MDedge Rheumatology

Key clinical point: The incidence of rheumatoid arthritis-related bronchiectasis (RA-BR) was almost 20%, suggesting that bronchiectasis is a common extra-articular feature of rheumatoid arthritis (RA).

Major finding: The pooled overall prevalence of RA-BR was 18.7% (95% CI 13.7%-24.3%) in the random effects meta-analysis and 22.6% (95% CI 16.8%-29.0%) in studies that used high-resolution chest computed tomography imaging.

Study details: Findings are from a systematic review and meta-analysis of 41 studies that reported on RA-BR prevalence, risk factors, or both.

Disclosures: The study did not receive any external funding. Dr. Sparks, Dr. Doyle, and Dr. Shadick reported receiving research support and consultancy fees from various sources.

Source: Martin LW et al. Semin Arthritis Rheum. 2021 Aug 20. doi: 10.1016/j.semarthrit.2021.08.005.

Key clinical point: The incidence of rheumatoid arthritis-related bronchiectasis (RA-BR) was almost 20%, suggesting that bronchiectasis is a common extra-articular feature of rheumatoid arthritis (RA).

Major finding: The pooled overall prevalence of RA-BR was 18.7% (95% CI 13.7%-24.3%) in the random effects meta-analysis and 22.6% (95% CI 16.8%-29.0%) in studies that used high-resolution chest computed tomography imaging.

Study details: Findings are from a systematic review and meta-analysis of 41 studies that reported on RA-BR prevalence, risk factors, or both.

Disclosures: The study did not receive any external funding. Dr. Sparks, Dr. Doyle, and Dr. Shadick reported receiving research support and consultancy fees from various sources.

Source: Martin LW et al. Semin Arthritis Rheum. 2021 Aug 20. doi: 10.1016/j.semarthrit.2021.08.005.

Key clinical point: The incidence of rheumatoid arthritis-related bronchiectasis (RA-BR) was almost 20%, suggesting that bronchiectasis is a common extra-articular feature of rheumatoid arthritis (RA).

Major finding: The pooled overall prevalence of RA-BR was 18.7% (95% CI 13.7%-24.3%) in the random effects meta-analysis and 22.6% (95% CI 16.8%-29.0%) in studies that used high-resolution chest computed tomography imaging.

Study details: Findings are from a systematic review and meta-analysis of 41 studies that reported on RA-BR prevalence, risk factors, or both.

Disclosures: The study did not receive any external funding. Dr. Sparks, Dr. Doyle, and Dr. Shadick reported receiving research support and consultancy fees from various sources.

Source: Martin LW et al. Semin Arthritis Rheum. 2021 Aug 20. doi: 10.1016/j.semarthrit.2021.08.005.

Key clinical point: Disease activity is associated with fatigue in early rheumatoid arthritis (RA), and patients who achieve early remission are at lower risk for experiencing fatigue.

Major finding: Patients who achieved remission at 6 months had a lower chance of experiencing fatigue at 24 months (Disease Activity Score 44 remission, odds ratio [OR] 0.31; P < .001). Fewer swollen joints (OR 0.92; P = .006), lower power Doppler ultrasound score (OR 0.95; P = .027), and a higher patient global assessment score (OR 1.03; P < .001) raised the likelihood of clinically relevant fatigue at 24 months.

Study details: The findings come from the analysis of 205 individuals from the ARCTIC trial. Patients were randomly assigned to a treat-to-target approach with and without musculoskeletal ultrasonography during clinical examinations and treatment decisions.

Disclosures: This work was supported by the DAM Foundation. Some of the authors declared receiving personal fees, personal honoraria, consultancy honorariums/fees, and serving on the data safety monitoring board or advisory board of various sources.

Source: Holton K et al. Ann Rheum Dis. 2021 Aug 13. doi: 10.1136/annrheumdis-2021-220750.

Key clinical point: Disease activity is associated with fatigue in early rheumatoid arthritis (RA), and patients who achieve early remission are at lower risk for experiencing fatigue.

Major finding: Patients who achieved remission at 6 months had a lower chance of experiencing fatigue at 24 months (Disease Activity Score 44 remission, odds ratio [OR] 0.31; P < .001). Fewer swollen joints (OR 0.92; P = .006), lower power Doppler ultrasound score (OR 0.95; P = .027), and a higher patient global assessment score (OR 1.03; P < .001) raised the likelihood of clinically relevant fatigue at 24 months.

Study details: The findings come from the analysis of 205 individuals from the ARCTIC trial. Patients were randomly assigned to a treat-to-target approach with and without musculoskeletal ultrasonography during clinical examinations and treatment decisions.

Disclosures: This work was supported by the DAM Foundation. Some of the authors declared receiving personal fees, personal honoraria, consultancy honorariums/fees, and serving on the data safety monitoring board or advisory board of various sources.

Source: Holton K et al. Ann Rheum Dis. 2021 Aug 13. doi: 10.1136/annrheumdis-2021-220750.

Key clinical point: Disease activity is associated with fatigue in early rheumatoid arthritis (RA), and patients who achieve early remission are at lower risk for experiencing fatigue.

Major finding: Patients who achieved remission at 6 months had a lower chance of experiencing fatigue at 24 months (Disease Activity Score 44 remission, odds ratio [OR] 0.31; P < .001). Fewer swollen joints (OR 0.92; P = .006), lower power Doppler ultrasound score (OR 0.95; P = .027), and a higher patient global assessment score (OR 1.03; P < .001) raised the likelihood of clinically relevant fatigue at 24 months.

Study details: The findings come from the analysis of 205 individuals from the ARCTIC trial. Patients were randomly assigned to a treat-to-target approach with and without musculoskeletal ultrasonography during clinical examinations and treatment decisions.

Disclosures: This work was supported by the DAM Foundation. Some of the authors declared receiving personal fees, personal honoraria, consultancy honorariums/fees, and serving on the data safety monitoring board or advisory board of various sources.

Source: Holton K et al. Ann Rheum Dis. 2021 Aug 13. doi: 10.1136/annrheumdis-2021-220750.

Key clinical point: Over 6 years of prospective follow-up found no association between recent antibiotic use and subsequent risk for rheumatoid arthritis (RA) later in life.

Major finding: Compared with no antibiotic usage, short-term (adjusted hazard ratio [aHR] 0.88; 95% CI 0.38-1.38) and middle-to-long-term (aHR 1.06; 95% CI 0.42-1.71) antibiotic use was not associated with an increased risk for RA.

Study details: The study included 1,33,125 female participants from Nurses' Health Study (NHS; n=58,757) and NHS II (n=74,368) databases. Based on antibiotic usage, participants were categorized into nonuse, short-term use (1-14 days), and middle-to-long-term use (15 or more days) groups.

Disclosures: This work was supported by the Natural Science Foundation of China, the Guangdong Provincial Key Laboratory of Digestive Cancer Research, the Startup Fund for the 100 Top Talents Program, the Sun Yat-sen University, and the National Institutes of Health. All the authors reported no conflict of interests.

Source: Liu Y et al. Expert Opin Drug Saf. 2021 Aug 25. doi: 10.1080/14740338.2021.1970134.

Key clinical point: Over 6 years of prospective follow-up found no association between recent antibiotic use and subsequent risk for rheumatoid arthritis (RA) later in life.

Major finding: Compared with no antibiotic usage, short-term (adjusted hazard ratio [aHR] 0.88; 95% CI 0.38-1.38) and middle-to-long-term (aHR 1.06; 95% CI 0.42-1.71) antibiotic use was not associated with an increased risk for RA.

Study details: The study included 1,33,125 female participants from Nurses' Health Study (NHS; n=58,757) and NHS II (n=74,368) databases. Based on antibiotic usage, participants were categorized into nonuse, short-term use (1-14 days), and middle-to-long-term use (15 or more days) groups.

Disclosures: This work was supported by the Natural Science Foundation of China, the Guangdong Provincial Key Laboratory of Digestive Cancer Research, the Startup Fund for the 100 Top Talents Program, the Sun Yat-sen University, and the National Institutes of Health. All the authors reported no conflict of interests.

Source: Liu Y et al. Expert Opin Drug Saf. 2021 Aug 25. doi: 10.1080/14740338.2021.1970134.

Key clinical point: Over 6 years of prospective follow-up found no association between recent antibiotic use and subsequent risk for rheumatoid arthritis (RA) later in life.

Major finding: Compared with no antibiotic usage, short-term (adjusted hazard ratio [aHR] 0.88; 95% CI 0.38-1.38) and middle-to-long-term (aHR 1.06; 95% CI 0.42-1.71) antibiotic use was not associated with an increased risk for RA.

Study details: The study included 1,33,125 female participants from Nurses' Health Study (NHS; n=58,757) and NHS II (n=74,368) databases. Based on antibiotic usage, participants were categorized into nonuse, short-term use (1-14 days), and middle-to-long-term use (15 or more days) groups.

Disclosures: This work was supported by the Natural Science Foundation of China, the Guangdong Provincial Key Laboratory of Digestive Cancer Research, the Startup Fund for the 100 Top Talents Program, the Sun Yat-sen University, and the National Institutes of Health. All the authors reported no conflict of interests.

Source: Liu Y et al. Expert Opin Drug Saf. 2021 Aug 25. doi: 10.1080/14740338.2021.1970134.

Key clinical point: Patients with rheumatoid arthritis (RA) had worse prognosis after coronary artery bypass grafting surgery (CABG) than matched controls.

Major finding: The risk for mortality at 14.3 years’ follow-up after CABG was significantly higher in patients diagnosed with RA than those without (hazard ratio [HR] 1.50; P < .0001). Moreover, patients with RA were at a higher risk for myocardial infarction during the follow-up period (HR 1.61; P < .0001).

Study details: This was a retrospective analysis of patients with RA (n=378) matched with those without RA (n=7,560), all treated with CABG.

Disclosures: The Finnish Cultural Foundation, the Paulon Säätiö Foundation, the Finnish Governmental VTR-funding, and Suomen Kulttuurirahasto funded this study. The authors disclosed receipt of travel grants, consulting/speaker fees, honoraria, and congress sponsorship from and serving on advisory boards for various sources.

Source: Malmberg M et al. Ann Med. 2021 Aug 31. doi: 10.1080/07853890.2021.1969591.

Key clinical point: Patients with rheumatoid arthritis (RA) had worse prognosis after coronary artery bypass grafting surgery (CABG) than matched controls.

Major finding: The risk for mortality at 14.3 years’ follow-up after CABG was significantly higher in patients diagnosed with RA than those without (hazard ratio [HR] 1.50; P < .0001). Moreover, patients with RA were at a higher risk for myocardial infarction during the follow-up period (HR 1.61; P < .0001).

Study details: This was a retrospective analysis of patients with RA (n=378) matched with those without RA (n=7,560), all treated with CABG.

Disclosures: The Finnish Cultural Foundation, the Paulon Säätiö Foundation, the Finnish Governmental VTR-funding, and Suomen Kulttuurirahasto funded this study. The authors disclosed receipt of travel grants, consulting/speaker fees, honoraria, and congress sponsorship from and serving on advisory boards for various sources.

Source: Malmberg M et al. Ann Med. 2021 Aug 31. doi: 10.1080/07853890.2021.1969591.

Key clinical point: Patients with rheumatoid arthritis (RA) had worse prognosis after coronary artery bypass grafting surgery (CABG) than matched controls.

Major finding: The risk for mortality at 14.3 years’ follow-up after CABG was significantly higher in patients diagnosed with RA than those without (hazard ratio [HR] 1.50; P < .0001). Moreover, patients with RA were at a higher risk for myocardial infarction during the follow-up period (HR 1.61; P < .0001).

Study details: This was a retrospective analysis of patients with RA (n=378) matched with those without RA (n=7,560), all treated with CABG.

Disclosures: The Finnish Cultural Foundation, the Paulon Säätiö Foundation, the Finnish Governmental VTR-funding, and Suomen Kulttuurirahasto funded this study. The authors disclosed receipt of travel grants, consulting/speaker fees, honoraria, and congress sponsorship from and serving on advisory boards for various sources.

Source: Malmberg M et al. Ann Med. 2021 Aug 31. doi: 10.1080/07853890.2021.1969591.

Key clinical point: Joint swelling associated with rheumatoid arthritis (RA) tends to recur in the same joints swollen at RA onset, even in patients who are intensively treated.

Major finding: Overall, 46% of joints swollen at baseline showed swelling recurrence at least once during follow-up. Baseline joint swelling was predictive for swelling during follow-up (odds ratio [OR] 2.37; P < .001) and recurrent, persistent swelling in joints swollen (OR 1.52) and not swollen (OR 1.73) at the previous visit (both P < .001).

Study details: This is a subanalysis of the BeSt (Behandel-Strategieën) study, a treat-to-target trial involving 508 patients with newly diagnosed active RA followed up for a median of 10 years.

Disclosures: The original BeSt study was funded by a research grant from the Dutch College of Health Insurances with additional funding from Schering-Plough BV and Centocor Inc.

Source: Heckert SL et al. Ann Rheum Dis. 2021 Aug 30. doi: 10.1136/annrheumdis-2021-220882.

Key clinical point: Joint swelling associated with rheumatoid arthritis (RA) tends to recur in the same joints swollen at RA onset, even in patients who are intensively treated.

Major finding: Overall, 46% of joints swollen at baseline showed swelling recurrence at least once during follow-up. Baseline joint swelling was predictive for swelling during follow-up (odds ratio [OR] 2.37; P < .001) and recurrent, persistent swelling in joints swollen (OR 1.52) and not swollen (OR 1.73) at the previous visit (both P < .001).

Study details: This is a subanalysis of the BeSt (Behandel-Strategieën) study, a treat-to-target trial involving 508 patients with newly diagnosed active RA followed up for a median of 10 years.

Disclosures: The original BeSt study was funded by a research grant from the Dutch College of Health Insurances with additional funding from Schering-Plough BV and Centocor Inc.

Source: Heckert SL et al. Ann Rheum Dis. 2021 Aug 30. doi: 10.1136/annrheumdis-2021-220882.

Key clinical point: Joint swelling associated with rheumatoid arthritis (RA) tends to recur in the same joints swollen at RA onset, even in patients who are intensively treated.

Major finding: Overall, 46% of joints swollen at baseline showed swelling recurrence at least once during follow-up. Baseline joint swelling was predictive for swelling during follow-up (odds ratio [OR] 2.37; P < .001) and recurrent, persistent swelling in joints swollen (OR 1.52) and not swollen (OR 1.73) at the previous visit (both P < .001).

Study details: This is a subanalysis of the BeSt (Behandel-Strategieën) study, a treat-to-target trial involving 508 patients with newly diagnosed active RA followed up for a median of 10 years.

Disclosures: The original BeSt study was funded by a research grant from the Dutch College of Health Insurances with additional funding from Schering-Plough BV and Centocor Inc.

Source: Heckert SL et al. Ann Rheum Dis. 2021 Aug 30. doi: 10.1136/annrheumdis-2021-220882.

Key clinical point: Passive smoking exposure in childhood is associated with adult-onset seropositive rheumatoid arthritis (RA), suggesting that early life exposures influence RA risk.

Major finding: After adjusting for confounders, maternal smoking during pregnancy was associated with all-incident RA (adjusted hazard ratio [aHR] 1.25; 95% CI 1.03-1.52) and seropositive RA (aHR 1.34; 95% CI 1.06-1.70), whereas childhood parental smoking was associated with seropositive RA (aHR 1.41; 95% CI 1.08-1.83).

Study details: This was an analysis of prospectively collected data from the Nurses’ Health Study II, involving 90,923 women.

Disclosures: This work was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Rheumatology Research Foundation, and National Institutes of Health. K Yoshida and J Sparks reported receiving research support and consultancy fees from various sources.

Source: Yoshida K et al. Arthritis Rheumatol. 2021 Aug 18. doi: 10.1002/art.41939.

Key clinical point: Passive smoking exposure in childhood is associated with adult-onset seropositive rheumatoid arthritis (RA), suggesting that early life exposures influence RA risk.

Major finding: After adjusting for confounders, maternal smoking during pregnancy was associated with all-incident RA (adjusted hazard ratio [aHR] 1.25; 95% CI 1.03-1.52) and seropositive RA (aHR 1.34; 95% CI 1.06-1.70), whereas childhood parental smoking was associated with seropositive RA (aHR 1.41; 95% CI 1.08-1.83).

Study details: This was an analysis of prospectively collected data from the Nurses’ Health Study II, involving 90,923 women.

Disclosures: This work was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Rheumatology Research Foundation, and National Institutes of Health. K Yoshida and J Sparks reported receiving research support and consultancy fees from various sources.

Source: Yoshida K et al. Arthritis Rheumatol. 2021 Aug 18. doi: 10.1002/art.41939.

Key clinical point: Passive smoking exposure in childhood is associated with adult-onset seropositive rheumatoid arthritis (RA), suggesting that early life exposures influence RA risk.

Major finding: After adjusting for confounders, maternal smoking during pregnancy was associated with all-incident RA (adjusted hazard ratio [aHR] 1.25; 95% CI 1.03-1.52) and seropositive RA (aHR 1.34; 95% CI 1.06-1.70), whereas childhood parental smoking was associated with seropositive RA (aHR 1.41; 95% CI 1.08-1.83).

Study details: This was an analysis of prospectively collected data from the Nurses’ Health Study II, involving 90,923 women.

Disclosures: This work was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Rheumatology Research Foundation, and National Institutes of Health. K Yoshida and J Sparks reported receiving research support and consultancy fees from various sources.

Source: Yoshida K et al. Arthritis Rheumatol. 2021 Aug 18. doi: 10.1002/art.41939.

Key clinical point: Combination therapy of methotrexate with tofacitinib or adalimumab improved outcomes in patients with rheumatoid arthritis (RA) who did not respond well to tofacitinib alone.

Major finding: Overall, greater response was achieved by 28.8%, 37.2%, and 39.1% of patients receiving tofacitinib monotherapy, tofacitinib + metotrexate, and adalimumab + methotrexate, respectively. Patients with greater response showed similar 12-month cumulative probability plots for a mean percentage change in Clinical Disease Activity Index across treatment. However, patients with lower responses receiving tofacitinib monotherapy did not respond as well as those receiving combination therapies.

Study details: The data come from a post hoc analysis of the ORAL Strategy trial, which included 1,146 patients with active RA despite methotrexate treatment who were randomly assigned to receive 5 mg tofacitinib twice daily, 5 mg tofacitinib twice daily + methotrexate, or 40 mg adalimumab every other week + methotrexate.

Disclosures: This study was funded by Pfizer Inc. Some of the authors reported receiving grants/research support and consultancy fees from various sources including Pfizer Inc. J Paulissen reported being an employee of Syneos Health. N Iikuni, H Shi, K Soma, and T Hirose reported being employees and shareholders of Pfizer Inc.

Source: Takeuchi T et al. Arthritis Res Ther. 2021 Aug 24. doi: 10.1186/s13075-021-02591-y.

Key clinical point: Combination therapy of methotrexate with tofacitinib or adalimumab improved outcomes in patients with rheumatoid arthritis (RA) who did not respond well to tofacitinib alone.

Major finding: Overall, greater response was achieved by 28.8%, 37.2%, and 39.1% of patients receiving tofacitinib monotherapy, tofacitinib + metotrexate, and adalimumab + methotrexate, respectively. Patients with greater response showed similar 12-month cumulative probability plots for a mean percentage change in Clinical Disease Activity Index across treatment. However, patients with lower responses receiving tofacitinib monotherapy did not respond as well as those receiving combination therapies.

Study details: The data come from a post hoc analysis of the ORAL Strategy trial, which included 1,146 patients with active RA despite methotrexate treatment who were randomly assigned to receive 5 mg tofacitinib twice daily, 5 mg tofacitinib twice daily + methotrexate, or 40 mg adalimumab every other week + methotrexate.

Disclosures: This study was funded by Pfizer Inc. Some of the authors reported receiving grants/research support and consultancy fees from various sources including Pfizer Inc. J Paulissen reported being an employee of Syneos Health. N Iikuni, H Shi, K Soma, and T Hirose reported being employees and shareholders of Pfizer Inc.

Source: Takeuchi T et al. Arthritis Res Ther. 2021 Aug 24. doi: 10.1186/s13075-021-02591-y.

Key clinical point: Combination therapy of methotrexate with tofacitinib or adalimumab improved outcomes in patients with rheumatoid arthritis (RA) who did not respond well to tofacitinib alone.

Major finding: Overall, greater response was achieved by 28.8%, 37.2%, and 39.1% of patients receiving tofacitinib monotherapy, tofacitinib + metotrexate, and adalimumab + methotrexate, respectively. Patients with greater response showed similar 12-month cumulative probability plots for a mean percentage change in Clinical Disease Activity Index across treatment. However, patients with lower responses receiving tofacitinib monotherapy did not respond as well as those receiving combination therapies.

Study details: The data come from a post hoc analysis of the ORAL Strategy trial, which included 1,146 patients with active RA despite methotrexate treatment who were randomly assigned to receive 5 mg tofacitinib twice daily, 5 mg tofacitinib twice daily + methotrexate, or 40 mg adalimumab every other week + methotrexate.

Disclosures: This study was funded by Pfizer Inc. Some of the authors reported receiving grants/research support and consultancy fees from various sources including Pfizer Inc. J Paulissen reported being an employee of Syneos Health. N Iikuni, H Shi, K Soma, and T Hirose reported being employees and shareholders of Pfizer Inc.

Source: Takeuchi T et al. Arthritis Res Ther. 2021 Aug 24. doi: 10.1186/s13075-021-02591-y.

Key clinical point: The combination of filgotinib 200 mg and methotrexate showed an incremental benefit vs. methotrexate monotherapy in methotrexate-naive patients with rheumatoid arthritis (RA) and poor prognostic factors (PPF) with no new safety signals.

Major finding: Among patients with 4 PPFs, methotrexate + 200 mg filgotinib vs. methotrexate monotherapy was associated with higher rates of American College of Rheumatology (ACR) core criteria 20 (85.5% vs. 74.7%), ACR50 (70.3% vs. 48.2%), and ACR70 (54.1% vs. 28.3%) responses at week 24 and weeks 12 and 52 (nominal P < .05 for all).

Study details: This was a post hoc analysis of the phase 3 FINCH 3 study involving 1,249 methotrexate-naive adult patients with moderate-to-severe active RA with multiple PPFs. Patients were randomly assigned to once-weekly methotrexate with once-daily oral filgotinib (200 mg or 100 mg), 200 mg filgotinib monotherapy, or oral methotrexate monotherapy for up to 52 weeks.

Disclosures: The study was funded by Gilead Sciences, Inc. The authors, including the lead author, reported receiving grants, speaker’s fees, and consultancy fees from various sources. Three authors reported being employees and shareholders of Gilead Sciences, Inc.

Source: Aletaha D et al. RMD Open. 2021 Aug 12. doi: 10.1136/rmdopen-2021-001621.

Key clinical point: The combination of filgotinib 200 mg and methotrexate showed an incremental benefit vs. methotrexate monotherapy in methotrexate-naive patients with rheumatoid arthritis (RA) and poor prognostic factors (PPF) with no new safety signals.

Major finding: Among patients with 4 PPFs, methotrexate + 200 mg filgotinib vs. methotrexate monotherapy was associated with higher rates of American College of Rheumatology (ACR) core criteria 20 (85.5% vs. 74.7%), ACR50 (70.3% vs. 48.2%), and ACR70 (54.1% vs. 28.3%) responses at week 24 and weeks 12 and 52 (nominal P < .05 for all).

Study details: This was a post hoc analysis of the phase 3 FINCH 3 study involving 1,249 methotrexate-naive adult patients with moderate-to-severe active RA with multiple PPFs. Patients were randomly assigned to once-weekly methotrexate with once-daily oral filgotinib (200 mg or 100 mg), 200 mg filgotinib monotherapy, or oral methotrexate monotherapy for up to 52 weeks.

Disclosures: The study was funded by Gilead Sciences, Inc. The authors, including the lead author, reported receiving grants, speaker’s fees, and consultancy fees from various sources. Three authors reported being employees and shareholders of Gilead Sciences, Inc.

Source: Aletaha D et al. RMD Open. 2021 Aug 12. doi: 10.1136/rmdopen-2021-001621.

Key clinical point: The combination of filgotinib 200 mg and methotrexate showed an incremental benefit vs. methotrexate monotherapy in methotrexate-naive patients with rheumatoid arthritis (RA) and poor prognostic factors (PPF) with no new safety signals.

Major finding: Among patients with 4 PPFs, methotrexate + 200 mg filgotinib vs. methotrexate monotherapy was associated with higher rates of American College of Rheumatology (ACR) core criteria 20 (85.5% vs. 74.7%), ACR50 (70.3% vs. 48.2%), and ACR70 (54.1% vs. 28.3%) responses at week 24 and weeks 12 and 52 (nominal P < .05 for all).

Study details: This was a post hoc analysis of the phase 3 FINCH 3 study involving 1,249 methotrexate-naive adult patients with moderate-to-severe active RA with multiple PPFs. Patients were randomly assigned to once-weekly methotrexate with once-daily oral filgotinib (200 mg or 100 mg), 200 mg filgotinib monotherapy, or oral methotrexate monotherapy for up to 52 weeks.

Disclosures: The study was funded by Gilead Sciences, Inc. The authors, including the lead author, reported receiving grants, speaker’s fees, and consultancy fees from various sources. Three authors reported being employees and shareholders of Gilead Sciences, Inc.

Source: Aletaha D et al. RMD Open. 2021 Aug 12. doi: 10.1136/rmdopen-2021-001621.

Slips and falls are a major source of injuries, especially among the elderly, but they’re also a way for schemers to rake in big bucks, as a story in the New York Daily News, among other news outlets, indicates.

In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.

These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.

In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.

Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.

According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.

If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.

This isn’t the first time such a scheme has been hatched and carried out in New York City.

In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)

Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”

Sales reps in the OR — helpful or harmful?

Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.

In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.

Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.

In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.

The defendants have each denied any wrongdoing.

The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”

The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.

A trial is scheduled for this November.

But was the Houston incident typical?

Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.

Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.

The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.

Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.

Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.

Device makers have denied these and other allegations. Many of their cases have been settled confidentially.

This high-risk specialty found a way to lower its claim rates

Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.

Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.

The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.

Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)

For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)

“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
 

A version of this article first appeared on Medscape.com.

Slips and falls are a major source of injuries, especially among the elderly, but they’re also a way for schemers to rake in big bucks, as a story in the New York Daily News, among other news outlets, indicates.

In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.

These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.

In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.

Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.

According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.

If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.

This isn’t the first time such a scheme has been hatched and carried out in New York City.

In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)

Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”

Sales reps in the OR — helpful or harmful?

Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.

In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.

Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.

In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.

The defendants have each denied any wrongdoing.

The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”

The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.

A trial is scheduled for this November.

But was the Houston incident typical?

Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.

Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.

The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.

Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.

Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.

Device makers have denied these and other allegations. Many of their cases have been settled confidentially.

This high-risk specialty found a way to lower its claim rates

Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.

Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.

The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.

Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)

For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)

“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
 

A version of this article first appeared on Medscape.com.

Slips and falls are a major source of injuries, especially among the elderly, but they’re also a way for schemers to rake in big bucks, as a story in the New York Daily News, among other news outlets, indicates.

In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.

These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.

In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.

Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.

According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.

If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.

This isn’t the first time such a scheme has been hatched and carried out in New York City.

In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)

Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”

Sales reps in the OR — helpful or harmful?

Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.

In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.

Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.

In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.

The defendants have each denied any wrongdoing.

The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”

The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.

A trial is scheduled for this November.

But was the Houston incident typical?

Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.

Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.

The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.

Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.

Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.

Device makers have denied these and other allegations. Many of their cases have been settled confidentially.

This high-risk specialty found a way to lower its claim rates

Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.

Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.

The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.

Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)

For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)

“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
 

A version of this article first appeared on Medscape.com.

Withholding mycophenolate around the time of vaccination against SARS-CoV-2 proved safe and augmented the humoral response to vaccination among a group of patients at one center who were taking the immunosuppressive drug for a variety of rheumatic and musculoskeletal diseases (RMDs).

Previous studies have shown that use of mycophenolate attenuates the humoral response to SARS-CoV-2 vaccination, and the most up-to-date recommendations from the American College of Rheumatology on SARS-CoV-2 vaccination in patients with RMDs advise that mycophenolate should be withheld for a week after receiving the vaccine.

To understand better how withholding mycophenolate would affect immune response to SARS-CoV-2 vaccination, rheumatology fellow Caoilfhionn M. Connolly, MD, and coauthors at Johns Hopkins University, Baltimore, described in their report – published online Sept. 23, 2021, in Annals of the Rheumatic Diseases – how they compared the immune responses to vaccination in 24 patients who withheld mycophenolate and 171 patients who did not stop taking it. All but 1 of the 24 patients who withheld mycophenolate were female, with a median age of 51 years, and they had mostly systemic lupus erythematosus (6 patients), myositis (5), scleroderma (4), or overlap connective tissue disease (4). Three patients received the Janssen/Johnson & Johnson vaccine; all others received either the two-dose Moderna or Pfizer/BioNTech mRNA series.

At a median of 32 days after vaccination, all but two of the patients (92%) who withheld mycophenolate had detectable antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, compared with 65% of those who continued the drug (P = .01). This calculated to patients who withheld the drug as having nearly sixfold higher odds for a positive antibody response (odds ratio, 5.8; 95% CI, 1.3-25.5; P = .02). The association remained statistically significant in an logistic regression analysis that was adjusted for age, sex, race, vaccine type, and use of rituximab and glucocorticoids.

The withholding group also had significantly higher median anti-RBD immunoglobulin titers than did the group that continued therapy (125 vs. 7 U/L; P = .004).

Two patients who reported a flare of their underlying disease during the perivaccination period were treated with topical and oral glucocorticoids.

The patients who withdrew mycophenolate had taken it with twice daily dosing at a median total daily dose of 2,000 mg. They ended up withholding a median of 20 doses around the time of vaccination, with 54% withholding before, 38% both before and after, and 8% only after vaccination.

The researchers said that the conclusions that can be drawn from the study were limited by its small sample size, which “did not allow for evaluation of optimal duration of withholding therapy,” and also its “nonrandomized design, lack of data on cellular response, and limited information on dosing of other immunosuppressive agents.”

Three of the authors disclosed receiving consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. A fourth author has received consulting fees from Janssen, Boehringer Ingelheim, Mallinckrodt, EMD Serono, Allogene, and ArgenX.

[email protected]

Withholding mycophenolate around the time of vaccination against SARS-CoV-2 proved safe and augmented the humoral response to vaccination among a group of patients at one center who were taking the immunosuppressive drug for a variety of rheumatic and musculoskeletal diseases (RMDs).

Previous studies have shown that use of mycophenolate attenuates the humoral response to SARS-CoV-2 vaccination, and the most up-to-date recommendations from the American College of Rheumatology on SARS-CoV-2 vaccination in patients with RMDs advise that mycophenolate should be withheld for a week after receiving the vaccine.

To understand better how withholding mycophenolate would affect immune response to SARS-CoV-2 vaccination, rheumatology fellow Caoilfhionn M. Connolly, MD, and coauthors at Johns Hopkins University, Baltimore, described in their report – published online Sept. 23, 2021, in Annals of the Rheumatic Diseases – how they compared the immune responses to vaccination in 24 patients who withheld mycophenolate and 171 patients who did not stop taking it. All but 1 of the 24 patients who withheld mycophenolate were female, with a median age of 51 years, and they had mostly systemic lupus erythematosus (6 patients), myositis (5), scleroderma (4), or overlap connective tissue disease (4). Three patients received the Janssen/Johnson & Johnson vaccine; all others received either the two-dose Moderna or Pfizer/BioNTech mRNA series.

At a median of 32 days after vaccination, all but two of the patients (92%) who withheld mycophenolate had detectable antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, compared with 65% of those who continued the drug (P = .01). This calculated to patients who withheld the drug as having nearly sixfold higher odds for a positive antibody response (odds ratio, 5.8; 95% CI, 1.3-25.5; P = .02). The association remained statistically significant in an logistic regression analysis that was adjusted for age, sex, race, vaccine type, and use of rituximab and glucocorticoids.

The withholding group also had significantly higher median anti-RBD immunoglobulin titers than did the group that continued therapy (125 vs. 7 U/L; P = .004).

Two patients who reported a flare of their underlying disease during the perivaccination period were treated with topical and oral glucocorticoids.

The patients who withdrew mycophenolate had taken it with twice daily dosing at a median total daily dose of 2,000 mg. They ended up withholding a median of 20 doses around the time of vaccination, with 54% withholding before, 38% both before and after, and 8% only after vaccination.

The researchers said that the conclusions that can be drawn from the study were limited by its small sample size, which “did not allow for evaluation of optimal duration of withholding therapy,” and also its “nonrandomized design, lack of data on cellular response, and limited information on dosing of other immunosuppressive agents.”

Three of the authors disclosed receiving consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. A fourth author has received consulting fees from Janssen, Boehringer Ingelheim, Mallinckrodt, EMD Serono, Allogene, and ArgenX.

[email protected]

Withholding mycophenolate around the time of vaccination against SARS-CoV-2 proved safe and augmented the humoral response to vaccination among a group of patients at one center who were taking the immunosuppressive drug for a variety of rheumatic and musculoskeletal diseases (RMDs).

Previous studies have shown that use of mycophenolate attenuates the humoral response to SARS-CoV-2 vaccination, and the most up-to-date recommendations from the American College of Rheumatology on SARS-CoV-2 vaccination in patients with RMDs advise that mycophenolate should be withheld for a week after receiving the vaccine.

To understand better how withholding mycophenolate would affect immune response to SARS-CoV-2 vaccination, rheumatology fellow Caoilfhionn M. Connolly, MD, and coauthors at Johns Hopkins University, Baltimore, described in their report – published online Sept. 23, 2021, in Annals of the Rheumatic Diseases – how they compared the immune responses to vaccination in 24 patients who withheld mycophenolate and 171 patients who did not stop taking it. All but 1 of the 24 patients who withheld mycophenolate were female, with a median age of 51 years, and they had mostly systemic lupus erythematosus (6 patients), myositis (5), scleroderma (4), or overlap connective tissue disease (4). Three patients received the Janssen/Johnson & Johnson vaccine; all others received either the two-dose Moderna or Pfizer/BioNTech mRNA series.

At a median of 32 days after vaccination, all but two of the patients (92%) who withheld mycophenolate had detectable antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, compared with 65% of those who continued the drug (P = .01). This calculated to patients who withheld the drug as having nearly sixfold higher odds for a positive antibody response (odds ratio, 5.8; 95% CI, 1.3-25.5; P = .02). The association remained statistically significant in an logistic regression analysis that was adjusted for age, sex, race, vaccine type, and use of rituximab and glucocorticoids.

The withholding group also had significantly higher median anti-RBD immunoglobulin titers than did the group that continued therapy (125 vs. 7 U/L; P = .004).

Two patients who reported a flare of their underlying disease during the perivaccination period were treated with topical and oral glucocorticoids.

The patients who withdrew mycophenolate had taken it with twice daily dosing at a median total daily dose of 2,000 mg. They ended up withholding a median of 20 doses around the time of vaccination, with 54% withholding before, 38% both before and after, and 8% only after vaccination.

The researchers said that the conclusions that can be drawn from the study were limited by its small sample size, which “did not allow for evaluation of optimal duration of withholding therapy,” and also its “nonrandomized design, lack of data on cellular response, and limited information on dosing of other immunosuppressive agents.”

Three of the authors disclosed receiving consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. A fourth author has received consulting fees from Janssen, Boehringer Ingelheim, Mallinckrodt, EMD Serono, Allogene, and ArgenX.

[email protected]