Psoriatic Arthritis

Risankizumab, an interleukin-23 inhibitor, has been approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the manufacturer announced on April 23.

Risankizumab selectively inhibits interleukin-23 (IL-23), a key inflammatory protein, by binding to its p19 subunit. The drug is administered at a dose of 150 mg, in two subcutaneous injections, every 12 weeks, after starting doses at weeks 0 and 4. It will be available in early May, according to an AbbVie press release announcing the approval.

The approval was based in part on data from two phase 3, 2-year studies, In UltIMMA-1 and UltIMMA-2, at 16 weeks, 75% of risankizumab patients in both studies achieved a Psoriasis Area and Severity Index (PASI 90), compared with 5% and 2% of those on placebo, respectively. These results were published in 2018 (Lancet. 2018 Aug 25;392[10148]:650-61).

At 1 year, 82% and 81% of those treated with risankizumab in the two studies achieved a PASI 90, and 56% and 60% achieved a PASI 100, respectively, according to the company.

Approval was also based on additional phase 3 studies, IMMhance and IMMvent.

Upper respiratory infections were among the most common adverse events associated with risankizumab in trials, reported in 13%, according to the company. Other adverse events associated with treatment included headache (3.5 %), fatigue (2.5 %), injection site reactions (1.5%) and tinea infections (1.1%). The AbbVie release states that candidates for treatment should be evaluated for tuberculosis before starting therapy, and patients should be instructed to report signs and symptoms of infection.

Risankizumab, which will be marketed as Skyrizi, was recently approved in Canada for the same indication, and in Japan, for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults. It currently is under review in Europe.

AbbVie and Boehringer Ingelheim are collaborating on the development of risankizumab, according to an AbbVie press release. Studies of risankizumab for treatment of psoriatic arthritis and Crohn’s disease are underway.

Risankizumab, an interleukin-23 inhibitor, has been approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the manufacturer announced on April 23.

Risankizumab selectively inhibits interleukin-23 (IL-23), a key inflammatory protein, by binding to its p19 subunit. The drug is administered at a dose of 150 mg, in two subcutaneous injections, every 12 weeks, after starting doses at weeks 0 and 4. It will be available in early May, according to an AbbVie press release announcing the approval.

The approval was based in part on data from two phase 3, 2-year studies, In UltIMMA-1 and UltIMMA-2, at 16 weeks, 75% of risankizumab patients in both studies achieved a Psoriasis Area and Severity Index (PASI 90), compared with 5% and 2% of those on placebo, respectively. These results were published in 2018 (Lancet. 2018 Aug 25;392[10148]:650-61).

At 1 year, 82% and 81% of those treated with risankizumab in the two studies achieved a PASI 90, and 56% and 60% achieved a PASI 100, respectively, according to the company.

Approval was also based on additional phase 3 studies, IMMhance and IMMvent.

Upper respiratory infections were among the most common adverse events associated with risankizumab in trials, reported in 13%, according to the company. Other adverse events associated with treatment included headache (3.5 %), fatigue (2.5 %), injection site reactions (1.5%) and tinea infections (1.1%). The AbbVie release states that candidates for treatment should be evaluated for tuberculosis before starting therapy, and patients should be instructed to report signs and symptoms of infection.

Risankizumab, which will be marketed as Skyrizi, was recently approved in Canada for the same indication, and in Japan, for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults. It currently is under review in Europe.

AbbVie and Boehringer Ingelheim are collaborating on the development of risankizumab, according to an AbbVie press release. Studies of risankizumab for treatment of psoriatic arthritis and Crohn’s disease are underway.

Risankizumab, an interleukin-23 inhibitor, has been approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the manufacturer announced on April 23.

Risankizumab selectively inhibits interleukin-23 (IL-23), a key inflammatory protein, by binding to its p19 subunit. The drug is administered at a dose of 150 mg, in two subcutaneous injections, every 12 weeks, after starting doses at weeks 0 and 4. It will be available in early May, according to an AbbVie press release announcing the approval.

The approval was based in part on data from two phase 3, 2-year studies, In UltIMMA-1 and UltIMMA-2, at 16 weeks, 75% of risankizumab patients in both studies achieved a Psoriasis Area and Severity Index (PASI 90), compared with 5% and 2% of those on placebo, respectively. These results were published in 2018 (Lancet. 2018 Aug 25;392[10148]:650-61).

At 1 year, 82% and 81% of those treated with risankizumab in the two studies achieved a PASI 90, and 56% and 60% achieved a PASI 100, respectively, according to the company.

Approval was also based on additional phase 3 studies, IMMhance and IMMvent.

Upper respiratory infections were among the most common adverse events associated with risankizumab in trials, reported in 13%, according to the company. Other adverse events associated with treatment included headache (3.5 %), fatigue (2.5 %), injection site reactions (1.5%) and tinea infections (1.1%). The AbbVie release states that candidates for treatment should be evaluated for tuberculosis before starting therapy, and patients should be instructed to report signs and symptoms of infection.

Risankizumab, which will be marketed as Skyrizi, was recently approved in Canada for the same indication, and in Japan, for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults. It currently is under review in Europe.

AbbVie and Boehringer Ingelheim are collaborating on the development of risankizumab, according to an AbbVie press release. Studies of risankizumab for treatment of psoriatic arthritis and Crohn’s disease are underway.

High plasma levels of tumor necrosis factor (TNF)–alpha and adiponectin can be used to differentiate patients with psoriasis and psoriatic arthritis, according to Wen-Qing Li, PhD, of Brown University, Providence, R.I., and his associates.

In a research letter published in the British Journal of Dermatology, the investigators detailed an analysis of 180 patients with psoriasis only and 143 patients with psoriatic arthritis (PsA) from the Psoriatic Arthritis and Psoriasis Follow-up Study. Patients in both groups had a mean age of 51 years. Plasma levels of interleukin-6, C-reactive protein, TNF-alpha, leptin, total adiponectin, and high-molecular-weight (HMW) adiponectin were assessed as potential biomarkers by ultrasensitive enzyme-linked immunosorbent assay or immunoturbidimetric assay.

Median TNF-alpha plasma levels were higher in patients with PsA, compared with those with psoriasis (3.27 vs. 1.32 pg/mL^–1), while total and HMW adiponectin levels were lower in patients with PsA, compared with those with psoriasis (4.66 vs. 5.36 mcg/mL^–1; 2.58 vs. 3.01 mcg/mL^–1). After logistic regression, TNF-alpha (adjusted odds ratio, 2.25; 95% confidence interval, 1.41-3.61) and total adiponectin (aOR, 0.61; 95% CI, 0.39-0.96) remained significantly associated as biomarkers. HMW adiponectin maintained marginal significance (aOR, 0.64; 95% CI, 0.41-1.01).

“Further large-scale investigation in a prospective setting of patients with PsO [psoriasis] would be warranted, if a clinically useful screening test is to be developed for risk prediction of PsA based on circulating biomarkers,” the investigators concluded.

Two study authors reported consulting with or advising numerous pharmaceutical companies.

[email protected]

SOURCE: Li W-Q et al. Br J Dermatol. 2019 Jan 29. doi: 10.1111/bjd.17700.

High plasma levels of tumor necrosis factor (TNF)–alpha and adiponectin can be used to differentiate patients with psoriasis and psoriatic arthritis, according to Wen-Qing Li, PhD, of Brown University, Providence, R.I., and his associates.

In a research letter published in the British Journal of Dermatology, the investigators detailed an analysis of 180 patients with psoriasis only and 143 patients with psoriatic arthritis (PsA) from the Psoriatic Arthritis and Psoriasis Follow-up Study. Patients in both groups had a mean age of 51 years. Plasma levels of interleukin-6, C-reactive protein, TNF-alpha, leptin, total adiponectin, and high-molecular-weight (HMW) adiponectin were assessed as potential biomarkers by ultrasensitive enzyme-linked immunosorbent assay or immunoturbidimetric assay.

Median TNF-alpha plasma levels were higher in patients with PsA, compared with those with psoriasis (3.27 vs. 1.32 pg/mL^–1), while total and HMW adiponectin levels were lower in patients with PsA, compared with those with psoriasis (4.66 vs. 5.36 mcg/mL^–1; 2.58 vs. 3.01 mcg/mL^–1). After logistic regression, TNF-alpha (adjusted odds ratio, 2.25; 95% confidence interval, 1.41-3.61) and total adiponectin (aOR, 0.61; 95% CI, 0.39-0.96) remained significantly associated as biomarkers. HMW adiponectin maintained marginal significance (aOR, 0.64; 95% CI, 0.41-1.01).

“Further large-scale investigation in a prospective setting of patients with PsO [psoriasis] would be warranted, if a clinically useful screening test is to be developed for risk prediction of PsA based on circulating biomarkers,” the investigators concluded.

Two study authors reported consulting with or advising numerous pharmaceutical companies.

[email protected]

SOURCE: Li W-Q et al. Br J Dermatol. 2019 Jan 29. doi: 10.1111/bjd.17700.

High plasma levels of tumor necrosis factor (TNF)–alpha and adiponectin can be used to differentiate patients with psoriasis and psoriatic arthritis, according to Wen-Qing Li, PhD, of Brown University, Providence, R.I., and his associates.

In a research letter published in the British Journal of Dermatology, the investigators detailed an analysis of 180 patients with psoriasis only and 143 patients with psoriatic arthritis (PsA) from the Psoriatic Arthritis and Psoriasis Follow-up Study. Patients in both groups had a mean age of 51 years. Plasma levels of interleukin-6, C-reactive protein, TNF-alpha, leptin, total adiponectin, and high-molecular-weight (HMW) adiponectin were assessed as potential biomarkers by ultrasensitive enzyme-linked immunosorbent assay or immunoturbidimetric assay.

Median TNF-alpha plasma levels were higher in patients with PsA, compared with those with psoriasis (3.27 vs. 1.32 pg/mL^–1), while total and HMW adiponectin levels were lower in patients with PsA, compared with those with psoriasis (4.66 vs. 5.36 mcg/mL^–1; 2.58 vs. 3.01 mcg/mL^–1). After logistic regression, TNF-alpha (adjusted odds ratio, 2.25; 95% confidence interval, 1.41-3.61) and total adiponectin (aOR, 0.61; 95% CI, 0.39-0.96) remained significantly associated as biomarkers. HMW adiponectin maintained marginal significance (aOR, 0.64; 95% CI, 0.41-1.01).

“Further large-scale investigation in a prospective setting of patients with PsO [psoriasis] would be warranted, if a clinically useful screening test is to be developed for risk prediction of PsA based on circulating biomarkers,” the investigators concluded.

Two study authors reported consulting with or advising numerous pharmaceutical companies.

[email protected]

SOURCE: Li W-Q et al. Br J Dermatol. 2019 Jan 29. doi: 10.1111/bjd.17700.

Patients with psoriasis or psoriatic arthritis who started ustekinumab (Stelara) versus a tumor necrosis factor inhibitor had no differences in the overall risks of incident atrial fibrillation (AFib) or major adverse cardiovascular events (MACE), according to authors of a retrospective cohort study of two commercial insurance databases.

Subgroup analyses in the study also revealed “no statistically significant heterogeneity” in risk of AFib or MACE by age, sex, or presence of diabetes, Moa P. Lee, PharmD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her coauthors reported in JAMA Dermatology.

These findings provide additional evidence on cardiovascular risks with ustekinumab versus other treatments.

The findings are consistent with previous observations of a small but nonsignificant increase in cardiovascular disease among patients with psoriatic disease and provide new insight into the risk of AFib with psoriatic treatments with the two therapies, Dr. Lee and her colleagues wrote.

The retrospective study of two U.S. commercial health care claims databases included 60,028 adult patients with psoriasis or psoriatic arthritis who initiated therapy with ustekinumab (n = 9,071) or a tumor necrosis factor (TNF) inhibitor (n = 50,957), including adalimumab, certolizumab pegol, golimumab, etanercept, or infliximab. The investigators excluded any patient with an AFib diagnosis at baseline and those receiving any antiarrhythmic or anticoagulant treatment.

The incidence of AFib was 5.0 and 4.1 per 1,000 person-years in the ustekinumab and TNF inhibitor groups, respectively, with an adjusted hazard ratio of 1.08 (95% CI, 0.76-1.54). The incidence of MACE (a composite endpoint of MI, stroke, and coronary revascularization) was 6.2 and 6.1 per 1,000 person-years in the ustekinumab and TNF inhibitor groups, with an adjusted hazard ratio of 1.10 (95% CI, 0.80-1.52).

In subgroup analyses, the adjusted HR for AFib with ustekinumab versus TNF inhibitor was 1.46 (95% CI, 0.98-2.18) for patients aged 60 years and older and 1.47 (95% CI, 0.93-2.31) in patients with diabetes, the investigators wrote.

The adjusted HR for AFib with ustekinumab versus TNF inhibitors was 1.21 in men (95% CI, 0.87-1.69) and 0.82 in women (95% CI, 0.49-1.39), while for MACE, the HRs were 1.31 in men (95% CI, 0.97-1.76) and 0.91 in women (95% CI, 0.56-1.47).

“Although the risk of these cardiovascular outcomes appeared to be similar across the subpopulations included in our study, further investigations on potentially modifying treatment effects stratified by important risk factors may be warranted,” Dr. Lee and her coauthors wrote.

The study was supported by the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital. Several authors reported financial relationships with pharmaceutical companies marketing biologics for psoriasis and psoriatic arthritis.

SOURCE: Lee MP et al. JAMA Dermatol. 2019 Mar 27. doi: 10.1001/jamadermatol.2019.0001.

Patients with psoriasis or psoriatic arthritis who started ustekinumab (Stelara) versus a tumor necrosis factor inhibitor had no differences in the overall risks of incident atrial fibrillation (AFib) or major adverse cardiovascular events (MACE), according to authors of a retrospective cohort study of two commercial insurance databases.

Subgroup analyses in the study also revealed “no statistically significant heterogeneity” in risk of AFib or MACE by age, sex, or presence of diabetes, Moa P. Lee, PharmD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her coauthors reported in JAMA Dermatology.

These findings provide additional evidence on cardiovascular risks with ustekinumab versus other treatments.

The findings are consistent with previous observations of a small but nonsignificant increase in cardiovascular disease among patients with psoriatic disease and provide new insight into the risk of AFib with psoriatic treatments with the two therapies, Dr. Lee and her colleagues wrote.

The retrospective study of two U.S. commercial health care claims databases included 60,028 adult patients with psoriasis or psoriatic arthritis who initiated therapy with ustekinumab (n = 9,071) or a tumor necrosis factor (TNF) inhibitor (n = 50,957), including adalimumab, certolizumab pegol, golimumab, etanercept, or infliximab. The investigators excluded any patient with an AFib diagnosis at baseline and those receiving any antiarrhythmic or anticoagulant treatment.

The incidence of AFib was 5.0 and 4.1 per 1,000 person-years in the ustekinumab and TNF inhibitor groups, respectively, with an adjusted hazard ratio of 1.08 (95% CI, 0.76-1.54). The incidence of MACE (a composite endpoint of MI, stroke, and coronary revascularization) was 6.2 and 6.1 per 1,000 person-years in the ustekinumab and TNF inhibitor groups, with an adjusted hazard ratio of 1.10 (95% CI, 0.80-1.52).

In subgroup analyses, the adjusted HR for AFib with ustekinumab versus TNF inhibitor was 1.46 (95% CI, 0.98-2.18) for patients aged 60 years and older and 1.47 (95% CI, 0.93-2.31) in patients with diabetes, the investigators wrote.

The adjusted HR for AFib with ustekinumab versus TNF inhibitors was 1.21 in men (95% CI, 0.87-1.69) and 0.82 in women (95% CI, 0.49-1.39), while for MACE, the HRs were 1.31 in men (95% CI, 0.97-1.76) and 0.91 in women (95% CI, 0.56-1.47).

“Although the risk of these cardiovascular outcomes appeared to be similar across the subpopulations included in our study, further investigations on potentially modifying treatment effects stratified by important risk factors may be warranted,” Dr. Lee and her coauthors wrote.

The study was supported by the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital. Several authors reported financial relationships with pharmaceutical companies marketing biologics for psoriasis and psoriatic arthritis.

SOURCE: Lee MP et al. JAMA Dermatol. 2019 Mar 27. doi: 10.1001/jamadermatol.2019.0001.

Patients with psoriasis or psoriatic arthritis who started ustekinumab (Stelara) versus a tumor necrosis factor inhibitor had no differences in the overall risks of incident atrial fibrillation (AFib) or major adverse cardiovascular events (MACE), according to authors of a retrospective cohort study of two commercial insurance databases.

Subgroup analyses in the study also revealed “no statistically significant heterogeneity” in risk of AFib or MACE by age, sex, or presence of diabetes, Moa P. Lee, PharmD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her coauthors reported in JAMA Dermatology.

These findings provide additional evidence on cardiovascular risks with ustekinumab versus other treatments.

The findings are consistent with previous observations of a small but nonsignificant increase in cardiovascular disease among patients with psoriatic disease and provide new insight into the risk of AFib with psoriatic treatments with the two therapies, Dr. Lee and her colleagues wrote.

The retrospective study of two U.S. commercial health care claims databases included 60,028 adult patients with psoriasis or psoriatic arthritis who initiated therapy with ustekinumab (n = 9,071) or a tumor necrosis factor (TNF) inhibitor (n = 50,957), including adalimumab, certolizumab pegol, golimumab, etanercept, or infliximab. The investigators excluded any patient with an AFib diagnosis at baseline and those receiving any antiarrhythmic or anticoagulant treatment.

The incidence of AFib was 5.0 and 4.1 per 1,000 person-years in the ustekinumab and TNF inhibitor groups, respectively, with an adjusted hazard ratio of 1.08 (95% CI, 0.76-1.54). The incidence of MACE (a composite endpoint of MI, stroke, and coronary revascularization) was 6.2 and 6.1 per 1,000 person-years in the ustekinumab and TNF inhibitor groups, with an adjusted hazard ratio of 1.10 (95% CI, 0.80-1.52).

In subgroup analyses, the adjusted HR for AFib with ustekinumab versus TNF inhibitor was 1.46 (95% CI, 0.98-2.18) for patients aged 60 years and older and 1.47 (95% CI, 0.93-2.31) in patients with diabetes, the investigators wrote.

The adjusted HR for AFib with ustekinumab versus TNF inhibitors was 1.21 in men (95% CI, 0.87-1.69) and 0.82 in women (95% CI, 0.49-1.39), while for MACE, the HRs were 1.31 in men (95% CI, 0.97-1.76) and 0.91 in women (95% CI, 0.56-1.47).

“Although the risk of these cardiovascular outcomes appeared to be similar across the subpopulations included in our study, further investigations on potentially modifying treatment effects stratified by important risk factors may be warranted,” Dr. Lee and her coauthors wrote.

The study was supported by the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital. Several authors reported financial relationships with pharmaceutical companies marketing biologics for psoriasis and psoriatic arthritis.

SOURCE: Lee MP et al. JAMA Dermatol. 2019 Mar 27. doi: 10.1001/jamadermatol.2019.0001.

A systematic review of herpes zoster incidence and consensus recommendations on vaccination in adult patients on systemic therapy for psoriasis or psoriatic arthritis: From the Medical Board of the National Psoriasis Foundation.

Baumrin E, Van Voorhees A, Garg A, Feldman SR, Merola JF. J Am Acad Dermatol. 2019 Mar 15

A systematic literature search was performed of HZ in patients with PsO/PsA. HZ vaccination guidelines were reviewed and the medical board of the National Psoriasis Foundation made consensus recommendations in PsO/PsA patients based on graded evidence. HZ risk depends on disease severity and treatment class. Recombinant zoster vaccine should be given to all PsO/PsA patients >50 years old and younger patients at increased risk.

Ultrasonographic and Clinical Assessment of Peripheral Enthesitis in Patients with Psoriatic Arthritis, Psoriasis, and Fibromyalgia Syndrome: The ULISSE Study.

Macchioni P, Salvarani C, Possemato N, et al. J Rheumatol. 2019 Mar 15.

The ULISSE study indicated that enthesitis is a common feature in patients with PsA, those with psoriasis, and in those with FMS if only clinical examination is used. US entheseal assessment showed findings more consistent with the 3 disorders.

The development of a modified Psoriatic Arthritis Disease Activity Score (mPASDAS) using SF-12 as a measure of quality of life.

Perruccio AV, Got M, Li S, Ye Y, Gladman DD, Chandran V. Arthritis Care Res (Hoboken). 2019 Mar 15.

The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure of psoriatic arthritis (PsA) disease activity. The length of its patient-reported components raises concern about questionnaire burden. The PASDAS includes the SF-36 measure. The study investigated the agreement between PASDAS and a modified PASDAS (mPASDAS) which substituted the SF-36 with the shortened SF-12.

The Impact of Intermittent Fasting (Ramadan Fasting) on Psoriatic Arthritis Disease Activity, Enthesitis, and Dactylitis: A Multicentre Study.

Adawi M, Damiani G, Bragazzi NL, et al. Nutrients. 2019 Mar 12;11(3).

Fasting was found to be a predictor of a decrease in PsA disease activity scores (DAPSA, BASDAI, LEI, DSS) even after adjustment for weight loss. IL-17 therapy was found to be an independent predictor of decreases in LEI after fasting.

Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition.

Scher JU, Ogdie A, Merola JF, Ritchlin C. Nat Rev Rheumatol. 2019 Mar;15(3):153-166.

The events responsible for progression to PsA are currently unclear. Genetic and clinical–demographic risk factors (most notably familial aggregation and psoriasis sub-phenotypes) provide relevant insights into the variables that promote transition.

A systematic review of herpes zoster incidence and consensus recommendations on vaccination in adult patients on systemic therapy for psoriasis or psoriatic arthritis: From the Medical Board of the National Psoriasis Foundation.

Baumrin E, Van Voorhees A, Garg A, Feldman SR, Merola JF. J Am Acad Dermatol. 2019 Mar 15

A systematic literature search was performed of HZ in patients with PsO/PsA. HZ vaccination guidelines were reviewed and the medical board of the National Psoriasis Foundation made consensus recommendations in PsO/PsA patients based on graded evidence. HZ risk depends on disease severity and treatment class. Recombinant zoster vaccine should be given to all PsO/PsA patients >50 years old and younger patients at increased risk.

Ultrasonographic and Clinical Assessment of Peripheral Enthesitis in Patients with Psoriatic Arthritis, Psoriasis, and Fibromyalgia Syndrome: The ULISSE Study.

Macchioni P, Salvarani C, Possemato N, et al. J Rheumatol. 2019 Mar 15.

The ULISSE study indicated that enthesitis is a common feature in patients with PsA, those with psoriasis, and in those with FMS if only clinical examination is used. US entheseal assessment showed findings more consistent with the 3 disorders.

The development of a modified Psoriatic Arthritis Disease Activity Score (mPASDAS) using SF-12 as a measure of quality of life.

Perruccio AV, Got M, Li S, Ye Y, Gladman DD, Chandran V. Arthritis Care Res (Hoboken). 2019 Mar 15.

The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure of psoriatic arthritis (PsA) disease activity. The length of its patient-reported components raises concern about questionnaire burden. The PASDAS includes the SF-36 measure. The study investigated the agreement between PASDAS and a modified PASDAS (mPASDAS) which substituted the SF-36 with the shortened SF-12.

The Impact of Intermittent Fasting (Ramadan Fasting) on Psoriatic Arthritis Disease Activity, Enthesitis, and Dactylitis: A Multicentre Study.

Adawi M, Damiani G, Bragazzi NL, et al. Nutrients. 2019 Mar 12;11(3).

Fasting was found to be a predictor of a decrease in PsA disease activity scores (DAPSA, BASDAI, LEI, DSS) even after adjustment for weight loss. IL-17 therapy was found to be an independent predictor of decreases in LEI after fasting.

Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition.

Scher JU, Ogdie A, Merola JF, Ritchlin C. Nat Rev Rheumatol. 2019 Mar;15(3):153-166.

The events responsible for progression to PsA are currently unclear. Genetic and clinical–demographic risk factors (most notably familial aggregation and psoriasis sub-phenotypes) provide relevant insights into the variables that promote transition.

A systematic review of herpes zoster incidence and consensus recommendations on vaccination in adult patients on systemic therapy for psoriasis or psoriatic arthritis: From the Medical Board of the National Psoriasis Foundation.

Baumrin E, Van Voorhees A, Garg A, Feldman SR, Merola JF. J Am Acad Dermatol. 2019 Mar 15

A systematic literature search was performed of HZ in patients with PsO/PsA. HZ vaccination guidelines were reviewed and the medical board of the National Psoriasis Foundation made consensus recommendations in PsO/PsA patients based on graded evidence. HZ risk depends on disease severity and treatment class. Recombinant zoster vaccine should be given to all PsO/PsA patients >50 years old and younger patients at increased risk.

Ultrasonographic and Clinical Assessment of Peripheral Enthesitis in Patients with Psoriatic Arthritis, Psoriasis, and Fibromyalgia Syndrome: The ULISSE Study.

Macchioni P, Salvarani C, Possemato N, et al. J Rheumatol. 2019 Mar 15.

The ULISSE study indicated that enthesitis is a common feature in patients with PsA, those with psoriasis, and in those with FMS if only clinical examination is used. US entheseal assessment showed findings more consistent with the 3 disorders.

The development of a modified Psoriatic Arthritis Disease Activity Score (mPASDAS) using SF-12 as a measure of quality of life.

Perruccio AV, Got M, Li S, Ye Y, Gladman DD, Chandran V. Arthritis Care Res (Hoboken). 2019 Mar 15.

The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure of psoriatic arthritis (PsA) disease activity. The length of its patient-reported components raises concern about questionnaire burden. The PASDAS includes the SF-36 measure. The study investigated the agreement between PASDAS and a modified PASDAS (mPASDAS) which substituted the SF-36 with the shortened SF-12.

The Impact of Intermittent Fasting (Ramadan Fasting) on Psoriatic Arthritis Disease Activity, Enthesitis, and Dactylitis: A Multicentre Study.

Adawi M, Damiani G, Bragazzi NL, et al. Nutrients. 2019 Mar 12;11(3).

Fasting was found to be a predictor of a decrease in PsA disease activity scores (DAPSA, BASDAI, LEI, DSS) even after adjustment for weight loss. IL-17 therapy was found to be an independent predictor of decreases in LEI after fasting.

Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition.

Scher JU, Ogdie A, Merola JF, Ritchlin C. Nat Rev Rheumatol. 2019 Mar;15(3):153-166.

The events responsible for progression to PsA are currently unclear. Genetic and clinical–demographic risk factors (most notably familial aggregation and psoriasis sub-phenotypes) provide relevant insights into the variables that promote transition.

There is no apparent association between proinflammatory foods and increased risk of incident psoriasis, psoriatic arthritis, or atopic dermatitis, reported Alanna C. Bridgman of Queen’s University, Kingston, Ont., and her associates.

©camij/thinkstockphotos.com

In a large, retrospective cohort study among women from the Nurses’ Health Study II (NHS-II), including 85,185 psoriasis participants and 63,443 atopic dermatitis participants, Ms. Bridgman and her associates sought to determine whether proinflammatory diet increased the risk of incident psoriasis, psoriatic arthritis, or atopic dermatitis. Clinicians administered food frequency questionnaires every 4 years beginning in 1991 among female nurses aged 25-42 years.

Food groups included in the evaluation were those most predictive of three plasma markers of inflammation: interleukin-6 (IL-6), C-reactive protein (CRP), and tumor necrosis factor–alpha R2 (TNF-R2). Proinflammatory foods included processed meat, red meat, organ meat, white fish, vegetables other than leafy green and dark yellow, refined grains, low- and high-energy drinks, and tomatoes. Anti-inflammatory foods included beer, wine, tea, coffee, dark yellow and green leafy vegetables, snacks such as popcorn and crackers, fruit juice, and pizza.

No association was found between proinflammatory diet and increased likelihood for incident psoriasis, psoriatic arthritis, or atopic dermatitis. Although proinflammatory dietary patterns were associated with psoriatic arthritis in the age-adjusted model, the hazard ratio was attenuated and found to be no longer statistically significant after adjustment for important confounders such as body mass index. In addition, no significant relationship between atopic dermatitis and proinflammatory diet was observed, they reported. The study was published in the Journal of the American Academy of Dermatology.

Ms. Bridgman and her associates measured dietary patterns using the Empirical Dietary Inflammatory Pattern (EDIP); dietary patterns measuring high on the EDIP scale were associated with higher levels of TNF-alpha, TNF-alpha R1, TNF-alpha R2, CRP, IL-6, and adiponectin. Psoriasis and psoriatic arthritis are Th1- and Th17-mediated diseases that exhibit higher serum levels of IL-6, CRP, and TNF-alpha, unlike atopic dermatitis, which is primarily a Th2-mediated condition featuring reduced involvement of the Th1/Th17 inflammatory cytokines.

Because a goal of the EDIP score was to “account for the overall effect of dietary patterns,” the researchers included in their analysis only those food groups that “explain the maximal variation in the three noted inflammatory biomarkers.”

All patients included in the study were questioned at baseline regarding their height and race/ethnicity. Weight, smoking status, and physical activity, and diagnoses of hypercholesterolemia, type 2 diabetes, cardiovascular disease, and asthma were monitored biennially.

Overall, patients with higher EDIP scores were found to have higher BMI, lower physical activity, and alcohol use, as well as increased rates of hypercholesterolemia and hypertension.

“Though we found no convincing evidence for an association with EDIP score for any of the investigated diseases, the results followed an internal pattern consistent with our hypotheses that higher EDIP scores would have more of an association with psoriatic disease than with atopic dermatitis,” the researchers wrote.

Citing recent evidence gathered in studies, such as the French NutriNet-Santé study, which demonstrated proinflammatory effects similar to those measured with the EDIP in cases where there was low adherence to the Mediterranean diet, the authors attributed their contradictory findings to “important methodological differences.” Unlike the NutriNet-Santé study, which classified psoriasis by severity, Ms. Bridgman and her colleagues examined the overall risk of incident psoriasis. “It is possible that a dietary index associated with more Th-2 inflammation would yield different results,” they noted.

The large sample size, prospectively collected dietary, and psoriatic disease data, as well as the ability to adjust for important confounding factors, were included among the strengths of the study.

That the participants were limited to U.S. women could be considered a limitation because the results may not be generalizable to other populations. The results also may not be relevant to child-onset disease because the patient population included only cases of adult-onset atopic dermatitis. Questionnaire-based diagnoses increase the likelihood of misclassification, so “dilution of the case pool with false-positive cases would bias our results towards the null,” they added.

Ultimately, the authors noted that proinflammatory diet may be associated with other health risks, but these do not warrant counseling patients concerning their possible impact in cases of psoriatic disease or atopic dermatitis.

The study was funded by Brown University department of dermatology and from Regeneron, Sanofi, the National Institutes of Health, and the National Cancer Institute. Two coauthors, one of whom has a patent pending for the nix-tix tick remover, disclosed ties with various companies.

SOURCE: Bridgman AC et al. J Am Acad Dermatol. 2019 Feb 21. pii: S0190-9622(19)30329-9.

There is no apparent association between proinflammatory foods and increased risk of incident psoriasis, psoriatic arthritis, or atopic dermatitis, reported Alanna C. Bridgman of Queen’s University, Kingston, Ont., and her associates.

©camij/thinkstockphotos.com

In a large, retrospective cohort study among women from the Nurses’ Health Study II (NHS-II), including 85,185 psoriasis participants and 63,443 atopic dermatitis participants, Ms. Bridgman and her associates sought to determine whether proinflammatory diet increased the risk of incident psoriasis, psoriatic arthritis, or atopic dermatitis. Clinicians administered food frequency questionnaires every 4 years beginning in 1991 among female nurses aged 25-42 years.

Food groups included in the evaluation were those most predictive of three plasma markers of inflammation: interleukin-6 (IL-6), C-reactive protein (CRP), and tumor necrosis factor–alpha R2 (TNF-R2). Proinflammatory foods included processed meat, red meat, organ meat, white fish, vegetables other than leafy green and dark yellow, refined grains, low- and high-energy drinks, and tomatoes. Anti-inflammatory foods included beer, wine, tea, coffee, dark yellow and green leafy vegetables, snacks such as popcorn and crackers, fruit juice, and pizza.

No association was found between proinflammatory diet and increased likelihood for incident psoriasis, psoriatic arthritis, or atopic dermatitis. Although proinflammatory dietary patterns were associated with psoriatic arthritis in the age-adjusted model, the hazard ratio was attenuated and found to be no longer statistically significant after adjustment for important confounders such as body mass index. In addition, no significant relationship between atopic dermatitis and proinflammatory diet was observed, they reported. The study was published in the Journal of the American Academy of Dermatology.

Ms. Bridgman and her associates measured dietary patterns using the Empirical Dietary Inflammatory Pattern (EDIP); dietary patterns measuring high on the EDIP scale were associated with higher levels of TNF-alpha, TNF-alpha R1, TNF-alpha R2, CRP, IL-6, and adiponectin. Psoriasis and psoriatic arthritis are Th1- and Th17-mediated diseases that exhibit higher serum levels of IL-6, CRP, and TNF-alpha, unlike atopic dermatitis, which is primarily a Th2-mediated condition featuring reduced involvement of the Th1/Th17 inflammatory cytokines.

Because a goal of the EDIP score was to “account for the overall effect of dietary patterns,” the researchers included in their analysis only those food groups that “explain the maximal variation in the three noted inflammatory biomarkers.”

All patients included in the study were questioned at baseline regarding their height and race/ethnicity. Weight, smoking status, and physical activity, and diagnoses of hypercholesterolemia, type 2 diabetes, cardiovascular disease, and asthma were monitored biennially.

Overall, patients with higher EDIP scores were found to have higher BMI, lower physical activity, and alcohol use, as well as increased rates of hypercholesterolemia and hypertension.

“Though we found no convincing evidence for an association with EDIP score for any of the investigated diseases, the results followed an internal pattern consistent with our hypotheses that higher EDIP scores would have more of an association with psoriatic disease than with atopic dermatitis,” the researchers wrote.

Citing recent evidence gathered in studies, such as the French NutriNet-Santé study, which demonstrated proinflammatory effects similar to those measured with the EDIP in cases where there was low adherence to the Mediterranean diet, the authors attributed their contradictory findings to “important methodological differences.” Unlike the NutriNet-Santé study, which classified psoriasis by severity, Ms. Bridgman and her colleagues examined the overall risk of incident psoriasis. “It is possible that a dietary index associated with more Th-2 inflammation would yield different results,” they noted.

The large sample size, prospectively collected dietary, and psoriatic disease data, as well as the ability to adjust for important confounding factors, were included among the strengths of the study.

That the participants were limited to U.S. women could be considered a limitation because the results may not be generalizable to other populations. The results also may not be relevant to child-onset disease because the patient population included only cases of adult-onset atopic dermatitis. Questionnaire-based diagnoses increase the likelihood of misclassification, so “dilution of the case pool with false-positive cases would bias our results towards the null,” they added.

Ultimately, the authors noted that proinflammatory diet may be associated with other health risks, but these do not warrant counseling patients concerning their possible impact in cases of psoriatic disease or atopic dermatitis.

The study was funded by Brown University department of dermatology and from Regeneron, Sanofi, the National Institutes of Health, and the National Cancer Institute. Two coauthors, one of whom has a patent pending for the nix-tix tick remover, disclosed ties with various companies.

SOURCE: Bridgman AC et al. J Am Acad Dermatol. 2019 Feb 21. pii: S0190-9622(19)30329-9.

There is no apparent association between proinflammatory foods and increased risk of incident psoriasis, psoriatic arthritis, or atopic dermatitis, reported Alanna C. Bridgman of Queen’s University, Kingston, Ont., and her associates.

©camij/thinkstockphotos.com

In a large, retrospective cohort study among women from the Nurses’ Health Study II (NHS-II), including 85,185 psoriasis participants and 63,443 atopic dermatitis participants, Ms. Bridgman and her associates sought to determine whether proinflammatory diet increased the risk of incident psoriasis, psoriatic arthritis, or atopic dermatitis. Clinicians administered food frequency questionnaires every 4 years beginning in 1991 among female nurses aged 25-42 years.

Food groups included in the evaluation were those most predictive of three plasma markers of inflammation: interleukin-6 (IL-6), C-reactive protein (CRP), and tumor necrosis factor–alpha R2 (TNF-R2). Proinflammatory foods included processed meat, red meat, organ meat, white fish, vegetables other than leafy green and dark yellow, refined grains, low- and high-energy drinks, and tomatoes. Anti-inflammatory foods included beer, wine, tea, coffee, dark yellow and green leafy vegetables, snacks such as popcorn and crackers, fruit juice, and pizza.

No association was found between proinflammatory diet and increased likelihood for incident psoriasis, psoriatic arthritis, or atopic dermatitis. Although proinflammatory dietary patterns were associated with psoriatic arthritis in the age-adjusted model, the hazard ratio was attenuated and found to be no longer statistically significant after adjustment for important confounders such as body mass index. In addition, no significant relationship between atopic dermatitis and proinflammatory diet was observed, they reported. The study was published in the Journal of the American Academy of Dermatology.

Ms. Bridgman and her associates measured dietary patterns using the Empirical Dietary Inflammatory Pattern (EDIP); dietary patterns measuring high on the EDIP scale were associated with higher levels of TNF-alpha, TNF-alpha R1, TNF-alpha R2, CRP, IL-6, and adiponectin. Psoriasis and psoriatic arthritis are Th1- and Th17-mediated diseases that exhibit higher serum levels of IL-6, CRP, and TNF-alpha, unlike atopic dermatitis, which is primarily a Th2-mediated condition featuring reduced involvement of the Th1/Th17 inflammatory cytokines.

Because a goal of the EDIP score was to “account for the overall effect of dietary patterns,” the researchers included in their analysis only those food groups that “explain the maximal variation in the three noted inflammatory biomarkers.”

All patients included in the study were questioned at baseline regarding their height and race/ethnicity. Weight, smoking status, and physical activity, and diagnoses of hypercholesterolemia, type 2 diabetes, cardiovascular disease, and asthma were monitored biennially.

Overall, patients with higher EDIP scores were found to have higher BMI, lower physical activity, and alcohol use, as well as increased rates of hypercholesterolemia and hypertension.

“Though we found no convincing evidence for an association with EDIP score for any of the investigated diseases, the results followed an internal pattern consistent with our hypotheses that higher EDIP scores would have more of an association with psoriatic disease than with atopic dermatitis,” the researchers wrote.

Citing recent evidence gathered in studies, such as the French NutriNet-Santé study, which demonstrated proinflammatory effects similar to those measured with the EDIP in cases where there was low adherence to the Mediterranean diet, the authors attributed their contradictory findings to “important methodological differences.” Unlike the NutriNet-Santé study, which classified psoriasis by severity, Ms. Bridgman and her colleagues examined the overall risk of incident psoriasis. “It is possible that a dietary index associated with more Th-2 inflammation would yield different results,” they noted.

The large sample size, prospectively collected dietary, and psoriatic disease data, as well as the ability to adjust for important confounding factors, were included among the strengths of the study.

That the participants were limited to U.S. women could be considered a limitation because the results may not be generalizable to other populations. The results also may not be relevant to child-onset disease because the patient population included only cases of adult-onset atopic dermatitis. Questionnaire-based diagnoses increase the likelihood of misclassification, so “dilution of the case pool with false-positive cases would bias our results towards the null,” they added.

Ultimately, the authors noted that proinflammatory diet may be associated with other health risks, but these do not warrant counseling patients concerning their possible impact in cases of psoriatic disease or atopic dermatitis.

The study was funded by Brown University department of dermatology and from Regeneron, Sanofi, the National Institutes of Health, and the National Cancer Institute. Two coauthors, one of whom has a patent pending for the nix-tix tick remover, disclosed ties with various companies.

SOURCE: Bridgman AC et al. J Am Acad Dermatol. 2019 Feb 21. pii: S0190-9622(19)30329-9.

A panel of four biomarkers of cartilage metabolism, metabolic syndrome, and inflammation could help physicians to distinguish between osteoarthritis and psoriatic arthritis, new research suggests.

Such a test for distinguishing between the two conditions, which have “similarities in the distribution of joints involved,” could offer a way to make earlier diagnoses and avoid inappropriate treatment, according to Vinod Chandran, MD, PhD, of the department of medicine at the University of Toronto and Toronto Western Hospital and his colleagues. Dr. Chandran was first author on a study published online in Annals of the Rheumatic Diseases that analyzed serum samples from the University of Toronto Psoriatic Arthritis Program and University Health Network Arthritis Program for differences in certain biomarkers from 201 individuals with osteoarthritis, 77 with psoriatic arthritis, and 76 healthy controls.

The samples were tested for 15 biomarkers, including those related to cartilage metabolism (cartilage oligomeric matrix protein and hyaluronan), to metabolic syndrome (adiponectin, adipsin, resistin, hepatocyte growth factor, insulin, and leptin), and to inflammation (C-reactive protein, interleukin-1-beta, interleukin-6, interleukin-8, tumor necrosis factor alpha, monocyte chemoattractant protein–1, and nerve growth factor).

Researchers found that levels of 12 of these markers were different in patients with psoriatic arthritis, osteoarthritis, or controls, and 9 markers showed altered expression in psoriatic arthritis, compared with osteoarthritis.

Further analysis showed that levels of cartilage oligomeric matrix protein, resistin, monocyte chemoattractant protein–1, and nerve growth factor were significantly different between patients with psoriatic arthritis and those with osteoarthritis. The ROC curve for a model based on these four biomarkers that also incorporated age and sex had an area under the curve of 0.9984.

Researchers then validated the four biomarkers in an independent set of 75 patients with osteoarthritis and 73 with psoriatic arthritis and found these biomarkers were able to discriminate between the two conditions beyond what would be achieved based on age and sex alone.

The authors noted that previous research has observed high expression of monocyte chemoattractant protein–1 and resistin in patients with psoriatic arthritis when compared with those with osteoarthritis.

Nerve growth factor has been seen at elevated levels in the synovial fluid of individuals with osteoarthritis and is known to play a role in the chronic pain associated with that disease.

Similarly, higher cartilage oligomeric matrix protein levels are associated with a higher risk of knee osteoarthritis.

However, the authors noted that individuals with osteoarthritis in the study were all undergoing joint replacement surgery and therefore may not be typical of patients presenting to family practices or rheumatology clinics.

The University of Toronto Psoriatic Arthritis Program is supported by the Krembil Foundation. No conflicts of interest were declared.

SOURCE: Chandran V et al. Ann Rheum Dis. 2019 Mar 25. doi: 10.1136/annrheumdis-2018-214737.
 

A panel of four biomarkers of cartilage metabolism, metabolic syndrome, and inflammation could help physicians to distinguish between osteoarthritis and psoriatic arthritis, new research suggests.

Such a test for distinguishing between the two conditions, which have “similarities in the distribution of joints involved,” could offer a way to make earlier diagnoses and avoid inappropriate treatment, according to Vinod Chandran, MD, PhD, of the department of medicine at the University of Toronto and Toronto Western Hospital and his colleagues. Dr. Chandran was first author on a study published online in Annals of the Rheumatic Diseases that analyzed serum samples from the University of Toronto Psoriatic Arthritis Program and University Health Network Arthritis Program for differences in certain biomarkers from 201 individuals with osteoarthritis, 77 with psoriatic arthritis, and 76 healthy controls.

The samples were tested for 15 biomarkers, including those related to cartilage metabolism (cartilage oligomeric matrix protein and hyaluronan), to metabolic syndrome (adiponectin, adipsin, resistin, hepatocyte growth factor, insulin, and leptin), and to inflammation (C-reactive protein, interleukin-1-beta, interleukin-6, interleukin-8, tumor necrosis factor alpha, monocyte chemoattractant protein–1, and nerve growth factor).

Researchers found that levels of 12 of these markers were different in patients with psoriatic arthritis, osteoarthritis, or controls, and 9 markers showed altered expression in psoriatic arthritis, compared with osteoarthritis.

Further analysis showed that levels of cartilage oligomeric matrix protein, resistin, monocyte chemoattractant protein–1, and nerve growth factor were significantly different between patients with psoriatic arthritis and those with osteoarthritis. The ROC curve for a model based on these four biomarkers that also incorporated age and sex had an area under the curve of 0.9984.

Researchers then validated the four biomarkers in an independent set of 75 patients with osteoarthritis and 73 with psoriatic arthritis and found these biomarkers were able to discriminate between the two conditions beyond what would be achieved based on age and sex alone.

The authors noted that previous research has observed high expression of monocyte chemoattractant protein–1 and resistin in patients with psoriatic arthritis when compared with those with osteoarthritis.

Nerve growth factor has been seen at elevated levels in the synovial fluid of individuals with osteoarthritis and is known to play a role in the chronic pain associated with that disease.

Similarly, higher cartilage oligomeric matrix protein levels are associated with a higher risk of knee osteoarthritis.

However, the authors noted that individuals with osteoarthritis in the study were all undergoing joint replacement surgery and therefore may not be typical of patients presenting to family practices or rheumatology clinics.

The University of Toronto Psoriatic Arthritis Program is supported by the Krembil Foundation. No conflicts of interest were declared.

SOURCE: Chandran V et al. Ann Rheum Dis. 2019 Mar 25. doi: 10.1136/annrheumdis-2018-214737.
 

A panel of four biomarkers of cartilage metabolism, metabolic syndrome, and inflammation could help physicians to distinguish between osteoarthritis and psoriatic arthritis, new research suggests.

Such a test for distinguishing between the two conditions, which have “similarities in the distribution of joints involved,” could offer a way to make earlier diagnoses and avoid inappropriate treatment, according to Vinod Chandran, MD, PhD, of the department of medicine at the University of Toronto and Toronto Western Hospital and his colleagues. Dr. Chandran was first author on a study published online in Annals of the Rheumatic Diseases that analyzed serum samples from the University of Toronto Psoriatic Arthritis Program and University Health Network Arthritis Program for differences in certain biomarkers from 201 individuals with osteoarthritis, 77 with psoriatic arthritis, and 76 healthy controls.

The samples were tested for 15 biomarkers, including those related to cartilage metabolism (cartilage oligomeric matrix protein and hyaluronan), to metabolic syndrome (adiponectin, adipsin, resistin, hepatocyte growth factor, insulin, and leptin), and to inflammation (C-reactive protein, interleukin-1-beta, interleukin-6, interleukin-8, tumor necrosis factor alpha, monocyte chemoattractant protein–1, and nerve growth factor).

Researchers found that levels of 12 of these markers were different in patients with psoriatic arthritis, osteoarthritis, or controls, and 9 markers showed altered expression in psoriatic arthritis, compared with osteoarthritis.

Further analysis showed that levels of cartilage oligomeric matrix protein, resistin, monocyte chemoattractant protein–1, and nerve growth factor were significantly different between patients with psoriatic arthritis and those with osteoarthritis. The ROC curve for a model based on these four biomarkers that also incorporated age and sex had an area under the curve of 0.9984.

Researchers then validated the four biomarkers in an independent set of 75 patients with osteoarthritis and 73 with psoriatic arthritis and found these biomarkers were able to discriminate between the two conditions beyond what would be achieved based on age and sex alone.

The authors noted that previous research has observed high expression of monocyte chemoattractant protein–1 and resistin in patients with psoriatic arthritis when compared with those with osteoarthritis.

Nerve growth factor has been seen at elevated levels in the synovial fluid of individuals with osteoarthritis and is known to play a role in the chronic pain associated with that disease.

Similarly, higher cartilage oligomeric matrix protein levels are associated with a higher risk of knee osteoarthritis.

However, the authors noted that individuals with osteoarthritis in the study were all undergoing joint replacement surgery and therefore may not be typical of patients presenting to family practices or rheumatology clinics.

The University of Toronto Psoriatic Arthritis Program is supported by the Krembil Foundation. No conflicts of interest were declared.

SOURCE: Chandran V et al. Ann Rheum Dis. 2019 Mar 25. doi: 10.1136/annrheumdis-2018-214737.
 

All individuals with psoriasis or psoriatic arthritis aged over 50 years should receive the recombinant herpes zoster vaccine, according to a systematic review and consensus recommendations from the National Psoriasis Foundation.

Joloei/Thinkstock

Emily Baumrin, MD, of Brigham and Women’s Hospital, Boston, and her coauthors reviewed 41 studies of herpes zoster in people with psoriasis or psoriatic arthritis according to treatment modality. Their report is in the Journal of the American Academy of Dermatology.

Overall, psoriasis was associated with an increased rate of herpes zoster when compared with the general population: 13.3 cases per 1,000 patient-years for psoriasis and 15.9 for psoriatic arthritis, compared with 8.5 in healthy controls after adjustment for age, sex, and systemic medications. Most of this increased incidence was seen in patients with more severe disease: Those with mild disease who were not receiving systemic therapy had a risk similar to that of healthy controls.

However, one study suggested much of the increased risk of herpes zoster in psoriasis was accounted for by immunosuppressive therapy; when those patients were excluded, there was an 8% increase in risk.


The authors found that people whose psoriasis was treated with tofacitinib (Xeljanz) had a two- to threefold increased risk of herpes zoster, compared with those treated with tumor necrosis factor (TNF) inhibitors or conventional synthetic disease-modifying antirheumatic drugs (DMARDs).

Corticosteroids – either alone or in combination with DMARDs – were also associated with significant increases in the risk of herpes zoster. Patients treated with TNF inhibitor monotherapy had a risk of herpes zoster similar to that of those treated with conventional synthetic DMARDs or no synthetic therapy.

On the question of immunization, the authors pointed to guidelines recommending use of the live attenuated zoster vaccine (Zostavax) in immunocompetent patients or those on low-dose immunosuppression, although they noted that the vaccine is currently contraindicated for patients on biologic DMARDs.

They also examined the evidence for the use of the recently-released non-live recombinant herpes zoster vaccine (Shingrix) in immunocompromised patients, which found no evidence of vaccine-related serious adverse events in individuals with HIV and low CD4 cell counts and in autologous hematopoietic stem cell transplant recipients.

Given this, they recommended that the recombinant vaccine be administered to all patients aged over 50 years with psoriasis or psoriatic arthritis, and to those aged under 50 years who were being treated with tofacitinib, systemic corticosteroids, or combination systemic therapy.

There were insufficient data to draw conclusions about the impact of treatment with the interleukin-12/23 blocker ustekinumab (Stelara) on herpes zoster risk, but the authors noted that there was a trend toward an increased risk. They found no increase in the risk of herpes zoster with interleukin-17 inhibitors (ixekizumab [Taltz], secukinumab [Cosentyx], and brodalumab [Siliq]) and interleukin-23 (p19 subunit) inhibitors (guselkumab [Tremfya], tildrakizumab [Ilumya], and risankizumab) but noted an absence of long-term safety data for these drugs.

Four authors declared advisory, consultancy, or speaker positions with the pharmaceutical sector.

SOURCE: Baumrin E et al. J Am Acad Dermatol. 2019 March 15. doi: 10.1016/j.jaad.2019.03.017.

All individuals with psoriasis or psoriatic arthritis aged over 50 years should receive the recombinant herpes zoster vaccine, according to a systematic review and consensus recommendations from the National Psoriasis Foundation.

Joloei/Thinkstock

Emily Baumrin, MD, of Brigham and Women’s Hospital, Boston, and her coauthors reviewed 41 studies of herpes zoster in people with psoriasis or psoriatic arthritis according to treatment modality. Their report is in the Journal of the American Academy of Dermatology.

Overall, psoriasis was associated with an increased rate of herpes zoster when compared with the general population: 13.3 cases per 1,000 patient-years for psoriasis and 15.9 for psoriatic arthritis, compared with 8.5 in healthy controls after adjustment for age, sex, and systemic medications. Most of this increased incidence was seen in patients with more severe disease: Those with mild disease who were not receiving systemic therapy had a risk similar to that of healthy controls.

However, one study suggested much of the increased risk of herpes zoster in psoriasis was accounted for by immunosuppressive therapy; when those patients were excluded, there was an 8% increase in risk.


The authors found that people whose psoriasis was treated with tofacitinib (Xeljanz) had a two- to threefold increased risk of herpes zoster, compared with those treated with tumor necrosis factor (TNF) inhibitors or conventional synthetic disease-modifying antirheumatic drugs (DMARDs).

Corticosteroids – either alone or in combination with DMARDs – were also associated with significant increases in the risk of herpes zoster. Patients treated with TNF inhibitor monotherapy had a risk of herpes zoster similar to that of those treated with conventional synthetic DMARDs or no synthetic therapy.

On the question of immunization, the authors pointed to guidelines recommending use of the live attenuated zoster vaccine (Zostavax) in immunocompetent patients or those on low-dose immunosuppression, although they noted that the vaccine is currently contraindicated for patients on biologic DMARDs.

They also examined the evidence for the use of the recently-released non-live recombinant herpes zoster vaccine (Shingrix) in immunocompromised patients, which found no evidence of vaccine-related serious adverse events in individuals with HIV and low CD4 cell counts and in autologous hematopoietic stem cell transplant recipients.

Given this, they recommended that the recombinant vaccine be administered to all patients aged over 50 years with psoriasis or psoriatic arthritis, and to those aged under 50 years who were being treated with tofacitinib, systemic corticosteroids, or combination systemic therapy.

There were insufficient data to draw conclusions about the impact of treatment with the interleukin-12/23 blocker ustekinumab (Stelara) on herpes zoster risk, but the authors noted that there was a trend toward an increased risk. They found no increase in the risk of herpes zoster with interleukin-17 inhibitors (ixekizumab [Taltz], secukinumab [Cosentyx], and brodalumab [Siliq]) and interleukin-23 (p19 subunit) inhibitors (guselkumab [Tremfya], tildrakizumab [Ilumya], and risankizumab) but noted an absence of long-term safety data for these drugs.

Four authors declared advisory, consultancy, or speaker positions with the pharmaceutical sector.

SOURCE: Baumrin E et al. J Am Acad Dermatol. 2019 March 15. doi: 10.1016/j.jaad.2019.03.017.

All individuals with psoriasis or psoriatic arthritis aged over 50 years should receive the recombinant herpes zoster vaccine, according to a systematic review and consensus recommendations from the National Psoriasis Foundation.

Joloei/Thinkstock

Emily Baumrin, MD, of Brigham and Women’s Hospital, Boston, and her coauthors reviewed 41 studies of herpes zoster in people with psoriasis or psoriatic arthritis according to treatment modality. Their report is in the Journal of the American Academy of Dermatology.

Overall, psoriasis was associated with an increased rate of herpes zoster when compared with the general population: 13.3 cases per 1,000 patient-years for psoriasis and 15.9 for psoriatic arthritis, compared with 8.5 in healthy controls after adjustment for age, sex, and systemic medications. Most of this increased incidence was seen in patients with more severe disease: Those with mild disease who were not receiving systemic therapy had a risk similar to that of healthy controls.

However, one study suggested much of the increased risk of herpes zoster in psoriasis was accounted for by immunosuppressive therapy; when those patients were excluded, there was an 8% increase in risk.


The authors found that people whose psoriasis was treated with tofacitinib (Xeljanz) had a two- to threefold increased risk of herpes zoster, compared with those treated with tumor necrosis factor (TNF) inhibitors or conventional synthetic disease-modifying antirheumatic drugs (DMARDs).

Corticosteroids – either alone or in combination with DMARDs – were also associated with significant increases in the risk of herpes zoster. Patients treated with TNF inhibitor monotherapy had a risk of herpes zoster similar to that of those treated with conventional synthetic DMARDs or no synthetic therapy.

On the question of immunization, the authors pointed to guidelines recommending use of the live attenuated zoster vaccine (Zostavax) in immunocompetent patients or those on low-dose immunosuppression, although they noted that the vaccine is currently contraindicated for patients on biologic DMARDs.

They also examined the evidence for the use of the recently-released non-live recombinant herpes zoster vaccine (Shingrix) in immunocompromised patients, which found no evidence of vaccine-related serious adverse events in individuals with HIV and low CD4 cell counts and in autologous hematopoietic stem cell transplant recipients.

Given this, they recommended that the recombinant vaccine be administered to all patients aged over 50 years with psoriasis or psoriatic arthritis, and to those aged under 50 years who were being treated with tofacitinib, systemic corticosteroids, or combination systemic therapy.

There were insufficient data to draw conclusions about the impact of treatment with the interleukin-12/23 blocker ustekinumab (Stelara) on herpes zoster risk, but the authors noted that there was a trend toward an increased risk. They found no increase in the risk of herpes zoster with interleukin-17 inhibitors (ixekizumab [Taltz], secukinumab [Cosentyx], and brodalumab [Siliq]) and interleukin-23 (p19 subunit) inhibitors (guselkumab [Tremfya], tildrakizumab [Ilumya], and risankizumab) but noted an absence of long-term safety data for these drugs.

Four authors declared advisory, consultancy, or speaker positions with the pharmaceutical sector.

SOURCE: Baumrin E et al. J Am Acad Dermatol. 2019 March 15. doi: 10.1016/j.jaad.2019.03.017.

MAUI, HAWAII – Industry-funded randomized, controlled clinical trials published in the three top-rated rheumatology journals during the past 20 years are of significantly higher overall quality than the nonindustry-funded ones, Michael Putman, MD, said at the 2019 Rheumatology Winter Clinical Symposium.

Bruce Jancin/MDedge News

Dr. Putman, a second-year rheumatology fellow at Northwestern University, Chicago, analyzed all randomized, controlled trials (RCTs) of pharmacotherapy featuring a comparator – either placebo or an active agent – published in 1998, 2008, and 2018 in Annals of the Rheumatic Diseases, Rheumatology, and Arthritis & Rheumatology.

His main takeaway: “Rheumatologic interventions seem to work pretty well. The mean absolute risk reduction in the trials is 17.5%, so the average number of patients who need to be treated with a rheumatologic intervention is about five. This is why it’s such a great specialty to be a part of: A lot of our patients get better.”

He created an RCT quality rating scale that captured the strength of study design, methodology, and findings based upon whether a randomized trial used a double-blind design; identified a prespecified primary outcome; and featured patient-reported outcomes, power calculations, sensitivity analysis, adjustment for multiple hypotheses, and intention-to-treat analysis. He then applied the rating scale to the 85 published RCTs in the three study years.

Of note, 84% of the trials published in 2018 were industry funded, up from 74% in 2008 and 1998.

“Industry funds the vast majority of studies. Industry studies are significantly more likely to be appropriately double blinded, report patient-reported outcome measures, use intention to treat, and they have a higher overall quality,” according to Dr. Putman.

Indeed, the industry-funded studies averaged a 66% score on his quality grading scale, compared with 45% for nonindustry-funded studies.

Utilization of most of the quality metrics remained stable over time. The exceptions: Incorporation of intent-to-treat analysis increased from 58% in 1998 to 87% in 2018, and sensitivity analysis was employed in just 5% of the trials published in 1998, compared with 37% in 2008 and 26% in 2018.

The most important change over the past 2 decades, in his view, has been the shrinking proportion of RCTs featuring an active-drug, head-to-head comparator arm. In 1998, 42% of studies featured that design; for example, comparing methotrexate to sulfasalazine. By 2018, that figure had dropped to just 13%.

“Most of our trials today compare an active compound, such an interleukin-17 inhibitor, to a placebo. I think that’s a big change in how we do things,” Dr. Putman observed. “With 84% of our studies being funded by industry, the incentives in medicine right now don’t support active comparator research. It’s harder to show a difference between two things that work than it is to show a difference between something and nothing.”

However, he’d welcome a revival of head-to-head active comparator trials.

“I’d really love to have that happen,” he said. “We have basic questions we haven’t answered yet about a lot of our basic drugs: Like in myositis, should you start with Imuran [azathioprine], CellCept [mycophenolate mofetil], or methotrexate?”

Another striking change over time has been the dwindling proportion of published trials with a statistically significant finding for the primary outcome: 79% in 1998, 46% in 2008, and 36% last year. Dr. Putman suspects the explanation lies in the steady improvement in the effectiveness of standard background therapy for many conditions, which makes it tougher to show a striking difference between the add-on study drug and add-on placebo.

“We’re a victim of our own success,” he commented.

In any event, many key secondary outcomes in the RCTs were positive, even when the primary endpoint wasn’t, according to Dr. Putman, and there was a notable dearth of completely negative clinical RCTs published in the three top journals.

“The more cynical interpretation is there’s an incredible amount of publication bias, where we’re only publishing studies that show an effect and the journals or investigators are censoring the ones that don’t. The more charitable explanation, which is probably also true, is that by the time you get to putting on an RCT you kind of think, ‘This thing works.’ You’re not testing random stuff, so your pretest probability of a drug being effective when it enters into an RCT is probably shifted toward effectiveness,” Dr. Putman speculated.

He reported having no financial conflicts regarding his study.

[email protected]

MAUI, HAWAII – Industry-funded randomized, controlled clinical trials published in the three top-rated rheumatology journals during the past 20 years are of significantly higher overall quality than the nonindustry-funded ones, Michael Putman, MD, said at the 2019 Rheumatology Winter Clinical Symposium.

Bruce Jancin/MDedge News

Dr. Putman, a second-year rheumatology fellow at Northwestern University, Chicago, analyzed all randomized, controlled trials (RCTs) of pharmacotherapy featuring a comparator – either placebo or an active agent – published in 1998, 2008, and 2018 in Annals of the Rheumatic Diseases, Rheumatology, and Arthritis & Rheumatology.

His main takeaway: “Rheumatologic interventions seem to work pretty well. The mean absolute risk reduction in the trials is 17.5%, so the average number of patients who need to be treated with a rheumatologic intervention is about five. This is why it’s such a great specialty to be a part of: A lot of our patients get better.”

He created an RCT quality rating scale that captured the strength of study design, methodology, and findings based upon whether a randomized trial used a double-blind design; identified a prespecified primary outcome; and featured patient-reported outcomes, power calculations, sensitivity analysis, adjustment for multiple hypotheses, and intention-to-treat analysis. He then applied the rating scale to the 85 published RCTs in the three study years.

Of note, 84% of the trials published in 2018 were industry funded, up from 74% in 2008 and 1998.

“Industry funds the vast majority of studies. Industry studies are significantly more likely to be appropriately double blinded, report patient-reported outcome measures, use intention to treat, and they have a higher overall quality,” according to Dr. Putman.

Indeed, the industry-funded studies averaged a 66% score on his quality grading scale, compared with 45% for nonindustry-funded studies.

Utilization of most of the quality metrics remained stable over time. The exceptions: Incorporation of intent-to-treat analysis increased from 58% in 1998 to 87% in 2018, and sensitivity analysis was employed in just 5% of the trials published in 1998, compared with 37% in 2008 and 26% in 2018.

The most important change over the past 2 decades, in his view, has been the shrinking proportion of RCTs featuring an active-drug, head-to-head comparator arm. In 1998, 42% of studies featured that design; for example, comparing methotrexate to sulfasalazine. By 2018, that figure had dropped to just 13%.

“Most of our trials today compare an active compound, such an interleukin-17 inhibitor, to a placebo. I think that’s a big change in how we do things,” Dr. Putman observed. “With 84% of our studies being funded by industry, the incentives in medicine right now don’t support active comparator research. It’s harder to show a difference between two things that work than it is to show a difference between something and nothing.”

However, he’d welcome a revival of head-to-head active comparator trials.

“I’d really love to have that happen,” he said. “We have basic questions we haven’t answered yet about a lot of our basic drugs: Like in myositis, should you start with Imuran [azathioprine], CellCept [mycophenolate mofetil], or methotrexate?”

Another striking change over time has been the dwindling proportion of published trials with a statistically significant finding for the primary outcome: 79% in 1998, 46% in 2008, and 36% last year. Dr. Putman suspects the explanation lies in the steady improvement in the effectiveness of standard background therapy for many conditions, which makes it tougher to show a striking difference between the add-on study drug and add-on placebo.

“We’re a victim of our own success,” he commented.

In any event, many key secondary outcomes in the RCTs were positive, even when the primary endpoint wasn’t, according to Dr. Putman, and there was a notable dearth of completely negative clinical RCTs published in the three top journals.

“The more cynical interpretation is there’s an incredible amount of publication bias, where we’re only publishing studies that show an effect and the journals or investigators are censoring the ones that don’t. The more charitable explanation, which is probably also true, is that by the time you get to putting on an RCT you kind of think, ‘This thing works.’ You’re not testing random stuff, so your pretest probability of a drug being effective when it enters into an RCT is probably shifted toward effectiveness,” Dr. Putman speculated.

He reported having no financial conflicts regarding his study.

[email protected]

MAUI, HAWAII – Industry-funded randomized, controlled clinical trials published in the three top-rated rheumatology journals during the past 20 years are of significantly higher overall quality than the nonindustry-funded ones, Michael Putman, MD, said at the 2019 Rheumatology Winter Clinical Symposium.

Bruce Jancin/MDedge News

Dr. Putman, a second-year rheumatology fellow at Northwestern University, Chicago, analyzed all randomized, controlled trials (RCTs) of pharmacotherapy featuring a comparator – either placebo or an active agent – published in 1998, 2008, and 2018 in Annals of the Rheumatic Diseases, Rheumatology, and Arthritis & Rheumatology.

His main takeaway: “Rheumatologic interventions seem to work pretty well. The mean absolute risk reduction in the trials is 17.5%, so the average number of patients who need to be treated with a rheumatologic intervention is about five. This is why it’s such a great specialty to be a part of: A lot of our patients get better.”

He created an RCT quality rating scale that captured the strength of study design, methodology, and findings based upon whether a randomized trial used a double-blind design; identified a prespecified primary outcome; and featured patient-reported outcomes, power calculations, sensitivity analysis, adjustment for multiple hypotheses, and intention-to-treat analysis. He then applied the rating scale to the 85 published RCTs in the three study years.

Of note, 84% of the trials published in 2018 were industry funded, up from 74% in 2008 and 1998.

“Industry funds the vast majority of studies. Industry studies are significantly more likely to be appropriately double blinded, report patient-reported outcome measures, use intention to treat, and they have a higher overall quality,” according to Dr. Putman.

Indeed, the industry-funded studies averaged a 66% score on his quality grading scale, compared with 45% for nonindustry-funded studies.

Utilization of most of the quality metrics remained stable over time. The exceptions: Incorporation of intent-to-treat analysis increased from 58% in 1998 to 87% in 2018, and sensitivity analysis was employed in just 5% of the trials published in 1998, compared with 37% in 2008 and 26% in 2018.

The most important change over the past 2 decades, in his view, has been the shrinking proportion of RCTs featuring an active-drug, head-to-head comparator arm. In 1998, 42% of studies featured that design; for example, comparing methotrexate to sulfasalazine. By 2018, that figure had dropped to just 13%.

“Most of our trials today compare an active compound, such an interleukin-17 inhibitor, to a placebo. I think that’s a big change in how we do things,” Dr. Putman observed. “With 84% of our studies being funded by industry, the incentives in medicine right now don’t support active comparator research. It’s harder to show a difference between two things that work than it is to show a difference between something and nothing.”

However, he’d welcome a revival of head-to-head active comparator trials.

“I’d really love to have that happen,” he said. “We have basic questions we haven’t answered yet about a lot of our basic drugs: Like in myositis, should you start with Imuran [azathioprine], CellCept [mycophenolate mofetil], or methotrexate?”

Another striking change over time has been the dwindling proportion of published trials with a statistically significant finding for the primary outcome: 79% in 1998, 46% in 2008, and 36% last year. Dr. Putman suspects the explanation lies in the steady improvement in the effectiveness of standard background therapy for many conditions, which makes it tougher to show a striking difference between the add-on study drug and add-on placebo.

“We’re a victim of our own success,” he commented.

In any event, many key secondary outcomes in the RCTs were positive, even when the primary endpoint wasn’t, according to Dr. Putman, and there was a notable dearth of completely negative clinical RCTs published in the three top journals.

“The more cynical interpretation is there’s an incredible amount of publication bias, where we’re only publishing studies that show an effect and the journals or investigators are censoring the ones that don’t. The more charitable explanation, which is probably also true, is that by the time you get to putting on an RCT you kind of think, ‘This thing works.’ You’re not testing random stuff, so your pretest probability of a drug being effective when it enters into an RCT is probably shifted toward effectiveness,” Dr. Putman speculated.

He reported having no financial conflicts regarding his study.

[email protected]

The Food and Drug Administration has approved Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector, for the treatment of moderate to severe plaque psoriasis in adults, the manufacturer announced.

FDA approval is based on results from the phase 3, multicenter, randomized ORION trial, according to a press release issued by Janssen. In a Self-Injection Assessment Questionnaire, patients who received the One-Press injection rated their satisfaction with self-injection a mean score of 9.18 (0 indicated least satisfaction, 10 indicated highest satisfaction) and rated ease of use at 9.24 (10 indicated “very easy”).

In addition, 81% of patients who received One-Press achieved a Investigator’s Global Assessment score of 0 or 1, and 76% achieved a Psoriasis Area Severity Index (PASI) 90 response after 16 weeks; no patients who received the placebo achieved either.

The most common adverse event during the ORION study was injection-site reaction; the most common adverse events associated with guselkumab, an interleukin-23 blocker, include upper respiratory infections, headache, injection-site reactions, joint pain, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections.

[email protected]

The Food and Drug Administration has approved Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector, for the treatment of moderate to severe plaque psoriasis in adults, the manufacturer announced.

FDA approval is based on results from the phase 3, multicenter, randomized ORION trial, according to a press release issued by Janssen. In a Self-Injection Assessment Questionnaire, patients who received the One-Press injection rated their satisfaction with self-injection a mean score of 9.18 (0 indicated least satisfaction, 10 indicated highest satisfaction) and rated ease of use at 9.24 (10 indicated “very easy”).

In addition, 81% of patients who received One-Press achieved a Investigator’s Global Assessment score of 0 or 1, and 76% achieved a Psoriasis Area Severity Index (PASI) 90 response after 16 weeks; no patients who received the placebo achieved either.

The most common adverse event during the ORION study was injection-site reaction; the most common adverse events associated with guselkumab, an interleukin-23 blocker, include upper respiratory infections, headache, injection-site reactions, joint pain, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections.

[email protected]

The Food and Drug Administration has approved Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector, for the treatment of moderate to severe plaque psoriasis in adults, the manufacturer announced.

FDA approval is based on results from the phase 3, multicenter, randomized ORION trial, according to a press release issued by Janssen. In a Self-Injection Assessment Questionnaire, patients who received the One-Press injection rated their satisfaction with self-injection a mean score of 9.18 (0 indicated least satisfaction, 10 indicated highest satisfaction) and rated ease of use at 9.24 (10 indicated “very easy”).

In addition, 81% of patients who received One-Press achieved a Investigator’s Global Assessment score of 0 or 1, and 76% achieved a Psoriasis Area Severity Index (PASI) 90 response after 16 weeks; no patients who received the placebo achieved either.

The most common adverse event during the ORION study was injection-site reaction; the most common adverse events associated with guselkumab, an interleukin-23 blocker, include upper respiratory infections, headache, injection-site reactions, joint pain, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections.

[email protected]

For patients with early psoriatic arthritis, starting the tumor necrosis factor inhibitor golimumab (Simponi) at the same time as methotrexate nearly doubled the chances of remission, compared with methotrexate monotherapy, researchers reported in Annals of the Rheumatic Diseases.

In this multicenter, double-blind trial, 51 adults with CASPAR-defined psoriatic arthritis who were naive to methotrexate and biologic disease-modifying antirheumatic drugs were randomly assigned to receive monthly golimumab (50 mg subcutaneously) or placebo, in addition to methotrexate (15 mg/week, increased to 25 mg/week over 8 weeks). All patients had current active disease: At baseline, most had at least five swollen joints and at least nine tender joints.

Among 45 patients who completed the study, rates of Disease Activity Score (DAS) remission (DAS C-reactive protein score less than 1.6) at week 22 were 81% for golimumab-methotrexate and 42% for methotrexate-placebo (P = .004). “This difference in DAS remission was already observed at week 8,” wrote Leonieke J.J. van Mens, MD, of AMC/University of Amsterdam and her colleagues.

Golimumab-methotrexate also topped methotrexate monotherapy on secondary outcome measures. By week 22, median swollen joint counts were 0 with combined therapy versus 3 with methotrexate monotherapy (P = .04). Median tender joint counts were 0 and 2, respectively (P = .02). Combined golimumab-methotrexate therapy also produced significantly higher rates of low disease activity based on Disease Activity in Psoriatic Arthritis score (92% vs. 54%, respectively), Minimal Disease Activity (81% vs. 29%), and ACR20, 50, or 70 response (85% vs. 58%, 81% vs. 33%, and 58% vs. 13%, respectively).


Most differences were already statistically significant by week 8, and many were more pronounced by week 22, the researchers said. “It remains unknown if the responses – in particular the stringent responses such as remission – have already plateaued at week 22 or could even further increase over time,” they added. “Similarly, it remains to be determined if the combination of tumor necrosis factor inhibitor and methotrexate is only needed for the induction of remission or is also needed to maintain this state of remission over time.”

They explained that golimumab (or placebo) was stopped at week 22 in patients who achieved DAS CRP remission. An extension of the current study will assess whether methotrexate monotherapy can maintain responses for up to 50 weeks.

The only serious adverse event in the study occurred in the methotrexate arm and consisted of spinal stenosis that was not seen as treatment related. Rates of other adverse events were similar between arms, and those that required a dose halt or dose reduction were related to methotrexate, not golimumab. There were no deaths on trial.

Merck Sharp & Dohme provided medication and unrestricted funding for the study. Dr. van Mens and two coinvestigators reported having no disclosures. Several other coinvestigators disclosed ties to UCB, AbbVie, Novartis, Janssen, Eli Lilly, and other pharmaceutical companies.

SOURCE: van Mens LJJ et al. Ann Rheum Dis. 2019 Feb 26. doi: 10.1136/annrheumdis-2018-214746.

For patients with early psoriatic arthritis, starting the tumor necrosis factor inhibitor golimumab (Simponi) at the same time as methotrexate nearly doubled the chances of remission, compared with methotrexate monotherapy, researchers reported in Annals of the Rheumatic Diseases.

In this multicenter, double-blind trial, 51 adults with CASPAR-defined psoriatic arthritis who were naive to methotrexate and biologic disease-modifying antirheumatic drugs were randomly assigned to receive monthly golimumab (50 mg subcutaneously) or placebo, in addition to methotrexate (15 mg/week, increased to 25 mg/week over 8 weeks). All patients had current active disease: At baseline, most had at least five swollen joints and at least nine tender joints.

Among 45 patients who completed the study, rates of Disease Activity Score (DAS) remission (DAS C-reactive protein score less than 1.6) at week 22 were 81% for golimumab-methotrexate and 42% for methotrexate-placebo (P = .004). “This difference in DAS remission was already observed at week 8,” wrote Leonieke J.J. van Mens, MD, of AMC/University of Amsterdam and her colleagues.

Golimumab-methotrexate also topped methotrexate monotherapy on secondary outcome measures. By week 22, median swollen joint counts were 0 with combined therapy versus 3 with methotrexate monotherapy (P = .04). Median tender joint counts were 0 and 2, respectively (P = .02). Combined golimumab-methotrexate therapy also produced significantly higher rates of low disease activity based on Disease Activity in Psoriatic Arthritis score (92% vs. 54%, respectively), Minimal Disease Activity (81% vs. 29%), and ACR20, 50, or 70 response (85% vs. 58%, 81% vs. 33%, and 58% vs. 13%, respectively).


Most differences were already statistically significant by week 8, and many were more pronounced by week 22, the researchers said. “It remains unknown if the responses – in particular the stringent responses such as remission – have already plateaued at week 22 or could even further increase over time,” they added. “Similarly, it remains to be determined if the combination of tumor necrosis factor inhibitor and methotrexate is only needed for the induction of remission or is also needed to maintain this state of remission over time.”

They explained that golimumab (or placebo) was stopped at week 22 in patients who achieved DAS CRP remission. An extension of the current study will assess whether methotrexate monotherapy can maintain responses for up to 50 weeks.

The only serious adverse event in the study occurred in the methotrexate arm and consisted of spinal stenosis that was not seen as treatment related. Rates of other adverse events were similar between arms, and those that required a dose halt or dose reduction were related to methotrexate, not golimumab. There were no deaths on trial.

Merck Sharp & Dohme provided medication and unrestricted funding for the study. Dr. van Mens and two coinvestigators reported having no disclosures. Several other coinvestigators disclosed ties to UCB, AbbVie, Novartis, Janssen, Eli Lilly, and other pharmaceutical companies.

SOURCE: van Mens LJJ et al. Ann Rheum Dis. 2019 Feb 26. doi: 10.1136/annrheumdis-2018-214746.

For patients with early psoriatic arthritis, starting the tumor necrosis factor inhibitor golimumab (Simponi) at the same time as methotrexate nearly doubled the chances of remission, compared with methotrexate monotherapy, researchers reported in Annals of the Rheumatic Diseases.

In this multicenter, double-blind trial, 51 adults with CASPAR-defined psoriatic arthritis who were naive to methotrexate and biologic disease-modifying antirheumatic drugs were randomly assigned to receive monthly golimumab (50 mg subcutaneously) or placebo, in addition to methotrexate (15 mg/week, increased to 25 mg/week over 8 weeks). All patients had current active disease: At baseline, most had at least five swollen joints and at least nine tender joints.

Among 45 patients who completed the study, rates of Disease Activity Score (DAS) remission (DAS C-reactive protein score less than 1.6) at week 22 were 81% for golimumab-methotrexate and 42% for methotrexate-placebo (P = .004). “This difference in DAS remission was already observed at week 8,” wrote Leonieke J.J. van Mens, MD, of AMC/University of Amsterdam and her colleagues.

Golimumab-methotrexate also topped methotrexate monotherapy on secondary outcome measures. By week 22, median swollen joint counts were 0 with combined therapy versus 3 with methotrexate monotherapy (P = .04). Median tender joint counts were 0 and 2, respectively (P = .02). Combined golimumab-methotrexate therapy also produced significantly higher rates of low disease activity based on Disease Activity in Psoriatic Arthritis score (92% vs. 54%, respectively), Minimal Disease Activity (81% vs. 29%), and ACR20, 50, or 70 response (85% vs. 58%, 81% vs. 33%, and 58% vs. 13%, respectively).


Most differences were already statistically significant by week 8, and many were more pronounced by week 22, the researchers said. “It remains unknown if the responses – in particular the stringent responses such as remission – have already plateaued at week 22 or could even further increase over time,” they added. “Similarly, it remains to be determined if the combination of tumor necrosis factor inhibitor and methotrexate is only needed for the induction of remission or is also needed to maintain this state of remission over time.”

They explained that golimumab (or placebo) was stopped at week 22 in patients who achieved DAS CRP remission. An extension of the current study will assess whether methotrexate monotherapy can maintain responses for up to 50 weeks.

The only serious adverse event in the study occurred in the methotrexate arm and consisted of spinal stenosis that was not seen as treatment related. Rates of other adverse events were similar between arms, and those that required a dose halt or dose reduction were related to methotrexate, not golimumab. There were no deaths on trial.

Merck Sharp & Dohme provided medication and unrestricted funding for the study. Dr. van Mens and two coinvestigators reported having no disclosures. Several other coinvestigators disclosed ties to UCB, AbbVie, Novartis, Janssen, Eli Lilly, and other pharmaceutical companies.

SOURCE: van Mens LJJ et al. Ann Rheum Dis. 2019 Feb 26. doi: 10.1136/annrheumdis-2018-214746.