DX44
Infusion-Related Reactions with Ocrelizumab: Pooled Analysis of the Open-Label Extension of the Phase III, Interferon Beta-1a-Controlled OPERA Studies

Thursday, May 25, 2017
B2 (New Orleans Convention Center)
Lori Mayer, DNP, MSN, RN , Central Texas Neurology Consultants, Multiple Sclerosis Clinic of Central Texas, Round Rock, TX
Ludwig Kappos, MD , University Hospital Basel, University of Basel, Basel, Switzerland
Michael K Racke, MD , Wexner Medical Center, Ohio State University, Columbus, OH
Kottil Rammohan, MD , University of Miami, Miami, FL
Anthony Traboulsee, MD , University of British Columbia, Vancouver, BC, Canada
Jerry S Wolinsky, MD , McGovern Medical School, UTHealth, Houston, TX
Cathy Chognot, PhD , F. Hoffmann-La Roche Ltd, Basel, Switzerland
Laura Julian, PhD , Genentech, Inc., South San Francisco, CA
Julie Napieralski, PhD , F. Hoffmann-La Roche Ltd, Basel, Switzerland
Johan van Beek, PhD , F. Hoffmann-La Roche Ltd, Basel, Switzerland
Hanzhe Zheng, PhD , Genentech, Inc., South San Francisco, CA
Stephen L Hauser, MD , University of California, San Francisco, San Francisco, CA
Lori Mayer, DNP, MSN, RN , Central Texas Neurology Consultants, Multiple Sclerosis Clinic of Central Texas, Round Rock, TX
PDF


Background: Infusion-related reaction (IRR) was the most common adverse event (AE) in the OPERA I and II studies of ocrelizumab (OCR) vs subcutaneous interferon β-1a (SC IFNβ1a) in relapsing multiple sclerosis. Events were mostly mild to moderate and more frequent with the first infusion, decreasing substantially thereafter. All patients who completed the OPERA studies were eligible to enter an OCR open-label extension (OLE) phase.

Objectives: To report IRRs in the OLE among patients switching from SC IFNβ1a to OCR and those who continued OCR treatment from the OPERA studies (pooled population).

Methods: During the OPERA studies, patients received OCR 600 mg via intravenous (IV) infusion every 24 weeks (dose 1 was administered as two 300-mg infusions on Days 1 and 15) or SC IFNβ1a 44 µg three times weekly; patients in both groups received corresponding IV or SC placebo treatments. During the OLE, patients from the SC IFNβ1a group switched to OCR; dosing in both the switch and continuous OCR groups was consistent with the controlled study procedure. Prior to each infusion, all patients were pretreated with methylprednisolone 100 mg; use of analgesics/antipyretics and antihistamines was also recommended. IRRs were defined as AEs that occurred during or within 24 hours of infusion.

Results: The OLE included 623/660 (94.4%) SC IFNβ1a-treated patients and 702/726 (96.7%) OCR-treated patients who completed the OPERA studies. Of these, 614 (98.6%) who switched from SC IFNβ-1a and 698 (99.4%) who continued OCR completed the first dual infusion in the OLE. During the initial OCR dose in OLE, 19.3% and 3.9% of SC IFNβ1a–switch patients reported IRRs with the first and second infusions, respectively. This was lower than the percentage of OCR-treated patients who reported IRRs with the first dose in the controlled studies (27.5% and 4.7%). In continuous-OCR patients, 9.4% and 2.3% reported IRRs with the first and second infusions in OLE vs 7.8% with the last dose in the controlled studies. The most frequent IRR symptoms were pruritus, rash, flushing, throat irritation and headache. Overall, 1.3% (11/825) of OCR-enrolled patients had an IRR leading to study treatment discontinuation; none were observed with the first OCR dose in the OLE.

Conclusions: In patients switching from SC IFNβ1a, the frequency of IRRs with the initial ocrelizumab dose in the OLE was highest with the first infusion and decreased with the second infusion, consistent with the controlled studies.

See more of: Disease Modifying Therapy
See more of: Poster
<< Previous Abstract | Next Abstract >>