MDedge Rheumatology

Key clinical point: The long-term safety profile of sarilumab was consistent with prior clinical studies and postmarketing reports in patients with rheumatoid arthritis (RA) refractory to tumor necrosis factor inhibitors (TNFi).

Major finding: Incidence rates of adverse events (AEs) and serious AEs were 160.4 and 10.2 per 100 patient-years (PY), respectively, with 132 discontinuations (8.1/100 PY). The rate of serious infections was 3.9 per 100 PY. Grade 3/4 neutropenia was observed in 14% of patients and normalized on treatment in 65% of patients. Clinical efficacy was sustained throughout the 5-year follow-up.

Study details: Findings are from the open-label extension (OLE), EXTEND study, which included 454 patients with TNFi-refractory RA who completed the phase 3 TARGET study. In the OLE, patients received sarilumab 200 mg twice per week plus conventional synthetic disease-modifying antirheumatic drugs.

Disclosures: This work was supported by Sanofi (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). Some of the authors reported receiving research grants and/or consulting fees from various sources. Some authors declared being an employee of and/or holding stocks/stock options at Sanofi or Regeneron Pharmaceuticals, Inc.

Source: Fleischmann R et al. Rheumatology (Oxford). 2021 Jun 24. doi: 10.1093/rheumatology/keab355.

Key clinical point: The long-term safety profile of sarilumab was consistent with prior clinical studies and postmarketing reports in patients with rheumatoid arthritis (RA) refractory to tumor necrosis factor inhibitors (TNFi).

Major finding: Incidence rates of adverse events (AEs) and serious AEs were 160.4 and 10.2 per 100 patient-years (PY), respectively, with 132 discontinuations (8.1/100 PY). The rate of serious infections was 3.9 per 100 PY. Grade 3/4 neutropenia was observed in 14% of patients and normalized on treatment in 65% of patients. Clinical efficacy was sustained throughout the 5-year follow-up.

Study details: Findings are from the open-label extension (OLE), EXTEND study, which included 454 patients with TNFi-refractory RA who completed the phase 3 TARGET study. In the OLE, patients received sarilumab 200 mg twice per week plus conventional synthetic disease-modifying antirheumatic drugs.

Disclosures: This work was supported by Sanofi (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). Some of the authors reported receiving research grants and/or consulting fees from various sources. Some authors declared being an employee of and/or holding stocks/stock options at Sanofi or Regeneron Pharmaceuticals, Inc.

Source: Fleischmann R et al. Rheumatology (Oxford). 2021 Jun 24. doi: 10.1093/rheumatology/keab355.

Key clinical point: The long-term safety profile of sarilumab was consistent with prior clinical studies and postmarketing reports in patients with rheumatoid arthritis (RA) refractory to tumor necrosis factor inhibitors (TNFi).

Major finding: Incidence rates of adverse events (AEs) and serious AEs were 160.4 and 10.2 per 100 patient-years (PY), respectively, with 132 discontinuations (8.1/100 PY). The rate of serious infections was 3.9 per 100 PY. Grade 3/4 neutropenia was observed in 14% of patients and normalized on treatment in 65% of patients. Clinical efficacy was sustained throughout the 5-year follow-up.

Study details: Findings are from the open-label extension (OLE), EXTEND study, which included 454 patients with TNFi-refractory RA who completed the phase 3 TARGET study. In the OLE, patients received sarilumab 200 mg twice per week plus conventional synthetic disease-modifying antirheumatic drugs.

Disclosures: This work was supported by Sanofi (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). Some of the authors reported receiving research grants and/or consulting fees from various sources. Some authors declared being an employee of and/or holding stocks/stock options at Sanofi or Regeneron Pharmaceuticals, Inc.

Source: Fleischmann R et al. Rheumatology (Oxford). 2021 Jun 24. doi: 10.1093/rheumatology/keab355.

Key clinical point: Systemic glucocorticoids (GCs) were effective at reducing pain in patients with active rheumatoid arthritis (RA), with the effect being greatest within 3 months of initiation, whereas it appeared to be less effective beyond 6 months.

Major finding: Treatment with systemic GCs significantly decreased spontaneous pain (standardized mean differences [MD], −0.67; 95% confidence interval [CI], −0.84 to −0.50), with the effect being greatest at 3 months or lesser (MD, −14.55 mm; 95% CI, −20.40 to −8.69) and appeared to be less effective at more than 3 to 6 months (MD, −7.82 mm; 95% CI, −12.27 to -3.38) and beyond 6 months (MD, −6.52 mm; 95% CI, −13.28 to 0.24).

Study details: Findings are from a systematic review and meta-analysis of 33 randomized controlled trials including 2,658 patients with RA.

Disclosures: The study received no specific funding. D McWilliams, DA Walsh, and NG Shanker reported receiving grant support and consultancy fees from various sources like Pfizer Ltd., Eli Lilly, UCB, AbbVie, GSK, and Cambridge Nutraceuticals.

Source: McWilliams DF et al. Rheumatology (Oxford). 2021 Jul 2. doi: 10.1093/rheumatology/keab503.

Key clinical point: Systemic glucocorticoids (GCs) were effective at reducing pain in patients with active rheumatoid arthritis (RA), with the effect being greatest within 3 months of initiation, whereas it appeared to be less effective beyond 6 months.

Major finding: Treatment with systemic GCs significantly decreased spontaneous pain (standardized mean differences [MD], −0.67; 95% confidence interval [CI], −0.84 to −0.50), with the effect being greatest at 3 months or lesser (MD, −14.55 mm; 95% CI, −20.40 to −8.69) and appeared to be less effective at more than 3 to 6 months (MD, −7.82 mm; 95% CI, −12.27 to -3.38) and beyond 6 months (MD, −6.52 mm; 95% CI, −13.28 to 0.24).

Study details: Findings are from a systematic review and meta-analysis of 33 randomized controlled trials including 2,658 patients with RA.

Disclosures: The study received no specific funding. D McWilliams, DA Walsh, and NG Shanker reported receiving grant support and consultancy fees from various sources like Pfizer Ltd., Eli Lilly, UCB, AbbVie, GSK, and Cambridge Nutraceuticals.

Source: McWilliams DF et al. Rheumatology (Oxford). 2021 Jul 2. doi: 10.1093/rheumatology/keab503.

Key clinical point: Systemic glucocorticoids (GCs) were effective at reducing pain in patients with active rheumatoid arthritis (RA), with the effect being greatest within 3 months of initiation, whereas it appeared to be less effective beyond 6 months.

Major finding: Treatment with systemic GCs significantly decreased spontaneous pain (standardized mean differences [MD], −0.67; 95% confidence interval [CI], −0.84 to −0.50), with the effect being greatest at 3 months or lesser (MD, −14.55 mm; 95% CI, −20.40 to −8.69) and appeared to be less effective at more than 3 to 6 months (MD, −7.82 mm; 95% CI, −12.27 to -3.38) and beyond 6 months (MD, −6.52 mm; 95% CI, −13.28 to 0.24).

Study details: Findings are from a systematic review and meta-analysis of 33 randomized controlled trials including 2,658 patients with RA.

Disclosures: The study received no specific funding. D McWilliams, DA Walsh, and NG Shanker reported receiving grant support and consultancy fees from various sources like Pfizer Ltd., Eli Lilly, UCB, AbbVie, GSK, and Cambridge Nutraceuticals.

Source: McWilliams DF et al. Rheumatology (Oxford). 2021 Jul 2. doi: 10.1093/rheumatology/keab503.

Key clinical point: Treatment with bazedoxifene for 48 weeks significantly increased bone mineral density (BMD) of L-spine and decreased bone turnover markers in postmenopausal women with rheumatoid arthritis (RA) receiving low-dose glucocorticoids.

Major finding: Treatment with bazedoxifene significantly increased L-spine BMD (0.015 g/cm²; P = .007), whereas the change in the control group was not significant (0.002 g/cm²; P = .694). At 24 weeks, all bone turnover biomarkers decreased significantly with bazedoxifene, which persisted to 48 weeks (all P less than .01), whereas recovery observed in the control group was not significant.

Study details: The data come from an open-label study involving 114 postmenopausal women with osteopenia who had been receiving low-dose glucocorticoids for RA and were randomly assigned to either daily bazedoxifene (20 mg/day) with calcium and vitamin D or only calcium and vitamin D (control group).

Disclosures: The study was supported by a research grant from Pfizer Pharmaceuticals Korea Ltd. YK Sung reported receiving research grants from Bristol-Myers Squibb, Eisai, Pfizer, and JW Pharmaceutical.

Source: Cho SK et al. Arthritis Res Ther. 2021 Jul 2. doi: 10.1186/s13075-021-02564-1.

Key clinical point: Treatment with bazedoxifene for 48 weeks significantly increased bone mineral density (BMD) of L-spine and decreased bone turnover markers in postmenopausal women with rheumatoid arthritis (RA) receiving low-dose glucocorticoids.

Major finding: Treatment with bazedoxifene significantly increased L-spine BMD (0.015 g/cm²; P = .007), whereas the change in the control group was not significant (0.002 g/cm²; P = .694). At 24 weeks, all bone turnover biomarkers decreased significantly with bazedoxifene, which persisted to 48 weeks (all P less than .01), whereas recovery observed in the control group was not significant.

Study details: The data come from an open-label study involving 114 postmenopausal women with osteopenia who had been receiving low-dose glucocorticoids for RA and were randomly assigned to either daily bazedoxifene (20 mg/day) with calcium and vitamin D or only calcium and vitamin D (control group).

Disclosures: The study was supported by a research grant from Pfizer Pharmaceuticals Korea Ltd. YK Sung reported receiving research grants from Bristol-Myers Squibb, Eisai, Pfizer, and JW Pharmaceutical.

Source: Cho SK et al. Arthritis Res Ther. 2021 Jul 2. doi: 10.1186/s13075-021-02564-1.

Key clinical point: Treatment with bazedoxifene for 48 weeks significantly increased bone mineral density (BMD) of L-spine and decreased bone turnover markers in postmenopausal women with rheumatoid arthritis (RA) receiving low-dose glucocorticoids.

Major finding: Treatment with bazedoxifene significantly increased L-spine BMD (0.015 g/cm²; P = .007), whereas the change in the control group was not significant (0.002 g/cm²; P = .694). At 24 weeks, all bone turnover biomarkers decreased significantly with bazedoxifene, which persisted to 48 weeks (all P less than .01), whereas recovery observed in the control group was not significant.

Study details: The data come from an open-label study involving 114 postmenopausal women with osteopenia who had been receiving low-dose glucocorticoids for RA and were randomly assigned to either daily bazedoxifene (20 mg/day) with calcium and vitamin D or only calcium and vitamin D (control group).

Disclosures: The study was supported by a research grant from Pfizer Pharmaceuticals Korea Ltd. YK Sung reported receiving research grants from Bristol-Myers Squibb, Eisai, Pfizer, and JW Pharmaceutical.

Source: Cho SK et al. Arthritis Res Ther. 2021 Jul 2. doi: 10.1186/s13075-021-02564-1.

Key clinical point: In patients with active rheumatoid arthritis (RA), adalimumab biosimilar CT-P17 and reference adalimumab showed comparable efficacy and safety during 1 year of treatment even after switching to CT-P17 from reference adalimumab.

Major finding: At 52 weeks, the proportion of patients achieving a 20%/50%/70% improvement by American College of Rheumatology criteria was comparable among those who continued CT-P17 (80.5%/66.3%/44.6%), continued reference adalimumab (77.8%/62.1%/49.0%), or switched to CT-P17 (82.2%/66.4%/47.4%), respectively. Similar proportions of patients in each treatment group experienced 1 or more treatment-emergent adverse events.

Study details: This was a 52-week, randomized, phase 3 study of 607 patients with active RA who received either 40 mg (100 mg/mL) CT-P17 or reference adalimumab subcutaneously every 2 weeks until week 24. Later, patients receiving CT-P17 continued to receive the same, whereas those receiving reference adalimumab either continued the same or switched to CT-P17.

Disclosures: This work was supported by Celltrion, Inc. Some of the authors reported receiving research grants, consulting, speaker fees, and/or honoraria from various sources. SJ Lee, SH Kim, YJ Bae, GE Yang, and JK Yoo declared being employees of Celltrion, Inc.

Source: Furst DE et al. Rheumatology (Oxford). 2021 Jun 17. doi: 10.1093/rheumatology/keab460.

Key clinical point: In patients with active rheumatoid arthritis (RA), adalimumab biosimilar CT-P17 and reference adalimumab showed comparable efficacy and safety during 1 year of treatment even after switching to CT-P17 from reference adalimumab.

Major finding: At 52 weeks, the proportion of patients achieving a 20%/50%/70% improvement by American College of Rheumatology criteria was comparable among those who continued CT-P17 (80.5%/66.3%/44.6%), continued reference adalimumab (77.8%/62.1%/49.0%), or switched to CT-P17 (82.2%/66.4%/47.4%), respectively. Similar proportions of patients in each treatment group experienced 1 or more treatment-emergent adverse events.

Study details: This was a 52-week, randomized, phase 3 study of 607 patients with active RA who received either 40 mg (100 mg/mL) CT-P17 or reference adalimumab subcutaneously every 2 weeks until week 24. Later, patients receiving CT-P17 continued to receive the same, whereas those receiving reference adalimumab either continued the same or switched to CT-P17.

Disclosures: This work was supported by Celltrion, Inc. Some of the authors reported receiving research grants, consulting, speaker fees, and/or honoraria from various sources. SJ Lee, SH Kim, YJ Bae, GE Yang, and JK Yoo declared being employees of Celltrion, Inc.

Source: Furst DE et al. Rheumatology (Oxford). 2021 Jun 17. doi: 10.1093/rheumatology/keab460.

Key clinical point: In patients with active rheumatoid arthritis (RA), adalimumab biosimilar CT-P17 and reference adalimumab showed comparable efficacy and safety during 1 year of treatment even after switching to CT-P17 from reference adalimumab.

Major finding: At 52 weeks, the proportion of patients achieving a 20%/50%/70% improvement by American College of Rheumatology criteria was comparable among those who continued CT-P17 (80.5%/66.3%/44.6%), continued reference adalimumab (77.8%/62.1%/49.0%), or switched to CT-P17 (82.2%/66.4%/47.4%), respectively. Similar proportions of patients in each treatment group experienced 1 or more treatment-emergent adverse events.

Study details: This was a 52-week, randomized, phase 3 study of 607 patients with active RA who received either 40 mg (100 mg/mL) CT-P17 or reference adalimumab subcutaneously every 2 weeks until week 24. Later, patients receiving CT-P17 continued to receive the same, whereas those receiving reference adalimumab either continued the same or switched to CT-P17.

Disclosures: This work was supported by Celltrion, Inc. Some of the authors reported receiving research grants, consulting, speaker fees, and/or honoraria from various sources. SJ Lee, SH Kim, YJ Bae, GE Yang, and JK Yoo declared being employees of Celltrion, Inc.

Source: Furst DE et al. Rheumatology (Oxford). 2021 Jun 17. doi: 10.1093/rheumatology/keab460.

Recently, ACR guidelines were published on the prevention and treatment of glucocorticoid-induced osteoporosis, emphasizing use of supplemental calcium and vitamin D and antiresorptive therapy. This randomized, controlled, open-label trial by Cho et al looks at the efficacy of selective estrogen receptor modulators (SERMs) in preventing bone loss and fractures in postmenopausal RA patients with osteopenia on long-term glucocorticoids. Patients were randomized to bazedoxefine, a 3^rd-generation SERM vs no therapy in addition to background calcium and vitamin D supplementation and bone mineral density (BMD) and trabecular bone score (TBS). Bone turnover markers were assessed over the course of 48 weeks, in addition to adverse events. Prednisone dose was relatively low, with a baseline of ~3 mg/day. Bone density increased by almost 2% in the L spine (P < 0.05), but the increases in BMD at the femoral neck and TBS were not significant. Bone turnover markers did decrease in the bazedoxefine group, though not in the control group. These findings are not striking but are promising given the short duration of the study (<1 year), and potentially deserves longer-term follow-up, both for evaluation of efficacy as well as long-term safety. In the US, the medication is only available in combination with estrogen, and thus it is not currently a practical option for RA patients with GIOP.

Despite wider availability of both synthetic and biologic DMARDs for treatment of RA in recent years, persistent pain is an issue for many patients, perhaps due to peripheral sensitization. Though it seems almost unnecessary to investigate the utility of glucocorticoids for treatment of RA-related pain, the magnitude and duration of their benefit is unknown. McWilliams et al take the approach of quantitatively analyzing the benefit of glucocorticoids in RA over time in their systematic review and meta-analysis. The study looked at both spontaneous and evoked pain, and evaluated 65 studies that mostly used pain visual analogue scale, tender joint count, and Ritchie Articular Index. Reduction in spontaneous pain was greatest in the 0-3-month time period, with smaller reductions in 3-6 months and >6 month. A similar pattern was seen in evaluation of the time course of evoked pain. As such, the benefits of long-term systemic glucocorticoid therapy may not outweigh its well-known risks, especially in patients with persistent pain. Whether this is due to non-inflammatory sources of pain or other mechanisms remains unknown and is likely heavily impacted by the specific clinical scenario.

Due to the potential long-terms side effects of chronic immunosuppression, including long-term glucocorticoid therapy in patients with persistent pain in RA, the course and predictors of unacceptable pain are of interest. Eberhard et al examined an inception cohort of RA patients in a single center in Sweden over the course of 5 years. They were found to have reduction of VAS pain from inclusion to 6 months, but pain levels largely stayed the same during the rest of the follow-up period. The proportion of patients with unacceptable pain also decreased but remained stable at about 30% after 1 year, with 20% having unacceptable pain and low inflammation and about 10% having high inflammation and unacceptable pain. The study found seropositivity, high inflammatory parameters, high DAS28 and severe patient-reported outcomes to be predictive of high inflammation and unacceptable pain and lower age, higher VAS pain, and low ESR to be predictive of low inflammation and unacceptable pain. These findings highlight the importance of examining non-inflammatory mechanisms of pain as well as identifying treatments; however, in evaluating the risk of immunosuppression and glucocorticoid therapy, it does not guide increasing or reducing treatment in RA patients with persistent pain.

Recently, ACR guidelines were published on the prevention and treatment of glucocorticoid-induced osteoporosis, emphasizing use of supplemental calcium and vitamin D and antiresorptive therapy. This randomized, controlled, open-label trial by Cho et al looks at the efficacy of selective estrogen receptor modulators (SERMs) in preventing bone loss and fractures in postmenopausal RA patients with osteopenia on long-term glucocorticoids. Patients were randomized to bazedoxefine, a 3^rd-generation SERM vs no therapy in addition to background calcium and vitamin D supplementation and bone mineral density (BMD) and trabecular bone score (TBS). Bone turnover markers were assessed over the course of 48 weeks, in addition to adverse events. Prednisone dose was relatively low, with a baseline of ~3 mg/day. Bone density increased by almost 2% in the L spine (P < 0.05), but the increases in BMD at the femoral neck and TBS were not significant. Bone turnover markers did decrease in the bazedoxefine group, though not in the control group. These findings are not striking but are promising given the short duration of the study (<1 year), and potentially deserves longer-term follow-up, both for evaluation of efficacy as well as long-term safety. In the US, the medication is only available in combination with estrogen, and thus it is not currently a practical option for RA patients with GIOP.

Despite wider availability of both synthetic and biologic DMARDs for treatment of RA in recent years, persistent pain is an issue for many patients, perhaps due to peripheral sensitization. Though it seems almost unnecessary to investigate the utility of glucocorticoids for treatment of RA-related pain, the magnitude and duration of their benefit is unknown. McWilliams et al take the approach of quantitatively analyzing the benefit of glucocorticoids in RA over time in their systematic review and meta-analysis. The study looked at both spontaneous and evoked pain, and evaluated 65 studies that mostly used pain visual analogue scale, tender joint count, and Ritchie Articular Index. Reduction in spontaneous pain was greatest in the 0-3-month time period, with smaller reductions in 3-6 months and >6 month. A similar pattern was seen in evaluation of the time course of evoked pain. As such, the benefits of long-term systemic glucocorticoid therapy may not outweigh its well-known risks, especially in patients with persistent pain. Whether this is due to non-inflammatory sources of pain or other mechanisms remains unknown and is likely heavily impacted by the specific clinical scenario.

Due to the potential long-terms side effects of chronic immunosuppression, including long-term glucocorticoid therapy in patients with persistent pain in RA, the course and predictors of unacceptable pain are of interest. Eberhard et al examined an inception cohort of RA patients in a single center in Sweden over the course of 5 years. They were found to have reduction of VAS pain from inclusion to 6 months, but pain levels largely stayed the same during the rest of the follow-up period. The proportion of patients with unacceptable pain also decreased but remained stable at about 30% after 1 year, with 20% having unacceptable pain and low inflammation and about 10% having high inflammation and unacceptable pain. The study found seropositivity, high inflammatory parameters, high DAS28 and severe patient-reported outcomes to be predictive of high inflammation and unacceptable pain and lower age, higher VAS pain, and low ESR to be predictive of low inflammation and unacceptable pain. These findings highlight the importance of examining non-inflammatory mechanisms of pain as well as identifying treatments; however, in evaluating the risk of immunosuppression and glucocorticoid therapy, it does not guide increasing or reducing treatment in RA patients with persistent pain.

Recently, ACR guidelines were published on the prevention and treatment of glucocorticoid-induced osteoporosis, emphasizing use of supplemental calcium and vitamin D and antiresorptive therapy. This randomized, controlled, open-label trial by Cho et al looks at the efficacy of selective estrogen receptor modulators (SERMs) in preventing bone loss and fractures in postmenopausal RA patients with osteopenia on long-term glucocorticoids. Patients were randomized to bazedoxefine, a 3^rd-generation SERM vs no therapy in addition to background calcium and vitamin D supplementation and bone mineral density (BMD) and trabecular bone score (TBS). Bone turnover markers were assessed over the course of 48 weeks, in addition to adverse events. Prednisone dose was relatively low, with a baseline of ~3 mg/day. Bone density increased by almost 2% in the L spine (P < 0.05), but the increases in BMD at the femoral neck and TBS were not significant. Bone turnover markers did decrease in the bazedoxefine group, though not in the control group. These findings are not striking but are promising given the short duration of the study (<1 year), and potentially deserves longer-term follow-up, both for evaluation of efficacy as well as long-term safety. In the US, the medication is only available in combination with estrogen, and thus it is not currently a practical option for RA patients with GIOP.

Despite wider availability of both synthetic and biologic DMARDs for treatment of RA in recent years, persistent pain is an issue for many patients, perhaps due to peripheral sensitization. Though it seems almost unnecessary to investigate the utility of glucocorticoids for treatment of RA-related pain, the magnitude and duration of their benefit is unknown. McWilliams et al take the approach of quantitatively analyzing the benefit of glucocorticoids in RA over time in their systematic review and meta-analysis. The study looked at both spontaneous and evoked pain, and evaluated 65 studies that mostly used pain visual analogue scale, tender joint count, and Ritchie Articular Index. Reduction in spontaneous pain was greatest in the 0-3-month time period, with smaller reductions in 3-6 months and >6 month. A similar pattern was seen in evaluation of the time course of evoked pain. As such, the benefits of long-term systemic glucocorticoid therapy may not outweigh its well-known risks, especially in patients with persistent pain. Whether this is due to non-inflammatory sources of pain or other mechanisms remains unknown and is likely heavily impacted by the specific clinical scenario.

Due to the potential long-terms side effects of chronic immunosuppression, including long-term glucocorticoid therapy in patients with persistent pain in RA, the course and predictors of unacceptable pain are of interest. Eberhard et al examined an inception cohort of RA patients in a single center in Sweden over the course of 5 years. They were found to have reduction of VAS pain from inclusion to 6 months, but pain levels largely stayed the same during the rest of the follow-up period. The proportion of patients with unacceptable pain also decreased but remained stable at about 30% after 1 year, with 20% having unacceptable pain and low inflammation and about 10% having high inflammation and unacceptable pain. The study found seropositivity, high inflammatory parameters, high DAS28 and severe patient-reported outcomes to be predictive of high inflammation and unacceptable pain and lower age, higher VAS pain, and low ESR to be predictive of low inflammation and unacceptable pain. These findings highlight the importance of examining non-inflammatory mechanisms of pain as well as identifying treatments; however, in evaluating the risk of immunosuppression and glucocorticoid therapy, it does not guide increasing or reducing treatment in RA patients with persistent pain.

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

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The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

A former rheumatologist in Billings, Mont., and his business have agreed to pay more than $2 million to settle civil claims for alleged False Claims Act violations, according to Acting U.S. Attorney for the District of Montana Leif M. Johnson.

utah778/Thinkstock

Enrico Arguelles, MD, and his business, the Arthritis & Osteoporosis Center (AOC), which closed in September 2018, agreed to the settlement with the U.S. Attorney’s Office on July 14.

Under terms of the settlement, Dr. Arguelles and the AOC must pay $1,268,646 and relinquish any claim to $802,018 in Medicare payment suspensions held in escrow for AOC for the past 4 years by the Centers for Medicare and Medicaid Services.

Attempts to reach Dr. Arguelles or his attorney for comment were unsuccessful.

“This civil settlement resolves claims of improper medical treatments and false billing to a federal program. Over billed and unnecessary claims, like the ones at issue in this case, drive up the costs for providing care to the people who really need it,” Mr. Johnson said in a statement.

Among the allegations, related to diagnosis and treatment of RA, were improper billing for MRI scans, improper billing for patient visits, and administration of biologic infusions such as infliximab (Remicade) for some patients who did not have seronegative RA, from Jan. 1, 2015, to the closure of the AOC office in 2018, the press release from the Department of Justice stated.

The press release notes that the settlement is not an admission of liability by Dr. Arguelles or AOC, nor a concession by the United States that its case is not well founded.

Assistant U.S. Attorney Michael A. Kakuk represented the United States in the case, which was investigated by the U.S. Attorney’s Office’s Health Care Fraud Investigative Team, Department of Health & Human Services Office of Inspector General, and FBI.

Special Agent in Charge Curt L. Muller, of the HHS-OIG, said in the statement: “Working with our law enforcement partners, we will hold accountable individuals who provide medically unnecessary treatments and pass along the cost to taxpayers.”

According to the Billings Gazette, Dr. Arguelles’ offices in Billings were raided on March 31, 2017, by agents from the HHS-OIG, FBI, and Montana Medicaid Fraud Control Unit.

A spokesperson for the OIG did not disclose to the Gazette the nature of the raid or what, if anything, was found, as it was an open investigation.

In the month after the raid, the Gazette reported, the FBI set up a hotline for patients after a number of them began calling state and federal authorities with concerns “about the medical care they have received at Arthritis & Osteoporosis Center,” Katherine Harris, an OIG spokeswoman, said in a statement. 

The settlement comes after the previous fiscal year saw significant recovery of funds for U.S. medical fraud cases.

As this news organization has reported, the OIG recently announced that it had won or negotiated more than $1.8 billion in health care fraud settlements over the past fiscal year. The Department of Justice opened 1,148 criminal health care fraud investigations and 1,079 civil health care fraud investigations from Oct. 1, 2019, to Sept. 30, 2020.

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

A former rheumatologist in Billings, Mont., and his business have agreed to pay more than $2 million to settle civil claims for alleged False Claims Act violations, according to Acting U.S. Attorney for the District of Montana Leif M. Johnson.

utah778/Thinkstock

Enrico Arguelles, MD, and his business, the Arthritis & Osteoporosis Center (AOC), which closed in September 2018, agreed to the settlement with the U.S. Attorney’s Office on July 14.

Under terms of the settlement, Dr. Arguelles and the AOC must pay $1,268,646 and relinquish any claim to $802,018 in Medicare payment suspensions held in escrow for AOC for the past 4 years by the Centers for Medicare and Medicaid Services.

Attempts to reach Dr. Arguelles or his attorney for comment were unsuccessful.

“This civil settlement resolves claims of improper medical treatments and false billing to a federal program. Over billed and unnecessary claims, like the ones at issue in this case, drive up the costs for providing care to the people who really need it,” Mr. Johnson said in a statement.

Among the allegations, related to diagnosis and treatment of RA, were improper billing for MRI scans, improper billing for patient visits, and administration of biologic infusions such as infliximab (Remicade) for some patients who did not have seronegative RA, from Jan. 1, 2015, to the closure of the AOC office in 2018, the press release from the Department of Justice stated.

The press release notes that the settlement is not an admission of liability by Dr. Arguelles or AOC, nor a concession by the United States that its case is not well founded.

Assistant U.S. Attorney Michael A. Kakuk represented the United States in the case, which was investigated by the U.S. Attorney’s Office’s Health Care Fraud Investigative Team, Department of Health & Human Services Office of Inspector General, and FBI.

Special Agent in Charge Curt L. Muller, of the HHS-OIG, said in the statement: “Working with our law enforcement partners, we will hold accountable individuals who provide medically unnecessary treatments and pass along the cost to taxpayers.”

According to the Billings Gazette, Dr. Arguelles’ offices in Billings were raided on March 31, 2017, by agents from the HHS-OIG, FBI, and Montana Medicaid Fraud Control Unit.

A spokesperson for the OIG did not disclose to the Gazette the nature of the raid or what, if anything, was found, as it was an open investigation.

In the month after the raid, the Gazette reported, the FBI set up a hotline for patients after a number of them began calling state and federal authorities with concerns “about the medical care they have received at Arthritis & Osteoporosis Center,” Katherine Harris, an OIG spokeswoman, said in a statement. 

The settlement comes after the previous fiscal year saw significant recovery of funds for U.S. medical fraud cases.

As this news organization has reported, the OIG recently announced that it had won or negotiated more than $1.8 billion in health care fraud settlements over the past fiscal year. The Department of Justice opened 1,148 criminal health care fraud investigations and 1,079 civil health care fraud investigations from Oct. 1, 2019, to Sept. 30, 2020.

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

A former rheumatologist in Billings, Mont., and his business have agreed to pay more than $2 million to settle civil claims for alleged False Claims Act violations, according to Acting U.S. Attorney for the District of Montana Leif M. Johnson.

utah778/Thinkstock

Enrico Arguelles, MD, and his business, the Arthritis & Osteoporosis Center (AOC), which closed in September 2018, agreed to the settlement with the U.S. Attorney’s Office on July 14.

Under terms of the settlement, Dr. Arguelles and the AOC must pay $1,268,646 and relinquish any claim to $802,018 in Medicare payment suspensions held in escrow for AOC for the past 4 years by the Centers for Medicare and Medicaid Services.

Attempts to reach Dr. Arguelles or his attorney for comment were unsuccessful.

“This civil settlement resolves claims of improper medical treatments and false billing to a federal program. Over billed and unnecessary claims, like the ones at issue in this case, drive up the costs for providing care to the people who really need it,” Mr. Johnson said in a statement.

Among the allegations, related to diagnosis and treatment of RA, were improper billing for MRI scans, improper billing for patient visits, and administration of biologic infusions such as infliximab (Remicade) for some patients who did not have seronegative RA, from Jan. 1, 2015, to the closure of the AOC office in 2018, the press release from the Department of Justice stated.

The press release notes that the settlement is not an admission of liability by Dr. Arguelles or AOC, nor a concession by the United States that its case is not well founded.

Assistant U.S. Attorney Michael A. Kakuk represented the United States in the case, which was investigated by the U.S. Attorney’s Office’s Health Care Fraud Investigative Team, Department of Health & Human Services Office of Inspector General, and FBI.

Special Agent in Charge Curt L. Muller, of the HHS-OIG, said in the statement: “Working with our law enforcement partners, we will hold accountable individuals who provide medically unnecessary treatments and pass along the cost to taxpayers.”

According to the Billings Gazette, Dr. Arguelles’ offices in Billings were raided on March 31, 2017, by agents from the HHS-OIG, FBI, and Montana Medicaid Fraud Control Unit.

A spokesperson for the OIG did not disclose to the Gazette the nature of the raid or what, if anything, was found, as it was an open investigation.

In the month after the raid, the Gazette reported, the FBI set up a hotline for patients after a number of them began calling state and federal authorities with concerns “about the medical care they have received at Arthritis & Osteoporosis Center,” Katherine Harris, an OIG spokeswoman, said in a statement. 

The settlement comes after the previous fiscal year saw significant recovery of funds for U.S. medical fraud cases.

As this news organization has reported, the OIG recently announced that it had won or negotiated more than $1.8 billion in health care fraud settlements over the past fiscal year. The Department of Justice opened 1,148 criminal health care fraud investigations and 1,079 civil health care fraud investigations from Oct. 1, 2019, to Sept. 30, 2020.

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

COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.

Steve Mann/Thinkstock

“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.

To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).

Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).

Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).

In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.

When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”

He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.

“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”

More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”

The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”

“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”

Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.

COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.

Steve Mann/Thinkstock

“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.

To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).

Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).

Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).

In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.

When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”

He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.

“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”

More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”

The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”

“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”

Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.

COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.

Steve Mann/Thinkstock

“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.

To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).

Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).

Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).

In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.

When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”

He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.

“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”

More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”

The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”

“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”

Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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

In most patients with psoriatic arthritis (PsA), the musculoskeletal manifestations occur after the onset of cutaneous manifestations. The mechanisms underlying the triggering of joint disease is still not well understood, one burning question is whether early and effective treatment of cutaneous psoriasis will reduce the incidence of PsA. In a retrospective non-randomised study, Gisondi et al compared the incidence rates of PsA in patients with chronic plaque psoriasis receiving either continuous treatment with a biologic disease modifying anti-rheumatic drugs (bDMARD- infliximab, etanercept, adalimumab, ustekinumab and secukinumab) for at least 5 years (n=234, 1584 person-year of follow-up) or at least three courses of narrow band ultraviolet B (nb-UVB) phototherapy (n=230, 1478 person-year of follow-up). bDMARDs treatment was associated with a lower risk of incident PsA (adjusted hazard ratio 0.27, 95% Confidence Interval 0.11–0.66). However, analysis after propensity score matching found no significant difference between treatment with bDMARDs and nb-UVB phototherapy and the risk of incident PsA. Prospective studies are required to answer this important question. Interestingly, nail psoriasis was associated with higher risk of PsA, confirming previous observations.

Due to lack of disease activity biomarkers clinical assessment of disease activity in PsA patients with concomitant fibromyalgia can be challenging. Ultrasound (US) may however be useful in providing objective assessment of disease activity. Polachek et al compared 42 patients with PsA and coexisting fibromyalgia syndrome (FMS) (satisfying CASPAR criteria and the 2016 fibromyalgia classification criteria) to 114 PsA patients without FMS (satisfying CASPAR criteria alone). All patients underwent detailed US evaluation including 52 joints, 40 tendons and 14 entheses, and a scores for synovitis, tenosynovitis and enthesitis were summed to obtain a final US disease activity score for each patient. Those with FMS had higher scores of composite clinical disease activity indices. However, the total US score and its subcategories were similar for those with and without FMS. The total US score significantly correlated with composite indices in PsA patients without FMS but not in PsA patients with FMS. Thus, US is a tool that can be employed to determine PsA disease activity in patients with concomitant FMS. However, the scanning protocol as described is time consuming. A shortened protocol as well as training of rheumatologists and radiologists for reliably assessing synovitis, tenosynovitis and enthesitis is required before US can be feasibly and reliably used in clinical practice.

IL-23 inhibitors were not found to be efficacious in the treatment of axial spondyloarthritis. It is not clear whether these inhibitors improve axial disease in PsA patients, and if indeed axial PsA is distinct from primary axial spondyloarthritis. In a post-hoc analyses of the DISCOVER 1 and DISCOVER 2 studies that included 312 patients with PsA with imaging-confirmed sacroiliitis randomly assigned to either placebo (n=118), guselkumab Q4 (n=103), or Q8 (n=91), Mease et al demonstrated that at week 24, guselkumab Q4 and Q8 groups vs placebo showed higher least-squares mean changes in BASDAI (−2.7 and −2.7 vs −1.3; P less than .0001) and ASDAS (−1.4 and −1.4 vs −0.7; P less than .0001) scores, which were maintained until week 52. Thus, Guselkumab may improve axial PsA. However, axial PsA has not yet been formally defined, and BASDAI and ASDAS are not specific for axial PsA. Once axial PsA is defined, prospective randomised clinical trials with associated MRI studies will be required to determine if IL-23 inhibitors improve symptoms of axial PsA.

In most patients with psoriatic arthritis (PsA), the musculoskeletal manifestations occur after the onset of cutaneous manifestations. The mechanisms underlying the triggering of joint disease is still not well understood, one burning question is whether early and effective treatment of cutaneous psoriasis will reduce the incidence of PsA. In a retrospective non-randomised study, Gisondi et al compared the incidence rates of PsA in patients with chronic plaque psoriasis receiving either continuous treatment with a biologic disease modifying anti-rheumatic drugs (bDMARD- infliximab, etanercept, adalimumab, ustekinumab and secukinumab) for at least 5 years (n=234, 1584 person-year of follow-up) or at least three courses of narrow band ultraviolet B (nb-UVB) phototherapy (n=230, 1478 person-year of follow-up). bDMARDs treatment was associated with a lower risk of incident PsA (adjusted hazard ratio 0.27, 95% Confidence Interval 0.11–0.66). However, analysis after propensity score matching found no significant difference between treatment with bDMARDs and nb-UVB phototherapy and the risk of incident PsA. Prospective studies are required to answer this important question. Interestingly, nail psoriasis was associated with higher risk of PsA, confirming previous observations.

Due to lack of disease activity biomarkers clinical assessment of disease activity in PsA patients with concomitant fibromyalgia can be challenging. Ultrasound (US) may however be useful in providing objective assessment of disease activity. Polachek et al compared 42 patients with PsA and coexisting fibromyalgia syndrome (FMS) (satisfying CASPAR criteria and the 2016 fibromyalgia classification criteria) to 114 PsA patients without FMS (satisfying CASPAR criteria alone). All patients underwent detailed US evaluation including 52 joints, 40 tendons and 14 entheses, and a scores for synovitis, tenosynovitis and enthesitis were summed to obtain a final US disease activity score for each patient. Those with FMS had higher scores of composite clinical disease activity indices. However, the total US score and its subcategories were similar for those with and without FMS. The total US score significantly correlated with composite indices in PsA patients without FMS but not in PsA patients with FMS. Thus, US is a tool that can be employed to determine PsA disease activity in patients with concomitant FMS. However, the scanning protocol as described is time consuming. A shortened protocol as well as training of rheumatologists and radiologists for reliably assessing synovitis, tenosynovitis and enthesitis is required before US can be feasibly and reliably used in clinical practice.

IL-23 inhibitors were not found to be efficacious in the treatment of axial spondyloarthritis. It is not clear whether these inhibitors improve axial disease in PsA patients, and if indeed axial PsA is distinct from primary axial spondyloarthritis. In a post-hoc analyses of the DISCOVER 1 and DISCOVER 2 studies that included 312 patients with PsA with imaging-confirmed sacroiliitis randomly assigned to either placebo (n=118), guselkumab Q4 (n=103), or Q8 (n=91), Mease et al demonstrated that at week 24, guselkumab Q4 and Q8 groups vs placebo showed higher least-squares mean changes in BASDAI (−2.7 and −2.7 vs −1.3; P less than .0001) and ASDAS (−1.4 and −1.4 vs −0.7; P less than .0001) scores, which were maintained until week 52. Thus, Guselkumab may improve axial PsA. However, axial PsA has not yet been formally defined, and BASDAI and ASDAS are not specific for axial PsA. Once axial PsA is defined, prospective randomised clinical trials with associated MRI studies will be required to determine if IL-23 inhibitors improve symptoms of axial PsA.

In most patients with psoriatic arthritis (PsA), the musculoskeletal manifestations occur after the onset of cutaneous manifestations. The mechanisms underlying the triggering of joint disease is still not well understood, one burning question is whether early and effective treatment of cutaneous psoriasis will reduce the incidence of PsA. In a retrospective non-randomised study, Gisondi et al compared the incidence rates of PsA in patients with chronic plaque psoriasis receiving either continuous treatment with a biologic disease modifying anti-rheumatic drugs (bDMARD- infliximab, etanercept, adalimumab, ustekinumab and secukinumab) for at least 5 years (n=234, 1584 person-year of follow-up) or at least three courses of narrow band ultraviolet B (nb-UVB) phototherapy (n=230, 1478 person-year of follow-up). bDMARDs treatment was associated with a lower risk of incident PsA (adjusted hazard ratio 0.27, 95% Confidence Interval 0.11–0.66). However, analysis after propensity score matching found no significant difference between treatment with bDMARDs and nb-UVB phototherapy and the risk of incident PsA. Prospective studies are required to answer this important question. Interestingly, nail psoriasis was associated with higher risk of PsA, confirming previous observations.

Due to lack of disease activity biomarkers clinical assessment of disease activity in PsA patients with concomitant fibromyalgia can be challenging. Ultrasound (US) may however be useful in providing objective assessment of disease activity. Polachek et al compared 42 patients with PsA and coexisting fibromyalgia syndrome (FMS) (satisfying CASPAR criteria and the 2016 fibromyalgia classification criteria) to 114 PsA patients without FMS (satisfying CASPAR criteria alone). All patients underwent detailed US evaluation including 52 joints, 40 tendons and 14 entheses, and a scores for synovitis, tenosynovitis and enthesitis were summed to obtain a final US disease activity score for each patient. Those with FMS had higher scores of composite clinical disease activity indices. However, the total US score and its subcategories were similar for those with and without FMS. The total US score significantly correlated with composite indices in PsA patients without FMS but not in PsA patients with FMS. Thus, US is a tool that can be employed to determine PsA disease activity in patients with concomitant FMS. However, the scanning protocol as described is time consuming. A shortened protocol as well as training of rheumatologists and radiologists for reliably assessing synovitis, tenosynovitis and enthesitis is required before US can be feasibly and reliably used in clinical practice.

IL-23 inhibitors were not found to be efficacious in the treatment of axial spondyloarthritis. It is not clear whether these inhibitors improve axial disease in PsA patients, and if indeed axial PsA is distinct from primary axial spondyloarthritis. In a post-hoc analyses of the DISCOVER 1 and DISCOVER 2 studies that included 312 patients with PsA with imaging-confirmed sacroiliitis randomly assigned to either placebo (n=118), guselkumab Q4 (n=103), or Q8 (n=91), Mease et al demonstrated that at week 24, guselkumab Q4 and Q8 groups vs placebo showed higher least-squares mean changes in BASDAI (−2.7 and −2.7 vs −1.3; P less than .0001) and ASDAS (−1.4 and −1.4 vs −0.7; P less than .0001) scores, which were maintained until week 52. Thus, Guselkumab may improve axial PsA. However, axial PsA has not yet been formally defined, and BASDAI and ASDAS are not specific for axial PsA. Once axial PsA is defined, prospective randomised clinical trials with associated MRI studies will be required to determine if IL-23 inhibitors improve symptoms of axial PsA.