Biologics

First Clinical Practice Guidelines for Sjögren's Syndrome Developed

First Clinical Practice Guidelines for Sjögren's Syndrome Developed

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A clinical expert panel from the Sjögren's Syndrome Foundation has published the first-ever clinical practice guidelines for the disease in the United States.

FDA Delays Approval of JAK Inhibitor Baricitinib

FDA Delays Approval of JAK Inhibitor Baricitinib

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After 3-month extension to review, regulator says NDA for baricitinib cannot be approved in its current form.

First Line Biologic for Psoriasis Influenced By Certain Factors

First Line Biologic for Psoriasis Influenced By Certain Factors

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Psoriatic arthritis, patient weight, registration country and more influence first-line biologic treatment selection for patients with psoriasis.

Biosimilar Confidence: Physician-Patient Communication Sets the Tone

Biosimilar Confidence: Physician-Patient Communication Sets the Tone

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Jonathan Krant, MD, FACP, confronts the issues surrounding biosimilar substitution for biologic treatments.

Second Biologic Effective in Rheumatoid Arthritis After Initial Treatment Failure

Second Biologic Effective in Rheumatoid Arthritis After Initial Treatment Failure

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Investigators conduct a systematic review to evaluate the risks and benefits of biologics as monotherapy or in combination with methotrexate in patients with rheumatoid arthritis who have not responded to previous biologic treatment.

The Handoff: Your Week in Rheumatology News - 4/7/17

The Handoff: Your Week in Rheumatology News - 4/7/17

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WCO 2017, FDA grants Rituxan Breakthrough Therapy status, and a close-up of pediatric Sjögren's syndrome highlight this week's The Handoff.

FDA Grants Breakthrough Therapy Designation to Rituxan

FDA Grants Breakthrough Therapy Designation to Rituxan

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FDA gives breakthrough therapy designation to rituxan for treatment of pemphigus vulgaris and is indicated for treating rheumatoid arthritis

Etanercept May Increase Risk of Anterior Uveitis in Ankylosing Spondylitis

Etanercept May Increase Risk of Anterior Uveitis in Ankylosing Spondylitis

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Researchers examined whether different TNF inhibitors were associated with different rates of anterior uveitis in patients with ankylosing spondylitis undergoing treatment with adalimumab, etanercept, or infliximab.

Tocilizumab Highly Effective in Refractory Juvenile Idiopathic Arthritis-associated Uveitis

Tocilizumab Highly Effective in Refractory Juvenile Idiopathic Arthritis-associated Uveitis

Tocilizumab therapy showed rapid improvement in ocular parameters for uveitis in juvenile idiopathic arthritis patients.

Sirukumab Rapidly Improves Rheumatoid Arthritis Symptoms in Difficult-to-Treat Patients

Sirukumab Rapidly Improves Rheumatoid Arthritis Symptoms in Difficult-to-Treat Patients

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Study examined patients with active rheumatoid arthritis who failed to derive benefit from or were intolerant to TNF-inhibitor therapy.

The Handoff: Your Week in Rheumatology News - 3/3/17

The Handoff: Your Week in Rheumatology News - 3/3/17

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Connecticut considers rheumatoid arthritis and fibromyalgia for medical marijuana treatment, while Lyme disease-carrying deer ticks continue to invade Michigan. All this and more in this week's edition.

Baricitinib Superior to Adalimumab for Rheumatoid Arthritis Treatment

Baricitinib Superior to Adalimumab for Rheumatoid Arthritis Treatment

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Phase 3 trial in patients taking baricitinib, adalimumab, or placebo in addition to methotrexate background therapy.

Psoriasis Treatment Negatively Impacted By Interrupted Ixekizumab Therapy

Psoriasis Treatment Negatively Impacted By Interrupted Ixekizumab Therapy

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Most patients with psoriasis who were withdrawn from ixekizumab therapy experienced disease relapse.

Short-Course Tocilizumab for Rheumatoid Arthritis May Increase HBV Reactivation

Short-Course Tocilizumab for Rheumatoid Arthritis May Increase HBV Reactivation

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Prospective observational study yields patients with hepatitis B reactivation, but all were asymptomatic.

Predicting Lowest Effective Dose For Biologics in Rheumatoid Arthritis Treatment

Predicting Lowest Effective Dose For Biologics in Rheumatoid Arthritis Treatment

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Study finds weak evidence for using biomarkers as a guide to tapering or discontinuing biologic therapy in patients with rheumatoid arthritis.

Clinical Outcomes With Rituximab Retreatment in Rheumatoid Arthritis

Clinical Outcomes With Rituximab Retreatment in Rheumatoid Arthritis

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Rituximab significantly reduces mean DAS28 scores in patients with rheumatoid arthritis after retreatment cycles.

FDA Provides Final Recommendations For Naming of Biologics

FDA Provides Final Recommendations For Naming of Biologics

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Regulator advises use of unique suffix system to identify each biological product and biosimilars.

FDA Gives Tocilizumab Priority Review Status for Giant Cell Arteritis

FDA Gives Tocilizumab Priority Review Status for Giant Cell Arteritis

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FDA will fast track review of nonsteroidal treatment option for giant cell arteritis.

Early Biologic Therapy for Rheumatoid Arthritis Improves Ability to Work

Early Biologic Therapy for Rheumatoid Arthritis Improves Ability to Work

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The likelihood of regaining ability to work was studied in patients with rheumatoid arthritis who initiated anti-tumor necrosis factor therapy within 5 years.

Biologic Therapy in Rheumatoid Arthritis Yields Mixed Results for Comorbid Conditions

Biologic Therapy in Rheumatoid Arthritis Yields Mixed Results for Comorbid Conditions

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Data show biologics may help with comorbid cardiovascular disease conditions, but more studies are needed regarding their impact on depression, gastrointestinal disease, and osteoporosis.

Applicability of Randomized Controlled Trials in RA Clinical Practice

Applicability of Randomized Controlled Trials in RA Clinical Practice

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High exclusion rates were associated with RCTs conducted over short periods of time, resulting in necessary caution when applying study results to daily clinical practice.

Methotrexate Use in RA Suboptimal Prior to Biologic Therapy

Methotrexate Use in RA Suboptimal Prior to Biologic Therapy

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Data from a recent study show under-utilization of MTX before initiating biologic therapies in patients with RA.

FDA: Biologics Application for Subcutaneous Rituximab Accepted

FDA: Biologics Application for Subcutaneous Rituximab Accepted

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The US Food and Drug Administration (FDA) has accepted Genentech's Biologics License Application for a subcutaneous formulation of rituximab.

VIDEO: Biosimilar Insurance Coverage and Therapeutic Substitution

VIDEO: Biosimilar Insurance Coverage and Therapeutic Substitution

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This video discusses issues related to insurance coverage and therapeutic substitution of biologic biosimilars.

Real World Incidence Rates of Lower GI Perforations With TCZ for RA

Real World Incidence Rates of Lower GI Perforations With TCZ for RA

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Data from a large German cohort found a greater risk for lower intestinal perforation with tocilizumab as compared with conventional synthetic disease-modifying antirheumatic drug therapy for rheumatoid arthritis (RA).

Complications of Biologic Response Modifier Use in Pediatric Patients

Complications of Biologic Response Modifier Use in Pediatric Patients

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A recent clinical report published in Pediatrics confirms the real-world increased risk of infectious complications associated with biologic response modifiers.

Secukinumab Efficacy in TNFi-Naïve & Exposed PsA Patients Compared

Secukinumab Efficacy in TNFi-Naïve & Exposed PsA Patients Compared

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Post-hoc analysis of the FUTURE-2 trial was performed to assess if there was a differential treatment responses to secukinumab in TNFi-exposed or naïve patients with active psoriatic arthritis.

Similar Improvements in Etanercept-Treated PsA With or Without Methotrexate

Similar Improvements in Etanercept-Treated PsA With or Without Methotrexate

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Results of 2 clinical trials suggest that etanercept monotherapy and etanercept-methotrexate combination therapy may confer similar benefits in the treatment of psoriatic arthritis.

FDA Releases Briefing Report on Infliximab Biosimilar

FDA Releases Briefing Report on Infliximab Biosimilar

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CT-P13 is highly similar to infliximab (Remicade), with no noted clinical differences in safety, purity, or potency.

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