Elevated serum gamma globulin or low complement levels in patients with symptoms of Sjögren’s syndrome (SS) may predict their likelihood of progression to the autoimmune disease, according to findings from a longitudinal cohort study.

“Identification of serological variables that predict the development of Sjögren’s syndrome may contribute to earlier diagnosis and treatment of the disease and, ultimately, better long-term outcome,” Caroline H. Shiboski, DDS, PhD, chair of the department of orofacial sciences at the University of California, San Francisco, and her coauthors wrote.

The researchers described the results of a follow-up visit 2 years after baseline for 771 of 3,310 participants in the Sjögren’s International Collaborative Clinical Alliance (SICCA) registry.

Approximately half of the participants did not meet either the 2012 American College of Rheumatology criteria or the 2016 ACR-European League Against Rheumatism criteria for Sjögren’s syndrome at baseline. At follow-up, 8% met the ACR criteria, and 9% met the ACR-EULAR criteria (Arthritis Care Res. 2017 April 24. doi: 10.1002/acr.23264).

For the other patients, those who did not progress according to either criteria, the researchers “observed remarkable stability over 2-3 years for both individual phenotypic features of SS and SS status, a finding consistent with smaller prospective studies with longer durations of follow-up.”

The participants with hypergammaglobulinemia at study entry, defined as immunoglobulin G greater than 1,445 mg/dL, were four times more likely to progress to full disease after 2 years (P = .006), while those with hypocomplementemia were six times more likely to progress (P = .004) than were those without. Hypocomplementemia was defined as C3 less than 90 mg/dL and/or C4 less than 16 mg/dL.

“However, the highest percentage of progression from not meeting the SS criteria at baseline to meeting them at the 2- to 3-year follow-up was among those who reported receiving immunomodulating/suppressive medications at both time points, both when using the ACR criteria (18% progressors) and the ACR-EULAR criteria (12% progressors),” the authors wrote.

In general, those with confirmed diagnosis at study entry showed reasonable stability in both individual phenotypic features and disease status.

Overall, 93% of participants who met the ACR criteria for SS at baseline still met those criteria at the 2- to 3-year follow-up, as did 89% of participants who met the ACR-EULAR criteria at baseline.

A majority of the participants who reverted from SS classification at baseline to failure to meet the criteria at follow-up had a change in labial salivary gland biopsy results. This occurred in 60% who met ACR criteria at baseline and 75% who met ACR-EULAR criteria at baseline.

More than 85% of participants in the study reported dry mouth or dry eyes, but participants with SS were much more likely to have positive anti-SSA, positive rheumatoid factor, antinuclear antibody titer of 1:320 or greater, hypergammaglobulinemia, and focal lymphocytic sialadenitis with a focus score of 1 or more focus per 4 mm².

The researchers also reported a very low incidence (0.5%) of lymphoma among the participants available for follow-up.

The study was supported by the National Institutes of Health, the Jerome L. Greene Foundation, and the Rosalind Russell/Ephraim P. Engleman Rheumatology Research Center. Six authors declared consultancies, honoraria, and grants from pharmaceutical companies.

[email protected]

Elevated serum gamma globulin or low complement levels in patients with symptoms of Sjögren’s syndrome (SS) may predict their likelihood of progression to the autoimmune disease, according to findings from a longitudinal cohort study.

“Identification of serological variables that predict the development of Sjögren’s syndrome may contribute to earlier diagnosis and treatment of the disease and, ultimately, better long-term outcome,” Caroline H. Shiboski, DDS, PhD, chair of the department of orofacial sciences at the University of California, San Francisco, and her coauthors wrote.

The researchers described the results of a follow-up visit 2 years after baseline for 771 of 3,310 participants in the Sjögren’s International Collaborative Clinical Alliance (SICCA) registry.

Approximately half of the participants did not meet either the 2012 American College of Rheumatology criteria or the 2016 ACR-European League Against Rheumatism criteria for Sjögren’s syndrome at baseline. At follow-up, 8% met the ACR criteria, and 9% met the ACR-EULAR criteria (Arthritis Care Res. 2017 April 24. doi: 10.1002/acr.23264).

For the other patients, those who did not progress according to either criteria, the researchers “observed remarkable stability over 2-3 years for both individual phenotypic features of SS and SS status, a finding consistent with smaller prospective studies with longer durations of follow-up.”

The participants with hypergammaglobulinemia at study entry, defined as immunoglobulin G greater than 1,445 mg/dL, were four times more likely to progress to full disease after 2 years (P = .006), while those with hypocomplementemia were six times more likely to progress (P = .004) than were those without. Hypocomplementemia was defined as C3 less than 90 mg/dL and/or C4 less than 16 mg/dL.

“However, the highest percentage of progression from not meeting the SS criteria at baseline to meeting them at the 2- to 3-year follow-up was among those who reported receiving immunomodulating/suppressive medications at both time points, both when using the ACR criteria (18% progressors) and the ACR-EULAR criteria (12% progressors),” the authors wrote.

In general, those with confirmed diagnosis at study entry showed reasonable stability in both individual phenotypic features and disease status.

Overall, 93% of participants who met the ACR criteria for SS at baseline still met those criteria at the 2- to 3-year follow-up, as did 89% of participants who met the ACR-EULAR criteria at baseline.

A majority of the participants who reverted from SS classification at baseline to failure to meet the criteria at follow-up had a change in labial salivary gland biopsy results. This occurred in 60% who met ACR criteria at baseline and 75% who met ACR-EULAR criteria at baseline.

More than 85% of participants in the study reported dry mouth or dry eyes, but participants with SS were much more likely to have positive anti-SSA, positive rheumatoid factor, antinuclear antibody titer of 1:320 or greater, hypergammaglobulinemia, and focal lymphocytic sialadenitis with a focus score of 1 or more focus per 4 mm².

The researchers also reported a very low incidence (0.5%) of lymphoma among the participants available for follow-up.

The study was supported by the National Institutes of Health, the Jerome L. Greene Foundation, and the Rosalind Russell/Ephraim P. Engleman Rheumatology Research Center. Six authors declared consultancies, honoraria, and grants from pharmaceutical companies.

[email protected]

Elevated serum gamma globulin or low complement levels in patients with symptoms of Sjögren’s syndrome (SS) may predict their likelihood of progression to the autoimmune disease, according to findings from a longitudinal cohort study.

“Identification of serological variables that predict the development of Sjögren’s syndrome may contribute to earlier diagnosis and treatment of the disease and, ultimately, better long-term outcome,” Caroline H. Shiboski, DDS, PhD, chair of the department of orofacial sciences at the University of California, San Francisco, and her coauthors wrote.

The researchers described the results of a follow-up visit 2 years after baseline for 771 of 3,310 participants in the Sjögren’s International Collaborative Clinical Alliance (SICCA) registry.

Approximately half of the participants did not meet either the 2012 American College of Rheumatology criteria or the 2016 ACR-European League Against Rheumatism criteria for Sjögren’s syndrome at baseline. At follow-up, 8% met the ACR criteria, and 9% met the ACR-EULAR criteria (Arthritis Care Res. 2017 April 24. doi: 10.1002/acr.23264).

For the other patients, those who did not progress according to either criteria, the researchers “observed remarkable stability over 2-3 years for both individual phenotypic features of SS and SS status, a finding consistent with smaller prospective studies with longer durations of follow-up.”

The participants with hypergammaglobulinemia at study entry, defined as immunoglobulin G greater than 1,445 mg/dL, were four times more likely to progress to full disease after 2 years (P = .006), while those with hypocomplementemia were six times more likely to progress (P = .004) than were those without. Hypocomplementemia was defined as C3 less than 90 mg/dL and/or C4 less than 16 mg/dL.

“However, the highest percentage of progression from not meeting the SS criteria at baseline to meeting them at the 2- to 3-year follow-up was among those who reported receiving immunomodulating/suppressive medications at both time points, both when using the ACR criteria (18% progressors) and the ACR-EULAR criteria (12% progressors),” the authors wrote.

In general, those with confirmed diagnosis at study entry showed reasonable stability in both individual phenotypic features and disease status.

Overall, 93% of participants who met the ACR criteria for SS at baseline still met those criteria at the 2- to 3-year follow-up, as did 89% of participants who met the ACR-EULAR criteria at baseline.

A majority of the participants who reverted from SS classification at baseline to failure to meet the criteria at follow-up had a change in labial salivary gland biopsy results. This occurred in 60% who met ACR criteria at baseline and 75% who met ACR-EULAR criteria at baseline.

More than 85% of participants in the study reported dry mouth or dry eyes, but participants with SS were much more likely to have positive anti-SSA, positive rheumatoid factor, antinuclear antibody titer of 1:320 or greater, hypergammaglobulinemia, and focal lymphocytic sialadenitis with a focus score of 1 or more focus per 4 mm².

The researchers also reported a very low incidence (0.5%) of lymphoma among the participants available for follow-up.

The study was supported by the National Institutes of Health, the Jerome L. Greene Foundation, and the Rosalind Russell/Ephraim P. Engleman Rheumatology Research Center. Six authors declared consultancies, honoraria, and grants from pharmaceutical companies.

[email protected]

PORTLAND – Short-term daily oral supplementation with 5000 IU of vitamin D₃ was safe and significantly outperformed placebo for lessening the signs and symptoms of atopic dermatitis (AD), according to the results of a randomized, double-blind trial of 65 patients with moderate to severe disease.

At week 12, average improvements on the Scoring Atopic Dermatitis (SCORAD) index (standard deviation, 11.1 points) were 21.2 points in the vitamin D₃ group and 13.9 points (standard deviation, 12.3 points) in the placebo group (P = .02), Karen Sanchez-Armendariz, MD, reported at the annual meeting of the Society for Investigative Dermatology. “Vitamin D₃ should be considered a valuable adjuvant in the treatment of AD, especially in patients with relapses,” she said.

Past studies have reported an inverse relationship between 25(OH)D (vitamin D) serum levels and the severity of AD, noted Dr. Sanchez-Armendariz, who is with the National Autonomous University of Mexico in Mexico City. This finding makes sense, as vitamin D₃ induces the topical production of antimicrobial peptides, which have direct antimicrobial activity and induce a host response characterized by cytokine release, chemotaxis, inflammation, angiogenesis, and re-epithelialization, she added.

Consequently, 25(OH)D deficiency has been posited as a culprit in the pathophysiology of AD. However, scientific and endocrine societies have published differing recommendations about safe and optimal doses for vitamin D₃ supplementation, while experts have noted that 5000 IU per day is needed to achieve an increase of 10 ng 25(OH)D per mL serum (J Am Board Fam Med. 2014 Jul-Aug;27[4]:495-509).

For the study, therefore, Dr. Sanchez-Armendariz and her associates evaluated this dose as adjuvant therapy in patients with moderate to severe AD despite topical hydrocortisone aceponate, soap substitute, and emollient. Patients continued this usual care and received either a cellulose capsule placebo or 5000 IU oral vitamin D₃ per day. Based on previously recommended cutoff values, the researchers considered serum 25(OH)D levels sufficient if they exceeded 30 ng per mL, insufficient if they were between 20 and 30 ng per mL, and deficient if they were less than 20 ng per mL (J Bone Miner Res. 2011 Mar;26[3]:455-7).

At baseline, the placebo and intervention groups resembled each other in terms of baseline levels of 25(OH)D, calcium, and phosphorus, pruritus, and scores on SCORAD and the six-area Total Body Severity Assessment. A total of 59% of patients had insufficient serum 25(OH)D, and 39% were deficient.

Patients in both groups improved on the Total Body Severity Assessment, but the extent of improvement did not statistically differ between groups, Dr. Sanchez-Armendariz reported. Supplementation did significantly increase serum 25(OH)D levels, which at week 12 averaged 58.3 ng per mL (SD, 18.5 ng per mL), compared with 22.2 (SD, 7.6 ng per mL) with placebo (P less than .001).

Interestingly, at week 12, all patients in the vitamin D₃ group achieved serum 25(OH)D levels of at least 30 ng per mL, as did 41% of patients in the placebo arm. Patients in both groups who achieved this “sufficient” serum 25(OH)D level averaged a nearly 21-point improvement on the SCORAD (SD, 11.1 points), compared with 7.5 points (SD, 9.9 points) among patients who remained deficient, and 17.4 points (SD, 12.7 points) among patients who remained insufficient (P = .004 for difference among groups; P = .02 for difference between sufficient and insufficient groups).

An analysis of variance confirmed this finding, showing that, regardless of treatment group, patients whose final serum 25(OH)D level was at least 20 ng per mL scored an average of 20 points on the SCORAD, compared with 38 points for patients whose 25(OH)D level remained below 20 ng per mL. Patients whose final 25(OH)D level exceeded 20 ng per mL had fivefold greater odds of having a SCORAD below 25 than did patients with lower serum 25(OH)D levels (odds ratio, 5.1; 95% confidence interval, 1.2-22.6; P = .03).

The investigators identified no adverse effects of vitamin D₃ supplementation, Dr. Sanchez-Armendariz said. “Attaining 25(OH)D levels above 20 ng per mL in addition to baseline therapy reduced the SCORAD of patients with moderate to severe atopic dermatitis,” she added. Clinicians should consider vitamin D3 deficiency and supplementation in patients with relapsing or refractory AD, she emphasized.

Dr. Sanchez-Armendariz reported no external funding sources and no conflicts of interest.

PORTLAND – Short-term daily oral supplementation with 5000 IU of vitamin D₃ was safe and significantly outperformed placebo for lessening the signs and symptoms of atopic dermatitis (AD), according to the results of a randomized, double-blind trial of 65 patients with moderate to severe disease.

At week 12, average improvements on the Scoring Atopic Dermatitis (SCORAD) index (standard deviation, 11.1 points) were 21.2 points in the vitamin D₃ group and 13.9 points (standard deviation, 12.3 points) in the placebo group (P = .02), Karen Sanchez-Armendariz, MD, reported at the annual meeting of the Society for Investigative Dermatology. “Vitamin D₃ should be considered a valuable adjuvant in the treatment of AD, especially in patients with relapses,” she said.

Past studies have reported an inverse relationship between 25(OH)D (vitamin D) serum levels and the severity of AD, noted Dr. Sanchez-Armendariz, who is with the National Autonomous University of Mexico in Mexico City. This finding makes sense, as vitamin D₃ induces the topical production of antimicrobial peptides, which have direct antimicrobial activity and induce a host response characterized by cytokine release, chemotaxis, inflammation, angiogenesis, and re-epithelialization, she added.

Consequently, 25(OH)D deficiency has been posited as a culprit in the pathophysiology of AD. However, scientific and endocrine societies have published differing recommendations about safe and optimal doses for vitamin D₃ supplementation, while experts have noted that 5000 IU per day is needed to achieve an increase of 10 ng 25(OH)D per mL serum (J Am Board Fam Med. 2014 Jul-Aug;27[4]:495-509).

For the study, therefore, Dr. Sanchez-Armendariz and her associates evaluated this dose as adjuvant therapy in patients with moderate to severe AD despite topical hydrocortisone aceponate, soap substitute, and emollient. Patients continued this usual care and received either a cellulose capsule placebo or 5000 IU oral vitamin D₃ per day. Based on previously recommended cutoff values, the researchers considered serum 25(OH)D levels sufficient if they exceeded 30 ng per mL, insufficient if they were between 20 and 30 ng per mL, and deficient if they were less than 20 ng per mL (J Bone Miner Res. 2011 Mar;26[3]:455-7).

At baseline, the placebo and intervention groups resembled each other in terms of baseline levels of 25(OH)D, calcium, and phosphorus, pruritus, and scores on SCORAD and the six-area Total Body Severity Assessment. A total of 59% of patients had insufficient serum 25(OH)D, and 39% were deficient.

Patients in both groups improved on the Total Body Severity Assessment, but the extent of improvement did not statistically differ between groups, Dr. Sanchez-Armendariz reported. Supplementation did significantly increase serum 25(OH)D levels, which at week 12 averaged 58.3 ng per mL (SD, 18.5 ng per mL), compared with 22.2 (SD, 7.6 ng per mL) with placebo (P less than .001).

Interestingly, at week 12, all patients in the vitamin D₃ group achieved serum 25(OH)D levels of at least 30 ng per mL, as did 41% of patients in the placebo arm. Patients in both groups who achieved this “sufficient” serum 25(OH)D level averaged a nearly 21-point improvement on the SCORAD (SD, 11.1 points), compared with 7.5 points (SD, 9.9 points) among patients who remained deficient, and 17.4 points (SD, 12.7 points) among patients who remained insufficient (P = .004 for difference among groups; P = .02 for difference between sufficient and insufficient groups).

An analysis of variance confirmed this finding, showing that, regardless of treatment group, patients whose final serum 25(OH)D level was at least 20 ng per mL scored an average of 20 points on the SCORAD, compared with 38 points for patients whose 25(OH)D level remained below 20 ng per mL. Patients whose final 25(OH)D level exceeded 20 ng per mL had fivefold greater odds of having a SCORAD below 25 than did patients with lower serum 25(OH)D levels (odds ratio, 5.1; 95% confidence interval, 1.2-22.6; P = .03).

The investigators identified no adverse effects of vitamin D₃ supplementation, Dr. Sanchez-Armendariz said. “Attaining 25(OH)D levels above 20 ng per mL in addition to baseline therapy reduced the SCORAD of patients with moderate to severe atopic dermatitis,” she added. Clinicians should consider vitamin D3 deficiency and supplementation in patients with relapsing or refractory AD, she emphasized.

Dr. Sanchez-Armendariz reported no external funding sources and no conflicts of interest.

PORTLAND – Short-term daily oral supplementation with 5000 IU of vitamin D₃ was safe and significantly outperformed placebo for lessening the signs and symptoms of atopic dermatitis (AD), according to the results of a randomized, double-blind trial of 65 patients with moderate to severe disease.

At week 12, average improvements on the Scoring Atopic Dermatitis (SCORAD) index (standard deviation, 11.1 points) were 21.2 points in the vitamin D₃ group and 13.9 points (standard deviation, 12.3 points) in the placebo group (P = .02), Karen Sanchez-Armendariz, MD, reported at the annual meeting of the Society for Investigative Dermatology. “Vitamin D₃ should be considered a valuable adjuvant in the treatment of AD, especially in patients with relapses,” she said.

Past studies have reported an inverse relationship between 25(OH)D (vitamin D) serum levels and the severity of AD, noted Dr. Sanchez-Armendariz, who is with the National Autonomous University of Mexico in Mexico City. This finding makes sense, as vitamin D₃ induces the topical production of antimicrobial peptides, which have direct antimicrobial activity and induce a host response characterized by cytokine release, chemotaxis, inflammation, angiogenesis, and re-epithelialization, she added.

Consequently, 25(OH)D deficiency has been posited as a culprit in the pathophysiology of AD. However, scientific and endocrine societies have published differing recommendations about safe and optimal doses for vitamin D₃ supplementation, while experts have noted that 5000 IU per day is needed to achieve an increase of 10 ng 25(OH)D per mL serum (J Am Board Fam Med. 2014 Jul-Aug;27[4]:495-509).

For the study, therefore, Dr. Sanchez-Armendariz and her associates evaluated this dose as adjuvant therapy in patients with moderate to severe AD despite topical hydrocortisone aceponate, soap substitute, and emollient. Patients continued this usual care and received either a cellulose capsule placebo or 5000 IU oral vitamin D₃ per day. Based on previously recommended cutoff values, the researchers considered serum 25(OH)D levels sufficient if they exceeded 30 ng per mL, insufficient if they were between 20 and 30 ng per mL, and deficient if they were less than 20 ng per mL (J Bone Miner Res. 2011 Mar;26[3]:455-7).

At baseline, the placebo and intervention groups resembled each other in terms of baseline levels of 25(OH)D, calcium, and phosphorus, pruritus, and scores on SCORAD and the six-area Total Body Severity Assessment. A total of 59% of patients had insufficient serum 25(OH)D, and 39% were deficient.

Patients in both groups improved on the Total Body Severity Assessment, but the extent of improvement did not statistically differ between groups, Dr. Sanchez-Armendariz reported. Supplementation did significantly increase serum 25(OH)D levels, which at week 12 averaged 58.3 ng per mL (SD, 18.5 ng per mL), compared with 22.2 (SD, 7.6 ng per mL) with placebo (P less than .001).

Interestingly, at week 12, all patients in the vitamin D₃ group achieved serum 25(OH)D levels of at least 30 ng per mL, as did 41% of patients in the placebo arm. Patients in both groups who achieved this “sufficient” serum 25(OH)D level averaged a nearly 21-point improvement on the SCORAD (SD, 11.1 points), compared with 7.5 points (SD, 9.9 points) among patients who remained deficient, and 17.4 points (SD, 12.7 points) among patients who remained insufficient (P = .004 for difference among groups; P = .02 for difference between sufficient and insufficient groups).

An analysis of variance confirmed this finding, showing that, regardless of treatment group, patients whose final serum 25(OH)D level was at least 20 ng per mL scored an average of 20 points on the SCORAD, compared with 38 points for patients whose 25(OH)D level remained below 20 ng per mL. Patients whose final 25(OH)D level exceeded 20 ng per mL had fivefold greater odds of having a SCORAD below 25 than did patients with lower serum 25(OH)D levels (odds ratio, 5.1; 95% confidence interval, 1.2-22.6; P = .03).

The investigators identified no adverse effects of vitamin D₃ supplementation, Dr. Sanchez-Armendariz said. “Attaining 25(OH)D levels above 20 ng per mL in addition to baseline therapy reduced the SCORAD of patients with moderate to severe atopic dermatitis,” she added. Clinicians should consider vitamin D3 deficiency and supplementation in patients with relapsing or refractory AD, she emphasized.

Dr. Sanchez-Armendariz reported no external funding sources and no conflicts of interest.

Photo courtesy of Janssen

The European Commission (EC) has expanded the approved use of the anti-CD38 antibody daratumumab (Darzalex®).

Daratumumab is now approved for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of adults with multiple myeloma (MM) who have received at least 1 prior therapy.

The EC previously granted conditional approval for daratumumab as monotherapy for the treatment of adults with relapsed or refractory MM whose prior treatment included a proteasome inhibitor and an immunomodulatory agent and who demonstrated disease progression on their last therapy.

Now, the EC has granted daratumumab full approval for this indication. The conditional approval was contingent upon Janssen, the company developing daratumumab, providing additional data from the phase 3 POLLUX and CASTOR trials.

As these data have been provided, the EC said the specific obligations associated with the conditional approval have been fulfilled, allowing the switch from conditional to full approval.

The EC’s decision to grant daratumumab approval in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone was also based on data from the POLLUX and CASTOR trials.

In the POLLUX trial, researchers compared treatment with lenalidomide and dexamethasone to treatment with daratumumab, lenalidomide, and dexamethasone in patients with relapsed or refractory MM.

Patients who received daratumumab in combination had a significantly higher response rate and longer progression-free survival than patients who received the 2-drug combination.

However, treatment with daratumumab was associated with infusion-related reactions and a higher incidence of neutropenia.

Results from this trial were published in NEJM in October 2016.

In the CASTOR trial, researchers compared treatment with bortezomib and dexamethasone to treatment with daratumumab, bortezomib, and dexamethasone in patients with previously treated MM.

Patients who received the 3-drug combination had a higher response rate, longer progression-free survival, and a higher incidence of grade 3/4 adverse events than those who received the 2-drug combination.

Results from this trial were published in NEJM in August 2016.

Photo courtesy of Janssen

The European Commission (EC) has expanded the approved use of the anti-CD38 antibody daratumumab (Darzalex®).

Daratumumab is now approved for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of adults with multiple myeloma (MM) who have received at least 1 prior therapy.

The EC previously granted conditional approval for daratumumab as monotherapy for the treatment of adults with relapsed or refractory MM whose prior treatment included a proteasome inhibitor and an immunomodulatory agent and who demonstrated disease progression on their last therapy.

Now, the EC has granted daratumumab full approval for this indication. The conditional approval was contingent upon Janssen, the company developing daratumumab, providing additional data from the phase 3 POLLUX and CASTOR trials.

As these data have been provided, the EC said the specific obligations associated with the conditional approval have been fulfilled, allowing the switch from conditional to full approval.

The EC’s decision to grant daratumumab approval in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone was also based on data from the POLLUX and CASTOR trials.

In the POLLUX trial, researchers compared treatment with lenalidomide and dexamethasone to treatment with daratumumab, lenalidomide, and dexamethasone in patients with relapsed or refractory MM.

Patients who received daratumumab in combination had a significantly higher response rate and longer progression-free survival than patients who received the 2-drug combination.

However, treatment with daratumumab was associated with infusion-related reactions and a higher incidence of neutropenia.

Results from this trial were published in NEJM in October 2016.

In the CASTOR trial, researchers compared treatment with bortezomib and dexamethasone to treatment with daratumumab, bortezomib, and dexamethasone in patients with previously treated MM.

Patients who received the 3-drug combination had a higher response rate, longer progression-free survival, and a higher incidence of grade 3/4 adverse events than those who received the 2-drug combination.

Results from this trial were published in NEJM in August 2016.

Photo courtesy of Janssen

The European Commission (EC) has expanded the approved use of the anti-CD38 antibody daratumumab (Darzalex®).

Daratumumab is now approved for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of adults with multiple myeloma (MM) who have received at least 1 prior therapy.

The EC previously granted conditional approval for daratumumab as monotherapy for the treatment of adults with relapsed or refractory MM whose prior treatment included a proteasome inhibitor and an immunomodulatory agent and who demonstrated disease progression on their last therapy.

Now, the EC has granted daratumumab full approval for this indication. The conditional approval was contingent upon Janssen, the company developing daratumumab, providing additional data from the phase 3 POLLUX and CASTOR trials.

As these data have been provided, the EC said the specific obligations associated with the conditional approval have been fulfilled, allowing the switch from conditional to full approval.

The EC’s decision to grant daratumumab approval in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone was also based on data from the POLLUX and CASTOR trials.

In the POLLUX trial, researchers compared treatment with lenalidomide and dexamethasone to treatment with daratumumab, lenalidomide, and dexamethasone in patients with relapsed or refractory MM.

Patients who received daratumumab in combination had a significantly higher response rate and longer progression-free survival than patients who received the 2-drug combination.

However, treatment with daratumumab was associated with infusion-related reactions and a higher incidence of neutropenia.

Results from this trial were published in NEJM in October 2016.

In the CASTOR trial, researchers compared treatment with bortezomib and dexamethasone to treatment with daratumumab, bortezomib, and dexamethasone in patients with previously treated MM.

Patients who received the 3-drug combination had a higher response rate, longer progression-free survival, and a higher incidence of grade 3/4 adverse events than those who received the 2-drug combination.

Results from this trial were published in NEJM in August 2016.

BOSTON – Cannabidiol add-on treatment significantly reduces the frequency of drop seizures in patients with Lennox-Gastaut syndrome, according to findings from the randomized, double-blind, placebo-controlled GWPCARE4 and GWPCARE3 trials.

In GWPCARE4 – the first controlled trial of cannabidiol in Lennox-Gastaut syndrome (LGS) – 171 patients were randomized to receive either placebo or cannabidiol oral solution at a dose of 20 mg/kg per day for 14 weeks, including 2 weeks of titration and 12 weeks of maintenance therapy. The drop seizure frequency decreased by a median of 44% in the cannabidiol group vs. 22% in the placebo group. The difference between the groups was statistically significant and was apparent within the first 4 weeks of the maintenance period, Jacqueline French, MD, director of translational research and clinical trials in epilepsy at New York University Langone Medical Center reported at the annual meeting of the American Academy of Neurology.

Study participants had a mean age of 15 years, and 34% were aged 18 years or older. The median drop seizure frequency was 74 per month at baseline.

“That is a very high seizure burden,” Dr. French said, noting that the median total drop and non-drop seizure frequency was in the mid to high 100s. “So you can see that these children were very afflicted by seizures.”

Interestingly, there was a “very substantial drop” in non-drop seizures, as well, she said.

“And that’s really hard to demonstrate, so that’s impressive to me, at least,” she added.

Patients had taken a median of six antiepileptic drugs (AEDs) in their past and were taking a median of three AEDs in addition to the cannabidiol throughout the study period.

Adverse events were common, occurring in 86% of cannabidiol patients and 69% of placebo patients. The most common were diarrhea, somnolence, pyrexia, decreased appetite, and vomiting, but most were mild or moderate. Treatment-related serious adverse events were reported in nine cannabidiol patients and one placebo patient. All patients who completed the trial entered an open-label extension study, Dr. French said.

GWPCARE4 was followed by GWPCARE3, which compared both 20 mg/kg per day and 10 mg/kg per day doses of cannabidiol with placebo.

In that study, 225 patients with a mean age of 16 years (30% were aged 18 years or older) were randomized, and the median drop in seizure frequency was 42% with 20 mg/kg of cannabidiol and 37% with 10 mg/kg of cannabidiol versus 17% with placebo, Anup D. Patel, MD, reported at the meeting.

Approximately 40% and 36% of patients in the 20 mg/kg and 10 mg/kg groups, respectively, achieved the secondary outcome of a 50% or greater drop in seizure frequency, compared with 15% of placebo patients.

“Overall, 5 patients in the 20 mg/kg per day arm, 3 in the 10 [mg/kg per day arm], and 1 in the placebo arm achieved drop seizure freedom during the maintenance period of our study,” said Dr. Patel, a pediatric neurologist at Nationwide Children’s Hospital, Columbus, Ohio.

The median monthly drop seizure frequency at baseline was 80-87 in the three groups, and patients had previously failed a median of six to seven AEDs. They took a median of three AEDs during the study.

Adverse events occurred in 94% of patients in the 20-mg/kg cannabidiol group, 84% of those in the 10-mg/kg group, and 72% of placebo patients, and most were mild or moderate. The most common were somnolence and decreased appetite.

Treatment-related serious adverse events were reported in 5, 2, and 0 patients in the groups, respectively. Some elevations in transaminases were seen (in 11 patients in the 20-mg/kg dose group, and 2 in the 10-mg/kg dose group), but no patients met criteria for drug-induced liver injury with concurrent elevated bilirubin, and all cases resolved, Dr. Patel said.

Similar findings were noted in GWPCARE4, and both Dr. Patel and Dr. French noted that most patients with elevated transaminases were also taking valproic acid.

No deaths occurred in either GWPCARE4 or GWPCARE3.

“We feel both doses... produce significantly greater reductions in drop seizures as compared to placebo,” Dr. Patel said.

In an interview, he noted that the two cannabidiol doses were not compared directly to determine if the differences in response rates and adverse events were statistically significant, but said that the rates appeared comparable, and that the adverse event rates were high in all of the groups, reflecting a very sick patient population.

Of the 212 patients who completed GWPCARE3, 99% entered an open-label extension study.

Eligible patients in both trials were children and adults aged 2-55 years with a clinical diagnosis of LGS, at least two drop seizures (including tonic, atonic, and tonic-clonic seizures) each week at baseline, and documented failures on at least one AED.

Patients and caregivers in both trials were more likely to report improvement in overall condition among treated vs. placebo patients, as measured using the Subject/Caregiver Global Impression of Change scale.

The findings provide class 1 evidence that cannabidiol as add-on therapy in LGS is efficacious for reducing seizure frequency, and is generally well tolerated, Dr. French and Dr. Patel said.

Dr. French noted that enthusiasm for the trials was high, with many study sites reporting waiting lists for patient enrollment.

Some of the authors in each study have consulted for, conducted studies funded by, or received honoraria from GW Pharmaceuticals, which funded the GWPCARE4 and GWPCARE3 trials and manufacturers the oral cannabidiol solution. Several authors in each study were employees of GW Pharmaceuticals.

[email protected]

BOSTON – Cannabidiol add-on treatment significantly reduces the frequency of drop seizures in patients with Lennox-Gastaut syndrome, according to findings from the randomized, double-blind, placebo-controlled GWPCARE4 and GWPCARE3 trials.

In GWPCARE4 – the first controlled trial of cannabidiol in Lennox-Gastaut syndrome (LGS) – 171 patients were randomized to receive either placebo or cannabidiol oral solution at a dose of 20 mg/kg per day for 14 weeks, including 2 weeks of titration and 12 weeks of maintenance therapy. The drop seizure frequency decreased by a median of 44% in the cannabidiol group vs. 22% in the placebo group. The difference between the groups was statistically significant and was apparent within the first 4 weeks of the maintenance period, Jacqueline French, MD, director of translational research and clinical trials in epilepsy at New York University Langone Medical Center reported at the annual meeting of the American Academy of Neurology.

Study participants had a mean age of 15 years, and 34% were aged 18 years or older. The median drop seizure frequency was 74 per month at baseline.

“That is a very high seizure burden,” Dr. French said, noting that the median total drop and non-drop seizure frequency was in the mid to high 100s. “So you can see that these children were very afflicted by seizures.”

Interestingly, there was a “very substantial drop” in non-drop seizures, as well, she said.

“And that’s really hard to demonstrate, so that’s impressive to me, at least,” she added.

Patients had taken a median of six antiepileptic drugs (AEDs) in their past and were taking a median of three AEDs in addition to the cannabidiol throughout the study period.

Adverse events were common, occurring in 86% of cannabidiol patients and 69% of placebo patients. The most common were diarrhea, somnolence, pyrexia, decreased appetite, and vomiting, but most were mild or moderate. Treatment-related serious adverse events were reported in nine cannabidiol patients and one placebo patient. All patients who completed the trial entered an open-label extension study, Dr. French said.

GWPCARE4 was followed by GWPCARE3, which compared both 20 mg/kg per day and 10 mg/kg per day doses of cannabidiol with placebo.

In that study, 225 patients with a mean age of 16 years (30% were aged 18 years or older) were randomized, and the median drop in seizure frequency was 42% with 20 mg/kg of cannabidiol and 37% with 10 mg/kg of cannabidiol versus 17% with placebo, Anup D. Patel, MD, reported at the meeting.

Approximately 40% and 36% of patients in the 20 mg/kg and 10 mg/kg groups, respectively, achieved the secondary outcome of a 50% or greater drop in seizure frequency, compared with 15% of placebo patients.

“Overall, 5 patients in the 20 mg/kg per day arm, 3 in the 10 [mg/kg per day arm], and 1 in the placebo arm achieved drop seizure freedom during the maintenance period of our study,” said Dr. Patel, a pediatric neurologist at Nationwide Children’s Hospital, Columbus, Ohio.

The median monthly drop seizure frequency at baseline was 80-87 in the three groups, and patients had previously failed a median of six to seven AEDs. They took a median of three AEDs during the study.

Adverse events occurred in 94% of patients in the 20-mg/kg cannabidiol group, 84% of those in the 10-mg/kg group, and 72% of placebo patients, and most were mild or moderate. The most common were somnolence and decreased appetite.

Treatment-related serious adverse events were reported in 5, 2, and 0 patients in the groups, respectively. Some elevations in transaminases were seen (in 11 patients in the 20-mg/kg dose group, and 2 in the 10-mg/kg dose group), but no patients met criteria for drug-induced liver injury with concurrent elevated bilirubin, and all cases resolved, Dr. Patel said.

Similar findings were noted in GWPCARE4, and both Dr. Patel and Dr. French noted that most patients with elevated transaminases were also taking valproic acid.

No deaths occurred in either GWPCARE4 or GWPCARE3.

“We feel both doses... produce significantly greater reductions in drop seizures as compared to placebo,” Dr. Patel said.

In an interview, he noted that the two cannabidiol doses were not compared directly to determine if the differences in response rates and adverse events were statistically significant, but said that the rates appeared comparable, and that the adverse event rates were high in all of the groups, reflecting a very sick patient population.

Of the 212 patients who completed GWPCARE3, 99% entered an open-label extension study.

Eligible patients in both trials were children and adults aged 2-55 years with a clinical diagnosis of LGS, at least two drop seizures (including tonic, atonic, and tonic-clonic seizures) each week at baseline, and documented failures on at least one AED.

Patients and caregivers in both trials were more likely to report improvement in overall condition among treated vs. placebo patients, as measured using the Subject/Caregiver Global Impression of Change scale.

The findings provide class 1 evidence that cannabidiol as add-on therapy in LGS is efficacious for reducing seizure frequency, and is generally well tolerated, Dr. French and Dr. Patel said.

Dr. French noted that enthusiasm for the trials was high, with many study sites reporting waiting lists for patient enrollment.

Some of the authors in each study have consulted for, conducted studies funded by, or received honoraria from GW Pharmaceuticals, which funded the GWPCARE4 and GWPCARE3 trials and manufacturers the oral cannabidiol solution. Several authors in each study were employees of GW Pharmaceuticals.

[email protected]

BOSTON – Cannabidiol add-on treatment significantly reduces the frequency of drop seizures in patients with Lennox-Gastaut syndrome, according to findings from the randomized, double-blind, placebo-controlled GWPCARE4 and GWPCARE3 trials.

In GWPCARE4 – the first controlled trial of cannabidiol in Lennox-Gastaut syndrome (LGS) – 171 patients were randomized to receive either placebo or cannabidiol oral solution at a dose of 20 mg/kg per day for 14 weeks, including 2 weeks of titration and 12 weeks of maintenance therapy. The drop seizure frequency decreased by a median of 44% in the cannabidiol group vs. 22% in the placebo group. The difference between the groups was statistically significant and was apparent within the first 4 weeks of the maintenance period, Jacqueline French, MD, director of translational research and clinical trials in epilepsy at New York University Langone Medical Center reported at the annual meeting of the American Academy of Neurology.

Study participants had a mean age of 15 years, and 34% were aged 18 years or older. The median drop seizure frequency was 74 per month at baseline.

“That is a very high seizure burden,” Dr. French said, noting that the median total drop and non-drop seizure frequency was in the mid to high 100s. “So you can see that these children were very afflicted by seizures.”

Interestingly, there was a “very substantial drop” in non-drop seizures, as well, she said.

“And that’s really hard to demonstrate, so that’s impressive to me, at least,” she added.

Patients had taken a median of six antiepileptic drugs (AEDs) in their past and were taking a median of three AEDs in addition to the cannabidiol throughout the study period.

Adverse events were common, occurring in 86% of cannabidiol patients and 69% of placebo patients. The most common were diarrhea, somnolence, pyrexia, decreased appetite, and vomiting, but most were mild or moderate. Treatment-related serious adverse events were reported in nine cannabidiol patients and one placebo patient. All patients who completed the trial entered an open-label extension study, Dr. French said.

GWPCARE4 was followed by GWPCARE3, which compared both 20 mg/kg per day and 10 mg/kg per day doses of cannabidiol with placebo.

In that study, 225 patients with a mean age of 16 years (30% were aged 18 years or older) were randomized, and the median drop in seizure frequency was 42% with 20 mg/kg of cannabidiol and 37% with 10 mg/kg of cannabidiol versus 17% with placebo, Anup D. Patel, MD, reported at the meeting.

Approximately 40% and 36% of patients in the 20 mg/kg and 10 mg/kg groups, respectively, achieved the secondary outcome of a 50% or greater drop in seizure frequency, compared with 15% of placebo patients.

“Overall, 5 patients in the 20 mg/kg per day arm, 3 in the 10 [mg/kg per day arm], and 1 in the placebo arm achieved drop seizure freedom during the maintenance period of our study,” said Dr. Patel, a pediatric neurologist at Nationwide Children’s Hospital, Columbus, Ohio.

The median monthly drop seizure frequency at baseline was 80-87 in the three groups, and patients had previously failed a median of six to seven AEDs. They took a median of three AEDs during the study.

Adverse events occurred in 94% of patients in the 20-mg/kg cannabidiol group, 84% of those in the 10-mg/kg group, and 72% of placebo patients, and most were mild or moderate. The most common were somnolence and decreased appetite.

Treatment-related serious adverse events were reported in 5, 2, and 0 patients in the groups, respectively. Some elevations in transaminases were seen (in 11 patients in the 20-mg/kg dose group, and 2 in the 10-mg/kg dose group), but no patients met criteria for drug-induced liver injury with concurrent elevated bilirubin, and all cases resolved, Dr. Patel said.

Similar findings were noted in GWPCARE4, and both Dr. Patel and Dr. French noted that most patients with elevated transaminases were also taking valproic acid.

No deaths occurred in either GWPCARE4 or GWPCARE3.

“We feel both doses... produce significantly greater reductions in drop seizures as compared to placebo,” Dr. Patel said.

In an interview, he noted that the two cannabidiol doses were not compared directly to determine if the differences in response rates and adverse events were statistically significant, but said that the rates appeared comparable, and that the adverse event rates were high in all of the groups, reflecting a very sick patient population.

Of the 212 patients who completed GWPCARE3, 99% entered an open-label extension study.

Eligible patients in both trials were children and adults aged 2-55 years with a clinical diagnosis of LGS, at least two drop seizures (including tonic, atonic, and tonic-clonic seizures) each week at baseline, and documented failures on at least one AED.

Patients and caregivers in both trials were more likely to report improvement in overall condition among treated vs. placebo patients, as measured using the Subject/Caregiver Global Impression of Change scale.

The findings provide class 1 evidence that cannabidiol as add-on therapy in LGS is efficacious for reducing seizure frequency, and is generally well tolerated, Dr. French and Dr. Patel said.

Dr. French noted that enthusiasm for the trials was high, with many study sites reporting waiting lists for patient enrollment.

Some of the authors in each study have consulted for, conducted studies funded by, or received honoraria from GW Pharmaceuticals, which funded the GWPCARE4 and GWPCARE3 trials and manufacturers the oral cannabidiol solution. Several authors in each study were employees of GW Pharmaceuticals.

[email protected]

The Food and Drug Administration has granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Approval was based on a meaningful and durable overall response rate in a two-arm, open-label, multicenter trial of 222 patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib. Patients were randomized to brigatinib orally either 90 mg once daily (112 patients) or 180 mg once daily following a 7-day lead-in at 90 mg once daily (110 patients).

[email protected]

The Food and Drug Administration has granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Approval was based on a meaningful and durable overall response rate in a two-arm, open-label, multicenter trial of 222 patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib. Patients were randomized to brigatinib orally either 90 mg once daily (112 patients) or 180 mg once daily following a 7-day lead-in at 90 mg once daily (110 patients).

[email protected]

The Food and Drug Administration has granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Approval was based on a meaningful and durable overall response rate in a two-arm, open-label, multicenter trial of 222 patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib. Patients were randomized to brigatinib orally either 90 mg once daily (112 patients) or 180 mg once daily following a 7-day lead-in at 90 mg once daily (110 patients).

[email protected]

Length of stay (LOS) may not be the best metric to use when trying to determine the cost effectiveness of invasive monitoring with subdural grid implantation or stereoelectroencephalography, suggests a recent analysis of 76 patients over a 2 year period. Researchers found that as LOS increased a hospital’s profit and contribution margins also increased, while patients maintained a low rate of complications. Investigators concluded that increased LOS does not necessarily result in lower financial gain for institutions. 

Chan AY, Kharrat S. Lundeen K, et al. Length of stay for patients undergoing invasive electrode monitoring with stereoelectroencephalography and subdural grids correlates positively with increased institutional profitability [published online April 20, 2017]. Epilespia. doi:10.1111/epi.13737

Length of stay (LOS) may not be the best metric to use when trying to determine the cost effectiveness of invasive monitoring with subdural grid implantation or stereoelectroencephalography, suggests a recent analysis of 76 patients over a 2 year period. Researchers found that as LOS increased a hospital’s profit and contribution margins also increased, while patients maintained a low rate of complications. Investigators concluded that increased LOS does not necessarily result in lower financial gain for institutions. 

Chan AY, Kharrat S. Lundeen K, et al. Length of stay for patients undergoing invasive electrode monitoring with stereoelectroencephalography and subdural grids correlates positively with increased institutional profitability [published online April 20, 2017]. Epilespia. doi:10.1111/epi.13737

Length of stay (LOS) may not be the best metric to use when trying to determine the cost effectiveness of invasive monitoring with subdural grid implantation or stereoelectroencephalography, suggests a recent analysis of 76 patients over a 2 year period. Researchers found that as LOS increased a hospital’s profit and contribution margins also increased, while patients maintained a low rate of complications. Investigators concluded that increased LOS does not necessarily result in lower financial gain for institutions. 

Chan AY, Kharrat S. Lundeen K, et al. Length of stay for patients undergoing invasive electrode monitoring with stereoelectroencephalography and subdural grids correlates positively with increased institutional profitability [published online April 20, 2017]. Epilespia. doi:10.1111/epi.13737

Death certificates fail to consistently report sudden unexplained death in epilepsy (SUDEP), making it difficult for researchers to study the phenomenon, according to a recent survey sent to medical examiners (MEs). Among 847 responses on 11 case vignettes, MEs did not use the ICD-10 seizure code in 3% to 62% of cases, depending on the specific vignette. Several factors may be responsible for the shortfall, including the complicated nature of SUDEP and uncertain circumstances involved in any individual death.

Atherton DS, Davis GG, Wright C, Devinsky O, Hesdorffer D. A Survey of medical examiner death certification of vignettes on death in epilepsy: gaps in identifying SUDEP [published online April 21, 2017]. Epilepsy Res. doi: http://dx.doi.org/10.1016/j.eplepsyres.2017.04.013.

Death certificates fail to consistently report sudden unexplained death in epilepsy (SUDEP), making it difficult for researchers to study the phenomenon, according to a recent survey sent to medical examiners (MEs). Among 847 responses on 11 case vignettes, MEs did not use the ICD-10 seizure code in 3% to 62% of cases, depending on the specific vignette. Several factors may be responsible for the shortfall, including the complicated nature of SUDEP and uncertain circumstances involved in any individual death.

Atherton DS, Davis GG, Wright C, Devinsky O, Hesdorffer D. A Survey of medical examiner death certification of vignettes on death in epilepsy: gaps in identifying SUDEP [published online April 21, 2017]. Epilepsy Res. doi: http://dx.doi.org/10.1016/j.eplepsyres.2017.04.013.

Death certificates fail to consistently report sudden unexplained death in epilepsy (SUDEP), making it difficult for researchers to study the phenomenon, according to a recent survey sent to medical examiners (MEs). Among 847 responses on 11 case vignettes, MEs did not use the ICD-10 seizure code in 3% to 62% of cases, depending on the specific vignette. Several factors may be responsible for the shortfall, including the complicated nature of SUDEP and uncertain circumstances involved in any individual death.

Atherton DS, Davis GG, Wright C, Devinsky O, Hesdorffer D. A Survey of medical examiner death certification of vignettes on death in epilepsy: gaps in identifying SUDEP [published online April 21, 2017]. Epilepsy Res. doi: http://dx.doi.org/10.1016/j.eplepsyres.2017.04.013.

Brain-responsive neurostimulation may be an effective treatment option for patients with mesial temporal lobe epilepsy, according to a recent study of 111 subjects. When following up for an average of 6.1 years on patients who had the procedure, researchers found it reduced seizures by a median average of 70%. Twenty-nine percent of patients had at least 1 seizure free period that lasted at least 6 months and 15% had at least 1 seizure free period lasting at least 1 year.

Geller EB, Skarpaas TL, Gross RE, et al. Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy [published online April 11, 2017]. Epilepsia. doi: 10.1111/epi.13740

Brain-responsive neurostimulation may be an effective treatment option for patients with mesial temporal lobe epilepsy, according to a recent study of 111 subjects. When following up for an average of 6.1 years on patients who had the procedure, researchers found it reduced seizures by a median average of 70%. Twenty-nine percent of patients had at least 1 seizure free period that lasted at least 6 months and 15% had at least 1 seizure free period lasting at least 1 year.

Geller EB, Skarpaas TL, Gross RE, et al. Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy [published online April 11, 2017]. Epilepsia. doi: 10.1111/epi.13740

Brain-responsive neurostimulation may be an effective treatment option for patients with mesial temporal lobe epilepsy, according to a recent study of 111 subjects. When following up for an average of 6.1 years on patients who had the procedure, researchers found it reduced seizures by a median average of 70%. Twenty-nine percent of patients had at least 1 seizure free period that lasted at least 6 months and 15% had at least 1 seizure free period lasting at least 1 year.

Geller EB, Skarpaas TL, Gross RE, et al. Brain-responsive neurostimulation in patients with medically intractable mesial temporal lobe epilepsy [published online April 11, 2017]. Epilepsia. doi: 10.1111/epi.13740

The Society of Hospital Medicine presents a variety of special interest forums during its annual meeting. The small-group sessions take place Tuesday, May 2, 4:30–5:25 p.m. in designated meeting rooms (as of April 12, 2017).

Academic and Research – Palm B
Joanna Bonsall, Vineet Chopra
The Academic and Research forum brings together faculty and researchers to discuss topics of interest to the academic hospital medicine community, such as mentorship, research support, and professional development. Join this collaborative offering of the academic and research committees.

Advocacy & Public Policy – Surf D
Joshua Lenchus, Ron Greeno
During this forum with SHM’s Advocacy leaders and staff, you will learn about the direction of SHM’s Advocacy & Public Policy work and how you can help. Discussion will focus on SHM’s new Advocacy & Public Policy Section, its role, and how you can participate and share your own ideas.

Canadian Hospitalists – Reef A
Serge Soolsma
This forum provides a unique setting for Canadian-based hospitalists to gather as an organized group, network, and discuss the issues with which they are faced.


Care of Vulnerable Populations – Oceanside E
Jack Chase, Gabriel Ortiz
SHM’s Caring for Vulnerable Populations Section aims to increase awareness and improve quality of care for vulnerable and underserved patient populations in the hospital setting. The principles and skills needed to care effectively for vulnerable patients span practitioners across all health systems, though they particularly apply to hospitalists practicing in safety-net and resource-limited settings.



Community-Based Hospitalists – Mandalay Bay I
Steve Behnke, Jason Robertson
Join us and share successful clinical practices, quality care, professional sustainability, and other “hot” topics of interest to the community-based hospitalist.

Global Health and Human Rights Section – Oceanside F
Phuoc Le
SHM’s Global Health and Human Rights Section has been established to build interest and engagement in global health and human rights work among hospitalists in order to share expertise. In this section, we also plan to build long-term collaborations in the U.S. and abroad.

Hospitalists Trained in Family Medicine – Breakers D
David Goldstein
Participants will network and discuss training, achievement of recognition, access in the job market, and national trends related to hospitalists trained in family medicine.

Information Technology – Palm F
Rupesh Prasad
This forum is an opportunity for attendees to provide SHM and the SHM IT Committee with input on what would be most beneficial to them regarding implementing, managing, and participating in health/hospital IT initiatives.

International Hospital Medicine – Palm H
Efren Manjarrez, Felipe Lucena
Do you practice hospital medicine outside of North America? Join us to share issues and ideas.

Leadership in Hospital Medicine – Mandalay Bay J
Eric Howell, Rob Zipper
Want to be a better leader? A better coach and mentor? Do you want to drive quality improvement at your hospital? Investing in the development of ourselves and our teams is what we are all here to do. This forum will review, discuss, and shape the resources and programmatic offerings that are needed to promote leadership skill development at all levels. We will also review SHMs existing programs, including Leadership Academies, the Leadership Certificate Program, e-Learning, and HMX: Leadership Alumni Forum.

Med-Peds Hospitalists – Breakers I
Leonard Feldman, Heather Toth, Carrie Herzke
Explore the role of Med-Peds physicians in hospitalist medicine. Discussion items may include personal experiences, how to create more Med-Peds jobs, and how to succeed as a Med-Peds hospitalist.
 

Multi-Site HMG Leaders – Palm C
Tom Frederickson, Leslie Flores
This forum is for physician and administrative leaders who are responsible for managing multiple hospitalist practice sites within the same health system. The number of people with this role has increased significantly in the last few years and comes with challenges that are different from those faced by the lead hospitalist at a single site.

Nurse Practitioner/Physician Assistant – Palm D
Tracy Cardin, Emilie Thornhill
Share your opinions and concerns. Network with your peers and learn about the work of the SHM Committee on Hospitalist Nurse Practitioners/Physician Assistants.

Oncology Hospitalists – Reef D
Maria Campagna, Barbara Egan, Charlotta Weaver
Explore the role of hospitalists on oncology services. Discussion items may include personal experiences and how to succeed as an oncology hospitalist.

Palliative Care – Breakers J
Rab Razzak, Jeff Greenwald, Wendy Anderson
Convene with other hospitalists charged with providing some level of palliative care at their institutions. Participants should come prepared to discuss and share their own experiences, including their current role in providing palliative care, institutional barriers, and gaps in training.

Patient Experience – Lagoon K
Mark Rudolph

Join the PX forum to exchange ideas about the how hospitalists can enhance patients’ care experiences while also improving professional satisfaction. Learn about the work of SHM’s Patient Experience committee and opportunities for getting involved in SHM’s patient experience initiatives.

Pediatric Hospitalists – Lagoon J
Kris Rehm, Sandy Gage
Network, share, and discuss topics and issues of particular interest to pediatric hospitalists. Topics will include an update on SHM’s pediatric activities, updates on potential paths to specialty certification, and relationships between SHM, AAP, APA, PRIS, and the Joint Council on Pediatric Hospital Medicine.

Point-of-Care Ultrasound (POCUS) – Palm A
Benji Mathews, Gordon Johnson
This forum will discuss opportunities to collaborate and standardize processes for POCUS certification, including what resources already exist. In addition, discussion will revolve around privileging at your own institution, gaining skills, and the challenges and successes of procedural teams in the hospital.

Post-Acute Care Providers – Lagoon D
Speaker, TBA
Join other hospitalists who practice in or are interested in learning more about working in or becoming more involved in the post-acute care arena, including SNFs, LTACs, and rehab facilities.

Practice Administrators – Surf AB
Heather Fordyce
Practice administrators are important members of the hospitalist team, providing key management and organizational skills. Voice your unique perspectives and hear from your peers.

Quality Improvement – Breakers C
Mangla Gulati
Hospitalists are at the center of the national quality and patient safety movement and are increasingly responsible for performance at their institutions. Connect with SHM’s QI and patient safety community and engage with leaders, peers, and collaborators to share ideas and inform SHM’s QI efforts. Discussion during the forum will focus on what hospitalists need to know to become involved with QI at SHM or locally. Hear about SHM’s plans for future QI initiatives, and share your own ideas.

Rural Hospitalists – Lagoon E
Brad Eshbaugh, Ken Simone
HM groups in rural areas face some unique problems, from recruitment, night call, and staffing to communicating with geographically dispersed primary care physicians. Rural hospitalists may also face clinical challenges because of limited technological resources and/or limited access to specialists. Share your issues and concerns and see how others have solved similar problems.

Veterans Affairs Hospitalists – Palm E
Kathlyn Fletcher, Peter Kaboli
Network and discuss issues unique to VA hospitalists.

Women in Hospital Medicine – Lagoon L
Melissa Mattison
Discuss issues relevant to women in hospital medicine and strategies for success/coping. Discussion items may include career satisfaction, occupational stresses, opportunities for change, promotion of leadership, and identification of resources

The Society of Hospital Medicine presents a variety of special interest forums during its annual meeting. The small-group sessions take place Tuesday, May 2, 4:30–5:25 p.m. in designated meeting rooms (as of April 12, 2017).

Academic and Research – Palm B
Joanna Bonsall, Vineet Chopra
The Academic and Research forum brings together faculty and researchers to discuss topics of interest to the academic hospital medicine community, such as mentorship, research support, and professional development. Join this collaborative offering of the academic and research committees.

Advocacy & Public Policy – Surf D
Joshua Lenchus, Ron Greeno
During this forum with SHM’s Advocacy leaders and staff, you will learn about the direction of SHM’s Advocacy & Public Policy work and how you can help. Discussion will focus on SHM’s new Advocacy & Public Policy Section, its role, and how you can participate and share your own ideas.

Canadian Hospitalists – Reef A
Serge Soolsma
This forum provides a unique setting for Canadian-based hospitalists to gather as an organized group, network, and discuss the issues with which they are faced.


Care of Vulnerable Populations – Oceanside E
Jack Chase, Gabriel Ortiz
SHM’s Caring for Vulnerable Populations Section aims to increase awareness and improve quality of care for vulnerable and underserved patient populations in the hospital setting. The principles and skills needed to care effectively for vulnerable patients span practitioners across all health systems, though they particularly apply to hospitalists practicing in safety-net and resource-limited settings.



Community-Based Hospitalists – Mandalay Bay I
Steve Behnke, Jason Robertson
Join us and share successful clinical practices, quality care, professional sustainability, and other “hot” topics of interest to the community-based hospitalist.

Global Health and Human Rights Section – Oceanside F
Phuoc Le
SHM’s Global Health and Human Rights Section has been established to build interest and engagement in global health and human rights work among hospitalists in order to share expertise. In this section, we also plan to build long-term collaborations in the U.S. and abroad.

Hospitalists Trained in Family Medicine – Breakers D
David Goldstein
Participants will network and discuss training, achievement of recognition, access in the job market, and national trends related to hospitalists trained in family medicine.

Information Technology – Palm F
Rupesh Prasad
This forum is an opportunity for attendees to provide SHM and the SHM IT Committee with input on what would be most beneficial to them regarding implementing, managing, and participating in health/hospital IT initiatives.

International Hospital Medicine – Palm H
Efren Manjarrez, Felipe Lucena
Do you practice hospital medicine outside of North America? Join us to share issues and ideas.

Leadership in Hospital Medicine – Mandalay Bay J
Eric Howell, Rob Zipper
Want to be a better leader? A better coach and mentor? Do you want to drive quality improvement at your hospital? Investing in the development of ourselves and our teams is what we are all here to do. This forum will review, discuss, and shape the resources and programmatic offerings that are needed to promote leadership skill development at all levels. We will also review SHMs existing programs, including Leadership Academies, the Leadership Certificate Program, e-Learning, and HMX: Leadership Alumni Forum.

Med-Peds Hospitalists – Breakers I
Leonard Feldman, Heather Toth, Carrie Herzke
Explore the role of Med-Peds physicians in hospitalist medicine. Discussion items may include personal experiences, how to create more Med-Peds jobs, and how to succeed as a Med-Peds hospitalist.
 

Multi-Site HMG Leaders – Palm C
Tom Frederickson, Leslie Flores
This forum is for physician and administrative leaders who are responsible for managing multiple hospitalist practice sites within the same health system. The number of people with this role has increased significantly in the last few years and comes with challenges that are different from those faced by the lead hospitalist at a single site.

Nurse Practitioner/Physician Assistant – Palm D
Tracy Cardin, Emilie Thornhill
Share your opinions and concerns. Network with your peers and learn about the work of the SHM Committee on Hospitalist Nurse Practitioners/Physician Assistants.

Oncology Hospitalists – Reef D
Maria Campagna, Barbara Egan, Charlotta Weaver
Explore the role of hospitalists on oncology services. Discussion items may include personal experiences and how to succeed as an oncology hospitalist.

Palliative Care – Breakers J
Rab Razzak, Jeff Greenwald, Wendy Anderson
Convene with other hospitalists charged with providing some level of palliative care at their institutions. Participants should come prepared to discuss and share their own experiences, including their current role in providing palliative care, institutional barriers, and gaps in training.

Patient Experience – Lagoon K
Mark Rudolph

Join the PX forum to exchange ideas about the how hospitalists can enhance patients’ care experiences while also improving professional satisfaction. Learn about the work of SHM’s Patient Experience committee and opportunities for getting involved in SHM’s patient experience initiatives.

Pediatric Hospitalists – Lagoon J
Kris Rehm, Sandy Gage
Network, share, and discuss topics and issues of particular interest to pediatric hospitalists. Topics will include an update on SHM’s pediatric activities, updates on potential paths to specialty certification, and relationships between SHM, AAP, APA, PRIS, and the Joint Council on Pediatric Hospital Medicine.

Point-of-Care Ultrasound (POCUS) – Palm A
Benji Mathews, Gordon Johnson
This forum will discuss opportunities to collaborate and standardize processes for POCUS certification, including what resources already exist. In addition, discussion will revolve around privileging at your own institution, gaining skills, and the challenges and successes of procedural teams in the hospital.

Post-Acute Care Providers – Lagoon D
Speaker, TBA
Join other hospitalists who practice in or are interested in learning more about working in or becoming more involved in the post-acute care arena, including SNFs, LTACs, and rehab facilities.

Practice Administrators – Surf AB
Heather Fordyce
Practice administrators are important members of the hospitalist team, providing key management and organizational skills. Voice your unique perspectives and hear from your peers.

Quality Improvement – Breakers C
Mangla Gulati
Hospitalists are at the center of the national quality and patient safety movement and are increasingly responsible for performance at their institutions. Connect with SHM’s QI and patient safety community and engage with leaders, peers, and collaborators to share ideas and inform SHM’s QI efforts. Discussion during the forum will focus on what hospitalists need to know to become involved with QI at SHM or locally. Hear about SHM’s plans for future QI initiatives, and share your own ideas.

Rural Hospitalists – Lagoon E
Brad Eshbaugh, Ken Simone
HM groups in rural areas face some unique problems, from recruitment, night call, and staffing to communicating with geographically dispersed primary care physicians. Rural hospitalists may also face clinical challenges because of limited technological resources and/or limited access to specialists. Share your issues and concerns and see how others have solved similar problems.

Veterans Affairs Hospitalists – Palm E
Kathlyn Fletcher, Peter Kaboli
Network and discuss issues unique to VA hospitalists.

Women in Hospital Medicine – Lagoon L
Melissa Mattison
Discuss issues relevant to women in hospital medicine and strategies for success/coping. Discussion items may include career satisfaction, occupational stresses, opportunities for change, promotion of leadership, and identification of resources

The Society of Hospital Medicine presents a variety of special interest forums during its annual meeting. The small-group sessions take place Tuesday, May 2, 4:30–5:25 p.m. in designated meeting rooms (as of April 12, 2017).

Academic and Research – Palm B
Joanna Bonsall, Vineet Chopra
The Academic and Research forum brings together faculty and researchers to discuss topics of interest to the academic hospital medicine community, such as mentorship, research support, and professional development. Join this collaborative offering of the academic and research committees.

Advocacy & Public Policy – Surf D
Joshua Lenchus, Ron Greeno
During this forum with SHM’s Advocacy leaders and staff, you will learn about the direction of SHM’s Advocacy & Public Policy work and how you can help. Discussion will focus on SHM’s new Advocacy & Public Policy Section, its role, and how you can participate and share your own ideas.

Canadian Hospitalists – Reef A
Serge Soolsma
This forum provides a unique setting for Canadian-based hospitalists to gather as an organized group, network, and discuss the issues with which they are faced.


Care of Vulnerable Populations – Oceanside E
Jack Chase, Gabriel Ortiz
SHM’s Caring for Vulnerable Populations Section aims to increase awareness and improve quality of care for vulnerable and underserved patient populations in the hospital setting. The principles and skills needed to care effectively for vulnerable patients span practitioners across all health systems, though they particularly apply to hospitalists practicing in safety-net and resource-limited settings.



Community-Based Hospitalists – Mandalay Bay I
Steve Behnke, Jason Robertson
Join us and share successful clinical practices, quality care, professional sustainability, and other “hot” topics of interest to the community-based hospitalist.

Global Health and Human Rights Section – Oceanside F
Phuoc Le
SHM’s Global Health and Human Rights Section has been established to build interest and engagement in global health and human rights work among hospitalists in order to share expertise. In this section, we also plan to build long-term collaborations in the U.S. and abroad.

Hospitalists Trained in Family Medicine – Breakers D
David Goldstein
Participants will network and discuss training, achievement of recognition, access in the job market, and national trends related to hospitalists trained in family medicine.

Information Technology – Palm F
Rupesh Prasad
This forum is an opportunity for attendees to provide SHM and the SHM IT Committee with input on what would be most beneficial to them regarding implementing, managing, and participating in health/hospital IT initiatives.

International Hospital Medicine – Palm H
Efren Manjarrez, Felipe Lucena
Do you practice hospital medicine outside of North America? Join us to share issues and ideas.

Leadership in Hospital Medicine – Mandalay Bay J
Eric Howell, Rob Zipper
Want to be a better leader? A better coach and mentor? Do you want to drive quality improvement at your hospital? Investing in the development of ourselves and our teams is what we are all here to do. This forum will review, discuss, and shape the resources and programmatic offerings that are needed to promote leadership skill development at all levels. We will also review SHMs existing programs, including Leadership Academies, the Leadership Certificate Program, e-Learning, and HMX: Leadership Alumni Forum.

Med-Peds Hospitalists – Breakers I
Leonard Feldman, Heather Toth, Carrie Herzke
Explore the role of Med-Peds physicians in hospitalist medicine. Discussion items may include personal experiences, how to create more Med-Peds jobs, and how to succeed as a Med-Peds hospitalist.
 

Multi-Site HMG Leaders – Palm C
Tom Frederickson, Leslie Flores
This forum is for physician and administrative leaders who are responsible for managing multiple hospitalist practice sites within the same health system. The number of people with this role has increased significantly in the last few years and comes with challenges that are different from those faced by the lead hospitalist at a single site.

Nurse Practitioner/Physician Assistant – Palm D
Tracy Cardin, Emilie Thornhill
Share your opinions and concerns. Network with your peers and learn about the work of the SHM Committee on Hospitalist Nurse Practitioners/Physician Assistants.

Oncology Hospitalists – Reef D
Maria Campagna, Barbara Egan, Charlotta Weaver
Explore the role of hospitalists on oncology services. Discussion items may include personal experiences and how to succeed as an oncology hospitalist.

Palliative Care – Breakers J
Rab Razzak, Jeff Greenwald, Wendy Anderson
Convene with other hospitalists charged with providing some level of palliative care at their institutions. Participants should come prepared to discuss and share their own experiences, including their current role in providing palliative care, institutional barriers, and gaps in training.

Patient Experience – Lagoon K
Mark Rudolph

Join the PX forum to exchange ideas about the how hospitalists can enhance patients’ care experiences while also improving professional satisfaction. Learn about the work of SHM’s Patient Experience committee and opportunities for getting involved in SHM’s patient experience initiatives.

Pediatric Hospitalists – Lagoon J
Kris Rehm, Sandy Gage
Network, share, and discuss topics and issues of particular interest to pediatric hospitalists. Topics will include an update on SHM’s pediatric activities, updates on potential paths to specialty certification, and relationships between SHM, AAP, APA, PRIS, and the Joint Council on Pediatric Hospital Medicine.

Point-of-Care Ultrasound (POCUS) – Palm A
Benji Mathews, Gordon Johnson
This forum will discuss opportunities to collaborate and standardize processes for POCUS certification, including what resources already exist. In addition, discussion will revolve around privileging at your own institution, gaining skills, and the challenges and successes of procedural teams in the hospital.

Post-Acute Care Providers – Lagoon D
Speaker, TBA
Join other hospitalists who practice in or are interested in learning more about working in or becoming more involved in the post-acute care arena, including SNFs, LTACs, and rehab facilities.

Practice Administrators – Surf AB
Heather Fordyce
Practice administrators are important members of the hospitalist team, providing key management and organizational skills. Voice your unique perspectives and hear from your peers.

Quality Improvement – Breakers C
Mangla Gulati
Hospitalists are at the center of the national quality and patient safety movement and are increasingly responsible for performance at their institutions. Connect with SHM’s QI and patient safety community and engage with leaders, peers, and collaborators to share ideas and inform SHM’s QI efforts. Discussion during the forum will focus on what hospitalists need to know to become involved with QI at SHM or locally. Hear about SHM’s plans for future QI initiatives, and share your own ideas.

Rural Hospitalists – Lagoon E
Brad Eshbaugh, Ken Simone
HM groups in rural areas face some unique problems, from recruitment, night call, and staffing to communicating with geographically dispersed primary care physicians. Rural hospitalists may also face clinical challenges because of limited technological resources and/or limited access to specialists. Share your issues and concerns and see how others have solved similar problems.

Veterans Affairs Hospitalists – Palm E
Kathlyn Fletcher, Peter Kaboli
Network and discuss issues unique to VA hospitalists.

Women in Hospital Medicine – Lagoon L
Melissa Mattison
Discuss issues relevant to women in hospital medicine and strategies for success/coping. Discussion items may include career satisfaction, occupational stresses, opportunities for change, promotion of leadership, and identification of resources

The steps that hospitalists can take to effect change in their home institutions will be the focus of Tuesday morning’s session at 10:35–11:15 a.m., “Overcoming a Culture Overrun with Overuse.”

“Overuse is one of the [biggest] issues that we’re facing right now in health care,” said presenter Christopher Moriates, MD, assistant dean for health care value at the University of Texas at Austin. “The estimates are that about a third of what we do in health care is unnecessary. If you look at areas like lab testing in hospitals, it might be even more than that.”

Overcoming a Culture Overrun with Overuse
Tuesday, 10:35 a.m.-11:15 a.m.

The steps that hospitalists can take to effect change in their home institutions will be the focus of Tuesday morning’s session at 10:35–11:15 a.m., “Overcoming a Culture Overrun with Overuse.”

“Overuse is one of the [biggest] issues that we’re facing right now in health care,” said presenter Christopher Moriates, MD, assistant dean for health care value at the University of Texas at Austin. “The estimates are that about a third of what we do in health care is unnecessary. If you look at areas like lab testing in hospitals, it might be even more than that.”

Overcoming a Culture Overrun with Overuse
Tuesday, 10:35 a.m.-11:15 a.m.

The steps that hospitalists can take to effect change in their home institutions will be the focus of Tuesday morning’s session at 10:35–11:15 a.m., “Overcoming a Culture Overrun with Overuse.”

“Overuse is one of the [biggest] issues that we’re facing right now in health care,” said presenter Christopher Moriates, MD, assistant dean for health care value at the University of Texas at Austin. “The estimates are that about a third of what we do in health care is unnecessary. If you look at areas like lab testing in hospitals, it might be even more than that.”

Overcoming a Culture Overrun with Overuse
Tuesday, 10:35 a.m.-11:15 a.m.