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The Digest

Pharma news roundup and Larvol updates

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Month: June 2019

Weekly Top News – Psoriasis – June 3, 2019

June 3, 2019

Cosentyx (secukinumab) / Novartis
SUBCUTANEOUS SECUKINUMAB 300MG AND 150MG PROVIDES SUSTAINED INHIBITION OF RADIOGRAPHIC PROGRESSION IN PSORIATIC ARTHRITIS OVER 2 YEARS: RESULTS FROM THE PHASE 3 FUTURE-5 TRIAL (EULAR 2019) – May 27, 2019 – Abstract #LB0006; Pres time: Jun 15, 2019; 08:18 AM – 08:24 AM; Location: Hall 7B; “Subcutaneous secukinumab provided sustained inhibition of radiographic progression and sustained clinical responses through 2 years of treatment in pts with active PsA.”

 

Taltz (ixekizumab) / Eli Lilly
EFFICACY OF IXEKIZUMAB IN ACTIVE PSORIATIC ARTHRITIS (PSA) PATIENTS WITH AXIAL PAIN STARTING BEFORE AGE 45: A SUBGROUP ANALYSIS OF SPIRIT-P1 AND SPIRIT-P2 PHASE 3 CLINICAL TRIALS (EULAR 2019) – May 27, 2019 – Abstract #AB0744; P3; “Ixekizumab treatment yielded significantly higher improvements than placebo in axial pain, fatigue, stiffness, and physical function at Weeks 16 and 24 in the integrated PsA subpopulation self-reporting axial pain at baseline. These analyses were limited by a lack of baseline axial imaging.”

 

Halimatoz (adalimumab biosimilar) / Novartis
EFFICACY, SAFETY, AND IMMUNOGENICITY RESULTS OF THE SWITCH FROM REFERENCE ADALIMUMAB (REFADL) TO SANDOZ BIOSIMILAR ADALIMUMAB (GP2017, SDZ-ADL) FROM ADMYRA PHASE 3 STUDY IN PATIENTS WITH MODERATE-TO-SEVERE RHEUMATOID ARTHRITIS (RA) (EULAR 2019) – May 27, 2019 – Abstract #FRI0087; Pres time: Jun 14, 2019; P3; “ADMYRA was a Phase 3 study comparing efficacy and safety of SDZ-ADL and refADL in patients with moderate-to-severe RA with inadequate response to disease modifying anti-rheumatic drugs, including methotrexate (NCT02744755). After the switch from reference to biosimilar, the rates of EULAR remission/response and Boolean remission were high and maintained until Week 48. Treatment switch from refADL to SDZ-ADL at Wk 24 did not impact efficacy, safety, or immunogenicity.”

 

Cosentyx (secukinumab) / Novartis
SECUKINUMAB PROVIDES SUSTAINED IMPROVEMENTS IN THE SIGNS AND SYMPTOMS IN PSORIATIC ARTHRITIS: FINAL 5 YEAR EFFICACY AND SAFETY RESULTS FROM A PHASE 3 TRIAL (EULAR 2019) – May 27, 2019 – Abstract #FRI0451; Pres time: Jun 14, 2019; P3; “SEC provided sustained improvements in the signs and symptoms in the major clinical domains of PsA through 5 years. SEC was well tolerated with a safety profile consistent with that previously reported.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE, PHASE 2B STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF TILDRAKIZUMAB, A HIGH-AFFINITY ANTI-INTERLEUKIN-23P19 MONOCLONAL ANTIBODY, IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (EULAR 2019)- May 27, 2019 – Abstract #LB0002; Pres time: Jun 12, 2019; 05:35 PM – 05:45 PM; Location: Hall 6; P2b; “Stable concomitant methotrexate or leflunomide use was permitted but not mandated. By week 24, TIL was significantly more efficacious than PBO in treatment of joint and skin manifestations of PsA. Furthermore, there was a clear separation between TIL and PBO as early as 8 weeks for ACR20 (TIL 200 mg Q4W and 100 mg) and 12 weeks for ACR50 (all TIL groups). Shortening the dosing interval from Q12W to Q4W for the 200-mg dose did not result in a measurable increase in skin or joint response scores.”

 

Humira (adalimumab) / Eisai, AbbVie; Taltz (ixekizumab) / Eli Lilly
MULTICENTRE, RANDOMISED, OPEN-LABEL, ASSESSOR-BLINDED, PARALLEL-GROUP HEAD-TO-HEAD COMPARISON OF THE EFFICACY AND SAFETY OF IXEKIZUMAB VERSUS ADALIMUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS NAIVE TO BIOLOGIC DISEASE-MODIFYING ANTI-RHEUMATIC (EULAR 2019)- May 27, 2019 – Abstract #LB0005; Pres time: Jun 15, 2019; 08:12 AM – 08:18 AM; Location: Hall 7B; P4; “In bDMARD naive pts with active PsA and skin disease, IXE showed superior efficacy to ADA based on simultaneous achievement of ACR50 and PASI100 responses at wk 24. Greater improvements with IXE vs ADA were also attained in individual PsA domains and composite T2T outcomes.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
ANVISA approves Skyrizi (risanquizumab) for the treatment of moderate to severe plaque psoriasis [Google translation] (PRNewswire) – May 28, 2019 – “Abbvie…today announced that ANVISA approved SKYRIZI ® (risanquizumabe) for the treatment of psoriasis in moderate to severe plaque in patients adults who are candidates for phototherapy or systemic treatment….The approval was published in the Official Gazette of the Union on May 27, 2019.”

 

Tremfya (guselkumab) / J&J
Janssen announces Health Canada approval of Tremfya One-Press (guselkumab) – A patient-controlled injector for adults with moderate-to-severe plaque psoriasis(Canada Newswire) – May 29, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Health Canada has approved TREMFYA ONE-PRESS, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.”

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
INTEGRATED SAFETY ANALYSIS ACROSS PHASE 3 CLINICAL STUDIES INCLUDING THE CONTROLLED AND UNCONTROLLED PERIODS FOR INTRAVENOUS GOLIMUMAB IN RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AND ANKYLOSING SPONDYLITIS (EULAR 2019) – May 27, 2019 – Abstract #AB0385; “The proportion of IV GLM and PBO pts with post-baseline ALT elevations ≥5X ULN was 2.1% vs 0% with methotrexate and 0.7% vs 1.4% without methotrexate use at baseline, respectively. IV GLM demonstrated a consistent safety profile across indications in the PBO-controlled (up to WK 24) and uncontrolled study periods. Similar to WK 24 (1), more safety events occurred in RA pts, who represented the largest study population with older pts, longer disease duration, and more concomitant medication use.”

 

Orencia (abatacept) / BMS
SAFETY OF ABATACEPT TREATMENT OVER 2 YEARS IN A PHASE III ACTIVE PSORIATIC ARTHRITIS RANDOMIZED TRIAL (ASTRAEA) (EULAR 2019) – May 27, 2019 – Abstract #AB0763; P3; “Abatacept was well tolerated up to 2 years with no new safety signals during the LTE in this Phase III study in PsA. There was no impact of concomitant MTX use or prior TNFi exposure on the safety profile of abatacept. The occurrence of anti-abatacept antibodies had no impact on abatacept efficacy or safety.”

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Weekly Top News – IBD – June 3, 2019

June 3, 2019

Cosentyx (secukinumab) / Novartis
LONG-TERM EVALUATION OF SECUKINUMAB 150 MG IN ANKYLOSING SPONDYLITIS: 5-YEAR END-OF-STUDY EFFICACY AND SAFETY RESULTS FROM A PHASE 3 TRIAL (EULAR 2019) – May 27, 2019 – Abstract #FRI0379; Pres time: Jun 14, 2019; 01:00 PM – 01:10 PM; Location: Poster area (Hall 10); P3; “Secukinumab 150 mg provided sustained improvement in the signs, symptoms, and physical function in pts with AS through 5 years of treatment. The safety profile of secukinumab remained consistent with previous reports. 1–3”

 

Cosentyx (secukinumab) / Novartis
SECUKINUMAB PROVIDES SUSTAINED IMPROVEMENTS IN THE SIGNS AND SYMPTOMS IN PSORIATIC ARTHRITIS: FINAL 5 YEAR EFFICACY AND SAFETY RESULTS FROM A PHASE 3 TRIAL (EULAR 2019) – May 27, 2019 – Abstract #FRI0451; Pres time: Jun 14, 2019; P3; “SEC provided sustained improvements in the signs and symptoms in the major clinical domains of PsA through 5 years. SEC was well tolerated with a safety profile consistent with that previously reported.”

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Launch of Simponi subcutaneous injection 50 mg autoinjector (Mitsubishi Tanabe Press Release) – May 29, 2019 – “Mitsubishi Tanabe Pharma…announced today the launch of SIMPONI® Subcutaneous Injection 50 mg Autoinjector…in Japan.”

 

Cimzia (certolizumab pegol) / Astellas, Dermira, UCB; Humira (adalimumab) / Eisai, AbbVie
THE IMPACT OF EXTRA-ARTICULAR MANIFESTATIONS ON THE CHOICE OF TNF INHIBITOR IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS IN THE BSRBR-AS REGISTER (EULAR 2019) – May 27, 2019 – Abstract #OP0233; Pres time: Jun 14, 2019; 10:40 AM – 10:50 AM; Location: Hall 7A; ” First-line biologic data was available for 441 patients, compromising of 284 (64.4%) adalimumab (ADA), 109 (24,7%) etanercept (ETA) and 48 (10.9%) certolizumab (CZP). EAMs appear to play an important role in the choice of TNFi in axSpA. Patients with previous AAU and IBD are more likely to be prescribed ADA and less likely to receive ETA, consistent with the superior efficacy of monoclonal TNFi for these conditions. The presence or absence of EAMS did not influence the use of CZP, although small sample size might explain the lack of associations.”

 

Humira (adalimumab) / Eisai, AbbVie; Remicade (infliximab) / Mitsubishi Tanabe, J&J; Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
EXPERIENCE IN THE USUAL PRACTICE OF PATIENTS WITH BEHÇET’S DISEASE WHO ARE IN FOLLOW-UP IN THE UVEITIS UNIT OF THE DONOSTIA UNIVERSITY HOSPITAL (EULAR 2019) – May 27, 2019 – Abstract #AB0625; “The immunosuppressant’s sought were methotrexate (MTX), azathioprine (AZA), tacrolimus, sulfasalazine (SSZ), cyclosporine (CsA), leflunomide (LFN), cyclophosphamide (CFM); adalimumab (ADA); infliximab (IFX), golimumab (GLM), intravenous immunoglobulins (IVIG). We observed an improvement in VA during the follow-up of these patients compared to VA at the beginning; 70% of patients continued with immunosuppressive treatment with good control of the disease at more than 85 months of follow-up.”

 

Entyvio (vedolizumab) / Takeda
Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn’s Disease (clinicaltrials.gov) – May 31, 2019 – P3; N=215; Active, not recruiting; Sponsor: Takeda; Recruiting –> Active, not recruiting; Trial completion date: Apr 2020 –> Aug 2020; Trial primary completion date: Jan 2020 –> Apr 2020

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