Spondylometaphyseal Dysplasia, Axial

Congress of Neurological Surgeons Presentation Recommends Vx® Therapy as a Groundbreaking Alternative to Opioids in Pain Management WASHINGTON--(BUSINESS WIRE)-- A breakthrough study presented today at the annual meeting of the Congress of Neurological Surgeons found that a combination of remote cognitive behavioral therapy with in-home virtual reality sessions, Vx® Therapy, is effective in reducing pain and behavioral health conditions in patients with chronic cervical and lumbar pain. For the first time ever, physicians and surgeons have a tool to help treat patients without the need for dangerous opioids or additional procedures. “Back and neck pain is often treated with potentially addictive pain medications and even surgery,” said Matt McGirt, M.D., the presenter and author of the study. Dr. McGirt is a practicing neurosurgeon and partner at the Carolina Neurosurgery & Spine Associates of Charlotte, the largest neurosurgery practice in the U.S. He is also co-founder of the American Spine Registry, the largest shared data-collection platform for spine outcomes. “This study shows that there is a less dangerous and highly effective alternative. The non-invasive, non-pharmacological nature of Vx® Therapy makes it an ideal option for pain management in the post-opioid epidemic era. This is truly a breakthrough in safely alleviating the pain and suffering of millions of Americans,” stated Dr. McGirt. While cognitive behavioral therapy (CBT) has been proven effective for chronic pain and associated anxiety, depression, and physical disability, many patients cannot access this therapy because of a shortage of trained care providers, lack of adequate transportation for in-person encounters, and inconsistent engagement in the therapy. Vx® Therapy, developed by Harvard MedTech, overcomes these barriers by offering therapy remotely along with an in-home virtual reality program that is guided by a behavioral health clinician. “As a practicing neurosurgeon, it is groundbreaking to have something to address pain that treats the entire patient, not just the symptoms of pain,” said Nicholas Theodore, M.D., co-author of the study, practicing neurosurgeon and Professor of Neurosurgery at Johns Hopkins University. “Vx Therapy is able to effectively address pain and the associated psychological sequalae that have historically been ignored by traditional biomedical healthcare models and support patients in a very wholistic manner.” “This is the first commercially available VR product designed specifically to treat acute and chronic pain with scientific data to support those outcomes,” noted Dr. McGirt. “This marks the beginning of a new era in healthcare as we have been waiting for a technology that is programmatically created to achieve results like this. Harvard MedTech has created a platform that serves our needs as neurosurgeons, but more importantly addresses an unmet need for our patients.” In the study, 145 workers’ compensation patients with chronic degenerative neck/back pain participated in a guided 14-week virtual reality and cognitive behavioral therapy program, Vx® Therapy. The treatment consisted of weekly telephone calls with trained therapists and 50 modules of virtual reality therapy. Patients recorded pain, anxiety, and severity scores before and immediately after the sessions, along with the time that pain began to recur. Measures recorded included daily pain intensity, pain behavior, pain interference, anxiety, and depression. After 14 weeks, results showed that the therapy acutely reduced pain during use by an average of 33 percent, lasting for an average of 2.8 hours after use. Anxiety was reduced by 46%. “Patients’ pain levels were cut in half with this treatment, and this relief lasted up to four hours after the session. These results are what we see when a person takes a four-hour opioid tablet, but without the side effects and without the danger of addiction,” noted Dr. McGirt. “We are also seeing that the person’s ability to function increases during the 14-week treatment. These findings have tremendous implications for how we treat pain in a rapidly aging population. Now we have a proven solution that is effective, highly scalable, and conveniently delivered in a home setting.” Other authors of the study are: Christopher M. Holland, MD, PhD, Carolina Neurosurgery & Spine Associates, Atrium-Wake Forest University S. Harrison Farber, MD, Department of Neurosurgery, Barrow Neurological Institute, St. Joseph’s Hospital and Medical Center Scott L. Zuckerman, MD, MPH, Department of Neurosurgery, Vanderbilt University Michael S. Spertus, MD, Whole Health in Pain Medicine, Miami Veterans Affairs Health System Nicholas Theodore, MD, Department of Neurosurgery, Johns Hopkins University Deborah Pfortmiller, PhD, Carolina Neurosurgery & Spine Associates, Atrium-Wake Forest University Gerry Stanley, MD, Harvard MedTech Other studies presented at the conference on related subjects found that: “In-home Virtual Reality Guided by Remote Cognitive Behavioural Therapists (Vx therapy TM) Reduces Pain, Anxiety, And Depression in Patients with Orthopedic Upper Extremity, Lower Extremity, Spinal”: Vx® Therapy provided sustained relief for both acute and chronic orthopedic multisystem pain, regardless of pain duration. It also reduced anxiety, depression, and pain interference with physical and recreational activities. “Effect of workers’ compensation status on pain, disability, quality of life, and return to work after anterior cervical discectomy and fusion: a 1-year propensity score–matched analysis”: Workers’ compensation patients fared worse than other patients in treatment outcomes. Workers’ compensation status was associated with greater one-year residual disability and axial pain along with delayed return to work, without any difference in quality of life despite having fewer comorbidities and being a younger population. Workers’ compensation status was also associated with significantly greater residual disability and pain post-operatively, a lower quality of life, and delayed return to work. “Mental Health Comorbidities in Workers’ Compensation Patients and the Effect on Pain, Disability, Quality of Life, and Return to Work After Lumbar Spine Surgery”: Workers’ Disparities in outcomes after lumbar spine surgery in workers’ compensation patients are exacerbated in patients with anxiety and depression. Those with mental health comorbidities receive the least benefit from lumbar spine surgery and may represent the most vulnerable subset of patients with spinal pathology. About Harvard MedTech Harvard MedTech is an innovative digital health company that applies current science on how the brain works with specially designed virtual reality experiences, psychosocial support, and digital engagement. Vx® Therapy is the first modality to comprehensively integrate this unique combination of digital technologies with behavioral health interventions, delivered through virtual reality in the patient’s home. This virtual engagement drives high compliance, patient satisfaction, and optimal outcomes. Vx® Therapy is also affordable and scalable at a population health level. This non-invasive and non-pharmacological approach also provides data that is trackable for a clear assessment of its value to patients and healthcare providers. Visit for more information.

The inflammatory bowel disorder Crohn’s disease can be treated by several different biologic drugs administered as injections or infusions. The FDA just approved the first daily pill for the chronic condition. Rinvoq, a blockbuster AbbVie drug already approved for multiple autoimmune and inflammatory disorders, is now approved as a treatment for moderately to severely active Crohn’s disease. The decision announced Thursday specifically covers the treatment of adults whose disease has not been adequately managed by tumor necrosis factors inhibitors, a class of biologic drugs currently used to treat the disorder. The AbbVie drug belongs to a class of therapies that block Janus kinases (JAKs), a family of enzymes that play key roles in signaling pathways associated with inflammation. Rinvoq won its first FDA approval in 2019 for the treatment of moderate-to-severe rheumatoid arthritis. Crohn’s disease is a chronic inflammatory bowel condition that causes inflammation in the digestive tract. While the location and severity of this intestinal inflammation varies, common symptoms include diarrhea, cramps and stomach pain, and weight loss. FDA approval of Rinvoq for Crohn’s disease is based on the results of two clinical trials that enrolled 857 patients total. Those participants were randomly assigned at a 2:1 ratio to receive the AbbVie drug or a placebo once a day for 12 weeks. The main goal was to show clinical remission, which was measured according to a scale used to assess the severity of Crohn’s disease symptoms. Results showed that at week 12, a greater proportion of those who received Rinvoq achieved clinical remission compared to those in the placebo group. Also, a greater proportion of patients who received the AbbVie drug showed improvement in intestinal inflammation as assessed by a colonoscopy. In yet another Phase 3 study, Rinvoq was assessed as a maintenance treatment for Crohn’s disease. Study participants were again randomly assigned to receive one of two doses of Rinvoq or a placebo for 52 weeks. At week 52, the results showed a greater proportion of those who received the AbbVie drug achieved clinical remission compared to who received a placebo. The most common side effects reported from the Crohn’s disease studies included upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache. The drug’s label still carries a black box warning that cautions physicians and patients about the risk that those who use JAK inhibitors have higher rates of cardiovascular complications and cancer. That warning also covers other JAK-blocking drugs following greater FDA scrutiny on the potentially fatal adverse effects associated with the drug class. For those taking Rinvoq for Crohn’s disease, the FDA said the drug is not recommended for use in combination with other JAK inhibitors, nor should it be used alongside strong immune system suppressing drugs such as azathioprine and cyclosporine. FDA approval of Rinvoq for Crohn’s disease marks the drug’s second intestinal indication. Last year, the agency approved the drug for treating moderately to severely active ulcerative colitis. Crohn’s disease is Rinvoq’s seventh indication. Its approved uses include treatment of atopic dermatitis, ankylosing spondylitis, and axial sponyloarthritis. In 2022, AbbVie reported more than $2.5 billion in Rinvoq sales. “AbbVie recognizes the need for more treatment options for Crohn’s disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage,” Thomas Hudson, senior vice president of research and development and chief scientific officer at AbbVie, said in a prepared statement. “We’re pleased that Rinvoq may provide this relief and is now available to treat Crohn’s disease.” Photo by Smith Collection/Gado/Getty Images

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced a Network Meta-Analysis (NMA) comparing first-in-class interleukin (IL)-23 inhibitor TREMFYA® (guselkumab) to all advanced therapiesa approved for active psoriatic arthritis (PsA) using data from 33 Phase 3 randomized clinical trials (RCTs).1 The NMA concluded TREMFYA ranked highestb for skin clearance based on Psoriasis (PsO) Area Severity Index (PASI)c 90 response among 23 treatment regimens (15 unique treatments including IL-23 inhibitors like TREMFYA and risankizumab, subcutaneous [SC] tumor necrosis factor inhibitors [TNFi], and Janus kinase inhibitors [JAKi]).1 In terms of joint inflammation improvement, both TREMFYA dosing regimens (100 mg every four weeks [q4w] and every eight weeks [q8w])d were comparableb to most other treatments for the modified van der Heijde-Sharp (vdH-S)e score, and TREMFYA was generally comparableb to TNFi and most IL-17Ai for American College of Rheumatology (ACR) 20 response.1,f The analysis also confirmed the established safety pro TREMFYA in active PsA.1 The NMA is being presented at the Maui Dermatology 2022 Meeting taking place January 24-28, 2022. TREMFYA is U.S. Food and Drug Administration (FDA) approved for administration as a 100 mg SC injection q8w, following two initial doses at weeks 0 and 4.2,d "This comprehensive analytical approach helps to provide a useful comparative picture of available psoriatic arthritis medicines," said Philip J. Mease,g M.D., Swedish Medical Center/Providence St. Joseph Health and University of Washington in Seattle, Washington. "In my experience, thorough NMAs such as this one can help equip physicians to discuss treatment choices and therapeutic outcomes with their patients in daily practice." NMA is a structured, protocol-driven analytical process widely accepted and utilized by regulatory agencies, health technology assessment agencies and medical guideline committees to comparatively evaluate treatment options where head-to-head data are limited or unavailable.3-5 NMA is the most cited and the most comprehensive method available to compare studies indirectly; however, NMAs cannot replace and should not be considered the same as head-to-head clinical trials. In this NMA, the timing of primary endpoint assessment varied across RCTs, and placebo was used as the reference treatment throughout with the exception of two head-to-head studies.1 Baseline risk adjustment was used to account for heterogeneity across study populations. The NMA builds on previous analyses, including a 2021 publication in Rheumatology, and now incorporates all recent clinical data updates, including the COSMOS study of TREMFYA in PsA patients who had an inadequate response to TNFi, as well as data for two new comparators, the IL-23i risankizumab and the JAKi upadacitinib.1,6,7 NMA results showed:1 Skin Clearance: TREMFYA ranked first and secondb in PASI 90 response for q4wd and q8w dosing, respectively. Joint Inflammation Improvement: TREMFYA was comparable to SC TNFi and most IL-17Ai, as measured by ACR20 response. While dosing frequency impacted modified vdH-S score,e both TREMFYA dosing regimens achieved improvements that were comparable to most treatments and both doses of TREMFYA ranked more highly on vdH-S score than risankizumab and upadacitinib.b Low Numbers of Serious Adverse Events (SAEs): TREMFYA showed low rates of SAEs, with both dosing regimens ranking favorably among the 23 treatments for low rates of events. The number of SAEs for TREMFYA were consistent with the established TREMFYA safety profile.1 "Psoriatic arthritis is a complex disease, and physicians must consider many factors when making treatment decisions, including the relative efficacy of therapies in treating both skin and joints, as well as established safety," said Terence Rooney, M.D., Vice President, Rheumatology and Maternal-Fetal Immunology Disease Area Leader, Janssen Research & Development, LLC. "NMAs are a comprehensive, well-established approach, and can provide physicians with useful information on available therapies." TREMFYA was approved in the U.S. for the treatment of adult patients with moderate to severe plaque PsO in July 2017 and in July 2020 for adults with active PsA.2 The PsA approval was based on results from DISCOVER-1 and DISCOVER-2, which showed TREMFYA achieved the studies' primary endpoint of ACR20 response at 24 weeks.8,9 A comprehensive analysis of DISCOVER-2 data was recently published in Arthritis & Rheumatology, representing the final results of the first-ever two-year clinical trial with an open label extension investigating a selective IL-23 inhibitor therapy in active PsA.10 Janssen will present five additional posters at the Maui Dermatology Meeting, including the study design of APEX (NCT04882098),11 investigating the effect of TREMFYA on radiographic progression;h the design of the SOLSTICE trial (NCT04936308),12 which further evaluates TREMFYA efficacy for PsA patients with intolerance or inadequate response to TNF therapy; evidence of molecular and genetic distinctions between patients with axial PsA (axPsA) and ankylosing spondylitis and the significant pharmacodynamic effects of TREMFYA in axPsA patients; and real-world evidence for PsA patients initiating TREMFYA treatment in the CorEvitas Psoriatic Arthritis/Spondyloarthritis (PsA/SpA) Registry. Editor's Note: a. Advanced therapies were defined as any targeted or biologic therapies for the treatment of PsA including: TNFi, JAKi, IL-17Ai, IL-12/23i, IL-23i, PDE4i, CTLA-4i, biologic biosimilar agents, and placebo/no treatment.1 b. Results are summarized by ranking treatments according to findings derived from NMAs. Conclusions (i.e., comparable) are based on an overlap of pairwise 95 percent credible intervals.1 c. PASI 90 is defined as at least 90 percent improvement from baseline in the PASI score. The PASI score grades the amount of surface area on each body region that is covered by PsO plaques and the severity of plaques for their redness, thickness, and scaliness.13 PASI 90 was not a controlled endpoint in DISCOVER-1 or -2.8,9 d. TREMFYA q4w dosing is not currently FDA-approved.2 e. The PsA-modified vdH-S score combines erosion and joint space narrowing scores derived from radiographs of joints in body regions impacted by PsA.14 TREMFYA is not approved in the U.S. for inhibition of structural damage.2 f. ACR20 response is defined as both at least 20 percent improvement from baseline in the number of tender and number of swollen joints, and a 20 percent improvement from baseline in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure, visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.15 g. Dr. Mease is a paid consultant for Janssen. He has not been compensated for any media work. h. Radiographic progression is a key indicator of structural damage, which includes erosion and joint space narrowing. Radiographic progression is not in the FDA label for TREMFYA.2 About the Network Meta-Analysis1 A systematic literature review was conducted to identify randomized controlled trials up to February 2021. A hand search identified newer agents up to July 2021. These searches identified 33 Phase 3 RCTs studying 15 targeted therapies for PsA approved or under review by the U.S. FDA or the European Medicines Agency in patients who were TNFi-naïve, TNFi-experienced, had an inadequate response (IR), or mixed populations for inclusion in this NMA, through July 2021. Bayesian NMAs were performed to compare therapies on ACR20 response, PASI response, modified vdH-S score and SAEs. Analyses used random effects models wherever possible, and fixed effects models when not. Wherever possible, analyses included meta-regression on baseline risk (placebo response) in order to reduce bias. Multinomial models were used for ACR and PASI. Several NMAs have compared the efficacy of treatments available for PsA, but none of these analyses have included the latest Phase 3 data for TREMFYA in the TNFi-IR population or the latest comparators risankizumab and upadacitinib.16-19 The objective of this study was to update the prior NMAs to include these new data to determine the relative skin and joint efficacy and safety for therapies available for PsA through NMA. This NMA adheres to all governing standards and requirements as demanded by global health technology assessment agencies, journal review committees and regulatory authorities. The NMA was funded by Janssen Research & Development, LLC. About COSMOS (NCT03796858)7 COSMOS was a Phase 3b, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of TREMFYA in 285 patients with active PsA and IR to TNFi therapy. The primary endpoint was ACR20 response at week 24. Participants were randomized (2:1) to receive TREMFYA 100 mg at weeks 0, 4 and q8w thereafter, or placebo. The study included two periods: a 24-week double-blind, placebo-controlled period for the primary analysis of the efficacy and safety of TREMFYA compared with placebo and a 32-week active-treatment and safety follow-up period for additional analysis of the efficacy and safety of TREMFYA. Through week 48, non-responder imputation (NRI) rules were used for missing data (after the application of treatment failure rules [TFR]). Safety was monitored throughout the study to week 56. About DISCOVER-1 (NCT03162796)8 DISCOVER-1 was a randomized, double-blind, multicenter Phase 3 study evaluating the efficacy and safety of TREMFYA administered by SC injection in participants with active PsA, including those previously treated with one or two TNF inhibitors. DISCOVER-1 evaluated 381 participants who were treated and followed through approximately one year. The primary endpoint was response of ACR20 at week 24 and primary endpoint data were previously presented at scientific congresses and published in The Lancet. In addition to ACR20, multiple other clinical outcomes were assessed, including ACR50/70, resolution of soft tissue inflammation, enthesitis and dactylitis, improvement in physical function, skin clearance (IGA), and general health outcomes (36-Item Short-Form Health Survey [SF-36] Physical Component Summary [PCS] and Mental Component Summary [MCS]). The study consisted of a screening phase of up to six weeks, a blinded treatment phase of 52 weeks that included a placebo-controlled period from week 0 to week 24 and a blinded active treatment period from week 24 to week 52. It also included a safety follow-up phase through week 60 (i.e., approximately 12 weeks from the last administration of study agent at week 48). Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule. About DISCOVER-2 (NCT03158285)9 DISCOVER-2 is a randomized, double-blind, multicenter Phase 3 study evaluating the efficacy and safety of TREMFYA administered by SC injection in biologic-naïve patients with active PsA. DISCOVER-2 evaluated 739 participants who were treated and followed through approximately two years. The primary endpoint was response of ACR20 at week 24 and primary endpoint data were previously presented at scientific congresses and published in The Lancet. In addition to ACR20, multiple other clinical outcomes were assessed, including ACR50/70; resolution of soft tissue inflammation, enthesitis and dactylitis; improvement in physical function; skin clearance (IGA); and general health outcomes (SF-36 PCS and MCS). DISCOVER-2 also assessed changes in structural damage as a key secondary endpoint (PsA-modified vdH-S score). The study consisted of a screening phase of up to six weeks, a blinded treatment phase of approximately 100 weeks that included a placebo-controlled period from week 0 to week 24 and a blinded active treatment period from week 24 to week 100. It also included a safety follow-up phase through week 112 (i.e., approximately 12 weeks after the last administration of study agent at week 100). Clinical efficacy, radiographic efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker, and pharmacogenomics evaluations were performed in the study on a defined schedule. About Psoriatic Arthritis (PsA) PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (severe inflammation of the fingers and toes), axial disease, and the skin lesions associated with plaque PsO.20-22 In addition, in patients with PsA, comorbidities, such as obesity, cardiovascular diseases, anxiety and depression are often present.23 Studies show up to 30 percent of people with plaque PsO also develop PsA.24 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.24 Nearly half of patients with PsA experience moderate fatigue and about 30 percent suffer from severe fatigue as measured by the modified fatigue severity scale.25 Although the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in disease onset.26 About TREMFYA® (guselkumab)2 Developed by Janssen, TREMFYA is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of the pathogenesis of inflammatory diseases such as moderate to severe plaque PsO and active PsA.27 TREMFYA is approved in the U.S., Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate to severe plaque PsO who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light), and for the treatment of adult patients with active PsA. It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy. The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®. IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue or throat trouble breathing or throat tightness chest tightness skin rash, hives itching Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills muscle aches weight loss cough warm, red, or painful skin or sores on your body different from your psoriasis diarrhea or stomach pain shortness of breath blood in your phlegm (mucus) burning when you urinate or urinating more often than normal Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. cp-82626v3 About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. References Mease, P., et al. Comparative Effectiveness of Guselkumab in Psoriatic Arthritis: Updates to a Systematic Literature Review and Network Meta-Analysis. Presented at Maui Derm, January 24-26, 2022. Food and Drug Administration. TREMFYA® Prescribing Information. Horsham, PA. 2017. Available at: . Accessed January 2022. Dias, S., et al. Evidence Synthesis for Decision Making 2. Medical Decision Making, 2012:33(5), 607–617. Dias, S., et al. Evidence Synthesis for Decision Making 3. Medical Decision Making, 2013:33(5), 618–640. Dias, S., et al. Evidence Synthesis for Decision Making 4. Medical Decision Making, 2013:33(5), 641–656. Mease, P., et al. Comparative effectiveness of guselkumab in psoriatic arthritis: results from systematic literature review and network meta-analysis. Rheumatology (Oxford). 2021 May 14;60(5):2109-2121. Coates L, et al. Efficacy and Safety of Guselkumab in Patients With Active Psoriatic Arthritis who are Inadequate Responders to Tumor Necrosis Factor Inhibitors: Results Through One Year of a Phase 3b, Randomized, Controlled Study (COSMOS). Annals of the Rheumatic Diseases. November 2021. Deodhar, A., et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. The Lancet, 2020:395(10230), 1115–1125. (20)30265-8 Mease, P., et al Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. The Lancet, 2020:395(10230), 1126–1136. (20)30263-4 McInnes, I., et al. Long-term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin-23, Through 2 Years: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conducted in Biologic-naïve Patients with Active Psoriatic Arthritis. Arthritis & Rheumatology, November 2021. ClinicalTrials.gov. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Available at: . Accessed January 2022. ClinicalTrials.gov. Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE). Available at: . Accessed January 2022. Thompson Jr., Dennis. How the Psoriasis Area and Severity Index Works. Everyday Health. Sharp van der Heijde Score | Rheumatology. Department of Medicine Division of Rheumatology. Accessed January 2022. Felson, D. T., & LaValley, M. P. The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thing. Arthritis Research & Therapy, 2014:16(1), 101. Ruyssen-Witrand, A., et al. Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis. RMD Open, 2020:6(1), e001117. Kawalec, P., et al. Comparative effectiveness of abatacept, apremilast, secukinumab and ustekinumab treatment of psoriatic arthritis: a systematic review and network meta-analysis. Rheumatology International, 2017:38(2), 189–201. McInnes, I., et al. Secukinumab for psoriatic arthritis: comparative effectiveness versus licensed biologics/apremilast: a network meta-analysis. Journal of Comparative Effectiveness Research, 2018:7(11), 1107–1123. Lu, C., et al. Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: A systematic review and network meta-analysis. Seminars in Arthritis and Rheumatism, 2019:49(3), 381–388. Belasco, J., & Wei, N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatology and Therapy, 2019: 6(3), 305–315. Donvito T. CreakyJoints: What Is Enthesitis? The Painful Arthritis Symptom You Should Know About. Available at: . Accessed October 2021. Donvito T. CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: . Accessed October 2021. Haddad A and Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J. 2017;8(1):e0004.