Breakthrough SARS-CoV-2 infections and prediction of moderate-to-severe outcomes during rituximab therapy in patients with rheumatic and musculoskeletal diseases in the UK: a single-centre cohort study

Md Yusof, MY; Arnold, J; Saleem, B; Vandevelde, C; Dass, S; Savic, S; Vital, EM; Emery, P

doi:10.1016/s2665-9913(23)00004-8

Across rheumatic diseases

Breakthrough SARS-CoV-2 infections and prediction of moderate-to-severe outcomes during rituximab therapy in patients with rheumatic and musculoskeletal diseases in the UK: a single-centre cohort study

Lancet RheumatolPublished 10 Jan 2023Retrospective cohort study

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Authors' conclusion

In later stages of the pandemic, the SARS-CoV-2 breakthrough infection rate was high but severe COVID-19 rates were similar to any severe infection event rate in patients who were vaccinated.

Study context

Population: Adults ≥18 years with established rheumatic and musculoskeletal diseases treated with ≥1 rituximab infusion, single centre in Leeds, UK, March 1, 2020 to April 1, 2022
Participants: 400 adults774.6 patient-years

Exposure: Fully vaccinated vs partially vaccinated or unvaccinated rituximab-treated patients
Fully vaccinatedn = 372
Outcome: Breakthrough COVID-19 infection (infection ≥14 days after the second vaccine dose)

Methodological detailssingle-centre, multivariable Cox regression

Single-centre
Multivariable Cox regression

Main finding

As reported in the abstract

Breakthrough COVID-19 in fully vaccinated patients with complete data (n=370)

All severity type breakthrough COVID-19

110

30%

Moderate-to-severe breakthrough COVID-19

16

4%

Died

one (<1%)

Observational data: associations, not effects.

Further findings

Incidence rate of COVID-19, all severities, post-vaccination phase (per 100 person-years) · after Dec 18, 2020

Fully vaccinated22.83 per 100 person-years95% CI 18.94–27.52

Partially vaccinated or unvaccinated89.46 per 100 person-years95% CI 52.98–151.05

Incidence rate of moderate-to-severe COVID-19, post-vaccination phase (per 100 person-years) · after Dec 18, 2020

Fully vaccinated3.32 per 100 person-years95% CI 2.03–5.42

Partially vaccinated or unvaccinated25.56 per 100 person-years95% CI 9.59–68.10

Predictors of moderate-to-severe COVID-19 (multivariable Cox regression)

	← Lower risk ←→ Higher risk →	HR (95% CI)	P value
Number of comorbidities	0.10.31310	1.46 (1.13–1.89)	P = 0.0037
Hypogammaglobulinaemia (pre-rituximab IgG <6 g/L)	0.10.31310	3.22 (1.27–8.19)	P = 0.014
	0.10.31310Hazard ratio (log scale)

Outcome	← Lower risk ←→ Higher risk →	HR (95% CI)	P value
Predictors of moderate-to-severe COVID-19 (multivariable Cox regression)Each vaccine dose received	0.20.5125	0.49 (0.37–0.65)	P < 0.0001
	0.20.5125Hazard ratio (log scale)

Predictors of moderate-to-severe COVID-19 (multivariable Cox regression)

Concomitant prednisolone, rituximab-associated factors (eg, dose, time to vaccination since last rituximab dose) and vaccine-associated factors (eg, vaccine type, peripheral B-cell depletion) not predictive

Moderate-to-severe COVID-19 across variant phases (wild-type or alpha, delta, omicron)

Rates broadly similar across the three variant phases; most infections mild

Safety

Other severe infection events (rate per 100 person-years)

Severe infection event rate, broadly similar to moderate-to-severe COVID-19: 5.68 per 100 person-years [95% CI 4.22-7.63]

Original publication

Breakthrough SARS-CoV-2 infections and prediction of moderate-to-severe outcomes during rituximab therapy in patients with rheumatic and musculoskeletal diseases in the UK: a single-centre cohort study. Lancet Rheumatol. Published 10 January 2023. doi:10.1016/s2665-9913(23)00004-8

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