker J, Li HH, Bernstein JA, Anderson J, Riedl MA, Manning ME, Keith PK, Levy DS, Caballero T, Banerji A, Gower RG, Farkas H, Lawo JP, Pragst I, Machnig T, Watson DJ.

J Allergy Clin Immunol Pract. 2018 Sep - Oct;6(5):1733-1741.e3. doi: 10.1016/j.jaip.2017.12.039. Epub 2018 Jan 31.

9.

Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial.

van Schaik IN, Bril V, van Geloven N, Hartung HP, Lewis RA, Sobue G, Lawo JP, Praus M, Mielke O, Durn BL, Cornblath DR, Merkies ISJ; PATH study group.

Lancet Neurol. 2018 Jan;17(1):35-46. doi: 10.1016/S1474-4422(17)30378-2. Epub 2017 Nov 6. Erratum in: Lancet Neurol. 2018 Jan;17 (1):26. Erratum in: Lancet Neurol. 2018 Aug;17(8):661.

10.

Hemolysis related to intravenous immunoglobulins is dependent on the presence of anti-blood group A and B antibodies and individual susceptibility.

Mielke O, Fontana S, Goranova-Marinova V, Shebl A, Spycher MO, Wymann S, Durn BL, Lawo JP, Hubsch A, Salama A.

Transfusion. 2017 Nov;57(11):2629-2638. doi: 10.1111/trf.14289. Epub 2017 Aug 25.

PMID:
28840942
11.

Minimum clinically important difference analysis confirms the efficacy of IgPro10 in CIDP: the PRIMA trial.

Merkies ISJ, Lawo JP, Edelman JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Léger JM; PRIMA trial investigators.

J Peripher Nerv Syst. 2017 Jun;22(2):149-152. doi: 10.1111/jns.12204. No abstract available.

12.

Prevention of Hereditary Angioedema Attacks with a Subcutaneous C1 Inhibitor.

Longhurst H, Cicardi M, Craig T, Bork K, Grattan C, Baker J, Li HH, Reshef A, Bonner J, Bernstein JA, Anderson J, Lumry WR, Farkas H, Katelaris CH, Sussman GL, Jacobs J, Riedl M, Manning ME, Hebert J, Keith PK, Kivity S, Neri S, Levy DS, Baeza ML, Nathan R, Schwartz LB, Caballero T, Yang W, Crisan I, Hernandez MD, Hussain I, Tarzi M, Ritchie B, Králíčková P, Guilarte M, Rehman SM, Banerji A, Gower RG, Bensen-Kennedy D, Edelman J, Feuersenger H, Lawo JP, Machnig T, Pawaskar D, Pragst I, Zuraw BL; COMPACT Investigators.

N Engl J Med. 2017 Mar 23;376(12):1131-1140. doi: 10.1056/NEJMoa1613627.

13.

Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial.

van Schaik IN, van Geloven N, Bril V, Hartung HP, Lewis RA, Sobue G, Lawo JP, Mielke O, Cornblath DR, Merkies IS; PATH study group.

Trials. 2016 Jul 25;17(1):345. doi: 10.1186/s13063-016-1466-2.

14.

Quantitative Evidence of Wear-Off Effect at the End of the Intravenous IgG (IVIG) Dosing Cycle in Primary Immunodeficiency.

Rojavin MA, Hubsch A, Lawo JP.

J Clin Immunol. 2016 Apr;36(3):210-9. doi: 10.1007/s10875-016-0243-z. Epub 2016 Feb 24.

15.

Affinity of FVIII-specific antibodies reveals major differences between neutralizing and nonneutralizing antibodies in humans.

Hofbauer CJ, Whelan SF, Hirschler M, Allacher P, Horling FM, Lawo JP, Oldenburg J, Tiede A, Male C, Windyga J, Greinacher A, Knöbl PN, Schrenk G, Koehn J, Scheiflinger F, Reipert BM.

Blood. 2015 Feb 12;125(7):1180-8. doi: 10.1182/blood-2014-09-598268. Epub 2014 Dec 16.

PMID:
25515962
16.

Efficacy and safety of IgPro20, a subcutaneous immunoglobulin, in Japanese patients with primary immunodeficiency diseases.

Kanegane H, Imai K, Yamada M, Takada H, Ariga T, Bexon M, Rojavin M, Hu W, Kobayashi M, Lawo JP, Nonoyama S, Hara T, Miyawaki T.

J Clin Immunol. 2014 Feb;34(2):204-11. doi: 10.1007/s10875-013-9985-z. Epub 2014 Feb 7.

17.

Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease.

Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, Wasserman RL.

Clin Immunol. 2014 Feb;150(2):161-9. doi: 10.1016/j.clim.2013.10.008. Epub 2013 Oct 26.

18.

Safety and pharmacokinetics of a recombinant fusion protein linking coagulation factor VIIa with albumin in healthy volunteers.

Golor G, Bensen-Kennedy D, Haffner S, Easton R, Jung K, Moises T, Lawo JP, Joch C, Veldman A.

J Thromb Haemost. 2013 Nov;11(11):1977-85. doi: 10.1111/jth.12409.

19.

A comparison of methods for classifying samples as truly specific with confirmatory immunoassays.

Jaki T, Lawo JP, Wolfsegger MJ, Allacher P, Horling F.

J Pharm Biomed Anal. 2014 Jan;88:27-35. doi: 10.1016/j.jpba.2013.08.013. Epub 2013 Aug 21.

PMID:
24013033
20.

A formal comparison of different methods for establishing cut points to distinguish positive and negative samples in immunoassays.

Jaki T, Lawo JP, Wolfsegger MJ, Singer J, Allacher P, Horling F.

J Pharm Biomed Anal. 2011 Jul 15;55(5):1148-56. doi: 10.1016/j.jpba.2011.04.006. Epub 2011 Apr 15.

PMID:
21561734
21.

Establishing bioequivalence in complete and incomplete data designs using AUCs.

Jaki T, Wolfsegger MJ, Lawo JP.

J Biopharm Stat. 2010 Jul;20(4):803-20. doi: 10.1080/10543401003618835.

PMID:
20496207
22.

Similar efficacy of ciclesonide once daily versus fluticasone propionate twice daily in patients with persistent asthma.

Magnussen H, Hofman J, Staneta P, Lawo JP, Hellwig M, Engelstätter R.

J Asthma. 2007 Sep;44(7):555-63.

PMID:
17885859

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