Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy
Peer-reviewed phase 3 trial; NEJM 2026, 2026 · paper · Clinical trials
A phase 3 randomized trial comparing obinutuzumab with tacrolimus in 142 adults with primary membranous nephropathy. Complete remission at week 104 occurred in 37% versus 6%, with similar rates of serious adverse events.
4 findings
Substance Grade ≥3 adverse events, obinutuzumab: "16 (22)" in Table 3 (N=71), repeated as "16 patients (22%)" in the Abstract and Results; 16/71 is 22.5%, which rounds to 23%.
- p. 10 Table 3, Grade ≥3 adverse event, obinutuzumab
16 (22)
- p. 1 Abstract, Results
reported in 16 patients (22%) in the obinutuzumab group
- p. 8 Results, Safety
or higher were reported in 16 patients (22%) in
- p. 8 Safety text
16 patients (22%) in the obinutuzumab group
Only the authors can say what is right here.
Judge's note: I read p10 (Table 3, safety population N=71) and the Safety paragraph on p8. 22% would match a denominator of 72 (ITT), but the paper states the safety population is 71. Other cells round conventionally on 71: 12/71→17, 62/71→87.
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Substance Table 1, tacrolimus anti-PLA2R: "Median (range) — U/ml 92.8 (29.9–1922.5)" sits beside "Positive, ≥14 U/ml — no. (%) 57 (81)". A minimum of 29.9 U/ml would make all 70 patients positive.
- p. 4 Table 1, Anti-PLA2R autoantibody level, Median (range), tacrolimus
92.8 (29.9–1922.5)
- p. 4 Table 1, Positive, ≥14 U/ml, tacrolimus
57 (81)
Only the authors can say what is right here.
Judge's note: I read both rows on the p4 image. High (23) plus low (47) gives 70, so every patient had a value. I found no footnote (p5 Table 1 footnotes) and no Methods text that defines positivity differently or uses another sample. The obinutuzumab column, with range 3.0–3043.8 and 54 (75) positive, is internally consistent. Only the authors can say whether the range minimum or the positive count is wrong.
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Substance Table 3, Covid-19, obinutuzumab group (N=71): "11 (16)"; 11/71 is 15.5%, which rounds to 15%.
- p. 10 Table 3, Infections occurring in ≥5%, Coronavirus disease 2019, obinutuzumab column
11 (16)
Only the authors can say what is right here.
Judge's note: I read p10. The other cells in Table 3 round conventionally on N=71 and N=70: 36/71→51, 34/71→48, 12/71→17, 7/71→10. A denominator of 72 would also give 15%. Only the authors can say whether the count or the percentage is wrong.
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Reference or label Ref 31 (Furie et al., obinutuzumab in active SLE) ends "N Engl J Med 2026;395:XXX-XXX." with placeholder page numbers left in the published issue.
- p. 13 References, ref 31
J Med 2026;395:XXX-XXX.
- p. 13 Reference 31
N Engl J Med 2026;395:XXX-XXX.
- p. 13 Reference 31
N Engl J Med 2026;395:XXX-XXX.
Judge's note: The p13 image shows the 'XXX-XXX' placeholder. The issue footer reads N Engl J Med 395;10, September 10, 2026.
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7 minor (typos and the like; most checked by the judge only)
Reference or label Intro: obinutuzumab "has been assessed for the treatment of systemic lupus erythematosus and childhood-onset idiopathic nephrotic syndrome in recent phase 3 trials ... 13-18"; none of refs 13–18 is the SLE phase 3 trial, which is ref 31 (first cited in the Discussion).
- p. 2 Introduction, paragraph 2
has been assessed for the treat-ment of systemic lupus erythematosus and child-hood-onset idiopathic nephrotic syndrome in recent phase 3 trials, with the primary analyses showing a significant treatment effect.13-18
- p. 12 References 13–18
Food and Drug Administration. Gazy-va: highlights of prescribing information.
- p. 13 Reference 31
Efficacy and safety of obinutuzumab in ac-tive systemic lupus erythematosus.
Only the authors can say what is right here.
Judge's note: I checked p2 and the reference list on p12–13. Refs 13–15 are the FDA label and two Roche approval releases for lupus nephritis. Ref 16 is the NOBILITY phase 2 lupus nephritis trial, ref 17 is Furie 2025 NEJM in 'active lupus nephritis', and ref 18 is INSHORE in nephrotic syndrome. Ref 31, 'Efficacy and safety of obinutuzumab in active systemic lupus erythematosus', is not in the cited range. Lupus nephritis is a manifestation of SLE, so the authors may have meant REGENCY. The authors should say whether ref 31 should be cited here.
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Wording Limitations: "end points were based on objective laboratory values that were assessed by personnel who were unaware of the trial-group assignments", yet a key secondary end point is the patient-reported PROMIS Fatigue T score in an open-label trial.
- p. 11 Discussion, limitations paragraph
end points were based on objective laboratory values that were assessed by personnel who were un-aware of the trial-group assignments
- p. 3 Methods, Assessment of Efficacy End Points
(PROMIS) Fatigue T score from baseline to week 104
Only the authors can say what is right here.
Judge's note: Table 2 (p7) and the Methods list the PROMIS Fatigue T score change as a key secondary end point. It is a patient-reported score, not a laboratory value. As written, the blanket statement does not cover it. The authors may have meant the remission end points only.
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Wording Discussion: "the peak percentage of patients who had complete remission in this trial was attained by week 76 (36%)", but Fig. 1 and Table 2 report 37% at week 104.
- p. 9 Discussion, right column
plete remission in this trial was attained by week 76 (36%)
- p. 8 Figure 1 bars
37
- p. 9 Discussion, second column
the peak percentage of patients who had com-plete remission in this trial was attained by week 76 (36%)
- p. 8 Figure 1 bar labels
36
Judge's note: Table 2 gives 26/72 (36) at week 76 and 26/71 (37) at week 104; Fig. 1 shows 24, 36 and 37. The responder count is the same at both time points, so 'by week 76' can be read as a plateau. Still, the numerical peak percentage is at week 104, so the wording is imprecise.
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Typo Table 2 prints the eGFR hazard-ratio CI as "(0.18–6.61)", while every other CI in the table uses 'to', e.g. "(0.23 to 1.70)".
- p. 7 Table 2, sustained eGFR reduction hazard ratio
(0.18–6.61)
- p. 7 Table 2, duration of complete remission hazard ratio
(0.23 to 1.70)
Judge's note: I confirmed this on the p7 image. It is a cosmetic style inconsistency and does not change the meaning.
Second check: none (judge only)
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Typo Discussion, first paragraph: "remission of protineu-ria in patients with resistance to rituximab" should read 'proteinuria'.
- p. 9 Discussion, first paragraph
remission of protineuria
- p. 9 Discussion, first paragraph
remission of protineu-ria in patients with resistance to rituximab
Judge's note: The p9 image shows 'protineu-ria'. The misspelling is in the printed letters themselves, so it is not a hyphenation artefact.
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Typo Limitations paragraph: "well as treatme nt outcomes such as progression" has a stray space inside 'treatment'.
- p. 11 Discussion, limitations paragraph
treatme nt outcomes
- p. 11 Discussion, limitations paragraph
well as treatme nt outcomes such as progression
Judge's note: The zoomed crop of p11 shows a visible mid-line gap in 'treatme nt'.
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Typo Ref 29 lists the author as "Logt A-V", whereas ref 3 gives "van de Logt A-E".
- p. 13 Reference 29
Logt A-V, et al.
- p. 12 Reference 3
van de Logt A-E
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that the STARMEN coauthor is the same A-E van de Logt as in ref 3. Both forms appear on the p12 and p13 images. The 'Logt A-V' form looks like a mis-parsed surname prefix and initial.
Second check: none (judge only)